420O - EAST-LC: Randomized controlled phase III trial of S-1 versus docetaxel (DOC) in patients with non-small cell lung cancer (NSCLC) who had received a...

Date 19 November 2017
Event ESMO Asia 2017 Congress
Session Thoracic malignancies 2
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
Lung and other Thoracic Tumours
Presenter Ross Soo
Citation Annals of Oncology (2017) 28 (suppl_10): x124-x143. 10.1093/annonc/mdx671
Authors R. Soo1, T.S.K. Mok2, Y. Shi3, L. Zhang4, S. Lu5, J.C. Yang6, K. Nakagawa7, N. Yamamoto8, H. Nokihara9, S. Sugawara10, M. Nishio11, T. Takahashi12, K. Goto13, J. Chang14, M. Maemondo15, Y. Ichinose16, Y. Cheng17, W. Lim18, S. Morita19, T. Tamura20
  • 1Haematology-oncology, National University Hospital, 119074 - Singapore/SG
  • 2Clinical Oncology, The Chinese University of Hong Kong, Shatin/HK
  • 3Medical Oncology, Beijing Key Laboratory Of Clinical Study On Anticancer Molecular Targeted Drugs, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
  • 4Medical Oncology, Cancer Centre Sun Yat-Sen University, 510060 - Guangzhou/CN
  • 5Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai/CN
  • 6Oncology, National Taiwan University Hospital, 100 - Taipei/TW
  • 7Medical Oncology, Kindai University School of Medicine, 577-8502 - Osaka/JP
  • 8Third Department Of Internal Medicine, Wakayama Medical University, Wakayama/JP
  • 9Thoracic Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 10Pulmonary Medicine, Sendai Kousei Hospital, 980-0873 - Sendai/JP
  • 11Thoracic Medical Oncology, Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP
  • 12Thoracic Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 13Thoracic Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 14Medical Oncology, Shanghai Cancer Center Fudan University, 200032 - Shanghai/CN
  • 15Thoracic Oncology, Miyagi Cancer Center, 981-1293 - Natori/JP
  • 16Cancer Infomation Research, National Kyushu Cancer Center, 811-1395 - FUKUOKA/JP
  • 17Thoracic Oncology, Jilin Provincial Cancer Hospital, Changchun, Jilin Province/CN
  • 18Medical Oncology, National Cancer Centre Singapore, 169610 - Singapore/SG
  • 19Biomedical Statistics And Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto/JP
  • 20Thoracic Center, St. Luke's International Hospital, 104-8560 - Tokyo/JP

Abstract

Background

Primary results of EAST-LC trial in previously-treated NSCLC demonstrated the non-inferiority in terms of overall survival (OS) of S-1 to DOC in Asia. Here we present PROs, an important consideration in assessing the benefit of particular anticancer therapies.

Methods

1154 patients were randomly assigned either S-1 (80–120 mg/day on days 1–28 every 42-days) or DOC (60 mg/m2 in Japan, 75 mg/m2 in other countries, on day 1 every 21 days). The EORTC QLQ-C30 and QLQ-LC13 were administered at baseline, every 6 weeks and end of treatment. Repeated measures mixed-effect modal was performed by overall scores and change from baseline scores.

Results

QOL questionnaire compliance was over 90% at baseline. The difference in least squares (LS) means of QLQ-C30 global health status was 2.454 (95% CI -0.124 to 5.033; P = 0.0621). The QOL score was -7.506 (-9.811to -5.201) for S-1 and -9.96 (-12.158 to -7.762) for DOC. The difference in LS means of QLQ LC-13 module partially comprises of diarrhea, decreased appetite, alopecia and peripheral neuropathy was 0.144 (95% CI -2.144 to 2.432; P = 0.9016), 5.511 (95% CI 2.320 to 8.703; P = 0.007), -46.02 (95% CI -49.616 to -42.424; P 

Conclusions

Small differences in PROs in gastrointestinal toxicity items (diarrhea and decreased appetite) were observed and these toxicities were higher in patients treated with S-1. In contrast, large differences in DOC related alopecia and peripheral neuropathy remained in PROs. The observed differences in PROs may provide a rationale in selecting S-1 over docetaxel.

Clinical trial identification

Legal entity responsible for the study

Taiho Pharmaceutical Co., Ltd

Funding

Taiho Pharamaceutical Co., Ltd.

Disclosure

R. Soo: Grants: AstraZeneca; Personal fee: AstraZeneca, Taiho, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, Pfizer, Roche, BMS. T.S.K. Mok: Grants and personal fee: AstraZeneca, Boehringer Ingelheim, Pfizer, Novartis, SFJ, Roche, MSD, Clovis Oncology, BMS; Personal fee: Genentech, Eli Lilly, Amgen, Janssen, GSK, PrIME Oncology, Merck Serono, BioMarin, ACEA Biosciences, Vertex, Aveo & Biodesix, Prime Oncology, OncoGenex Pharmaceutical, OncoGenex Technologies, PeerVoice, and geneDecode; Holds stock in Sanomics limited. L. Zhang: Grants: AstraZeneca, BMS, Pfizer. S. Lu: Grants and personal fee: AstraZeneca, Boehringer Ingelheim, Roche Hutchison, MediPharma, genomiCare, Pfizer. J.C-H. Yang: Personal fee: Boehringer Ingelheim, Eli Lilly, Bayer, Roche/Genentech/Chugai, AstraZeneca, Astellas, MSD, Merck Serono, Pfizer, Novartis, Clovis Oncology, Celgene, Innopharma, Merrimack. K. Nakagawa: Grants: Oncotherapy Science, EPS Associates, Quintiles, Japan Clinical Research Operations; Grants and personal fee: Taiho, Takeda, Eli Lilly, Eisai, MSD, Ono, Daiichi-Sankyo, Chugai, AstraZeneca, Astellas. N. Yamamoto: Grants and personal fee: Taiho. H. Nokihara: Grants and personal fee: Taiho, Boehringer Ingelheim, AstraZeneca, Ono, Eli Lilly, Chugai; Grants: Merck Serono, Pfizer, Eisai, Novartis, Daiichi Sankyo, GSK, Yakult, Quintiles, Astellas; Personal fee:Sanofi, BMS. S. Sugawara: Personal fee: Chugai, Pfizer, Nippon Boehringer Ingelheim, Taiho, AstraZeneca, Eli Lilly, Novartis, Kyowa Hakko Kirin, Bristol-Myers Squibb, Ono. M. Nishio: Grants: Novartis, Astellas; Grants and personal fee: Ono, Chugai, Bristol-Myers Squibb, Taiho, Eli Lilly, Pfizer, AstraZeneca. T. Takahashi: Grants and personal fee: AstraZeneca, Eli Lilly Japan, Chugai, Ono; Grants from Takeda, MSD; Personal fee: Boehringer Ingelheim Japan. K. Goto: Grants: MSD, Quintiles, GSK, OxOnc, Sumitomo Dainippon, Takeda, Astellas, Eisai, Amgen Astellas Biopharma, Merck Serono, AbbVie Stemcentrx, Riken Genesis; Grants and personal fee: AstraZeneca, Taiho, Chugai, BMS, Nippon Boehringer Ingelheim, Ono, Pfizer, Kyowa Hakko Kirin, Eli Lilly Japan, Novartis, Daiichi-Sankyo; Personal fee: Yakult Honsha, Abbott Japan. Y. Ichinose: Grants: Takeda Bio Development Center; Grants and personal fee: Taiho, Chugai; Personal fee: Kyowa Hakko Kirin, Taisho Toyama, Pfizer, Ono, Eli Lilly, Kaketsuken. S. Morita, T. Tamura: Personal fee: Taiho.

All other authors have declared no conflicts of interest.