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The Addition of Oxaliplatin to Gemcitabine Markedly Enhances Treatment Efficacy in Advanced Pancreas Cancer: Results of the Gem-GemOx Phase III Study

June 2, 2003
Chicago Illinois

The first results of the phase III trial comparing the combination of gemcitabine (Gem) and oxaliplatin (Ox) to gemcitabine alone were presented at the 39th annual meeting of the American Society of Clinical Oncology. This randomized trial demonstrated that the addition of oxaliplatin to gemcitabine, the current standard chemotherapy for pancreatic cancer, markedly increases tumor shrinkage and time to progression and significantly improves clinical benefit.

The trial was conducted by 2 academic cooperative groups: GERCOR in France and GISCAD in Italy. The trial enrolled 326 patients in 36 centers.

"The 2 drugs have proved synergistic in both preclinical and clinical settings. The rationale for evaluating this combination in pancreatic cancer was thus strong," said Christophe Louvet MD, Professor of Medicine, Deputy Director of the Oncology Department, Saint Antoine Hospital and University, Paris, Active Member of the GERCOR Group and Principal Investigator of the Gem-GemOx study. "Data available to date show that GemOx is superior to Gem in terms of tumor shrinkage, time to progression, clinical benefit and is also well tolerated. We hope that these positive results will also translate into an improvement in survival but what we have so far is very encouraging in this disease where very few therapeutic options are available to patients," he added.

"GemOx appears to be one of the most active and promising combinations in improving the outcome of patients suffering from advanced pancreatic cancer," concluded Pr Roberto Labianca MD, Director of the Oncology Department of Ospedali Riuniti, Bergamo, Italy, Chairman of the GISCAD Group.

Cancer of the pancreas is the 5th leading cause of cancer-related death in western countries with only 1 to 4% of the patients surviving at 5 years. 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 on survival.

The Gem-GemOx trial was conducted by the GERCOR and GISCAD groups and was supported by a grant from Sanofi-Synthelabo.

For further information, please contact:
Claire Hebdon: +44-788-755-1467
clairehebdon@hotmail.com
claire.hebdon@atriumhealth.com

References:
* Louvet C, Andre T, Lledo G et al: Gemcitabine combined with oxalplatine in advanced pancreatic adenocarcinoma; Final results of a GERCOR Multicenter Phase II study. J Clin Oncol, 2002: 1512-1518.

* Christophe Louvet, Roberto Labianca, Pascal Hemmel 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.

Press Release
SOURCE: Oncology Multidisciplinary Research Group; Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente

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	Pancreas Cancer News and Archives
		For educational purposes only; not to be relied upon. Please read Pancreatica Disclaimer
	The Addition of Oxaliplatin to Gemcitabine Markedly Enhances Treatment Efficacy in Advanced Pancreas Cancer: Results of the Gem-GemOx Phase III Study June 2, 2003 Chicago Illinois The first results of the phase III trial comparing the combination of gemcitabine (Gem) and oxaliplatin (Ox) to gemcitabine alone were presented at the 39th annual meeting of the American Society of Clinical Oncology. This randomized trial demonstrated that the addition of oxaliplatin to gemcitabine, the current standard chemotherapy for pancreatic cancer, markedly increases tumor shrinkage and time to progression and significantly improves clinical benefit. The trial was conducted by 2 academic cooperative groups: GERCOR in France and GISCAD in Italy. The trial enrolled 326 patients in 36 centers. "The 2 drugs have proved synergistic in both preclinical and clinical settings. The rationale for evaluating this combination in pancreatic cancer was thus strong," said Christophe Louvet MD, Professor of Medicine, Deputy Director of the Oncology Department, Saint Antoine Hospital and University, Paris, Active Member of the GERCOR Group and Principal Investigator of the Gem-GemOx study. "Data available to date show that GemOx is superior to Gem in terms of tumor shrinkage, time to progression, clinical benefit and is also well tolerated. We hope that these positive results will also translate into an improvement in survival but what we have so far is very encouraging in this disease where very few therapeutic options are available to patients," he added. "GemOx appears to be one of the most active and promising combinations in improving the outcome of patients suffering from advanced pancreatic cancer," concluded Pr Roberto Labianca MD, Director of the Oncology Department of Ospedali Riuniti, Bergamo, Italy, Chairman of the GISCAD Group. Cancer of the pancreas is the 5th leading cause of cancer-related death in western countries with only 1 to 4% of the patients surviving at 5 years. 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 on survival. The Gem-GemOx trial was conducted by the GERCOR and GISCAD groups and was supported by a grant from Sanofi-Synthelabo. For further information, please contact: Claire Hebdon: +44-788-755-1467 clairehebdon@hotmail.com claire.hebdon@atriumhealth.com References: * Louvet C, Andre T, Lledo G et al: Gemcitabine combined with oxalplatine in advanced pancreatic adenocarcinoma; Final results of a GERCOR Multicenter Phase II study. J Clin Oncol, 2002: 1512-1518. * Christophe Louvet, Roberto Labianca, Pascal Hemmel 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. Press Release SOURCE: Oncology Multidisciplinary Research Group; Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente

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