Phase II Trial of the combination of Paclitaxel and 5-Fluorouracil in the Treatment of Advanced Gastric Cancer ? A Novel, Safe, and Effective Regimen

Reviewers: Li Liu, MD
Source: American Journal of Clinical Oncology, 22(6):580-586, December 1999.

Précis: So far, the combination of paclitaxel and 5-fluorouracil have appeared to be very effective and safe in patients with advanced gastric cancer. More studies are necessary.

Introduction

Gastric cancer is the 9th leading cause of cancer related death in the United States, and second in the world. Curative surgery is the mainstay of treatment whenever the tumor is resectable. Adjuvant therapies have been investigated extensively for more than 30 years. Dr. Andre M. Murad and colleagues from Hospital das Clinicas in Brazil conducted this phase II study to explore the activity and efficacy of the combination of paclitaxel and 5-fluorouracil (5-FU) in the treatment of advanced gastric adenocarcinoma.

Method

A total of 31 patients with locally unresectable or metastatic gastric carcinoma received up to 7 cycles of paclitaxel and 5-FU. 29 patients were eligible for response and toxicity evaluation.

Results

• At 4 months, 24.1% of patients had complete responses and 41.4% had partial responses, and 51% of patients had improvement in quality of life.
• Median survival was 12 months and 30-month survival was 20%.
• There were no serious toxicities or deaths associated with this treatment.

Discussion

The combination of paclitaxel and 5-fluorouracil appeared to be very effective and safe in patients with advanced gastric cancer. Phase III randomized studies are warranted to confirm the real merit of this novel regimen.