A systematic review of photodynamic therapy in the treatment of pre-cancerous skin conditions, Barrett's oesophagus and cancers of the biliary tract, brain, head and neck, lung, oesophagus and skin

Population

The eligible populations included people with specified pre-cancerous conditions or primary cancer in the following sites:

• biliary tract

  1. – extrahepatic cholangiocarcinoma (usually adenocarcinoma)

  2. – perihilar cholangiocarcinoma

  3. – distal cholangiocarcinoma

  4. – gall bladder

  5. – ampulla

• brain

  1. – gliomas (astrocytoma, ependymoma, oligodendroglioma or mixed glioma)

  2. – any of the rarer brain cancer types, including invasive pituitary adenomas

• head and neck

  1. – laryngeal cancer

  2. – hypopharyngeal cancer

  3. – oropharyngeal cancer

  4. – oral cavity cancer

• lung

  1. – small cell, non-small cell lung cancer [squamous cell carcinoma (SCC), adenocarcinoma, large cell carcinoma]

  2. – tracheobronchial cancer was also classified as lung (based on advice from clinical advisors)

• oesophagus

  1. – Barrett’s oesophagus (a precursor to cancer)

  2. – squamous cell carcinoma, adenocarcinoma or undifferentiated cancer of the oesophagus

• skin

  1. – pre-cancerous conditions: actinic/solar keratosis, Bowen’s disease

  2. – non-melanoma skin cancers [basal cell carcinoma (BCC) (superficial and nodular), SCC, Merkel cell carcinoma, Kaposi’s sarcoma, T-cell lymphoma of skin or sarcoma].

We did not anticipate identifying any trials dealing with children as these cancers are extremely rare in such groups, but any data on children would have been included and considered separately where appropriate.

Where studies comprised populations covering more than one site of interest, these were included if the results were reported by diagnosis or where a minimum of 90% of patients was diagnosed with the same condition.

Intervention

Photodynamic therapy for either curative or palliative treatment The specific interventional details varied according to cancer site. There are a number of variations possible in the application of PDT, for example the type of photosensitising agent, the method of light delivery, wavelength and duration of light used. We have not restricted our review according to the details of the PDT treatment, but have extracted and reported data on agent, light source, wattage, light intensity, duration, number of treatment sessions and wavelength. Studies of prophylactic PDT alone were excluded; data relating to prophylactic PDT were not extracted when both treatment and prophylaxis were reported.

Comparators

No restrictions were placed on the inclusion criteria for comparators. The relevant comparators varied according to the cancer site. Studies comparing differing application of PDT treatments (e.g. photosensitising agents; source, duration, or wavelength of light) were also included.

Outcomes

Studies were included provided that they reported at least one relevant outcome. The primary outcomes the review focused on are listed below. These were addressed individually by site, where appropriate, due to differences in the specific outcome measures. Outcomes also reflected the curative or palliative nature of the intervention.

• mortality

• morbidity (symptom burden, symptom improvement, time to healing)

• quality of life (QoL) (patient-based outcomes, such as cosmetic appearance, QoL or depression scores)

• adverse events (AEs) (e.g. photosensitivity of skin in general, ulceration of the underlying tissues, haemoptysis, scarring, carcinogenicity, oesophageal strictures, cardiac complications, nausea, inflammation, pain, constipation)

• resource use (e.g. length of hospital stay)

• return to normal activities.

We also extracted data on recurrence and tumour response measures (such as tumour or lesion clearance or response), while bearing in mind the extent to which these outcomes relate to symptomatic morbidity and patient-perceived benefits.

Study designs

In the evaluation of effectiveness and safety of clinical procedures, RCTs are normally seen as providing a ‘gold standard’ of evidence that is less prone to bias. 22 However, such trials have not been conducted in large numbers for all of the conditions under investigation, so there was a need to consider other types of evidence. The particular study design inclusion criteria depended on the cancer site as shown below:

• Skin We anticipated sufficient RCTs and therefore restricted our attention to these.

• Barrett’s oesophagus In a change to the protocol, we restricted our attention to RCTs, as the initial screening identified a significant number of RCTs in this area.

• All other sites Given the paucity of RCTs identified in our initial scoping searches, we considered prospective experimental studies with a control group, in addition to RCTs.

Animal models, pre-clinical and biological studies, narrative reviews, editorials, opinions and reports containing no outcome data were excluded from the reviews.

Alongside the systematic review we conducted a scoping review of studies, which met all of our inclusion criteria except the study design. The aim of this scoping review was to document the extent of the observational research in those areas in which we anticipated a paucity of controlled trials (see Chapter 3, Scoping review).

Stage One

An initial sift of the records was carried out aiming to exclude any clearly irrelevant material. Records were excluded if they met any of the following criteria, i.e. the study:

• was not in human patients (could be animals or in vitro, cell cultures, etc. only)

• was not of PDT (i.e. not the use of photosensitising agents in combination with a light source)

• was of PDD without any actual therapy

• did not include patients with the identified conditions.

Stage Two

A more detailed assessment of the potentially relevant records identified in Stage One was carried out. An algorithm was used to determine which records were to be considered for inclusion (full paper obtained), which were considered for the scoping review (see Scoping review), and which should be rejected. The algorithm is described in Figure 2.

FIGURE 2.

Decision algorithm.

Stage Three

All non-rejected records from Stage Two were then imported into eppi-reviewer (systematic review software) for final assessment. 25 All references were screened and assessed, based on the complete set of inclusion criteria reported above (see Inclusion criteria). Foreign language papers were assessed by either a single reviewer who was competent in that language or an appointed external reviewer under guidance, but not checked by a second reviewer. Studies that did not fulfil all of the criteria were excluded, with documented reasons.

Data extraction

A standardised data extraction form was developed within eppi-reviewer (see Appendix 2). It was piloted by all reviewers on a selection of studies and refined to ensure consistency of data extraction between reviewers and across sites. Guidelines on its use were produced to enhance consistency.

Data from multiple publications of the same study were extracted and reported as a single study. Within the data extraction tables the term ‘linked publications’ refers to abstracts or full papers that report related information about the same patient group (see Appendices 13–21). Where publications appeared to be duplicates or linked, these were assessed independently by two reviewers.

Extraction included data on: study details (e.g. study identifier, author, year, country, setting, number of participants, and duration of follow-up), patient characteristics (e.g. age, gender, cancer site and stage), intervention (full details of photosensitising agent with dosage, light source, wavelength spectrum and method of delivery), comparator treatment (type of comparison with full details of delivery methods), and outcomes relating to effectiveness and safety as specified under Inclusion criteria, above. Attempts were made to contact authors for missing data.

Quality assessment

The quality of RCTs and non-RCTs was assessed using standard checklists, which were adapted, as necessary, to incorporate topic-specific quality issues (see Appendix 2). Quality assessment data were extracted directly into an excel spreadsheet.

PDT vs cryotherapy

Six trials compared PDT with cryotherapy, with five using MAL45,46,48,51,59 (one of which was in organ transplant recipients59), and one using ALA. 60

Morbidity

Four RCTs of MAL–PDT versus cryotherapy, in patients (other than organ transplant recipients) with mild or moderate lesions, reported lesion complete response (CR) data for the ITT populations (two at 12 weeks45,51 and two at 24 weeks46,48). Although only one study directly reported results for the ITT population, the necessary ITT data could be extracted from the other three studies. Morton et al. 48 reported CR at both 12 and 24 weeks, with the 24-week response rates being only marginally the better; this provided the basis of our justification for pooling the 12- and 24-week data. All four studies defined a complete lesion response as complete disappearance of a lesion. The individual study results have been combined into a pooled estimate and the results presented in a forest plot (Figure 6).

FIGURE 6.

Methyl aminolevulinate–photodynamic therapy versus cryotherapy.

Although the pooled result [odds ratio (OR) = 0.97; 95% confidence interval (CI) 0.64 to 1.46] indicates that there is no difference in effectiveness between the treatments, the substantial statistical heterogeneity (I² = 88%), coupled with the discernible polarity of individual study results, suggest this result may be unreliable. Two factors in particular may possibly explain the root of this variation. Firstly, the study quality of the trials was variable, with only one trial reporting the use of blinding (of outcome assessors) and reporting appropriate methods for randomisation and allocation concealment;45 the other three trials may therefore have been subject to bias. Secondly, there was variation in the cryotherapy regimens used, both within and between studies (mean freeze times ranged from 16 to 24 seconds between studies); two studies explicitly stated that individual centres could use their own preferred regimens (relevant details to clarify this information were not provided in the other two studies). 45,46 The effects of this are likely to have been exacerbated by the large numbers of recruiting sites for each trial (ranging from 9 to 25 centres). The large reported variances of freezing time means (which suggested the populations were not normally distributed) made it difficult to adequately assess the possible effect of differing freezing times (between studies). None of the studies reported median times, which could have been useful for this purpose.

Other factors may also have affected the individual study results. Although the number of lesions studied was large, the numbers of patients recruited were more modest (ranging from 119 to 202 participants), raising doubts as to whether the number of independent observations per treatment group was large enough for some trials. Additionally, trials recruiting across a large number of sites sometimes results in small numbers of participants recruited at many of the individual sites, a factor which appears to indicate reduced site performance, for example in terms of correct recruitment, or lower event rates. 62,63

The only study of PDT versus cryotherapy which used ALA as the photosensitiser utilised a standardised cryotherapy protocol (a freeze time of between 5 and 10 seconds) and reported complete clinical clearance rates at 12 weeks to be significantly better for patients treated with ALA–PDT than with cryotherapy (89% vs 77%, p = 0.007). 60 However, it should be noted that the cryotherapy freeze times used were considerably lower than for the trials comparing MAL–PDT with cryotherapy.

One RCT studied the use of MAL–PDT in organ transplant recipients. Wennberg et al. 59 evaluated MAL–PDT against investigators’ choice of other treatment, which was cryotherapy in 83% of cases. The lesion CR rate in the PDT group at 3 months was 77% compared with 74% in the control group, and recurrence rates were also similar with no statistically significant difference. The lesion response rate at 15 months was 88% in the PDT group versus 89% in the control group. Although the MAL–PDT group had more favourable outcomes for hypopigmentation, they also had more AEs, such as erythema, pain and crusting (reported by 75% of patients) compared with the control group (reported by 48% of patients).

PDT vs chemotherapy creams (5-FU and imiquimod)

Three trials evaluated the use of ALA–PDT compared with 5-FU,35,47,50 although one reported just AEs as an outcome,35 and one was a three-armed trial comparing treatment with 5-FU with PDT using a blue light illuminator, and PDT using a laser. 50 Kurwa et al. 47 studied patients with a long history of AK affecting forearms and hands, and randomised (left or right) both treatments to be received in each patient. One trial was of ALA–PDT compared with imiquimod in patients with AK on the hands and forearms. 61

PDT vs PDT with placebo cream

Nine RCTs compared PDT to PDT with placebo cream, with five using MAL42,45,49,56,58 and four using ALA41,44,60 as a photosensitiser (two trials were reported in one paper). 60 One study was of organ transplant recipients. 42

Morbidity

Four RCTs of MAL–PDT versus placebo PDT, in patients (other than organ transplant recipients) with mild or moderate lesions, reported CR data (complete disappearance of the lesion) at 3 months. 45,49,56,58 Where ITT results were not explicitly reported the relevant data were extracted and the results from the individual studies have been combined and presented in a forest plot (Figure 7).

FIGURE 7.

Methyl aminolevulinate–photodynamic therapy versus placebo PDT.

The pooled result (OR = 8.05; 95% CI 5.50 to 11.79) clearly indicates that MAL–PDT is more effective than treatment with placebo cream. However, the magnitude of effect is more uncertain as there was significant heterogeneity between studies (I² = 72%). There appears to be no obvious explanation for this variation (all studies appeared to be generally well conducted, with study investigators blinded in all four trials), other than the fact that all were multicentre trials (with between 5 and 10 sites) with quite small numbers of participants (between 80 and 204), increasing the possibility that institutional differences (e.g. experience of clinicians), protocol deviations, and data from sites with few participants, could have affected the reliability of results.

The one other RCT comparing MAL–PDT with placebo was also generally well conducted, and was of organ transplant recipients with mild to moderate AK. 42 The authors reported overall lesion CR rates of 56/62 for the MAL–PDT group versus 0/67 in the placebo group (p = 0.0003).

Of the four RCTs comparing ALA–PDT with placebo PDT one did not report methods and results adequately. 41 Two of the other three trials were reported in one paper and used an incubation time of 4 hours; both reported significantly better lesion CR rates with ALA–PDT (89% vs 29%, and 82% vs 19%). 60 Fowler and Zax44 also reported lesion CR results strongly favouring ALA–PDT – in two trials with identical protocols – although the incubation times used were not stated.

PDT using different treatment parameters

Twelve RCTs evaluated the use of PDT using different treatment parameters. Five of these trials studied light sources50,53 or light doses/durations,36,38,43 and another five evaluated photosensitisers/photosensitiser doses37,40 or incubation times (duration of photosensitiser),39,55 including one which examined both doses and incubation times. 54 One compared the number of PDT sessions52 and one studied incubation times and light doses. 57

MAL–PDT vs placebo

Overall, local AEs were reported by between 85% and 98% of patients receiving active PDT and in 45–60% of patients receiving placebo PDT. 49,56,58 Where an AE had been reported by patients receiving active treatment this was judged to be mild in 32–53% of cases, moderate in 42–49% and severe in 5–33%. Between 38% and 93% of patients receiving placebo reported mild AEs, 6–8% reported moderate AEs and 0–4% reported severe AEs. Dragieva et al. 42 reported that for placebo areas discomfort was judged to be mild in all cases while for active PDT discomfort was largely mild or moderate. 42

Severe local AEs (described as causing considerable interference with daily activities, may be incapacitating or life threatening) included skin-burning sensations, pain of the skin, erythema, skin exfoliation or blisters. 49,56,58 Common local AEs occurred as detailed in Table 3. 49,56,58

Szeimies et al. 58 reported that most AEs started during illumination and in the case of skin pain or burning sensations these were transient, resolving within 1 day. Erythema tended to be more persistent (median 4 days’ duration) and was also reported after treatment in around 40% of cases.

ALA–PDT vs placebo

Fowler and Zax44 found the proportion of patients reporting some or all lesions being oedematous (35% vs 0%) or erythematous shortly after treatment (99% vs 79%), to be higher in the ALA–PDT group compared with the placebo group. All AEs resolved or improved by 4 weeks. PostPDT itching was reported by more patients receiving ALA–PDT than patients receiving placebo (26% vs 7%, respectively). Seven patients had a serious AE (SAE), but none was deemed to be related to treatment.

Hauschild et al. ,60 in trial AK03, deemed that transient skin discoloration in one patient was related to ALA–PDT treatment. The same trial also found that patients treated with ALA–PDT had more overall local reactions compared with patients on placebo when treatment was applied (mostly itching, 42% vs 13%, although the 13% placebo figure appeared to be pooled from the two trials). In trial AK04 the authors reported AE rates related to study treatment as being 3% in the ALA group versus 2% in the placebo group. 60

Jeffes et al. 41 reported no differences in hyperpigmentation between the treatment groups, but reported a figure only for the ALA–PDT group (11%).

MAL–PDT using different treatment parameters

One RCT (n = 25) compared LED versus VPL illumination and reported on pain scores assessed immediately after treatment using a visual analogue scale (VAS) scale. 38 Patients receiving VPL reported significantly lower levels of pain (4.3) than with LED illumination (6.4) (p < 0.001).

Legat et al. 36 (n = 22) compared fractionated and unfractionated illumination. Two patients terminated treatment due to extreme pain and six areas assigned to unfractionated illumination had to be treated with an alternative fractionated protocol after the patients complained of intense pain. PDT-induced pain was significantly less in the fractionated area according to VAS score (6.0) than in the unfractionated area (6.7) (p = 0.02).

Braathen et al. 54 (n = 119) compared different doses and incubation times of MAL–PDT across four groups. No SAEs related to the treatment were reported and most AEs were both mild and local in nature. Between 96% and 99% of patients in each group reported at least one treatment-related AE. Erythema was the most commonly reported AE by 32–50% across groups, with a median duration of 17 days. Skin pain lasted around 12 days and other AEs were transient (< 1 day).

Tarstedt et al. 52 (n = 211) compared single-session versus double-session MAL–PDT. Although more AEs were reported in the double-PDT group, there was no indication of cumulative local phototoxicity (76 events after first treatment, 46 after the second). Overall 40% of patients receiving single PDT and 50% receiving double PDT reported any AE. The majority of the AEs were mild to moderate intensity and lasted less than 1 day including pain. Median erythema duration was 5 days for single treatment and 2 days for double treatment.

One RCT comparing two doses of MAL cream with daylight as the illumination (n = 29) reported that, generally, patients had mild to moderate pain (mean 3.7 on the VAS scale). 40 Erythema and crusting were reported in both 8% and 16% groups but no further details were available.

An RCT of 30 patients compared daylight versus red LED illumination for MAL–PDT and reported that pain was significantly less for the daylight exposed areas during treatment, mean pain score 2 versus 6.7 for LED (p < 0.001). 53 These differences were no longer statistically significant 6 hours post treatment. In the LED group, 50% of patients required cold-water spray to control the pain and 25% needed mid-treatment breaks. Both treatment areas developed erythema and crusting.

ALA–PDT using different treatment parameters

Touma et al. ,39 after studying different ALA incubation times, only stated (in an abstract) that phototoxic reactions were well tolerated. Ericson et al. 43 found no correlation between fluence rates and pain scores. Hauschild et al. 55 reported that five patients had AEs that were considered to be related to study medication (patch ALA), which were: headache, moderate epistaxis and a mild increase in alanine transaminase. The study also found that local reactions during illumination appeared to be dose dependent (26% in the 0.5-hour incubation group vs 66% in the 4-hour group), and that almost all patients had local reactions after treatment. Patients with clearance experienced local reactions to a greater extent than patients without clearance.

MAL–PDT vs cryotherapy

No systemic AEs were reported by any trial. Overall levels of AE in the PDT groups ranged from 43% to 75%, and 26–72% for cryotherapy. The majority of all reported AEs were recorded as mild/moderate and were transient in nature. Only one trial46 reported any SAEs – two cases of severe cold exposure injury in the cryotherapy arm.

One trial48 reported skin discomfort after the first treatment session using a VAS scale and found no significant differences between PDT (5.2) and cryotherapy (4.9) (p = 0.24). However, data from Wennberg et al. 59 showed that 6% of patients receiving PDT discontinued treatment due to pain despite fans and cold water sprays being used, and most reports of pain were of moderate intensity.

All trials reported that common AEs included skin pain/discomfort, erythema, blistering and crusting. Szeimies et al. 51 presented percentages of these AEs by treatment group as follows: burning sensation (PDT 32%, cryotherapy 9%), skin pain (PDT 10%, cryotherapy 13%) and crusting (PDT 5%, cryotherapy 6%).

ALA–PDT vs cryotherapy

Hauschild et al. ,60 in trial AK04, reported AEs related to study treatment as being at 3% in both the ALA–PDT and cryotherapy groups.

ALA–PDT vs chemotherapy creams (5-FU and imiquimod)

Gupta,35 in an abstract, reported only that after 1 week patients receiving ALA–PDT showed few signs of irritation (e.g. erythema), but patients treated with 5-FU exhibited moderate to severe erythema. Kurwa et al. 47 found that in the first week after treatment the ALA–PDT sites were significantly more painful than the 5-FU sites, but the difference was absent in week 2, and was reversed in week 4; overall there was no significant difference between the groups. A very similar pattern of results was reported for level of erythema. One patient experienced contact sensitivity to 5-FU.

Smith et al. 50 found erythema to be the most pronounced AE, with patients receiving 5-FU having the largest average increase. Crusting was only seen in the 5-FU group.

In the imiquimod study reactions to both treatments were reported as being well-tolerated, with erythema being very common in both groups. All patients experienced burning and pain after PDT, compared to 11% (burning) and 4% (pain) after treatment with imiquimod. 61

MAL–PDT vs ALA–PDT

Moloney and Collins,37 in a split-scalp study of 16 patients, reported statistically significant greater pain at 3, 6, 12 and 16 minutes, and longer duration of discomfort post treatment, on the side treated with ALA–PDT (although ALA was applied for a longer incubation period).

PDT vs cryotherapy

Two trials by Morton et al. 71,73 compared PDT with cryotherapy. One of the trials also compared PDT with placebo PDT and 5-FU and is further discussed below. 73 The larger trial used MAL–PDT,73 whereas the smaller one used ALA as a photosensitiser. 71

PDT vs 5-FU

Two trials compared PDT with 5-FU. 72,73 The larger trial by Morton et al. ,73 described above, used MAL–PDT, whereas the smaller one by Salim et al. 72 used ALA as a photosensitiser.

PDT with different treatment parameters

Different methods of delivering PDT were explored in four trials. 57,68–70 All four trials were small. One trial had a patient population of patients with various non-melanoma skin cancers in addition to a very small number with Bowen’s disease. This trial did not present all results by diagnosis and is not discussed here. 68 One trial had a sample with either AK or Bowen’s disease, again not presenting all results by diagnosis. 57 Three trials used ALA as a sensitiser but one evaluated red versus green light,70 whereas the other two considered the relative benefits of single and twofold illumination. 57,69

ALA–PDT

In one trial comparing single with twofold illumination, no SAEs were observed in either group. 69

In the trial by Morton et al. 71 comparing PDT with cryotherapy, PDT resulted in statistically significantly less pain during treatment (p = 0.01). Six patients in this trial who received both treatments reported PDT as less painful. The trial by Salim et al. 72 found that in a comparison of intensity and duration of pain, more pain was experienced in the 5-FU group than in the PDT group (p = 0.01). However, comparison of total pain over time resulted in no statistically significant difference in the median pain scores between the two treatment groups. In the trial by de Haas et al. ,69 pain during treatment was experienced by five patients in the twofold-illumination group and by none of the patients in the single-illumination group. In the trial by Morton et al. 70 comparing red and green light, no significant difference in pain was observed between the treatment groups.

Morton et al. 71 found that there were no instances of blistering and infection in the PDT groups in a trial comparing PDT with cryotherapy. In the trial by Morton et al. 70 of red and green light, no ulceration or infection was reported in either of the red- or green-light treatment groups. In the trial by Salim et al. ,72 no patients in the PDT group experienced ulceration of the lesions and there was no clinically obvious scar formation at 12 months at any PDT treatment site.

No photosensitivity reactions were found in either group in the trial comparing red and green light,70 and in the trial comparing PDT with cryotherapy. 71

MAL–PDT

In the trial by Morton et al. ,73 most treatment-related AEs were mild (60%) or moderate (34%). Severe AEs were noted in 6% of patients treated with PDT and 12% of patients undergoing cryotherapy. SAEs were reported in four PDT patients, two placebo patients and three cryotherapy patients, of which only one event in the cryotherapy group, and none of the others, were considered to be treatment related. At 24 months, AEs were said to be of a shorter duration than with other treatments (no data provided).

PDT vs cryotherapy

One RCT by Basset-Seguin et al. 79 compared MAL–PDT with double-freeze thaw cryotherapy with long-term follow-up. Data were reported at 3 months (n = 115 patients), 12 months (105 patients), 36 months (n = 107 patients) and 5 years.

PDT vs surgery

One RCT by Szeimies et al. 80 compared MAL–PDT with surgical excision (n = 196) and reported results from 12 months of follow-up.

PDT with different treatment parameters

MAL–PDT vs placebo PDT

Two RCTs compared MAL–PDT versus placebo PDT (n = 131 patients). 77,78 Both trials used surface debridement prior to application of MAL or placebo creams and treatment was repeated after 7 days in both studies. Insufficient details regarding the intervention parameters were reported to establish if the treatment was similar. Follow-up appeared to last around 6 months.

PDT vs excision surgery

Three RCTs compared PDT with excision surgery; the first87 looked at ALA–PDT versus surgery (n = 31 patients, 40 lesions); the second86 compared fractionated ALA–PDT with surgery (n = 149 patients, 173 lesions) and the third85 compared MAL–PDT versus surgery (n = 103 patients, 118 lesions). In all trials the lesion was prepared using superficial curettage before application of the photosensitiser in the PDT groups. It was not clear if patients received either one or two cycles of PDT. Each trial used illumination appropriate to the photosensitiser.

ALA–PDT vs MAL–PDT

One RCT84 compared ALA versus MAL–PDT (n = 39 patients, 43 lesions). This study used superficial curettage plus anaesthetic spray prior to application of the photosensitiser. The follow-up lasted 8 weeks.

PDT vs APC

Four trials compared PDT to APC. 97,98,100,101 Three trials used ALA as a photosensitiser and one used Ps. 100 One trial was of patients without dysplasia,98 one without or with LGD,97 one was LGD or HGD,100 and one was not stated. 101

PDT plus omeprazole vs omeprazole alone

One trial compared PDT with Ps plus omeprazole (PHOPDT) versus omeprazole alone (OM). 99 This was the largest trial for Barrett’s oesophagus (208 patients), although the 3- to 5-year follow-up phase of the trial had just 61 participants. All patients had HGD. The results of this multicentre trial were considered to be reliable but an unknown factor is the influence of any between-centre differences on the results found.

PDT vs placebo

Two trials compared PDT with placebo,95,96 one of which was reported as abstract only and did not provide any effectiveness outcomes and is therefore not discussed here. 96

ALA–PDT vs PDT with Ps

One trial compared ALA–PDT to Ps in patients with HGD but was reported in abstract only. 104 The trial reported preliminary data only, as recruitment is not yet complete.

PDT with different treatment parameters

Five trials compared PDT of varying parameters. 96,97,102,103,105 One trial, as previously mentioned in the placebo group, was reported as abstract only and did not have any effectiveness outcomes and so is not discussed here. 96 One trial has already been discussed in the PDT vs APC section but a reminder of the findings is provided here. 97

Two of the three additional trials to be discussed in this section were reported as a full paper,102,105 while the other was reported as an abstract only. 103 Patients had HGD in the trial published as an abstract103 and in one of those reported as a full publication. 105 In the other full publication patients did not have dysplasia. 102 ALA was used as a photosensitiser in all three trials.

ALA–PDT

Eight trials, comparing ALA with APC or placebo or ALA of various treatment parameters, provided information on AEs. 95–98,101–103,105

Serious AEs have not been reported in this group of studies. Specifically, it was reported that no major side effects in terms of perforations or strictures occurred in two trials. 98,102 No patients developed strictures in one trial comparing various ALA regimens103 and differences in stricture formation were not significant between PDT and APC groups in a further trial. 97 In a small trial comparing ALA with red or green light, there were no major complications. 105 Differences in fever and sudden death were not significant between PDT and APC groups in one trial. 97

Adverse effects were mainly short term. In one trial all patients receiving PDT experienced chest pain during treatment, which persisted for 3–5 days and was aggravated by swallowing and coughing. 95 In a further trial 23 of 26 patients receiving PDT and 5 out of 14 patients receiving APC experienced pain during treatment (p < 0.01). 97 Pain was not specifically mentioned in the other trials.

In two trials, PDT was found to result in more nausea and vomiting than APC. There were seven versus zero cases (p < 0.05) in one trial. 97 All patients in the ALA arm of a trial comparing ALA at a dose of 60 mg/kg to APC developed nausea and vomiting over a period of 4 hours after treatment, whereas there were no cases of vomiting in the APC group. 101 In a further trial comparing different modes of ALA, significant nausea and vomiting occurred in 32% of patients receiving ALA, and was more common in patients who received the higher dose of ALA. 102

Photosensitivity did not appear to be a significant problem in the trials in which this was reported. In two trials, one comparing PDT with APC and one testing various ALA treatment parameters, no patients suffered photosensitivity reactions. 101,103 In other trials small numbers experienced photosensitivity, which, where stated, tended to be mild and resolve fairly quickly. 95,96 Numbers were slightly higher in two further trials; 5 out of 25 patients in one trial102 and 5 out of 35 in another. 98

Dysphagia was not found to be a problem with PDT in the trials that specifically mentioned this. 95 In two trials, instances of dysphagia were not significantly different between the PDT and APC groups. 97,101 In one trial that specifically mentioned this, instances of odynophagia were not significantly different between PDT and APC groups. 101

Three trials suggested some disturbance in liver function tests. 96,97,105

Porfimer sodium

Two trials, one comparing Ps with APC and the other comparing PDT with Ps and omeprazole (PHOPDT) to omeprazole alone (OM) provided information on AEs. 99,100

In the omeprazole trial, events of severe intensity were similar for PHOPDT (16%) and OM (15%), with 65% of the PHOPDT group being related to the treatment compared with 2% in the OM group. 99 From years 2 to 5 in the trial there were no SAEs and, of those AEs reported, none was attributed to the treatments. The trial found that 36% of PDT patients developed oesophageal strictures, but that 94% of those with strictures were stricture free in the initial phase of the trial. 99 In the trial comparing PDT with APC, two of 13 patients in both groups developed oesophageal strictures. 100

In one trial, photosensitivity occurred in 69% of patients receiving PDT. 99 All photosensitivity events were resolved. In another trial 31% experienced photosensitivity. 100

ALA vs Ps

One trial of ALA versus Ps provided a direct comparison of the AEs of the two photosensitisers. 104 There was also a statistically significant difference in the development of strictures (6 out of 16 patients treated with Ps and 1 out of 16 treated with ALA). 104

There was a statistically significant difference in photosensitivity [7 out of 16 patients treated with Ps (one of who had to be admitted to hospital) vs no cases with ALA]. There were no other significant differences between groups regarding side effects.

PDT vs PDT (curative intent)

Two non-randomised trials have compared different kinds of PDT for early or superficial oesophageal cancer. Grosjean et al. 108 used Ps as the photosensitiser and compared two wavelengths (n = 15 patients, 22 tumours) of light. In this study, patients with both oesophageal and bronchial tumours were included; however, the majority (14/22) were oesophageal. Savary et al. 109 compared Ps, HpD and three different dosages of mTHPC using varying light doses (n = 24 patients, 31 tumours).

PDT vs CRT or EMR followed by PDT (curative intent)

Two non-randomised trials have examined primary PDT versus secondary PDT where another treatment is given initially. One trial looked at Ps-PDT versus endoscopic mucosal resection (EMR) followed by Ps-PDT (n = 80 patients),107 the second used PDT versus PDT following unsuccessful chemoradiotherapy (CRT) (n = 35 patients, 37 tumours). 111 Both of these trials were available only as abstracts and further treatment details were not reported.

PDT vs EMR vs oesophagectomy (curative intent)

One non-randomised trial (n = 37 patients) compared PDT or EMR in poor surgical candidates with oesophagectomy in good surgical candidates in a three-armed design. 110 Only a short abstract was available and no details were reported for any of the interventions.

PDT vs Nd:YAG laser

Two relatively old RCTs compared PDT with Nd:YAG laser for oesophageal carcinoma in patients who had refused, failed or were not suitable for surgery, and who had a Karnofsky performance status of > 30%. One trial used Ps as the photosensitiser (n = 236)112 and the second used HpD (n = 42). 114 Both trials were reported as full papers, and were generally well conducted and reported.

PDT vs radiotherapy

One RCT and one non-randomised trial have compared HpD-PDT plus radiotherapy versus radiotherapy alone. The RCT used standard radiotherapy of 40 grays (Gy) for 4 weeks,119 while the non-randomised trial used brachytherapy and 5 Gy per session for one to four sessions. 117 In this second study, patients who were judged to be in ‘fair condition’ completed their radiotherapy via external-beam irradiation (57% of the combination group and 23% of the brachytherapy-alone group).

PDT vs PDT plus 5-FU

One RCT compared PDT alone with PDT following 5-FU (n = 140). 113 This study was poorly reported overall, but the paper reports that after treating over 40 patients and reviewing the clinical data the randomisation was abandoned and all further patients were treated with the combination of PDT and 5-FU (no further details reported).

PDT and HBO

Two non-randomised trials have compared PDT alone versus PDT plus hyperbaric oxygen (HBO) (total n = 107)115,116 and a third non-randomised trial has compared two types of photosensitiser (HpD vs ALA), where both were given under HBO. 118 All three studies were carried out with patients who had advanced oesophageal carcinoma. The PDT versus PDT-plus-HBO studies both used HpD at 2 mg/kg and 630-nm illumination, and in both some patients received Nd:YAG and dilatation prior to PDT.

PDT plus radiotherapy

Two trials (n = 52) compared PDT plus radiotherapy with radiotherapy alone,123,124 neither providing adequate methodology details, and one trial recruited only 11 participants. 124 One trial was of the effects of ERT alone versus PDT preceding ERT versus high-dose irradiation preceding ERT, but results were not presented by treatment group. 121

PDT vs Nd:YAG laser resection

Three trials (n = 198) compared PDT with Nd:YAG. 122,125,126 All had methodological limitations and did not report methods in full.

ALA–PDT plus HBO vs PDT plus Photosan plus HBO

One non-randomised trial, conducted as a pilot study (n = 40), compared ALA–PDT with HBO versus PDT plus Photosan plus HBO. 127

PDT plus stenting vs stenting alone

Two RCTs (n = 71) compared PDT plus stenting with stenting alone. 134,136 Both were reported in full papers and seemed to be well conducted. One non-RCT also compared PDT plus stenting with stenting alone (n = 48), although there were important differences in baseline characteristics between the groups and definitive conclusions were difficult to draw. 133

One non-RCT (n = 191, 184 analysed) compared stenting alone with PDT plus stenting and resection for hilar cholangiocarcinoma in a prospective study over 10 years in one centre. 135 This was an unusual study, which appeared to include patients of varying cancer stages, and some patients in the resection group also received adjuvant PDT or stenting where required. Therefore, only the results of the PDT plus stenting versus stenting alone have been described here as these patients appear to be broadly comparable.

Photosan-3 vs Photofrin II

One non-RCT (n = 29) compared two different photosensitisers for the treatment of non-resectable cholangiocarcinoma (further details not reported). 132 This study was available only as an abstract, therefore it was difficult to quality assess. It was a small trial and may have been underpowered to detect any possible differences between photosensitisers.

PDT vs chemotherapy

One RCT (n = 30), which compared Photofrin-PDT with chemotherapy (cisplatin and 5-FU) in patients with nasopharyngeal carcinoma, was only a small pilot study, which provided no details on randomisation procedures or use of blinding. 141 Overall, clinical response was better with PDT (p = 0.001), and there was a greater improvement in Karnofsky score (from 45 to 70 vs 40 to 50, p = 0.02). In those patients with nasal obstruction PDT was more effective at debulking of tumours (7/8 improved vs 2/8, p = 0.04).

The authors reported that the PDT related adverse reactions and side effects were generally tolerable. See Appendix 21 for fuller details.

PDT vs other treatments

The two non-RCTs studying PDT and/or surgery compared with other PDT treatments (including PDT with laser only, or photosensitiser only) had limited relevance to clinical practice. 142,143 One non-RCT compared PDT using different photosensitisers (Photosense and Radachlorin). 144 All three studies were on different cancer sites. All were also reported as abstracts, and had minimal reporting of methods and results. Results are therefore not discussed in detail here but are available in Appendix 21.

Skin conditions

Although 28 RCTs have been conducted on PDT for AK, the only clear evidence of effectiveness found was that both MAL–PDT and ALA–PDT appear to be superior to placebo PDT. Uncertainties still exist regarding PDT’s effectiveness relative to cryotherapy, 5-FU and other topical treatments. While optimum parameters for PDT in treating AK remain to be determined, PDT using daylight as a light source may warrant further investigation. The treatment variation found in the cryotherapy studies indicates that the optimal freezing regimens for cryotherapy also appear yet to be determined. SAEs do not appear to be common with PDT, but local skin-related AEs are fairly common. It was unclear – due to inconsistent reporting – whether ALA–PDT and MAL–PDT have different AE profiles.

A small number of trials compared PDT with either cryotherapy or 5-FU for the treatment of Bowen’s disease. There are suggestions of better outcomes with PDT, but these would need further confirmation from larger, well-designed trials. All relevant comparators should be investigated. Further research is also needed to clarify the optimal parameters for PDT in terms of effectiveness and safety.

For superficial BCC, PDT may result in similar lesion response rates to surgery or cryotherapy with better cosmetic outcomes; however, these conclusions are tentative.

The use of MAL–PDT appears superior to placebo for CR in nodular lesions. PDT has been found to be less effective than surgery for nodular BCC in terms of lesion response, but may have better cosmetic outcome. SAEs have not been reported but level of pain needs further investigation in both superficial and nodular BCC. All relevant comparators should be investigated. Further research is also needed to clarify the optimal parameters for PDT in terms of effectiveness and safety.

Barrett’s oesophagus

The 11 RCTs relating to PDT and Barrett’s oesophagus are mainly small, and there is variation between trials in levels of dysplasia, comparators and parameters of PDT, making general statements more challenging. PDT with Ps in addition to omeprazole appears to be more effective than omeprazole alone at long-term ablation of HGD and slowing/preventing progression to cancer in Barrett’s oesophagus. However, PDT’s relative effectiveness compared with other relevant treatment options is unclear. SAEs have not been reported for PDT in Barrett’s oesophagus but AE profiles need to be more clearly established. The priority for PDT research in the area of Barrett’s oesophagus is to determine more clearly the role of PDT and its optimal delivery to patients with HGD.

Oesophageal cancer

Trials have been conducted with curative and palliative intent in oesophageal cancer, but the evidence is not yet sufficiently robust to draw firm conclusions of effectiveness when compared with other treatments such as surgery, radiotherapy or 5-FU. HBO appears to enhance the efficacy of PDT in oesophageal cancer but has not yet been tested in an RCT. It is not yet clear what are the optimal parameters or preferred photosensitisers for PDT in oesophageal cancer, and this is an area of ongoing research. Questions remain around the place of PDT; for example, should PDT be offered as a primary treatment for early-stage oesophageal cancer or following endoscopic mucosal resection or unsuccessful chemoradiotherapy in a palliative setting?

The most likely AEs from the PDT treatments were stricture formation and dysphagia, which may occur in either curative or palliative treatments. Patients who did not follow recommended precautions to prevent over exposure to light were vulnerable to photosensitivity.

Lung cancer

No trials were located for early-stage lung cancer. All included trials related to PDT used with palliative intent. Additionally, with the exception of one trial, the literature dates from the 1980s and 1990s. Further research is needed to determine the role of PDT in lung cancer in relation to current comparators and to identify particular subgroups who might benefit from PDT.

Cancers of the biliary tract

Photodynamic therapy may improve survival when compared with stenting alone, and an ongoing trial should provide more definitive evidence in a more generalisable patient population. SAEs do not appear to be common. Equally, photosensitisation has not been reported as a major issue. It is unclear if there are variations in effectiveness between photosensitisers in the treatment of cholangiocarcinoma, and there do not appear to have been any controlled trials carried out in other biliary tract cancer sites.

Brain cancer

There is very limited evidence available on PDT for brain cancer and no definitive statements can currently be made. Fluorescence-guided resection with repeated ALA–PDT may possibly have some effectiveness, but whether PDT has any role in treating brain cancer, using current technologies, is a subject needing further debate.

Head and neck cancer

There is a lack of good trial evidence for head and neck cancer. The true value of PDT, in relation to other treatment options, has therefore yet to be established, as have the optimum PDT parameters. PDT’s ability to preserve connective tissue and therefore allow re-treatment makes it worthy of investigation in RCTs for both early head and neck cancers, and palliative treatment.

MEDLINE and MEDLINE In-Process: Ovid

http://gateway.ovid.com/athens

The MEDLINE search covered the date range 1950 to present. The search was carried out on 14 August 2008 and identified 7178 records.

1. photochemotherapy/(8857)

2. photosensitizing agents/(5949)

3. ((photodynamic or (photo adj dynamic)) adj2 therap$).tw. (7397)

4. PDT.tw. (4852)

5. (photosensitise$or photosensitize$or photosensiti?ing or photochemotherapy or (photo adj chemotherapy)).tw. (8234)

6. ((photoradiation or (photo adj radiation)) adj2 therap$).tw. (174)

7. PRT.tw. (651)

8. 1 or 2 or 3 or 4 or 5 or 6 or 7 (17787)

9. exp neoplasms/(2011836)

10. (cancer$or neoplas$or oncolog$or tumour$or tumor$or lump or lumps).tw. (1412061)

11. (sarcoma$or malignan$or carcinoma$or growth$or mass or masses or lesion$or glioma$).tw. (2012713)

12. (premalig$or pre-malig$or pre malig$or cyst or cysts).tw. (78803)

13. (metastatic or metastases or metastasis or squamous cell$).tw. (250958)

14. “Barrett Esophagus”/(4295)

15. (barret$adj (oesophagus or esophagus)).tw. (4411)

16. 9 or 10 or 11 or 12 or 13 or 14 or 15 (3478621)

17. 8 and 16 (9326)

18. exp Animals/not humans/(3344509)

19. 17 not 18 (7178)

The search was re-run on 28 May 2009, using the same strategy to capture recent studies, and identified 460 additional records.

EMBASE: Ovid

http://gateway.ovid.com/athens

The EMBASE search covered the date range 1980–2008 (week 32). The search was carried out on 14 August 2008 and identified 5690 records.

1. photochemotherapy/(1635)

2. photosensitizing agent/(3791)

3. ((photodynamic or (photo adj dynamic)) adj2 therap$).tw. (6228)

4. PDT.tw. (3983)

5. (photosensitise$or photosensitize$or photosensiti?ing or photochemotherapy or (photo adj chemotherapy)).tw. (6580)

6. ((photoradiation or (photo adj radiation)) adj2 therap$).tw. (130)

7. PRT.tw. (487)

8. 1 or 2 or 3 or 4 or 5 or 6 or 7 (13196)

9. exp neoplasm/(1439539)

10. (cancer$or neoplas$or oncolog$or tumour$or tumor$or lump or lumps).tw. (1054121)

11. (sarcoma$or malignan$or carcinoma$or growth$or mass or masses or lesion$or glioma$).tw. (1531626)

12. (premalig$or pre-malig$or pre malig$or cyst or cysts).tw. (51404)

13. (metastatic or metastases or metastasis or squamous cell$).tw. (198043)

14. “Barrett Esophagus”/(5465)

15. (barret$adj (oesophagus or esophagus)).tw. (3915)

16. 9 or 10 or 11 or 12 or 13 or 14 or 15 (2518901)

17. 8 and 16 (7538)

18. exp animal/(18250)

19. exp animal-experiment/(1251475)

20. nonhuman/(3097648)

21. (rat or rats or mouse or mice or hamster or hamsters or animal or animals or dog or dogs or cat or cats or bovine or sheep).ti,ab,sh. (2000565)

22. 18 or 19 or 20 or 21 (3512709)

23. exp human/(6267311)

24. exp human-experiment/(249466)

25. 23 or 24 (6268176)

26. 22 and 25 (620556)

27. 22 not 26 (2892153)

28. 17 not 27 (5690)

The search was re-run using the same strategy on 21 May 2009 (2009, week 20) to capture recent studies and identified 357 additional records.

CINAHL: Ovid

http://gateway.ovid.com/athens

The CINAHL search covered the date range 1982–2008 (August, week 2). The search was carried out on 14 August 2008 and identified 229 records.

1. photochemotherapy/(124)

2. photosensitizing agents/(112)

3. ((photodynamic or (photo adj dynamic)) adj2 therap$).tw. (213)

4. PDT.tw. (119)

5. (photosensitise$or photosensitize$or photosensiti?ing or photochemotherapy or (photo adj chemotherapy)).tw. (55)

6. ((photoradiation or (photo adj radiation)) adj2 therap$).tw. (2)

7. PRT.tw. (50)

8. 1 or 2 or 3 or 4 or 5 or 6 or 7 (453)

9. exp neoplasm/(88899)

10. (cancer$or neoplas$or oncolog$or tumour$or tumor$or lump or lumps).tw. (72661)

11. (sarcoma$or malignan$or carcinoma$or growth$or mass or masses or lesion$or glioma$).tw. (54848)

12. (premalig$or pre-malig$or pre malig$or cyst or cysts).tw. (1672)

13. (metastatic or metastases or metastasis or squamous cell$).tw. (6333)

14. “Barrett Esophagus”/(249)

15. (barret$adj (oesophagus or esophagus)).tw. (214)

16. 9 or 10 or 11 or 12 or 13 or 14 or 15 (146875)

17. 8 and 16 (235)

18. “animal studies”/(7317)

19. 17 not 18 (229)

The search was re-run on 26 May 2009 (1982 to 15 May 2009) to capture recent studies, and identified 47 additional records. An amended strategy was used to search via EBSCO interface (http://web.ebscohost.com) as CINAHL was no longer available via the Ovid interface.

S20 S10 AND S19

S19 S11 or S12 or S13 or S14 or S15 or S16 or S17 or S18

S18 TX barret* N1 esophagus

S17 TX barret* N1 oesophagus

S16 MH Barrett Esophagus

S15 TX metastatic or metastases or metastasis or squamous cell*

S14 TX premalig* or pre-malig* or pre malig* or cyst or cysts

S13 TX sarcoma* or malignan* or carcinoma* or growth* or mass or masses or

lesion* or glioma*

S12 TX cancer* or neoplas* or oncolog* or tumour* or tumor* or lump or

lumps

S11 MH neoplasms

S10 S1 or S2 or S3 or S4 or S5 or S6 or S7 or S8 or S9

S9 TX PRT

S8 TX photo radiation N2 therap*

S7 TX photoradiation N2 therap*

S6 TX photosensitise* or photosensitize* or photosensiti?ing or

photochemotherapy or photo

S5 TX PDT

S4 TX photo dynamic N2 therap*

S3 TX photodynamic N2 therap*

S2 MH photosensitizing agents

S1 MH photochemotherapy

Cochrane Library

www3.interscience.wiley.com

Including:

• Cochrane Database of Systematic Reviews (CDSR)

• Health Technology Assessment Database (HTA)

• Cochrane Central Register of Controlled Trials (CENTRAL)

• NHS Economic Evaluation Database (NHS EED)

The search was carried out on 1 September 2008 and identified 334 records. No date limits applied.

#1 MeSH descriptor Photochemotherapy, this term only

#2 MeSH descriptor Photosensitizing Agents, this term only

#3 (photodynamic near/2 therap*):ti,ab

#4 PDT:ti,ab

#5 (photosensitise* or photosensitize* or photochemotherapy or photo chemotherapy or photo-chemotherapy):ti,ab

#6 (photoradiation near/2 therap*):ti,ab

#7 PRT:ti,ab

#8 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7)

#9 MeSH descriptor Neoplasms explode all trees

#10 (cancer* or neoplas* or oncolog* or tumour* or tumor* or lump or lumps):ti,ab

#11 (sarcoma* or malignan* or carcinoma* or growth* or mass or masses or lesion* or glioma*):ti,ab

#12 (premalig* or pre-malig* or pre malig* or cyst or cysts):ti,ab

#13 (metastatic or metastases or metastasis or squamous cell*):ti,ab

#14 MeSH descriptor Barrett Esophagus, this term only

#15 (barret* near/1 (oesophagus or esophagus)):ti,ab

#16 (#9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15)

#17 (#8 AND #16)

The search was re-run using the same strategy on 26 May 2009 to capture recent studies, and identified 5 additional records.

Database of Abstracts of Reviews of Effects (DARE)

The search was carried out on 7 September 2008, using the internal CRD administration system, and identified 122 records. No date limits applied.

RESTRICT MH Photochemotherapy

photochemotherapy:OK

photochemotherapy:CK

RESTRICT MH Photosensitizing Agents

Photosensitizing Agents:OK

Photosensitizing Agents:CK

photodynamic*

photo dynamic

PDT

photosensiti*

photochemotherapy

photoradiation

PRT

#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8

or #9 or #10 or #11 or #12 or #13

RESTRICT MH Neoplasms

Neoplasms:OK

Neoplasms:CK

cancer$or neoplas$or oncolog$or tumour$or

tumor$or lump or lumps

sarcoma* or malignan* or carcinoma* or growth*

or mass or masses or lesion* or glioma*

premalig* or pre-malig* or pre malig* or cyst or

cysts

metastatic or metastases or metastasis or squamous

cell*

RESTRICT MH Barrett Esophagus

Barrett Esophagus:OK

Barrett Esophagus:CK

barret* esophagus

barret* oesophagus

#15 or #16 or #17 or #18 or #19 or #20 or #21

or #22 or #23 or #24 or #25 or #26

#14 and #27

The search was re-run using the same strategy on 20 May 2009 to capture recent studies, and identified 19 additional records.

LILACS (Latin American and Caribbean Health Sciences Literature)

http://bases.bireme.br/cgi-bin/wxislind.exe/iah/online/?IsisScript=iah/iah.xiss%26;base=LILACSs%26;lang=i

The search was carried out on 1 September 2008 and identified 80 records. No date limits applied.

• photochemotherapy or photosensiti$or photodynamic therap$or PDT or photoradiation therap$(in WORDS)

AND

cancer$or neoplas$or oncolog$or tumour$or tumor$or lump or lumps or sarcoma$or malignan$or carcinoma$or mass or masses or lesion$or glioma$or premalig$or pre-malig$or pre malig$or cyst or cysts or metastatic or metastases or metastasis or squamous cell$or barret$oesophagus or barret$esophagus (in WORDS)

PASCAL [database of INIST (Institut de l’Information Scientifique et Téchnique)]

www.dialogclassic.com/

The search was carried out on 12 September 2008 and identified 2278 records. No date limits applied.

b 144

s (photodynamic or photo(w)dynamic)(2n)(therapy or therapies)

s (photoradiation or photo(w)radiation)(2n)(therapy or therapies)

s PDT or PRT

s photosensitis? or photosensitiz? or

photochemotherapy or photo(w)chemotherapy

s s1:s4

s cancer? or neoplas? or oncolog? or tumour?

or tumor? or lump or lumps or sarcoma? or

malignan? or carcinoma? or growth? or mass or

masses or lesion? or glioma? or premalig? or pre(w)

malig? or cyst or cysts or metastatic or metastases

or metastasis or squamous(w)cell?

s barret?(w)(oesophagus or esophagus)

s s6:s7

s s5 and s8

Current Controlled Trials

http://controlled-trials.com/

The search was carried out on 12 September 2008 and identified 204 records. No date limits applied.

photochemotherapy OR photosensitiser OR

photosensitizer OR “photodynamic therapy”

or “photodynamic therapies” or PDT or

“photoradiation therapy” or PRT

ISI Conference Proceedings Citation Index- Science (CPCI-S)

http://apps.isiknowledge.com

The search was carried out on 20 October 2008 and identified 958 records. No date limits applied.

Basic search (restricted to CPCI-S);

photochemotherapy OR photosensiti*

OR photodynamic therap* OR PDT OR

photoradiation therap* OR PRT

AND

cancer* OR neoplas* OR oncolog* OR tumour* OR tumor* OR lump OR lumps OR sarcoma* OR malignan* OR carcinoma* OR mass OR masses OR lesion* OR glioma* OR premalig* OR pre-malig* OR pre malig* OR cyst OR cysts OR metastatic OR metastases OR metastasis OR squamous cell* OR barret* oesophagus OR barret* esophagus OR Bowen* OR keratos*

Zetoc (British Library’s Electronic Table of Contents)

http://zetoc.mimas.ac.uk

The search was carried out on 22 October 2008 and identified 754 records. No date limits applied. Searches were run separately, and results combined and de-duplicated.

conference: photodynamic neoplas* (22)

conference: photochemotherapy neoplas* (16)

conference: PDT neoplas* (3)

conference: photosensiti* neoplas* (2)

conference: photoradiation neoplas* (nil)

conference: PRT neoplas* (nil)

conference: photodynamic cancer* (426)

conference: photochemotherapy cancer* (52)

conference: PDT cancer* (86)

conference: photosensiti* cancer* (98)

conference: photoradiation cancer* (1)

conference: PRT cancer* (nil)

conference: photodynamic barret* (26)

conference: photochemotherapy barret* (2)

conference: PDT barret* (4)

conference: photosensiti* barret* (1)

conference: photoradiation barret* (nil)

conference: PRT barret* (nil)

conference: photodynamic bowen* (14)

conference: photochemotherapy bowen* (1)

conference: PDT bowen* (nil)

conference: photosensiti* bowen* (nil)

conference: photoradiation bowen* (nil)

conference: PRT bowen* (nil)

Guidelines for data extraction

Quality assessment tool

TNM stages

The TNM system159 provides a framework for classifying solid tumours according to the site of the primary tumour, the histological type and degree to which the cancer has spread.

• ‘T’ refers to the primary tumour:

  1. – T0 – no evidence of primary tumour

  2. – Tis – carcinoma in situ

  3. – T1, T2, T3, T4 – size/extent of the primary tumour

  4. – TX – primary tumour cannot be evaluated.

• ‘N’ refers to regional lymph node involvement:

  1. – N0 – no regional lymph node involvement

  2. – N1, N2, N3 – involvement of regional lymph nodes (number/extent of spread)

  3. – NX – regional lymph nodes cannot be evaluated.

• ‘M’ refers to metastasis:

  1. – M0 – no metastasis (cancer has not spread to other parts of the body)

  2. – M1 – metastasis (cancer has spread to other parts of the body)

  3. – MX – metastasis cannot be evaluated.

Number staging systems

The number system159 uses numerical values (often written using Roman numerals) to distinguish stages:

• Stage 0 = carcinoma in situ.

• Stage I cancers are localized to one part of the body.

• Stage II cancers are locally advanced.

• Stage III cancers are also locally advanced. Whether a cancer is designated as Stage II or Stage III can depend on the specific type of cancer. The specific criteria for Stages II and III therefore differ according to diagnosis.

• Stage IV cancers have often metastasised (spread to other organs or throughout the body).

The stages can be further subdivided using the letters a, b, c, etc. (e.g. Stage IIIb).

The TNM combinations often correspond to one of these numbered stages, although the criteria for this differ for different types of cancer.

Fitzpatrick skin type

Within dermatology, generally, patient skin type may be described in terms of Fitzpatrick score. 160 This is a numerical schema that classifies skin according to how it reacts to UV light. The overall score includes genetic disposition, reaction to sun exposure and tanning habits.

• Type 1 (scores 0–7) White; very fair; red or blond hair; blue eyes; freckles. Always burns, never tans.

• Type II (scores 8–16) White; fair; red or blond hair; blue, hazel or green eyes. Usually burns, tans with difficulty.

• Type III (scores 17–25) Cream white; fair with any eye or hair color; very common. Sometimes mild burn, gradually tans.

• Type IV (scores 25–30) Dark brown; typical Mediterranean Caucasian skin. Rarely burns, tans with ease.

• Type V (scores over 30)  Dark brown; Middle Eastern skin types. Very rarely burns, tans very easily.

• Type VI Black; never burns, tans very easily.

References

1. Alexiades-Armenakas MR, Bernstein LJ, Chen J, Jacobson L, Geronemus R. Laser-assisted photodynamic therapy of actinic keratoses: long-term follow-up. Lasers Surg Med 2003;15(Suppl.):45.

2. Alexiades-Armenakas MR, Geronemus RG. Laser-mediated photodynamic therapy of actinic keratoses. Arch Dermatol 2003;139:1313–20.

3. Ammann R, Hunziker T. Photodynamic therapy for mycosis fungoides after topical photosensitization with 5-aminolevulinic acid. J Am Acad Dermatol 1995;33:541.

4. Antoniou C, Katsambas A, Rigopoulos D, Palaskas E, Tsikrikas GN. Aminolevulinic acid: topical photodynamic therapy in skin cancers and solar keratoses. Skin Cancer 1996;11:81–4.

5. Attili S, Cochrane A, McNeill A, Camacho-Lopez M, Moseley H, Ibbotson S, et al. An open pilot study of ambulatory photodynamic therapy using a wearable, low-irradiance, organic LED light source in the treatment of nonmelanoma skin cancer. Br J Dermatol 2008;159:130–1.

6. Bakos RM, Bakos L, Ferlin E, Cestari T, Orlandini T, Rezende R, et al. [Photodynamic therapy with delta-aminolevulinic acid for superficial keratinocytic neoplasms.] An Bras Dermatol 2003;78:197–207.

7. Baptista J, Martinez C, Leite L, Cochito M. Our PDT experience in the treatment of non-melanoma skin cancer over the last 7 years. J Eur Acad Dermatol Venereol 2006;20:693–7.

8. Baptista J, Paris F, Serrao V, Cochito M. Topical photodynamic therapy and imiquimod cream in the treatment of actinic keratoses: a case report. Skin Cancer 2006;21:49–53.

9. Baron E, Domingo DS, Hsia A, Colussi V, Oleinick N, Foster T, et al. Silicon phthalocyanine photodynamic therapy for treatment of cutaneous neoplasms. J Invest Dermatol 2008;128:395.

10. Berking C, Herzinger T, Flaig MJ, Brenner M, Borelli C, Degitz K. The efficacy of photodynamic therapy in actinic cheilitis of the lower lip: a prospective study of 15 patients. Dermatol Surg 2007;33:825–30.

11. Berroeta L, Lewis-Jones MS, Evans AT, Ibbotson SH. Woringer-Kolopp (localized pagetoid reticulosis) treated with topical photodynamic therapy (PDT). Clin Exp Dermatol 2005;30:446–7.

12. Breuninger H, Bonnekoh B, Gollnick H. Photodynamic therapy with methylaminooxopentanoate (MetvixR) and a broad band light source (PhotoDyn 501): Experiences in complicated patients with actinic keratoses and basal cell carcinomas [Multiple letters]. JDDG (Journal of the German Society of Dermatology) 2005;3:397.

13. Britton JER, Goulden V, Stables G, Stringer M, Sheehan-Dare R. Investigation of the use of the pulsed dye laser in the treatment of Bowen’s disease using 5-aminolaevulinic acid phototherapy. Br J Dermatol 2005;153:780–4.

14. Brookes PT, Jhawar S, Hinton CP, Murdoch S, Usman T. Bowen’s disease of the nipple: a new method of treatment. Breast (Edinburgh, Scotland) 2005;14:65–7.

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