Second-line chemotherapy with paclitaxel, cisplatin and gemcitabine in pre-treated sensitive cisplatin-based patients with advanced non-small cell lung cancer

Background: To investigate the safety and effectiveness of the combination of paclitaxel, cisplatin and gemcitabine as second-line in patients with ad vanced non-small cell lung cancer (NSCLC) sensitive to first-line cisplatin -based chemotherapy Patients and Methods: From June 1997 to December 1998, 26 patients with stage IIIB or IV NSCLC received paclitaxel 125 mg/m(2), as a one-hour infusion, followed by cisplatin 50 mg/m(2) and gemcitabine 1000 mg/m(2), intravenously, on day 1 and 8, every 3 weeks. Twenty-three patien ts were male; the median age was 59 years (range 44-70); The Eastern Cooper ative Oncology Group performance status was 0 to 1 in 88% of patients; 16 p atients had stage IV disease and 7 patients had 3 or more sites of disease. The predominant histology was adenocarcinoma in 14 patients. Prior treatme nt involved cisplatin plus vinorelbine in 14 patients and cisplatin plus mi tomycin C plus vindesine in 12 cases. Results: Seven (27%; exact 95% confid ence limits: 11.6 - 47.8%) patients achieved a partial response to treatmen t whilst 7 (27%) had stable disease The median duration of response was 22 weeks (range, 18 to 34 weeks). The median overall survival was 24 weeks (ra nge, 8 to 36 weeks). The main toxicities were: grade 3-4 neutropenia in 9 ( 34%) patients; grade 2-3 peripheral neuropathy in 10 (38%); and grade 2-3 a sthenia in 15 (57%) cases. Conclusion: The paclitaxel, cisplatin and gemcit abine combination is active as a second-line regimen in patients with advan ced NSCLC, but with mild toxicity. It seems suitable for patients with adva nced NSCLC as a first-line treatment.