Abstract:
Objective This study aims to assess the efficacy and toxicity of the combination of paclitaxel and nedaplatin as a front-line chemotherapy for patients with metastatic esophageal squamous cell carcinoma (ESCC).
Methods Patients with metastatic ESCC who previously received no palliative chemotherapy were enrolled into a two-center, open-label, single-arm phase Ⅱ study. The patients received 175 mg/m2 paclitaxel over a 3 h infusion on day 1, followed by 80 mg/m2 nedaplatin over a 2 h infusion on day 2. The treatments were done every 3 weeks until a documented disease progression occurs, unacceptable toxicity is reached, or when the patient refused treatment.
Results TA total of 39 patients were enrolled in the intention-to-treat analysis of efficacy and adverse events. Of the 36 patients assessed for efficacy, 2 (5.1 %) had complete responses and 16 patients (41.0 %) had partial responses, giving anoverall response rate of 46.1 %. With a median follow-up period of 13.1 months (range = 3.3 months to 28.6 months), the median progression-free survival and median overall survival for all patients were 7.1 months (95 % CI: 4.6 months to 9.7 months) and 12.4 months (95 % CI: 9.5 months to 15.3 months), respectively. The toxicities were moderate and manageable. Grade 3 / 4 toxicities included neutropenia (15.4 %), nausea (10.3 %), anemia (7.7 %), thrombocytopenia (5.1 %), vomiting (5.1 %), and neutropenia fever (2.6 %).
Conclusion The combination of paclitaxel and nedaplatin is active and well tolerated as a first-line therapy for patients with metastatic ESCC.