[Palliative treatment by photochemotherapy of 54 digestive cancers: phase I clinical trial].
Photochemotherapy (PDT) is based on the interaction of a phototoxic drug (HPD) retained by cancer tissues and excited with a specific laser light. We present here a phase I clinical trial including 54 patients selected on the grounds of non-operability and T1 NO MO staging (UICC) and divided into 3 groups: I) 24 squamous cell carcinoma (SCC), II) 14 adenocarcinomas (ADN) of the upper GI tract, III) 16 ADN of the rectosigmoid colon. All received an HPD infusion of 2.5 to 5 mg/kg I.V. 72 hours before being laser irradiated endoscopically (632 nm, 150 to 220 j/cm2). Results documented on histology obtained after grip biopsies and on resected specimens (6 cases), were classified as complete response (ST), partial response (PR) or no change (NC). Eleven patients of group I, 5 of group II, and 8 of group III (24/54 patients) were classified ST with a mean follow-up of 15.2 months. Analysis of resected specimens showed a complete disappearance of tumor tissue and prominent fibrosis all around the treated area. Adverse effects were noted in 22% of patients, PDT of rectosigmoid ADN gave a survival (life table analysis) at least equal to SCC. These results should allow clinical indications for PDT to be broadened in combined protocols.
Patrice
T
T
Foultier
M T
MT
Adam
F
F
Audouin
A F
AF
Galmiche
J P
JP
Le Bodic
L
L
D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000532:radiotherapy; D002986:Clinical Trials as Topic; D004067:Digestive System Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy; D005260:Female; D006414:Hematoporphyrin Photoradiation / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy / Q000009:adverse effects
Traitement palliatif par photochimiothérapie de 54 cancers digestifs: essai clinique de phase I.