SAN FRANCISCOIn patients with advanced pancreatic cancer, the combination of gemcitabine(Drug information on gemcitabine) (Gemzar) followed by oxaliplatin(Drug information on oxaliplatin) (investigational in the United States) (GEMOX) is active with low toxicity, Christophe Louvet, MD, Hôpital St-Antoine, Paris, France, said at the 37th Annual Meeting of the American Society of Clinical Oncology (ASCO abstract 506).
The rationale for the gemcitabine/oxaliplatin combination is that the two agents have distinctly different mechanisms of action and patterns of resistance without overlapping toxicities.
Preclinical investigations looking into the possible combined effects of gemcitabine/oxaliplatin or gemcitabine/cisplatin (Platinol) found the best synergy effects for the sequence of gemcitabine followed by oxaliplatin, Dr. Louvet said.
The current phase II trial included 64 patients (mean age, 59.5 years) treated at eight centers; 47% had stage II-III locally advanced disease and 53% had stage IV metastatic disease. Enrollment criteria included Karnofsky performance status of 60 to 100.
Patients received gemcitabine 1,000 mg/m² in a 10 mg/m²/min infusion on day 1 and oxaliplatin 100 mg/m² in a 2-hour infusion on day 2. Treatment was repeated every 2 weeks for six cycles followed by chemoradiation with fluorouracil(Drug information on fluorouracil) in locally advanced patients, or until progression of disease in metastatic patients.
Partial responses were reported in 19 patients, stable disease in 28, and progressive disease in 16, for a response rate of 30.2%. Response rates for locally advanced patients (31%) and metastatic disease patients (30.3%) were similar. The clinical benefit response rate was 39.7% (23 of 58 patients), Dr. Louvet said.