Cisplatin, etoposide, and paclitaxel with granulocyte colony-stimulating factor in untreated patients with extensive-stage small cell lung cancer: A phase II trial of the southwest oncology group

K. Kelly, L. Lovato, Jr Bunn P.A., R. B. Livingston, J. Zangmeister, S. A. Taylor, D. Roychowdhury, J. J. Crowley, D. R. Gandara, B. Granados

Research output: Contribution to journalArticle

27 Scopus citations

Abstract

Purpose: This study was designed to determine the efficacy and toxicity of cisplatin, etoposide, and paclitaxel (PET) in patients with extensive-stage small cell lung cancer (ES-SCLC). Experimental Design: Chemo-naive adult patients with a performance status (PS) of 0-2 and adequate organ function were eligible. Patients received cisplatin 80 mg/m2 i.v., etoposide 80 mg/m-2 i.v., and paclitaxel 175 mg/m2 i.v. over a 3-h period on day 1 followed by etoposide 160 mg/m2 p.o. on days 2 and 3 every 21 days for six cycles. G-CSF 5 μg/kg was injected s.c. on days 4-14. Results: Eighty-eight patients were assessable. The median age was 60 years; 50% were male, 78% had PS of 0-1, 28% had PS of 2, 53% had multiple sites, and 13% had brain involvement. The overall response rate was 57% with 10 (12%) of 84 patients achieving a complete response. Median progression-free survival was 6 months [95% confidence interval (CI), 5-7 months] with a median survival of 11 months (95% CI, 8-13 months) and a 1-year survival rate of 43% (95% CI, 33-54%). Six patients (7%) died from toxicity. Grade 5 toxicity occurred in 3 (14%) of 22 patients (with a PS of 2) versus 3 (5%) of 61 patients (with a PS of 0-1; P, not significant). Grade 4 neutropenia developed in 40% of patients. Grade 3 nonhematological toxicities were primarily nausea (20%), vomiting (16%), and fatigue (14%). Conclusion: The survival result achieved was superior to prior SWOG experiences; however, the toxic death rate was unacceptably high in PS-2 patients. These results provide the largest database for the ongoing randomized Intergroup trial comparing PET to cisplatin+etoposide in PS-0-1 patients with ES-SCLC.

Original languageEnglish (US)
Pages (from-to)2325-2329
Number of pages5
JournalClinical Cancer Research
Volume7
Issue number8
StatePublished - 2001

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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