Gemcitabine and vinorelbine as second-line therapy in non-small-cell lung cancer after prior treatment with taxane plus platinum-based regimens

Treatment options in patients with recurrent non-small-cell lung cancer (NS CLC) remain limited as a result of the poor activity of older agents after platinum-based therapy. The present phase II study aimed to evaluate the co mbination of gemcitabine and vinorelbine in patients with relapsed NSCLC af ter pretreatment with taxane + platinum-based regimens, since gemcitabine h as demonstrated activity in that setting and the combination has been well tolerated in previous phase I/II studies. Patients with advanced NSCLC (sta ges III/IV), World Health Organization (WHO), Performance Status (PS)less t han or equal to2, prior platinum + taxane-based chemotherapy and unimpaired haematopoietic and organ function were eligible. Chemotherapy was administ ered as follows: vinorelbine 25 mg/m(2) followed by gemcitabine 1000 mg/m(2 ). both administered on days 1 and 8, recycled every 3 weeks. 40 patients w ere entered and 39 were evaluable for response and all 40 for toxicity: med ian age was 61 years (range 50-72 years), median PS = 1 (range 0 2), gender ratio = 37 males/3 females, stages at initial diagnoses were ILIA = 2, III B - 14, IV = 24. Metastatic sites included: lymph nodes: 23, bone: 4, liver : 5, brain: 4, lung nodules: 9, adrenals: 8, pleural effusion: 4. 22 patien ts had prior paclitaxel/ifosfamide/cisplatin treatment. Objective responses were; partial response (PR): 9/40 (22.5%), stable disease (SD): 13/40 (32. 5%) and progressive disease (PD) 18/40 (45%). The median time-to-progressio n (TTP) was 4.5 months (range 1-17 months) and median survival 7 months (ra nge 2-17 + months), 1-year survival was 17%. Grade 3 neutropenia was seen i n 33% of patients. There was no grade 4 neutropenia and no episodes of febr ile neutropenia, No grade 3/4 thrombocytopenia or grade 3/4 other non-haema tological toxicities were observed. The combination of gemcitabine/vinorelb ine is active and well tolerated in patients with advanced NSCLC failing pr ior taxane/platinum therapy. This regimen represents a tolerable and effect ive combination to apply in the palliative treatment of relapsed NSCLC, (C) 2001 Elsevier Science Ltd. All rights reserved.