RANDOMIZED STUDY OF PACLITAXEL-CISPLATIN VERSUS CISPLATIN-TENIPOSIDE IN PATIENTS WITH ADVANCED NON-SMALL-CELL LUNG-CANCER

Purpose: To compare two cisplatin based chemotherapy schedules in pati ents with advanced non-small-cell lung cancer (NSCLC). Patients and Me thods: A total of 332 patients with advanced NSCLC were randomized to receive cisplatin 80 mg/m(2) on day 1 either in combination with tenip oside 100 mg/m(2) on days 1, 3, and 5 (arm A) or paclitaxel 175 mg/m(2 ) by 3-hour infusion on day 1 (arm B); cycles were repeated every 3 we eks. Results: Fifteen patients were ineligible; patient characteristic s were well balanced between the two arms: 71% were male, 71% had less than 5% weight loss, 89% had a World Health Organization (WHO) perfor mance status of 0 to 1, 51% had adenocarcinoma, and 61% had stage IV d isease. Hematologic toxicity was significantly more severe in arm A (l eukopenia, neutropenia, and thrombocytopenia grade 3 or 4: 66% v 19%, 83% v 55%, 36% v 2% in arms A and B, respectively), which resulted in more febrile neutropenia (27% v 3% in arms A and B, respectively), dos e reductions, and treatment delays. There were a total of nine toxic d eaths, six due to neutropenic sepsis: five in arm A and one in arm B. In contrast, arthralgia/myalgia (grade 2 or 3, 4% v 17%), peripheral n eurotoxicity (grade 2 or 3, 6% v 29%), and hypersensitivity reactions (1% v 7%, all grades) were significantly more frequent in arm B. The f requency and severity of other toxicities were comparable between the two arms. Responses were one complete and 44 partial on arm A (28%) an d two complete and 61 partial (41%) on arm B (P = .018). There was no significant difference in survival, with median and 1-year survivals 9 .9 versus 9.7 months and 41% versus 43%, respectively in arm A and B. Progression-free survival was 4.9 and 5.4 months in arm A and B, respe ctively. Selected centers participated in a quality-of-life (QoL) asse ssment, which was performed by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and LC-13 administered at base line and every 6 weeks thereafter. Arm B achieved a better score at we ek 6 for emotional, cognitive and social functioning, global health st atus, fatigue, and appetite loss, which was lost at 12 weeks. In concl usion, arm B appears superior to arm A with regard to response rate, s ide effects, and QoL. Conclusion: Although survival was not improved, arm B offers a better palliation for advanced NSCLC patients than arm A.