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

Ramaswamy Govindan, Daniel Morgensztern, Michael D. Kommor, Roy S. Herbst, Paul Schaefer, Jitendra Gandhi, Kaku Saito, Christopher Zergebel, Joan Schiller

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Purpose: Currently available agents for the treatment of advanced stage non-small cell lung cancer (NSCLC) have limited efficacy. S-1 is a novel formulation of oral fluoropyrimidine shown to be tolerable and active in patients with NSCLC in Japan. We conducted a multicenter phase II study in previously treated patients with NSCLC to evaluate the efficacy of single-agent S-1 in a predominantly non-Asian population. PATIENTS AND Methods: Patients with advanced NSCLC and previously treated with only one line of chemotherapy received oral S-1 at 30 mg/m every 12 hours for 14 consecutive days followed by a 7-day rest until meeting discontinuation criteria. The primary end point was to evaluate the overall response rate. Results: Fifty-seven patients were accrued from 21 centers across the United States. Overall response rates and stable disease according to independent review were 7.1% and 48.2%, respectively, with a disease control rate of 55.3%. Progression-free survival was 2.9 months, median overall survival 7.3 months, and 1-year survival 31.6%. There were no significant differences in survival according to histologic subtype. The treatment was well tolerated, with the most common treatment-related side effects being nausea (54%) and diarrhea (49%). Conclusion: Single-agent S-1 is well tolerated and has activity comparable with the other agents approved for use in recurrent/relapsed NSCLC.

Original languageEnglish (US)
Pages (from-to)790-795
Number of pages6
JournalJournal of Thoracic Oncology
Volume6
Issue number4
DOIs
StatePublished - Apr 2011

Fingerprint

Non-Small Cell Lung Carcinoma
Survival
Therapeutics
Nausea
Disease-Free Survival
Diarrhea
Japan
Drug Therapy
Population

Keywords

  • NSCLC
  • Phase II
  • S1

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Govindan, R., Morgensztern, D., Kommor, M. D., Herbst, R. S., Schaefer, P., Gandhi, J., ... Schiller, J. (2011). Phase II trial of S-1 as second-line therapy in patients with advanced non-small cell lung cancer. Journal of Thoracic Oncology, 6(4), 790-795. https://doi.org/10.1097/JTO.0b013e3182103b51

Phase II trial of S-1 as second-line therapy in patients with advanced non-small cell lung cancer. / Govindan, Ramaswamy; Morgensztern, Daniel; Kommor, Michael D.; Herbst, Roy S.; Schaefer, Paul; Gandhi, Jitendra; Saito, Kaku; Zergebel, Christopher; Schiller, Joan.

In: Journal of Thoracic Oncology, Vol. 6, No. 4, 04.2011, p. 790-795.

Research output: Contribution to journalArticle

Govindan, R, Morgensztern, D, Kommor, MD, Herbst, RS, Schaefer, P, Gandhi, J, Saito, K, Zergebel, C & Schiller, J 2011, 'Phase II trial of S-1 as second-line therapy in patients with advanced non-small cell lung cancer', Journal of Thoracic Oncology, vol. 6, no. 4, pp. 790-795. https://doi.org/10.1097/JTO.0b013e3182103b51
Govindan, Ramaswamy ; Morgensztern, Daniel ; Kommor, Michael D. ; Herbst, Roy S. ; Schaefer, Paul ; Gandhi, Jitendra ; Saito, Kaku ; Zergebel, Christopher ; Schiller, Joan. / Phase II trial of S-1 as second-line therapy in patients with advanced non-small cell lung cancer. In: Journal of Thoracic Oncology. 2011 ; Vol. 6, No. 4. pp. 790-795.
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