Efficacy and safety analysis according to histology for S-1 in combination with carboplatin as first-line chemotherapy in patients with advanced non-small-cell lung cancer: updated results of the West Japan Oncology Group LETS study.

Abstract

BACKGROUND:

A phase III study (Lung Cancer Evaluation of TS-1) previously demonstrated noninferiority in terms of overall survival (OS) at interim analysis for carboplatin-S-1 compared with carboplatin-paclitaxel for first-line treatment of advanced non-small-cell lung cancer (NSCLC).

PATIENTS AND METHODS:

A total of 564 patients were randomly assigned to receive either carboplatin on day 1 plus oral S-1 on days 1-14 or carboplatin-paclitaxel on day 1 every 21 days. Updated results and post hoc subgroup analysis according to tumor histology are presented.

RESULTS:

The updated analysis revealed a median OS of 15.2 months in the carboplatin-S-1 arm and 13.1 months in the carboplatin-paclitaxel arm, with a hazard ratio (HR) of 0.956 [95% confidence interval (CI) 0.793-1.151], consistent with the previous primary analysis. Median OS was 14.0 months in the carboplatin-S-1 arm and 10.6 months in the carboplatin-paclitaxel arm (HR 0.713; 95% CI 0.476-1.068) for patients with squamous cell carcinoma (SCC), with corresponding values of 15.5 and 13.9 months (HR 1.060; 95% CI 0.859-1.308) for those with non-SCC.

CONCLUSIONS:

These results establish the efficacy and safety of carboplatin-S-1 in patients with advanced NSCLC regardless of tumor histology.

• Authors: H Yoshioka, I Okamoto, S Morita, M Ando, K Takeda, T Seto, N Yamamoto, H Saka, S Atagi, T Hirashima, S Kudoh, M Satouchi, N Ikeda, Y Iwamoto, T Sawa, Y Nakanishi, K Nakagawa
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 24 Issue 5 Pg. 1326-31 (May 2013) ISSN: 1569-8041 [Electronic] England
• PMID: 23277482 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antimetabolites, Antineoplastic
• Antineoplastic Agents, Phytogenic
• Cross-Linking Reagents
• Drug Combinations
• S 1 (combination)
• Tegafur
• Oxonic Acid
• Carboplatin
• Paclitaxel

Topics

• Adult
• Aged
• Antimetabolites, Antineoplastic (adverse effects, therapeutic use)
• Antineoplastic Agents, Phytogenic (adverse effects, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carboplatin (adverse effects, therapeutic use)
• Carcinoma, Non-Small-Cell Lung (drug therapy, mortality)
• Cross-Linking Reagents (adverse effects, therapeutic use)
• Disease-Free Survival
• Drug Combinations
• Female
• Humans
• Japan
• Lung Neoplasms (drug therapy, mortality)
• Male
• Middle Aged
• Oxonic Acid (adverse effects, therapeutic use)
• Paclitaxel (adverse effects, therapeutic use)
• Tegafur (adverse effects, therapeutic use)
• Treatment Outcome
• Young Adult