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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

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

From the Hôpital Tenon and Hôpital Saint Antoine, Groupe Hospitalo-Universitaire Est, Université Paris VI, Paris; Centre Hospitalier Universitaire de Grenoble, Université Joseph Fourier, Grenoble; Institut Sainte Catherine, Avignon; Centre Hospitalier Universitaire Saint André, Université Victor Segalen, Bordeaux; Clinique Saint-Jean, Lyon; and Centre de Radiothérapie, Le Mans, France

Address reprint requests to Laurence Moureau-Zabotto, MD, Hopital Tenon, service de radiothérapie, 4 rue de la Chine, 75020 Paris, France; e-mail: moureaul{at}marseille.fnclcc.fr

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/m² on day 1 and oxaliplatin 100 mg/m² 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/m² FU as a continuous infusion and 60 mg/m²of 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.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.