Journal of Clinical Oncology, Vol 23, No 15 (May 20), 2005: pp. 3509-3516
© 2005 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2005.06.023
Gemcitabine in Combination With Oxaliplatin Compared With Gemcitabine Alone in Locally Advanced or Metastatic Pancreatic Cancer: Results of a GERCOR and GISCAD Phase III Trial
C. Louvet,
R. Labianca,
P. Hammel,
G. Lledo,
M.G. Zampino,
T. André,
A. Zaniboni,
M. Ducreux,
E. Aitini,
J. Taïeb,
R. Faroux,
C. Lepere,
A. de Gramont
From the Hôpital St-Antoine; Hôpital Tenon; Hôpital de la Pitié-Salpétrière, Paris; Hôpital Beaujon, Clichy; Clinique St-Jean, Lyon; Institut Gustave Roussy, Villejuif; Centre Hospitalier, La Roche-sur Yon; Hôpital Ambroise Paré, Boulogne, France; Azienda Ospedaliera C. Poma, Mantova; Istituto Europeo di Oncologia, Milano; Casa di Cura Poliambulanza, Brescia; and Ospedali Riuniti, Bergamo, Italy
Address reprint requests to Christophe Louvet, MD, Service d'Oncologie, Hôpital Saint Antoine, 184 rue du Faubourg Saint Antoine, 75571 Paris Cedex 12, France; e-mail: christophe.louvet{at}sat.ap-hop-paris.fr
PURPOSE: Gemcitabine (Gem) is the standard treatment for advanced pancreatic cancer. Given the promising phase II results obtained with the Gem-oxaliplatin (GemOx) combination, we conducted a phase III study comparing GemOx with Gem alone in advanced pancreatic cancer.
PATIENTS AND METHODS: Patients with advanced pancreatic cancer were stratified according to center, performance status, and type of disease (locally advanced v metastatic) and randomly assigned to either GemOx (gemcitabine 1 g/m2 as a 100-minute infusion on day 1 and oxaliplatin 100 mg/m2 as a 2-hour infusion on day 2 every 2 weeks) or Gem (gemcitabine 1 g/m2 as a weekly 30-minute infusion).
RESULTS: Three hundred twenty-six patients were enrolled; 313 were eligible, and 157 and 156 were allocated to the GemOx and Gem arms, respectively. GemOx was superior to Gem in terms of response rate (26.8% v 17.3%, respectively; P = .04), progression-free survival (5.8 v 3.7 months, respectively; P = .04), and clinical benefit (38.2% v 26.9%, respectively; P = .03). Median overall survival (OS) for GemOx and Gem was 9.0 and 7.1 months, respectively (P = .13). GemOx was well tolerated overall, although a higher incidence of National Cancer Institute Common Toxicity Criteria grade 3 and 4 toxicity per patient was observed for platelets (14.0% for GemOx v 3.2% for Gem), vomiting (8.9% for GemOx v 3.2% for Gem), and neurosensory symptoms (19.1% for GemOx v 0% for Gem).
CONCLUSION: These results confirm the efficacy and safety of GemOx, but this study failed to demonstrate a statistically significant advantage in terms of OS compared with Gem. Because GemOx is the first combined treatment to be superior to Gem alone in terms of clinical benefit, this promising regimen deserves further development.
Supported by a grant from Sanofi-Synthelabo.
Authors' disclosures of potential conflicts of interest are found at the end of this article.
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