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Cited by 881

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Phase III Study of Erlotinib in Combination With Cisplatin and Gemcitabine in Advanced Non–Small-Cell Lung Cancer: The Tarceva Lung Cancer Investigation Trial

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·2007·Journal of Clinical Oncology

Abstract

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-naïve advanced NSCLC.

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Metadata

Authors
Gatzemeier, U., Pluzanska, A., Szczesna, A., Kaukel, E., Roubec, J., De Rosa, F., Milanowski, J., Karnicka-Mlodkowski, H., Pesek, M., Serwatowski, P., Ramlau, R., Janaskova, T., Vansteenkiste, J., Strausz, J., Manikhas, G. M., & Von Pawel, J.
Venue
Journal of Clinical Oncology
Published
2007-04-20
Volume
25
Issue
12
Pages
1545-1552
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2152755651
Cited by
881
References
7
FWCI
79.16
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: Phase III Study of Erlotinib in Combination With Cisplatin and Gemcitabine in Advanced Non–Small-Cell Lung Cancer: The Tarceva Lung Cancer Investigation Trial. https://app.cochat.ai/papers/10.1200/jco.2005.05.1474
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Gatzemeier, U., Pluzanska, A., Szczesna, A., Kaukel, E., Roubec, J., De Rosa, F., Milanowski, J., Karnicka-Mlodkowski, H., Pesek, M., Serwatowski, P., Ramlau, R., Janaskova, T., Vansteenkiste, J., Strausz, J., Manikhas, G. M., & Von Pawel, J. (2007). Phase III Study of Erlotinib in Combination With Cisplatin and Gemcitabine in Advanced Non–Small-Cell Lung Cancer: The Tarceva Lung Cancer Investigation Trial. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2005.05.1474

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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