Concomitant administration of weekly oxaliplatin, fluorouracil continuous infusion, and radiotherapy after 2 months of gemcitabine and oxaliplatin induction in patients with locally advanced pancreatic cancer: a Groupe Coordinateur Multidisciplinaire en Oncologie phase II study.

Authors:	Laurence Moureau-Zabotto, Jean-Marc Phélip, Pauline Afchain, Laurent Mineur, Thierry André, Veronique Vendrely, Gerard Lledo, Olivier Dupuis, Florence Huguet, Emmanuel Touboul, Jacques Balosso, Christophe Louvet
Language:	Eng.
Date:	03-03-2008
Journal:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology (1527-7755)
Release:	J Clin Oncol. 2008 Mar;26(7):1080-5
Abstract:	BACKGROUND: According to previously reported Groupe Coordinateur Multidisciplinaire en Oncologie (GERCOR) studies in locally advanced pancreatic cancer (LAPC), concomitant chemoradiotherapy (CCRT) may be recommended for patients who do not experience disease progression after systemic induction chemotherapy (CT). To further improve patient outcome with classical fluorouracil (FU)-based CCRT, this study was designed to prospectively investigate a CCRT with FU infusion and weekly oxaliplatin after 2 months of gemcitabine and oxaliplatin (GEMOX) induction chemotherapy. PATIENTS AND METHODS: Nonpretreated patients with LAPC having WHO performance status (PS) of 0 to 2 received four induction cycles of GEMOX (gemcitabine 1 g/m(2) on day 1 and oxaliplatin 100 mg/m(2) on day 2; day 1 of a 15-day cycle). One month after cycle 4, patients who did not experience disease progression with PS 0 to 2 received 45 Gy over 5 weeks + 10 Gy (as a concomitant boost during the last 2 weeks) of radiotherapy (RT), with daily 250 mg/m(2) FU as a continuous infusion and 60 mg/m(2)of oxaliplatin weekly. RESULTS: Of 59 patients, 50 patients (84.7%) received CCRT, whereas nine patients did not because of disease progression (seven patients), CT toxicity (one patient), or personal decision (one patient). Forty-four patients (74.5%) completed the fully planned CCRT. Median progression-free survival and overall survival durations were 7.6 and 12.2 months, respectively, for the whole population and 9.4 and 12.6 months, respectively, for patients who completed CCRT. CCRT grade 3 to 4 toxicities (National Cancer Institute Common Toxicity Criteria) were neutropenia (10.4%), thrombocytopenia (8.4%), nausea and vomiting (16.7%), and diarrhea (12.5%). CONCLUSION: Concomitant administration of weekly oxaliplatin, continuous-infusion FU, and RT in patients with LAPC is feasible, with an acceptable acute and late safety profile. The encouraging results observed despite a nonoptimal patient selection (owing to the short induction time) indicates that further randomized evaluation to better define the specific role of oxaliplatin in CCRT is deserved.
Copyright:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology Hôpital Tenon, service de radiothérapie, 4 rue de la Chine, 75020 Paris, France. moureaul@marseille.fnclcc.fr
Full text:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology (DOI) HighWire Press - HTML (needs subscription)
Terms:	Adenocarcinoma, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Combined Modality Therapy, Deoxycytidine, Feasibility Studies, Female, Fluorouracil, Humans, Infusions, Intravenous, Male, Middle Aged, Organoplatinum Compounds, Pancreatic Neoplasms, Survival Rate, Treatment Outcome