TY  - EJOU
AU  - Wang, Yue-shen 
AU  - Tian, Jing 
AU  - Han, Yong 
AU  - Han, Shu-mei 
AU  - Shi, Sheng-bin 

TI  - Gemcitabine Plus Vinorelbine as Second-Line Therapy in Patients With Metastatic Esophageal Cancer Previously Treated With Platinum-Based Chemotherapy
T2  - Oncology Research

PY  - 2016
VL  - 24
IS  - 2
SN  - 1555-3906

AB  - 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/m<sup>2</sup>
 plus vinorelbine 25 mg/m<sup>2</sup>
; 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.
KW  - Advanced esophageal cancer; Second-line treatment; Gemcitabine plus vinorelbine;  Platinum-based chemotherapy; miRNA-214; Progression-free survival

DO  - 10.3727/096504016X14618564639213