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 Anticancer agents
Non-Small Cell Lung Cancer
Therapy
Biological Therapy
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.