NEW ORLEANS, June 7 /PRNewswire/ -- The final results of a Phase III trial comparing the combination of gemcitabine (Gem) and Eloxatin(TM) (oxaliplatin for injection) (Ox) to gemcitabine alone were presented at the 40th annual meeting of the American Society of Clinical Oncology (ASCO). This randomized trial demonstrated that the addition of ELOXATIN to gemcitabine, the current standard chemotherapy for pancreatic cancer, achieved significantly better results than gemcitabine alone in terms of response rate, progression-free survival and clinical benefit response. The difference did not reach statistical significance in terms of overall survival.
"The results of the Gem-GemOx study confirm the efficacy and safety of the gemcitabine + ELOXATIN combination," said Christophe Louvet, MD, principal investigator and deputy director of the Oncology Department, Saint Antoine Hospital and University, Paris. "The study encourages us to further explore the GemOx combination in future trials, particularly with new targeted drugs such as EGF-r and VEGF inhibitors."
The trial was conducted jointly by two academic cooperative groups: GERCOR (Groupe Cooperateur Multidisciplinaire en Oncologie) in France and GISCAD (Italian Group for the Study of Digestive Tract Cancer) in Italy. The trial enrolled 326 patients in 36 centers. Dr. Louvet is an active member of the GERCOR Group.
The results of the Gem-GemOx study showed a statistically significant improvement for the GemOx combination over gemcitabine alone in response rate (28.7% vs 16.7%, P=.02), median progression-free survival (5.5 months vs 3.7 months, P=.04), and clinical benefit response (38.9% vs 29.2%, P=.05). The GemOx combination also proved to be well tolerated. Overall survival, although not statistically significant, was better than had been expected in both arms of the study (7.1 months vs 9.0 months, P=.13). Projected survival for each arm was 6 months vs 8 months. These results extend and confirm Phase III study results presented at ASCO in 2003.
Cancer of the pancreas is the 5th leading cause of cancer-related death in western countries and has the lowest of all 5-year survival rates, only 1 to 4%, of all cancers. It is 1.5 times more common among African-Americans than among whites. Chemotherapy for pancreatic cancer with either a single agent or combination therapy achieves marginal tumor shrinkage, as evidenced by the low response rates obtained in most studies, and has limited impact survival.
"Few options currently exist for advanced pancreatic cancer patients, and adding oxaliplatin to gemcitabine appears to be one of the most active and promising combinations in improving patients' outcomes," said Roberto Labianca, MD, director of the Oncology Department of Ospedali Riuniti, Bergamo, Italy. "These results may translate into a significant improvement in patients' quality of life by improving treatment response, adding additional clinical benefit, and extending the time of progression-free survival." Dr. Labianca is Chairman of the GISCAD Group.
The Gem-GemOx trial was supported by a grant from Sanofi-Synthelabo.
References:
Louvet C, Andre T, Lledo G et al: Gemcitabine combined with oxaliplatine in advanced pancreatic adenocarcinoma: Final results of a GERCOR Multicenter Phase II study. J Clin Oncol 2002: 1512-1518.
Christophe Louvet, Roberto Labianca, Pascal Hammel et al: Gemcitabine versus GEMOX (Gemcitabine + Oxaliplatin) in non resectable pancreatic adenocarcinoma: Interim results of the GERCOR /GISCAD Intergroup Phase III. Proc Am Soc Clin Oncol, 2003, abstract 1004
GERCOR; GISCAD