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Langer C , Li SG , Schiller J , Tester W , Rapoport BL , Johnson DH
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
Journal of Clinical Oncology. 2007 Feb;25(4) :418-423
PMID: ISI:000244070400012   
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Abstract
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-naive 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/m(2) every 3 weeks (CbP) or gemcitabine 1 g/m(2) days 1 and 8 and cisplatin 60 mg/m(2) 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.
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ISI Document Delivery No.: 134GB Times Cited: 0 Cited Reference Count: 22 Cited References: ALBAIN KS, 1991, J CLIN ONCOL, V9, P1618 ALBEROLA V, 2003, J CLIN ONCOL, V21, P3207 BILLINGHAM LJ, 2001, ANN ONCOL, V12, P1671 CULLEN MH, 1999, J CLIN ONCOL, V17, P3188 FRASCI G, 2000, J CLIN ONCOL, V18, P2529 GRIDELLI C, 2003, J NATL CANCER I, V95, P362 HESKETH PJ, 2004, P SOC AM ONCOL, V23, P627 JIROUTEK M, 1998, P AN M AM SOC CLIN, V17, P461 KELLY K, 2004, SEMIN ONCOL S11, V31, P3 KOSIMIDIS PA, 2004, J CLIN ONCOL S, V23, P627 KOSMIDIS P, 2002, J CLIN ONCOL, V20, P3578 LECHEVALIER T, 1994, J CLIN ONCOL, V12, P360 LECHEVALIER T, 2001, ONCOLOGIST S1, V6, P8 LILENBAUM R, 2004, P AN M AM SOC CLIN, V23, P627 LILENBAUM RC, 2002, P AN M AM SOC CLIN, V21, A1 PAESMANS M, 1995, J CLIN ONCOL, V13, P1221 RUCKDESCHEL JC, 1986, J CLIN ONCOL, V4, P14 SCHILLER JH, 2002, NEW ENGL J MED, V346, P92 SMIT EF, 2003, J CLIN ONCOL, V21, P3909 STANLEY KE, 1980, J NATL CANCER I, V65, P25 SWEENEY CJ, 2001, CANCER, V92, P2639 VANSTEENKISTE J, 2003, LUNG CANCER-J IASLC, V40, P191