Randomized study of paclitaxel-cisplatin versus cisplatin-teniposide in patients with advanced non-small-cell lung cancer

被引:214
作者
Giaccone, G
Splinter, TAW
Debruyne, C
Kho, GS
Lianes, P
van Zandwijk, N
Pennucci, MC
Scagliotti, G
van Meerbeeck, J
van Hoesel, Q
Curran, D
Sahmoud, T
Postmus, PE
机构
[1] Free Univ Amsterdam Hosp, Div Oncol, NL-1081 HV Amsterdam, Netherlands
[2] Netherlands Canc Inst, Amsterdam, Netherlands
[3] Univ Hosp Dijkzigt, NL-3015 GD Rotterdam, Netherlands
[4] Radboud Hosp, Nijmegen, Netherlands
[5] European Org Res Treatment Canc, Ctr Data, Brussels, Belgium
[6] Univ Antwerp Hosp, Antwerp, Belgium
[7] Hosp 12 Octubre, E-28041 Madrid, Spain
[8] Osped S Luigi, Orbassano, Italy
[9] Ist Nazl Ric Canc, I-16132 Genoa, Italy
关键词
D O I
10.1200/JCO.1998.16.6.2133
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: To compare two cisplatin based chemotherapy schedules in patients with advanced non-small-cell lung cancer (NSCLC). Patients and Methods: A total of 332 patients with advanced NSCLC were randomized to receive cisplatin 80 mg/m(2) on day 1 either in combination with teniposide 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 weeks. Results: Fifteen patients were ineligible; patient characteristics were well balanced between the two arms: 71% were male, 71% had less than 5% weight loss, 89% had a World Health Organization (WHO) performance status of 0 to 1, 51% had adenocarcinoma, and 61% had stage IV disease. Hematologic toxicity was significantly more severe in arm A (leukopenia, 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), dose reductions, and treatment delays. There were a total of nine toxic deaths, 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 neurotoxicity (grade 2 or 3, 6% v 29%), and hypersensitivity reactions (1% v 7%, all grades) were significantly more frequent in arm B. The frequency and severity of other toxicities were comparable between the two arms. Responses were one complete and 44 partial on arm A (28%) and 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, respectively. Selected centers participated in a quality-of-life (QoL) assessment, which was performed by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and LC-13 administered at baseline and every 6 weeks thereafter. Arm B achieved a better score at week 6 for emotional, cognitive and social functioning, global health status, fatigue, and appetite loss, which was lost at 12 weeks. In conclusion, arm B appears superior to arm A with regard to response rate, side effects, and QoL. Conclusion: Although survival was not improved, arm B offers a better palliation for advanced NSCLC patients than arm A.
引用
收藏
页码:2133 / 2141
页数:9
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