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Annals of Oncology Advance Access originally published online on May 7, 2008
Annals of Oncology 2008 19(9):1592-1599; doi:10.1093/annonc/mdn281
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

gastrointestinal tumors

Phase III trial comparing intensive induction chemoradiotherapy (60 Gy, infusional 5-FU and intermittent cisplatin) followed by maintenance gemcitabine with gemcitabine alone for locally advanced unresectable pancreatic cancer. Definitive results of the 2000–01 FFCD/SFRO study

B. Chauffert1, F. Mornex2, F. Bonnetain3,*, P. Rougier4, C. Mariette5, O. Bouché6, J. F. Bosset7, T. Aparicio8, L. Mineur9, A. Azzedine10, P. Hammel11, J. Butel12, N. Stremsdoerfer13, P. Maingon1 and L. Bedenne14

1 Department of Oncology, Anticancer Center G.F. Leclerc, Dijon
2 University Hospital Lyon-Sud, Pierre Bénite
3 Fédération Francophone de Cancérologie Digestive, Dijon
4 University Hospital Ambroise Paré, Boulogne
5 University Hospital, Lille
6 University Hospital, Reims
7 University Hospital Besançon
8 University Hospital Bichat, Paris
9 Sainte Catherine Private Hospital, Avignon
10 Duffaut Hospital, Avignon
11 University Hospital Beaujon, Clichy
12 Abbeville Hospital, Abbeville
13 Oudot Hospital, Bourgoin-Jallieu
14 University Hospital, Dijon, France

* Correspondence to: Dr F. Bonnetain, Biostatistics and methodological unit of FFCD, Institut National de la Santé et de la Recherche Médicale U866, Faculty of Medicine, 7 Boulevard Jeanne d'Arc, BP 87900, 21079 Dijon Cedex, France. Tel: +33-3-80-73-77-84; Fax: +33-3-80-73-77-34; E-mail: fbonnetain{at}dijon.fnclcc.fr

Background: The role of chemoradiation with systemic chemotherapy compared with chemotherapy alone in locally advanced pancreatic cancer (LAPC) is uncertain.

Patients and methods: One hundred and nineteen patients with LAPC, World Health Organization performance status of zero to two were randomly assigned to either the induction CHRT group (60 Gy, 2 Gy/fraction; concomitant 5-fluorouracil infusion, 300 mg/m2/day, days 1–5 for 6 weeks; cisplatin, 20 mg/m2/day, days 1–5 during weeks 1 and 5) or the induction gemcitabine group (GEM: 1000 mg/m2 weekly for 7 weeks). Maintenance gemcitabine (1000 mg/m2 weekly, 3/4 weeks) was given in both arms until disease progression or toxicity.

Results: Overall survival was shorter in the CHRT than in GEM arm [median survival 8.6 (99% confidence interval 7.1–11.4) and 13 months (8.7–18.1), 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 CHRT arm, both during induction (36 versus 22%) and maintenance (32 versus 18%).

Conclusion: This intensive induction schedule of CHRT was more toxic and less effective than gemcitabine alone.

Key words: chemoradiotherapy, 5-fluorouracil, cisplatin, gemcitabine, maintenance, overall survival, pancreatic cancer, randomized phase III trial

Received for publication February 8, 2008. Revision received March 20, 2008. Revision received April 5, 2008. Accepted for publication April 7, 2008.


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