Paclitaxel and Cisplatin as First-Line Therapy in Recurrent or Advanced Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study

Reviewers: Li Liu, MD
Source: Journal of Clinical Oncology, 17(9): 2676, September 1999

Background

This is a phase II study testing the efficacy and toxicity of paclitaxel and cisplatin in recurrent or advanced squamous cell carcinoma of the cervix. It forms the basis for the phase III study by Gynecologic Oncology Group (GOG) comparing this regimin to cisplatin alone.

Methods

Patients with squamous cell carcinoma of the cervix who were not curable with surgery or radiation therapy received paclitaxel at a dose of 135mg/m2 as a 24-hour intravenous infusion followed immediately by cisplatin at a dose of 75mg/m2 intravenously at a rate of 1mg/min. Treatment cycles were repeated every 21 days.

Results

• Overall response rate was 46% (CR 12%, PR 34%) with a median survival of 10+ months.
• The major dose-limiting factors were neutropenia, thrombocytopenia, and gastrointestinal toxicities.
• Two out of 44 patients died of neutropenic sepsis.

Discussion

The combination of paclitaxel and cisplatin appeared to have a favorable response rate in patients with advanced cervical cancer. Toxicities seemed to be more significant when compared to previously reported regimens of cisplatin-based chemotherapy without paclitaxel. The ongoing phase III trial from the GOG will compare this regimen with cisplatin alone to assess response rate, toxicity, progression-free survival, and survival.