Published online Sep 21, 2013. doi: 10.3748/wjg.v19.i35.5910
Revised: August 1, 2013
Accepted: August 12, 2013
Published online: September 21, 2013
Processing time: 110 Days and 14.3 Hours
AIM: To evaluate the efficacy and safety of paclitaxel-nedaplatin combination as a front-line regimen in Chinese patients with metastatic esophageal squamous cell carcinoma (ESCC).
METHODS: A two-center, open-label, single-arm phase II study was designed. Thirty-nine patients were enrolled and included in the intention-to-treat analysis of efficacy and adverse events. Patients received 175 mg/m2 of paclitaxel over a 3 h infusion on 1 d, followed by nedaplatin 80 mg/m2 in a 1 h infusion on 2 d every 3 wk until the documented disease progression, unacceptable toxicity or patient’s refusal.
RESULTS: Of the 36 patients assessable for efficacy, there were 2 patients (5.1%) with complete response and 16 patients (41.0%) with partial response, giving an overall response rate of 46.1%. The median progression-free survival and median overall survival for all patients were 7.1 mo (95%CI: 4.6-9.7) and 12.4 mo (95%CI: 9.5-15.3), respectively. 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.
Core tip: Esophageal cancers are among the most aggressive tumors with a poor prognosis. Till now, there has been no standard chemotherapy regimen for advanced esophageal cancer. In this paper, we conducted a phase II study on combination chemotherapy consisting of paclitaxel and nedaplatin in previously untreated patients with metastatic esophageal squamous cell carcinoma (ESCC). Our results demonstrated that the combination of two drugs is active and well tolerated as a first-line therapy for patients with recurrent or metastatic ESCC.