Study authors (year published) / Cancer / Cell Type / Study Design / Patients / Intervention / Outcome Measures / Findings / Study quality /
ALA 15mg/kg administered orally /
Comparative studies /
None /
Non-comparative studies /
Ortner MA, et al. (2002)[26] / BE (7 patients)
BE + LGD (7 patients) / Clinical trial
Single centre
Prospective
Countries: Germany
Length of follow-up:
Mean: 32.6 months
Range: 12 to 48 months / Number of patients: 14
Gender:
Male: 12
Female:2
Age:
Mean: 61.8 yrs
Prior treatments: none reported
Length of Barrett’s: not reported
Inclusion criteria: none notable
Exclusion criteria:
Allergy to OM
Porphyria
Previous esophageal cancer
HGD
Contraindications for endoscopy
Clotting disturbances
Pregnant or lactating / PDT
Drug: 5-ALA
Dose: 15mg/kg
Route of administration: topical
Light source: argon dye laser @632nm
Light dose: 90 to 120 J/cm2
Time to photoactivation: 1.5 to 2 hours
Treatment time: not recorded
Number of sessions:
Mean: 1.4 sessions / patient
Co-interventions:
OM 80 mg/day for 2 months / Outcomes:
CR of BE
CR of LGD
Partial response of BE
Adverse events / Outcomes:
CR of BE:
- at 3 months: 3/14 patients (21%)
- at 6 months: 4/14 patients (29%)
CR of LGD:
- at 3 months: 4/7 patients (57%)
- at 6 months: 5/7 patients (71%)
Partial response of BE:
- at 3 months: 11/14 patients (79%)
- at 6 months: 10/14 patients (71%)
Adverse events:
Chest pain and dysphagia: 2/13 patients (15%)
Photosensitivity: 3/13 patients (23%)
Strictures: 0/13 patients (0%)
Hepatotoxicity: 0/13 patients (0%) / 4 /
Ortner M, et al. (1997)[27] / BE / Case series
Single centre
Countries: Germany
Length of follow-up:
2 months / Number of patients: 9
Gender: not reported
Age: not reported
Prior treatments: none reported
Length of Barrett’s: not reported
Inclusion criteria: none notable
Exclusion criteria: none notable / PDT
Drug: 5-ALA
Dose: 14 to 16 mg/kg
Route of administration: topical spray
Light source: argon dye laser @ 632nm
Light dose: 180J/cm2
Time to photoactivation: 1.5 to 2 hours
Treatment time: 180 to 300 seconds
Number of sessions: 1 session / patient
Co-interventions:
OM 40 mg 4 times daily for 2 months / Outcomes:
CR of BE
Partial response of BE
Non-response of BE
Adverse events / Outcomes:
CR of BE at 2 months: 4/9 patients (44%)
Partial response of BE at 2 months: 3/9 patients (33%)
Non-response of BE at 2 months: 2/9 patients (22%)
Adverse events:
Chest pain: occasionally
Dysphagia, mild: occasionally / 4 /
ALA 30mg/kg administered orally /
Comparative studies /
Kelty CJ, et al. (2004)[14] / BE / RCT
Single centre
Prospective
PDT vs. APC
Countries: UK
Length of follow-up: 24 months / Number of patients: 72
(PDT Group:35 patients; APC Group: 37 patients)
PDT Group
Gender:
Male: 28
Female: 7
Age:
Median: 61 yrs
Range: 33 to 83 yrs
APC Group
Gender:
Male: 30
Female: 7
Age:
Median: 59 yrs
Range: 28 to 79 yrs
Prior treatments: none reported
Length of Barrett’s:
PDT Group
Median: 4 cm
Range: 2 to 15 cm
APC Group
Median: 4 cm
Range: 2 to 8 cm
Inclustion criteria: none notable
Exclusion criteria: none notable / PDT vs. APC
PDT Group
Drug: 5-ALA
Dose: 30 mg/kg
Route of administration: oral
Light source: diode laser @ 633 nm
Light dose: 85 J/cm2
Time to photoactivation: 4 to 6 hours post ALA
Treatment time: not reported
Number of sessions:
Median: 5 sessions
Range: 1 to 5 sessions
Max allowed: 5 sessions
APC Group
Gas flow: 2L/minute
Power: 65 watts
Number of sessions:
Median: 3 sessions
Range: 1 to 5 sessions
Max allowed: 5 sessions
Co-interventions: none reported / Outcomes:
CR of BE (assessed through endoscopy and 4 quadrant biopsy every 2 cm)
Partial response of BE
Number of treatments to achieve CR of BE
Adverse events / Outcomes:
CR of BE at 4 weeks:
-PDT Group: 17/34 patients (50%)
-APC Group: 33/34 patients (97%)
Partial response of BE:
-PDT Group: 17/34 patients (50%)
-APC Group: 1/34 patients (3%)
Number of treatments to achieve CR of BE:
PDT Group
Median: 2 treatments
Range: 1 to 4 treatments
APC Group
Median: 3 treatments
Range: 1 to 5 treatments
Adverse events:
PDT Group
Nausea / vomiting: 11/34 patients (32%)
Photosensitivity: 5/34 patients (15 %)
Hypotension: 2/34 patients (6%)
Chest pain: 1/34 patients (3%)
Odynophagia: 1/34 patients (3%)
Dysphagia secondary to strictures: 0/34 patients (0%)
Elevated liver enzymes, mild: 4/34 patients (12%)
Buried glands (4 week follow-up): 4/17 patients (24%)
APC Group
Nausea / vomiting; photosensitivity; hypotension; chest pain; elevated liver enzymes, mild: 0/34 patients (0%)
Odynophagia: 32/34 patients (94%)
Dysphagia secondary to strictures: 1/34 patients (3%)
Buried glands (4 week follow-up): 7/33 patients (21%) / 1 /
Non-comparative studies /
Akroyd R, et al. (2003)[28] / BE + LGD / Case series
Single centre
Prospective
Countries: UK
Length of follow-up:
Median: 53 months
Range: 18 to 68 months / Number of patients: 40
Gender:
Male: 36
Female: 4
Age:
Median: 61 yrs
Range: 34 to 86 yrs
Prior treatments: not reported
Length of Barrett’s:
Median: 6 cm
Range: 3 to 18 cm
Inclusion criteria: none notable
Exclusion criteria: none notable / PDT
Drug: ALA
Dose: 30 mg/kg
Route of administration: oral
Light source: copper vapour laser @514nm
Light dose: 60 J/cm2
Time to photoactivation: 4 hours
Treatment time: not reported
Number of sessions: 1 session / patient
Co-interventions:
OM 20-40 mg/day
Endoscopy at 1, 6, 12 months / Outcomes:
CR of LGD
Reduction of BE area
Adverse events / Outcomes:
CR of LGD
-at 1 month: 40/40 patients (100%)
-at 24 months: 38/38 patients (100%)
-at 60 months: 15/15 patients (100%)
Reduction of BE area:
Median: 30%
Range: 0 to 90%
Adverse events:
Buried glands: 1/40 patients (2.5%)
Strictures: 0/40 patients (0%)
Discomfort, duration ≤ 3 days: most patients
Nausea and vomiting ≤ 24 hours: most patients
Photosensitivity, mild (patient exposed to direct sun for several hours): 1/40 patients (2.5%) / 4 /
Ackroyd R, et al. (1999)[30]
* Information extracted for BE or HGD patients only / BE + LGD (3 patients)
BE + HGD (4 patients) / Case series
Single centre
Prospective
Countries: UK
Length of follow-up: 28 months / Number of patients: 7
Gender:
Male: 5
Female: 2
Age:
Mean: 68.3 yrs
Range: 49 to 83 yrs
Prior treatments: not reported
Length of Barrett’s: not reported
Inclusion criteria: none notable
Exclusion criteria: none notable / PDT
Drug: ALA
Dose: 30 mg/kg
Route of administration: oral
Light source: copper vapour laser @514nm or 630nm
Light dose:
Mean: 80 J/cm2
Range: 50 to 100 J/cm2
Time to photoactivation: 4 hours
Treatment time: not reported
Number of sessions: 1 session / patient
Co-interventions:
OM 20 mg/day / Outcomes:
CR of BE
CR of HGD
CR of LGD
Reduction of BE area
Survival
Adverse events: No BE or HGD specific information available. / Outcomes:
CR of BE
-at 1 month: 1/7 patients (14%)
-at 24 months: 1/7 patients (14%)
CR of HGD
-at 1 month: 4/4 patients (100%)
-at 24 months: 4/4 patients (100%)
CR of LGD
-at 1 month: 3/3 patients (100%)
-at 24 months: 3/3 patients (100%)
Reduction of BE area at 1 month:
Mean: 44 %
Range: 10 to 100%
Survival
-at 1 month: 7/7 patients (100%)
-at 24 months: 7/7 patients (100%) / 4 /
Ackroyd R, et al. (1997)[29] *
* Information extracted for BE or HGD patients only / BE + LGD (1 patient)
BE + HGD (4 patients) / Case series
Single centre
Countries: UK
Length of follow-up: not reported / Number of patients: 5
Gender: not reported
Age: not reported
Prior treatments: not reported
Length of Barrett’s: not reported
Inclusion criteria: none notable
Exclusion criteria: none notable / PDT
Drug: ALA
Dose: 30 mg/kg
Route of administration: oral
Light source: copper vapour laser @514nm
Light dose: 1000J/cm2
Time to photoactivation: 4 hours
Treatment time: 1000 seconds of laser activation
Number of sessions: 1 session / patient
Co-interventions: none reported / Outcomes:
CR of HGD
CR of LGD
Reduction in BE area
Adverse events: none / Outcomes:
CR of HGD at unknown follow-up: 4/4 patients (100%)
CR of LGD at unknown follow-up: 1/1 patients (100%)
Reduction in BE area:
Mean: 48 %
Range: 10 to 70 % / 4 /
Mackenzie G, et al. (2005)[31]8 / BE + HGD / RCT
Single centre
Prospective
PDT (red light) vs. PDT (green light)
Countries: not reported
Length of follow-up: not reported / Number of patients:16
Gender: not reported
Age: not reported
PDT Red Light
Number of patients: not reported
PDT Green Light
Number of patients: not reported
Prior treatments:
EMR of nodular dysplasia in 4 patients
Length of Barrett’s: not reported
Inclusion criteria: none notable
Exclusion criteria: none notable / PDT with red light
Drug: 5-ALA
Dose: 30 mg/kg
Route of administration: oral
Light source: 600nm laser
Light dose: not reported
Time to photoactivation: 4 hours
Treatment time: not reported
Number of sessions:
Mean: 2.15 sessions / patient
PDT with green light
Light source: 520 to 570nm laser
Number of sessions:
Mean 2.15 sessions / patient
Other details as above
Co-interventions:
Treatments preceded by EMR / Outcomes:
Number of sessions reporting CR of dysplasia
Adverse events: no major complications. / Outcomes:
Number of sessions reporting CR of dysplasia:
-Red light: 4/17 sessions (24%)
-Green light: 1/19 sessions (5%) / 4 /
Mackenzie G, et al. (2005)[22] / BE + HGD / Case series
Single centre
Countries: UK
Length of follow-up:
Mean: 15.8 months
Range: 1 to 72 months / Number of patients: 51*
Gender: not reported
Age: not reported
Group A
Number of patients: 21 patients
Gender: not reported
Age: not reported
Group B
Number of patients: 12 patients
Gender: not reported
Age: not reported
Group C
Number of patients: 16 patients
Gender: not reported
Age: not reported
Prior treatments: none reported
Length of Barrett’s: not reported
Inclusion criteria: none notable
Exclusion criteria: none notable
* 3 patients unaccounted for. / PDT
Drug: ALA
Route of administration: oral
Light source: not reported
Time to photoactivation: not reported
Treatment time: not reported
Number of sessions:
Mean: 1.74 sessions / patient
Group A
Dose: 60 mg/kg
Light dose: 1000J/ cm2
Other details as above
Group B
Dose: 60 mg/kg
Light dose: 500 to 750J/cm2
Other details as above
Group C
Dose: 30 mg/kg
Light dose: 1000J/ cm2
Other details as above
Co-interventions: none reported / Outcomes:
CR of HGD:
Adverse events / Outcomes:
CR of dysplasia at 15.8 months (mean):
Group A: 16/21 patients (76%)
Group B: 2/12 patients (17%)
Group C: 5/16 patient (31%)
All patients: 23/49 patients (47%)
Adverse events:
Strictures and photosensitivity: 0/51 patients (0%)
Hypotension: 3/51 patients (6%)
GI bleed requiring transfusion: 1/51 patients (2%) / 4 /
ALA 40mg/kg administered orally /
Comparative studies /
None /
Non-comparative studies /
Peters F, et al. (2005)[32] / BE + HGD / Case series
Single centre
Countries: Netherlands
Length of follow-up:
Mean: 30 months
Range: 22 to 31 months / Number of patients: 20 patients
Gender:
Male: 16
Female: 4
Age:
Mean: 69 yrs
Range: 59 to 74 yrs
Prior treatments:
Diagnostic EMR for focal lesions
Length of Barrett’s: not reported
Inclusion criteria:
Ineligible for or refused surgery
Exclusion criteria: none notable / PDT
Drug: ALA
Dose: 40 mg/kg
Route of administration: oral
Light source: KTP/Nd:YAG laser @ 600 nm
Light dose: 100J/cm2
Time to photoactivation: not reported
Treatment time: not reported
Number of sessions:
Mean: 1 session / patient
Range: 1 to 2 sessions / patient
Co-interventions:
Ranitidine 300 mg @ night for 1st week
OM 40 mg twice daily for first week
Esomeprazole 40 mg twice daily from 2nd week on / Outcomes:
CR of HGD (assessed through endoscopy with 4 quadrant biopsies every 2 cm)
Adverse events / Outcomes:
CR of dysplasia at:
- at 3 months: 15 /20 patients (78%)
- at 23 months: 11/20 patients (55%)
Adverse events:
Hematemesis: 1/20 patients (5%)
Hypotension: 2/20 patients (10%)
Atrial fibrillation: 1/20 patients (5%)
Buried glands (at mean =30 months): 8/15 patients (53%) / 4 /
Van Hillegersberg R, et al. (2003)[33] / BE + HGD / Case report
Single centre
Retrospective
Countries: Netherlands
Length of follow-up:
Mean: 6 months
Range: 5 to 8 months / Number of patients: 2
Gender:
Male: 1
Female: 1
Age:
Mean: 65 yrs
Range: 61 to 69 yrs
Prior treatments:
PPI, unspecified (1/2 patients)
Length of Barrett’s: not reported
Inclusion criteria: none notable
Exclusion criteria: none notable / PDT
Drug: ALA
Dose: 40 mg/kg
Route of administration: oral
Light source: laser @630nm
Light dose: 70 to 100J/cm2
Time to photoactivation: 3.3 to 5.9 hours
Treatment time: not reported
Number of sessions:
Mean: 2 sessions / patient
Range: 1 to 3 sessions
Co-interventions:
High dose PPI
Ranitidine 150 mg as needed. / Outcomes:
CR of BE (assessed through endoscopy with random biopsies)
CR of HGD (assessed through endoscopy with random biopsies)
Progression to cancer
Adverse events / Outcomes:
CR of BE at 3 months: 0/2 patients (0%)
CR of HGD at 3 months: 0/2 patients (0%)
Progression to cancer at 6 months: 2/2 patients (100%)
Adverse events:
Nausea and vomiting: 1/2 patients (50%) / 4 /
ALA 60mg/kg administered orally /
Comparative studies /
Behrens A, et al. (2005)[25] / BE + HGD / Cohort study
Single centre
Prospective
PDT vs. EMR vs. PDT + EMR
Countries: Germany
Length of follow-up:
Mean: 38 months
Range: 7 to 61 months / Number of patients: 44
(PDT Group: 27 patients; EMR Group: 14 patients; PDT+EMR: 3 patients)
Gender:
Male: 38
Female: 6
Age:
Mean:61 yrs
Range: 33 to 79 yrs
PDT Group
Number of patients: 27 patients
Gender: not reported
Age: not reported
EMR Group
Number of patients: 14 patients
Gender: not reported
Age: not reported
PDT + EMR Group
Number of patients: 3 patients
Gender: not reported
Age: not reported
Prior treatments: none reported
Length of Barrett’s: not reported
Inclusion criteria: none notable
Exclusion criteria: none notable / PDT vs. EMR vs. PDT + EMR
PDT Group
Patients with microscopic / histologic HGD