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Phase II trial of S-1 as second-line therapy in patients with advanced non-small cell lung cancer

Ramaswamy Govindan1, Daniel Morgensztern, Michael D Kommor

  • 1Division of Oncology, Department of Medicine, Washington University School of Medicine, St Louis, Missouri 63110, USA. rgovinda@dom.wustl.edu

Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer
|February 18, 2011
PubMed
Abstract

Insights

Single-agent S-1 shows tolerable efficacy in previously treated non-small cell lung cancer (NSCLC) patients. This oral fluoropyrimidine demonstrated activity comparable to existing treatments for advanced NSCLC.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Current treatments for advanced non-small cell lung cancer (NSCLC) have limited effectiveness.
  • S-1, an oral fluoropyrimidine, has shown promise in Japanese NSCLC patients.
  • Evaluating S-1 in a non-Asian population is crucial for broader application.

Purpose of the Study:

  • To assess the efficacy of single-agent S-1 in previously treated advanced NSCLC patients.
  • To determine the overall response rate (ORR) as the primary endpoint.
  • To evaluate S-1's tolerability and activity in a predominantly non-Asian cohort.

Main Methods:

  • A multicenter phase II study involved 57 patients with advanced NSCLC.
  • Patients received oral S-1 (30 mg/m² every 12 hours for 14 days, followed by 7 days rest).
  • The primary endpoint was the overall response rate, with survival and tolerability also assessed.

Main Results:

  • The overall response rate was 7.1%, with a disease control rate of 55.3%.
  • Median overall survival was 7.3 months, and 1-year survival was 31.6%.
  • S-1 was well-tolerated, with nausea and diarrhea being the most common side effects.

Conclusions:

  • Single-agent S-1 is a well-tolerated treatment option for advanced NSCLC.
  • Its activity is comparable to other agents used for recurrent or relapsed NSCLC.
  • S-1 shows potential for use in a predominantly non-Asian patient population.

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