Phase III study of erlotinib in combination with cisplatin and gemcitabine in advanced non-small-cell lung cancer: The Tarceva Lung Cancer Investigation Trial

被引:710
作者
Gatzemeier, Ulrich
Pluzanska, Anna
Szczesna, Aleksandra
Kaukel, Eckhard
Roubec, Jaromir
De Rosa, Flavio
Milanowski, Janusz
Karnicka-Mlodkowski, Hanna
Pesek, Milos
Serwatowski, Piotr
Ramlau, Rodryg
Janaskova, Terezie
Vansteenkiste, Johan
Strausz, Janos
Manikhas, Georgy Moiseevich
Von Pawel, Joachim
机构
[1] Hosp Harburg, Zentrum Pneumol & Thoraxchirurg, Krankenhaus D LVA, Hamburg, Germany
[2] Asklepios Fachkliniken Muenchen Gauting, Gauting, Germany
[3] Med Acad Lodz, Chemotherapy Clin, Lodz, Poland
[4] Mazowieckie Centrum Leczenia Chorob Pluc I Gruzli, Otwock, Poland
[5] Karedra I Klin Chorob Pluc, Akad Med W Lublinie, Lublin, Poland
[6] Szpital Morski Im Pck, Oddzial Chemioterapii, Gdynia, Poland
[7] Specjalistyczny Szpital Im, Oddzial Chemioterapii, Szczecin, Poland
[8] Wielkopolskie Centrum Chorob Pluc & Grurlicy, Poznan, Poland
[9] Klin TBC Resp Onemocneni, Ostrava, Czech Republic
[10] F Hoffmann La Roche & Co Ltd, CH-4002 Basel, Switzerland
[11] Plicni Klin, Fak Nemocnice V Plzni, Plzen, Czech Republic
[12] Vitkovicka nemocnice Bma AS, Ostrava, Czech Republic
[13] Univ Ziekenhuis Leuven, Dept Pulm Med, Louvain, Belgium
[14] Inst Pulm Med Torokbalint, Dept Pulm Med 2, Torokbalint, Hungary
[15] St Petersburg City Oncol Dispensary, Dept Pulm, St Petersburg, Russia
关键词
D O I
10.1200/JCO.2005.05.1474
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose Erlotinib is a potent inhibitor of the epidermal growth factor receptor tyrosine kinase, with single-agent antitumor activity. Preclinically, erlotinib enhanced the cytotoxicity of chemotherapy. This phase III, randomized, double-blind, placebo-controlled, multicenter trial evaluated the efficacy and safety of erlotinib in combination with cisplatin and gemcitabine as first-line treatment for advanced non-small-cell lung cancer (NSCLC). Patients and Methods Patients received erlotinib (150 mg/d) or placebo, combined with up to six 21-day cycles of chemotherapy (gemcitabine 1,250 mg/m(2) on days 1 and 8 and cisplatin 80 mg/m(2) on day 1). The primary end point was overall survival (OS). Secondary end points included time to disease progression (TTP), response rate (RR), duration of response, and quality of life (QoL). Results A total of 1,172 patients were enrolled. Baseline demographic and disease characteristics were well balanced. There were no differences in OS (hazard ratio, 1.06; median, 43 v 44.1 weeks for erlotinib and placebo groups, respectively), TTP, RR, or QoL between treatment arms. In a small group of patients who had never smoked, OS and progression-free survival were increased in the erlotinib group; no other subgroups were found more likely to benefit. Erlotinib with chemotherapy was generally well tolerated; incidence of adverse events was similar between arms, except for an increase in rash and diarrhea with erlotinib (generally mild). Conclusion Erlotinib with concurrent cisplatin and gemcitabine showed no survival benefit compared with chemotherapy alone in patients with chemotherapy-naive advanced NSCLC.
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收藏
页码:1545 / 1552
页数:8
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