Originally published as JCO Early Release 10.1200/JCO.2008.17.4656 on December 1 2008

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Randomized Phase II Study of Pulse Erlotinib Before or After Carboplatin and Paclitaxel in Current or Former Smokers With Advanced Non–Small-Cell Lung Cancer

Gregory J. Riely, Naiyer A. Rizvi, Mark G. Kris, Daniel T. Milton, David B. Solit, Neal Rosen, Emir Senturk, Christopher G. Azzoli, Julie R. Brahmer, Francis M. Sirotnak, Venkatraman E. Seshan, Margaret Fogle, Michelle Ginsberg, Vincent A. Miller, Charles M. Rudin

From the Thoracic Oncology Service, Departments of Medicine, Radiology, and Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, Weill Medical College of Cornell University, New York, NY; and the Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD

Corresponding author: Gregory J. Riely, MD, PhD, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10022; e-mail: rielyg{at}mskcc.org

Purpose A prior study demonstrated that addition of continuous daily erlotinib fails to improve response rate or survival in non–small-cell lung cancer (NSCLC) patients treated with carboplatin and paclitaxel. However, preclinical data support the hypothesis that intermittent administration of erlotinib before or after chemotherapy may improve efficacy. We tested this hypothesis in patients with advanced NSCLC.

Patients and Methods Eligible patients were former or current smokers with chemotherapy-naive stage IIIB or IV NSCLC. All patients received up to six cycles of carboplatin (area under the curve = 6) and paclitaxel (200 mg/m²), with random assignment to one of the following three erlotinib treatments: erlotinib 150 mg on days 1 and 2 with chemotherapy on day 3 (150 PRE); erlotinib 1,500 mg on days 1 and 2 with chemotherapy on day 3 (1,500 PRE); or chemotherapy on day 1 with erlotinib 1,500 mg on days 2 and 3 (1,500 POST). The primary end point was response rate.

Results Eighty-six patients received treatment. The response rates for the 150 PRE, 1,500 PRE, and 1,500 POST arms were 18% (five of 28 patients), 34% (10 of 29 patients), and 28% (eight of 29 patients), respectively. The median overall survival times were 10, 15, and 10 months for the 150 PRE, 1,500 PRE, and 1,500 POST arms, respectively. The most common grade 3 and 4 toxicities were neutropenia (39%), fatigue (15%), and anemia (12%). Grade 3 and 4 rash and diarrhea were uncommon.

Conclusion Patients treated on the 1,500 PRE arm had the highest response rate and longest survival, with ranges similar to those reported for carboplatin, paclitaxel, and bevacizumab in a more restricted population. Further evaluation of this strategy in a phase III trial is proposed.

published online ahead of print at www.jco.org on December 1, 2008.

Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL

Supported in part by Genentech, Inc.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00287989 [ClinicalTrials.gov]

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