Locally advanced unresectable pancreatic cancer: Induction chemoradiotherapy followed by maintenance gemcitabine versus gemcitabine alone: Definitive results of the 2000-2001 FFCD/SFRO phase III trial

PURPOSE: To compare chemoradiation with systemic chemotherapy to chemotherapy alone in locally advanced pancreatic cancer. PATIENTS AND METHODS: One hundred and nineteen patients with locally advanced pancreatic cancer, with World Health Organization performance status of zero to two were randomly a...

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Bibliographic Details
Published in:Cancer radiothérapie 2011-06, Vol.15 (3), p.182-191
Main Authors: Barhoumi, M., Mornex, F., Bonnetain, Franck, Rougier, P., Mariette, C., Bouché, O., Bosset, J.-F., Aparicio, T., Mineur, L., Azzedine, A., Hammel, P., Butel, J., Stremsdoerfer, N., Maingon, P., Bedenne, L., Chauffert, B.
Format: Article
Language:fre
Subjects:
Adult
Aged
Aged, 80 and over
Antimetabolites, Antineoplastic
Antineoplastic Combined Chemotherapy Protocols
Cancer
Carcinoma, Pancreatic Ductal
Cisplatin
Combined Modality Therapy
Deoxycytidine
Disease Progression
Female
Fluorouracil
Gastrointestinal Diseases
Hematologic Diseases
Humans
Kaplan-Meier Estimate
Life Sciences
Male
Middle Aged
Pancreatic Neoplasms
Proportional Hazards Models
Radiotherapy, Conformal
Remission Induction
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Summary:PURPOSE: To compare chemoradiation with systemic chemotherapy to chemotherapy alone in locally advanced pancreatic cancer. PATIENTS AND METHODS: One hundred and nineteen patients with locally advanced pancreatic cancer, with World Health Organization performance status of zero to two were randomly assigned to either the induction chemoradiation group (60 Gy, 2 Gy/fraction; concomitant 5-fluoro-uracil infusion, 300 mg/m(2) per day, days 1-5 for 6 weeks; cisplatin, 20 mg/m(2) per day, days 1-5 during weeks 1 and 5) or the induction gemcitabine group (GEM: 1000 mg/m(2) weekly for 7 weeks). Maintenance gemcitabine (1000 mg/m(2) weekly, 3/4 weeks) was given in both arms until disease progression or toxicity. RESULTS: Overall survival was shorter in the chemoradiation than in the gemcitabine arm (median survival 8.6 [99% confidence interval 7.1-11.4] and 13 months [8,9,9-18], p=0.03). One-year survival was, respectively, 32 and 53%. These results were confirmed in a per-protocol analysis for patients who received 75% or more of the planned dose of radiotherapy. More overall grades 3-4 toxic effects were recorded in the chemoradiation arm, both during induction (36 versus 22%) and maintenance (32 versus 18%). CONCLUSION: This intensive induction schedule of chemoradiation was more toxic and less effective than gemcitabine alone.
ISSN:1278-3218
1769-6658
DOI:10.1016/j.canrad.2010.10.001