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Cisplatin Plus Gemcitabine Appears Active Against Advanced Gastric Cancer

A combination regimen of cisplatin-gemcitabine appears to have moderate efficacy in patients with unresectable gastric cancer, with myelosuppression being the most frequently occurring side effect, Dutch researchers have found.

Additive and synergistic effects of gemcitabine and cisplatin in combination have been demonstrated in several preclinical trials. To test the combination for advanced gastric cancer, S. M. De Lange of the Department of Medical Oncology, VU University Medical Centre, Amsterdam, and colleagues performed a phase 2 study of 40 chemo-naive patients.

All patients had measurable locoregionally advanced or metastatic gastric cancer. Treatment consisted of cisplatin 50 mg/m² administered by intravenous (i.v.) infusion over 1 hour on days 1 and 8, followed after 24 hours by gemcitabine 800 mg/m² administered by i.v. infusion over 30 minutes on days 2, 9 and 16. Chemotherapy cycles were repeated every 4 weeks. A total of 177 chemotherapy cycles were administered, with a median of 4 cycles.

Treatment response was observed after a median of 2 cycles. At the first evaluation, 24 patients had stable disease and 6 patients had progressive disease.

The overall objective response rate was 30%, with 2 complete remissions and 10 partial remissions. The median duration of response was 5 months, the median time to progression was 7 months, and the median survival was 11 months.

Thirty-five patients died, 34 due to malignant disease and 1 because of a perforation that occurred during endoscopy resulting in sepsis. A significant difference in survival was found between patients with stable disease and patients with progressive disease (11 vs. 4 months; P < .00001).

Toxicity was substantial, with myelotoxicity causing omission of gemcitabine on day 16 in 55% of cycles. Grade 3-4 thrombopaenia was observed in 48% of patients and grade 3-4 leucopaenia was observed in 58%. Grade 1-2 nausea and vomiting were the primary non-haematological toxicities.

While the study confirmed the activity of the cisplatin-gemcitabine combination regimen in gastric cancer patients, the investigators point out that managing the toxicity of the schedule appeared challenging.

"This and other studies underline the difficulties in identifying novel agents with activity in this disease and the increased toxicity of regimens with more than two agents," they said.






Ann Oncol 2004 Mar;15:3:484-8. "Phase II trial of cisplatin and gemcitabine in patients with advanced gastric cancer"

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