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Randomized Phase II Trial of Paclitaxel Plus Carboplatin or Gemcitabine Plus Cisplatin in Eastern Cooperative Oncology Group Performance Status 2 Non–Small-Cell Lung Cancer Patients: ECOG 1599

Corey Langer, Sigui Li, Joan Schiller, William Tester, Bernardo L. Rapoport, David H. Johnson

From the Fox Chase Cancer Center; Albert Einstein Cancer Center, Philadelphia, PA; Dana-Farber Cancer Institute, Boston, MA; University of Wisconsin Cancer Center, Madison, WI; Mayo Clinic, Rochester, MN; and Vanderbilt University, Nashville, TN

Address reprint requests to Corey J. Langer, MD, FACP, Thoracic Oncology, Fox Chase Cancer Center, 333 Cottman Ave, Philadelphia, PA 19111; e-mail: cj_langer{at}fccc.edu

Purpose Appropriate therapy for Eastern Cooperative Oncology Group (ECOG) performance status (PS) -2 patients with advanced non–small-cell lung cancer (NSCLC) remains challenging. PS-2 patients on ECOG 1594 had a median survival (MS) of only 4.1 months and 1-year overall survival (OS) of 19%. Three percent had grade 5 toxicity.

Patients and Methods ECOG 1599, the first PS 2–specific, US cooperative group trial for treatment-naïve advanced NSCLC, randomly assigned patients to dose-attenuated carboplatin/paclitaxel (the least toxic regimen in ECOG 1594) or gemcitabine/cisplatin (which yielded an MS of 7.9 months in PS-2 patients). Patients received either carboplatin (area under the concentration-time curve, 6) and paclitaxel 200 mg/m² every 3 weeks (CbP) or gemcitabine 1 g/m² days 1 and 8 and cisplatin 60 mg/m² day 1 every 3 weeks (CG).

Results One hundred three patients were enrolled; 100 proved eligible. Median age was 66 years; 46% had at least 5% weight loss; 88% had stage IV or recurrent disease. Median number of cycles administered was three per arm. CbP featured more grade 3 neutropathy (10% v 0%) and more grade 3 neutropenia (59% v 33%), whereas CG yielded more grade 3 thrombocytopenia (33% v 14%), more grade 3 fatigue (22% v 14%), and more grade 1 creatinine elevations (43% v 6%). One grade 5 toxicity, confined to the CbP arm, occurred. Response rate, time to progression, MS, and 1-year OS rates for CG and CbP, were 23%, 4.8 months, 6.9 months, and 25%, and 14%, 4.2 months, 6.2 months, and 19%, respectively.

Conclusion Platinum-based combination chemotherapy for PS-2 patients with NSCLC is feasible with acceptable toxicity, but survival in these patients remains inferior to that of PS-0 to -1 patients.

Supported in part by Public Health Service Grants No. CA23318, CA66636, CA21115, CA27525, CA21076, CA13650, CA49957, and by the National Cancer Institute, National Institutes of Health, and the Department of Health and Human Services.

The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

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

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