Phase II study of gemcitabine and cisplatin in patients with previously untreated extensive stage small cell lung cancer: Southwest Oncology Group study 9718

Paul J. Hesketh, Kari Chansky, Valerie Israel, Richard T. Grapski, Tarek M. Mekhail, C. Harris Spiridonidis, Glenn M. Mills, Karen Kelly, John J. Crowley, David R Gandara

Research output: Contribution to journalArticle

6 Scopus citations

Abstract

BACKGROUND: This phase II study (S9718) evaluated the antineoplastic activity and tolerability of the combination of gemcitabine and cisplatin in previously untreated patients with extensive stage small cell lung cancer (ES-SCLC). METHODS: Chemonaive patients with ES-SCLC, received gemcitabine 1250 mg/m intravenously (IV) over 30 minutes on days 1 and 8 and cisplatin 75 mg/m IV over 30 to 60 minutes on day 1. Treatments were repeated every 21 days for a maximum of six cycles. RESULTS: A total of 88 patients were enrolled in the study; seven patients were not eligible and one did not receive treatment; 80 patients were fully assessable for survival, response, and toxicity. Objective response was observed in 42 patients (53%; 95% confidence interval [CI]: 41%-64%) with two patients (3%; 95% CI: 0%-8%) achieving a complete response. Median PFS was 5 months (CI, 4.2-5.9 months), and median overall survival was 8.8 months (95% CI: 7.8-9.5 months). The 1- and 2-year survival rates were 27.5% (95% CI: 17.7%-37.3%) and 4% (95% CI: 0%-8%), respectively. The most common toxicity was neutropenia. Grade 3 and 4 neutropenia was noted in 17 (21%) and 17 (21%) patients, respectively. Two patients developed febrile neutropenia, with subsequent full recovery. Twenty-one patients (23%) developed grade 3 thrombocytopenia. Grade 4 thrombocytopenia was seen in only one patient. The most common nonhematologic toxicities included grade 3 and 4 vomiting in 12 (21%) patients and fatigue in nine (10%) patients. Two patients (3%) died of respiratory infections while on treatment. CONCLUSION: The combination of gemcitabine and cisplatin is an active and reasonably well tolerated regimen for the treatment of ES-SCLC. It does not appear to offer any compelling advantages over other commonly used two drug regimens in this disease.

Original languageEnglish (US)
Pages (from-to)440-444
Number of pages5
JournalJournal of Thoracic Oncology
Volume2
Issue number5
DOIs
StatePublished - May 2007

Keywords

  • Chemotherapy
  • Cisplatin
  • Gemcitabine
  • Lung cancer
  • Small cell
  • Small cell lung cancer

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Medicine(all)

Fingerprint Dive into the research topics of 'Phase II study of gemcitabine and cisplatin in patients with previously untreated extensive stage small cell lung cancer: Southwest Oncology Group study 9718'. Together they form a unique fingerprint.

  • Cite this