Seigo Minami, Yoshitaka Ogata, Suguru Yamamoto, Kiyoshi Komuta

Advanced non-small-cell lung cancer (NSCLC) eventually progresses after first-line chemotherapy, and usually requires salvage treatment. Although neither gemcitabine nor vinorelbine is approved as a candidate drug in the second- or further-line for NSCLC, they can be alternative drugs in terms of anti-tumor effects and toxicities. Actually, in our institution, we often use a combination of these two anti-tumor drugs in our daily practice. We retrospectively reviewed 85 patients with advanced NSCLC who had received combination chemotherapy of gemcitabine and vinorelbine after a platinum-based regimen from June 2007 to June 2014 in Osaka Police Hospital, and performed Cox proportional hazard analyses in order to detect predictive factors for progression-free survival (PFS). Patient characteristics included a mean age of 65.5 years, 56 males, 54 adenocarcinoma, 53 European Clinical Oncology Group performance status 0-1. Thirteen and 35 patients received the study treatment as the second- and third-line treatment, respectively. The overall response rate, disease control rate, PFS, and overall survival were 4.7% (95% confidence interval 1.3%-11.6%), 30.6% (21.0%-41.5%), 2.1 months (1.7-2.8 months), and 6.9 months (5.0-11.0 months). Twenty-one and six patients experienced grade 4 neutropenia and febrile neutropenia, respectively. European Clinical Oncology Group performance status 0-1 was detected as a factor predicting longer PFS by univariate (hazard ratio, 1.63; 95% confidence interval, 1.28-2.08; P<0.001) and multivariate (1.65, 1.27-2.14, P<0.001) analyses. This combination was ineffective and harmful to pretreated patients with NSCLC. We do not recommend this regimen as a later-line treatment option.