1181PD - Randomized phase II study of adjuvant chemotherapy with S-1 versus CDDP + S-1 in resected stage II-IIIA non-small-cell lung cancer (WJOG4107)

Date 29 September 2012
Event ESMO Congress 2012
Session NSCLC - Immunotherapy, SCLC and Mesothelioma
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Early Stage
Presenter Hiroshige Yoshioka
Authors H. Yoshioka1, Y. Iwamoto2, S. Ito3, T. Yamanaka4, H. Tada5, M. Yoshimura6, I. Okamoto7, I. Yoshino8, K. Nakagawa7, Y. Nakanishi9
  • 1Respiratory Medicine Dept., Kurashiki Central Hospital, 710-8602 - Kurashiki/JP
  • 2Medical Oncology, Hiroshima city hospital, Hiroshima/JP
  • 3Department Of Thoracic Surgery, Aichi Cancer Center Hospital, Nagoya/JP
  • 4Clinical Research Center, National Cancer Research Center, East Hospital, Kashiwa/JP
  • 5General Thoracic Surgery, Osaka City General Hospital, JP-534-0021 - Osaka/JP
  • 6Thoracic Surgery, Hyogo Cancer Center, Akashi/JP
  • 7Medical Oncology, Kinki University School of Medicine, Osakasayama/JP
  • 8General Thoracic Surgery, Chiba University Graduate School of Medicine, Chiba/JP
  • 9Research Institute For Diseases Of The Chest, Kyushu University Hospital, JP-812-8582 - Fukuoka/JP

 

Abstract

Background

Postoperative cisplatin doublet chemotherapy benefits patients with completely resected stage II-IIIA non-small-cell lung cancer (NSCLC). S-1 is an oral fluorinated pyrimidine formulation that combines tegafur (FT), 5-chloro-2, 4-dihydroxypyridine (CDHP), and potassium oxonate in a molar ratio of 1:0.4:1 and widely used by single agent or platinum doublet for advanced NSCLC in Japan. This phase II trial assessed the efficacy and safety of S-1 and cisplatin plus S-1 for adjuvant chemotherapy.

Methods

From September 2007 to Dec 2009, 200 patients with completely resected stage II and IIIA (exclude multi-station N2 cases) NSCLC were randomized to receive either oral S-1 (40 mg/m2 twice per day) for consecutive 2 weeks repeated every 3 weeks for 1 year or cisplatin (60 mg/m2 day1) plus oral S-1 (40 mg/m2 twice per day) for consecutive 2 weeks repeated every 3 weeks for 4 cycles within 8 weeks after surgery. Main inclusion criteria were no prior chemotherapy or radiotherapy, ECOG PS 0-1, an age of less than 75 years, and an adequate organ function. Stratification factors included histology, stage and institutions. Primary endpoint was relapse free survival rate on 2 years and secondary endpoints were overall survival (OS) and toxicity.

Results

Patient demographics were well balanced between the arms in terms of sex, age, histologic type and stage. 52.6% of patients in S-1 arm and 76.7% in cisplatin plus S-1 arm were completed planned administration. Relapse free survival rate on 2 years was 65.6% (95% confidence interval, 55.3-74.0%) in the S-1 arm and 58.1% (95% confidence interval, 47.7-67.2%) in the cisplatin plus S-1 arm. OS were not matured in the both arms. Though the rates of leukopenia or neutropenia of grade 3/4, febrile neutropenia, nausea, and vomiting were more frequent in the cisplatin plus S-1 arm, there were no treatment related deaths in the both groups.

Conclusion

Both S-1 monotherapy and cisplatin plus S-1 are feasible as adjuvant chemotherapy for completed resected NSCLC.

Disclosure

I. Yoshino: Research Funds from Taiho Pharmaceutical Co. and Chugai Pharmaceutical Co.

All other authors have declared no conflicts of interest.