Phase II study of paclitaxel and cisplatin in advanced esophageal cancer: A Chinese esophageal cancer group

Abstract

4173 Background: Esophageal cancer is not common in western countries, but it is one of the most frequent malignancies and the second leading cause of death from cancer in china. Paclitaxel is one of the most active single agents in the treatment of metastatic esophageal cancer. We performed a phase II trial of paclitaxel in combination with cisplatin for esophageal cancer. The antitumor response, toxicity and survival of patients treated with the two-drug regimen were evaluated. Methods: 28 patients with advanced, surgically unresectable, or metastatic squamous cell of the esophagus were enrolled. 25 patients had no priorchemotherapy. 3 patients had previous adjuvant chemotherapy. Patients received paclitaxel 175mg/m2 by 3-hour infusion day 1, and cisplatin 40mg/m2 daily days 2 through 3. Granulocyte colony-stimulating factor (G-CSF) was not routinely a administered unless the patient had neutropenia. Treatment was recycled every 21 days. Results: 28 patients (male/female, 27/1; median age 55, range 38–76 ) completed a median of 4 cycles, and 27 patients were evaluable for response (CR 14.8% PR 40.7%, SD 25.9%, PD18.5%). Toxicity was manageable with dose attenuation. 7 patients required a dose altenuation for toxicity. There were one toxic death due to grade 4 neutropenia. Conclusion: The combination of paclitaxel and cisplatin is active and a well tolerated regimen. No significant financial relationships to disclose.