Open Access

ARTICLE

Gemcitabine Plus Vinorelbine as Second-Line Therapy in Patients With Metastatic Esophageal Cancer Previously Treated With Platinum-Based Chemotherapy

Yue-shen Wang^*1, Jing Tian^†1, Yong Han^†, Shu-mei Han^†, Sheng-bin Shi^†

* Department of Oncology, Jilin People’s Hospital, Jilin, Jilin, P.R. China
† Department of Medical Oncology, Shandong Cancer Hospital Affiliated to Shandong University, Shandong Academy of Medical Sciences, Jinan, Shandong, P.R. China
1 These authors provided equal contribution to this work.

Oncology Research 2016, 24(2), 129-135. https://doi.org/10.3727/096504016X14618564639213

Abstract

We evaluated the efficacy and feasibility of the combination of gemcitabine plus vinorelbine in patients with platinum-based chemotherapy-refractory esophageal cancer. We enrolled 35 patients who received gemcitabine plus vinorelbine as second-line treatment after platinum-based chemotherapy failure between May 2009 and April 2012. Dosage: gemcitabine 1,000 mg/m² plus vinorelbine 25 mg/m² ; all drugs were administered on days 1 and 8 of a 21-day cycle, and this was continued until failure or unacceptable toxicity. A total of 125 cycles of treatment were administered, and all patients received at least two cycles of treatment (two to five cycles; median number of cycles: three). Thirty-two patients were evaluable for response. The response rate was 31.3%, and the disease control rate (partial response plus stable disease) was 62.5%. The progression-free survival (PFS) was 4.3±0.2 months [95% confidence interval (CI), 4.0–4.6], and the median overall survival (OS) was 7.3±0.3 months (95% CI, 6.7–7.8). In the subgroup analysis, median PFS was 4.0±0.2 months (95% CI, 3.6–4.3) in patients with high expression of miRNA-214, while it was 4.6±0.3 months (95% CI, 4.1–5.1) in patients with low expression of miRNA-214 (log rank=0.023). Myelosuppression with neutropenia and thrombocytopenia was the most common side effect observed with this combination regimen, and higher than grade 3 neutropenia and thrombocytopenia were observed in 10 (31.3%) and 8 patients (25.0%), respectively. Grade 3 fatigue was the most common nonhematologic toxicity, which was observed in 2 (6.1%) patients. The combination of gemcitabine plus vinorelbine was well tolerated as second-line treatment for platinum-based chemotherapy-refractory esophageal cancer patients and appeared to provide enhanced clinical activity especially in patients with low expression of miRNA-214.

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