A phase II tolerability study of cisplatin plus docetaxel as adjuvant chemotherapy for resected non-small cell lung cancer

被引:11
|
作者
Azzoli, Christopher G.
Krug, Lee M.
Miller, Vincent A.
Rizvi, Naiyer A.
Kris, Mark G.
Dunne, Megan
Farmer, Amy
Pizzo, Barbara
Tyson, Leslie
Seeger, Teresa
Coleman, Barbara
Moore, Erin
Lastinger, Lauren
Venkatraman, Ennapadam
Rudin, Charles M.
机构
[1] Cornell Univ, Weill Med Coll, Mem Sloan Kettering Canc Ctr, Div Solid Tumor Oncol,Dept Med,Thorac Oncol Serv, New York, NY 10021 USA
[2] Cornell Univ, Weill Med Coll, Mem Sloan Kettering Canc Ctr, Dept Nursing, New York, NY 10021 USA
[3] Cornell Univ, Weill Med Coll, Mem Sloan Kettering Canc Ctr, Clin Trials Off, New York, NY 10021 USA
[4] Sidney Kimmel Comprehens Canc Ctr, Baltimore, MD USA
关键词
non-small cell lung cancer; adjuvant chemotherapy; cisplatin; docetaxel;
D O I
10.1097/JTO.0b013e318074bbd0
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Introduction: We undertook this phase II study to measure postoperative drug delivery and toxicity of cisplatin plus docetaxel in patients with resected stage I-III non-small cell lung cancer. Methods: The primary endpoint was amount of cisplatin delivered over a planned four cycles of adjuvant chemotherapy. Statistical design required a cohort to close if the regimen proved unlikely to improve cisplatin delivery compared with published phase III data. The first cohort was treated with docetaxel 35 mg/m(2) intravenously (IV) on days 1, 8, and 15, and cisplatin 80 Mg/m(2) IV on day 15, every 4 weeks for four planned cycles. A second cohort was treated with docetaxel 75 mg/m(2) IV plus cisplatin 80 mg /m(2) IV on day 1 every 3 weeks for four planned cycles. Results: Sixteen patients were treated with weekly docetaxel and cisplatin every 4 weeks, with five of 16 (31%) unable to complete three cycles. Subsequently, 11 patients were treated with docetaxel and cisplatin every 3 weeks, with six of 11 (55%) unable to complete three cycles. Among the 11 patients who failed to complete three cycles, the reasons for stopping included one or more of the following: fatigue (n = 8), nausea (n = 4), febrile neutropenia (n=1), hypotension (n = 1), and nephrotoxicity (n = 1). Conclusions: The combination of cisplatin at 80 Mg/m(2) with docetaxel 35 Mg/m(2) weekly or 75 mg/m(2) every 3 weeks is no better tolerated than older chemotherapy regimens. The most common reason to stop chemotherapy was intolerable fatigue. These results suggest that the most common dose-limiting toxicities are attributable to the cisplatin, given similar problems were encountered whether the docetaxel was delivered as a single dose every 3 weeks or as a lower weekly dose.
引用
收藏
页码:638 / 644
页数:7
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