396P - Efficacy and safety of S-1 in elderly patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy: A subgroup analysis of the EAST-LC

Background

EAST-LC (JapicCTI-101155) was a randomized phase III trial conducted in East Asia that demonstrated the non-inferiority of oral S-1 to docetaxel (DTX) in previously treated patients (pts) with advanced non-small cell lung cancer (NSCLC) [H. Nokihara and S. Lu, Annals of Oncology (2017)]. Here, we report the results of elderly pts (EP) subgroup.

Methods

The key inclusion criteria were as follows: age ≥18 years; an ECOG performance status (PS) of 0 to 2; and ≤ 2 previous chemotherapy regimens, including a platinum-based one [if pts had received gefitinib or erlotinib, then three regimens were allowed]. Eligible pts were randomized 1:1 to receive S-1 (80-120 mg/day; days 1-28 in a 6-week cycle) or DTX (60 mg/m² in Japan, 75 mg/m² at the other sites; day 1 in a 3-week cycle). EP were defined as aged ≥ 70 years and evaluated the efficacy, safety and quality of life (QOL), using the EORTC QLQ-C30. The primary endpoint of the trial was overall survival (OS).

Results

A total of 190 EP were subjects to this analysis (90 in the S-1 arm and 100 in the DTX arm). There were no significant differences between both arms in terms of baseline characteristics, except for ECOG PS (P = 0.0132). Disease progression was the most common reason for treatment discontinuation in both arms (63.6% and 51.5% in S-1 and DTX arms, respectively), followed by adverse events (AEs) (13.6% and 24.2%). The median OS were 14.7 months versus 12.1 months; HR 0.76 (95% CI: 0.54–1.07) for S-1 versus DTX, respectively. The most common treatment-related AEs were decreased appetite (61.4%), diarrhea (47.7%) and pigmentation (39.8%) in the S-1 arm, and neutropenia (66.7%), alopecia (49.5%) and leukocytopenia (47.5%) in the DTX arm, respectively. The adjusted mean score difference (S-1 – DTX) of EORTC QLQ-C30 global health status until 48 weeks was 7.41 (95% CI: 0.37–14.46).

Conclusions

S-1 was showed the comparable efficacy, safety and QOL to DTX in previously treated EP with advanced NSCLC, and the results were consistent to those of the overall EAST-LC population. These results could support the usage of S-1 as a viable treatment option for EP.

Clinical trial identification

JapicCTI-101155.

Editorial acknowledgement

Legal entity responsible for the study

Taiho Pharmaceutical.

Funding

Taiho Pharmaceutical.

Disclosure

J.C-H. Yang: Honoraria (institution), Advisory/Consultancy: Boehringer Ingelheim; Honoraria (institution), Advisory/Consultancy: Novartis; Honoraria (institution), Advisory/Consultancy: AstraZeneca; Honoraria (institution), Advisory/Consultancy: Roche/Genentech; Honoraria (institution), Advisory/Consultancy: Lilly; Honoraria (institution), Advisory/Consultancy: MSD Oncology; Honoraria (institution), Advisory/Consultancy: Merck Serono; Honoraria (institution), Advisory/Consultancy: Celgene; Honoraria (institution), Advisory/Consultancy: Bayer; Honoraria (institution), Advisory/Consultancy: Pfizer; Honoraria (institution), Advisory/Consultancy: Ono Pharmaceutical; Honoraria (institution), Advisory/Consultancy: Bristol-Myers Squibb; Honoraria (institution), Advisory/Consultancy: Yuhan; Honoraria (institution), Advisory/Consultancy: Hansoh; Honoraria (institution), Advisory/Consultancy: Blueprint Medicines; Honoraria (institution), Advisory/Consultancy: Daiichi Sankyo; Honoraria (institution), Advisory/Consultancy: Amgen; Honoraria (institution), Advisory/Consultancy: Takeda Oncology; Honoraria (institution), Advisory/Consultancy: Incyte. T.S.K. Mok: Honoraria (self): Taiho; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Officer/Board of Directors: AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Clovis Oncology; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): SFJ Pharmaceuticals; Shareholder/Stockholder/Stock options, Officer/Board of Directors: Sanomics; Honoraria (self), Advisory/Consultancy: Eli Lilly; Honoraria (self), Advisory/Consultancy: Takeda; Advisory/Consultancy, Officer/Board of Directors: Chi-Med; Honoraria (self), Advisory/Consultancy: ACEA Biosciences; Honoraria (self), Advisory/Consultancy: Janssen; Honoraria (self), Advisory/Consultancy: Merck Serono; Research grant/Funding (institution): XCovery; Honoraria (self), Advisory/Consultancy: Ignyta; Honoraria (self), Advisory/Consultancy: ertex Pharmaceuticals. S. Lu: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Advisory/Consultancy, Research grant/Funding (self): Hutchison; Research grant/Funding (self): BMS; Research grant/Funding (self): Heng Rui ; Research grant/Funding (self): Beigene; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Roche; Honoraria (self): Hansoh; Honoraria (self): Hengrui Therapeutics; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: MediPharma; Advisory/Consultancy: Simcere; Advisory/Consultancy: ZaiLab; Advisory/Consultancy: GenomiCare; Advisory/Consultancy: Yuhan Corporation; Advisory/Consultancy: PrIME Oncology. K. Nakagawa: Honoraria (self), Research grant/Funding (institution): AstraZeneca K.K.; Honoraria (self), Research grant/Funding (institution): Astellas Pharma Inc.; Honoraria (self), Research grant/Funding (institution): MSD K.K.; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Ono Pharmaceutical Co., Ltd.; Honoraria (self), Research grant/Funding (institution): Nippon Boehringer Ingelheim Co., Ltd.; Honoraria (self), Research grant/Funding (institution): Novartis Pharma K.K.; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Pfizer Japan Inc.; Honoraria (self), Advisory/Consultancy: Kyorin Pharmaceutical Co., Ltd.; Honoraria (self), Research grant/Funding (institution): Bayer Yakuhin, Ltd.; Honoraria (self): Nichi-Iko Pharmaceutical Co., Ltd.; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Takeda Pharmaceutical Co., Ltd.; Honoraria (self), Research grant/Funding (institution): Taiho Pharmaceutical Co., Ltd.; Honoraria (self), Research grant/Funding (institution): Bristol-Myers Squibb Company; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Eli Lilly Japan K.K.; Research grant/Funding (institution): Kyowa Hakko Kirin Co., Ltd.; Honoraria (self), Research grant/Funding (institution): Chugai Pharmaceutical Co., Ltd.; Honoraria (self), Research grant/Funding (institution): Daiichi Sankyo Co., Ltd.; Honoraria (self): Nippon Kayaku Co., Ltd.; Honoraria (self), Research grant/Funding (institution): Merck Serono Co., Ltd./ Merck Biopharma Co., Ltd.; Honoraria (self), Research grant/Funding (institution): AbbVie Inc. N. Yamamoto: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): MSD; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): Ono Pharmaceutical Co., Ltd.; Honoraria (self), Research grant/Funding (self), Research grant/Funding (institution): Daiichi Sankyo Company; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): Taiho Pharmaceutical Co., Ltd.; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Takeda Pharmaceutical Co. Ltd.; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): Chugai Pharmaceutical Co., Ltd.; Honoraria (self), Research grant/Funding (self), Research grant/Funding (institution): Eli Lilly Japan K.K.; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): Boehringer-Ingelheim; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): Pfizer Inc.; Honoraria (self), Advisory/Consultancy: Bristol-Myers Squibb; Honoraria (self): Nippon Kayaku; Honoraria (self), Advisory/Consultancy: Merck Biopharma Co., Ltd; Research grant/Funding (self), Research grant/Funding (institution): Astellas Pharma Inc; Research grant/Funding (self), Research grant/Funding (institution): Tsumura & Co.; Research grant/Funding (self), Research grant/Funding (institution): AbbVie GK.; Research grant/Funding (institution): Amgen Inc; Research grant/Funding (institution): Kyorin Pharmaceutical Co., Ltd.; Research grant/Funding (institution): Eisai Co., Ltd. L. Zhang: Research grant/Funding (institution): Roche; Research grant/Funding (institution): BMS; Honoraria (self): MSD; Research grant/Funding (institution): Henrui Pharm. R.A. Soo: Honoraria (self), Research grant/Funding (self): AstraZeneca; Honoraria (self): BMS; Honoraria (self), Research grant/Funding (self): Boehringer Ingelheim; Honoraria (self): Amgen; Honoraria (self): Lilly; Honoraria (self): Merck; Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self): Roche; Honoraria (self): Taiho; Honoraria (self): Takeda; Honoraria (self): Yuhan. S. Morita: Honoraria (self): AstraZeneca K.K.; Honoraria (self): Bristol-Myers Squibb Company; Honoraria (self): Chugai Pharmaceutical Co. Ltd.; Honoraria (self): Eli Lilly Japan K.K; Honoraria (self): MSD K.K.; Honoraria (self), Research grant/Funding (institution): Nippon Boehringer Ingelheim Co. Ltd.; Honoraria (self): Ono Pharmaceutical Co. Ltd.; Honoraria (self): Pfizer Japan Inc.; Honoraria (self): Taiho Pharmaceutical Co. Ltd. T. Tamura: Honoraria (self), Research grant/Funding (institution): Taiho; Honoraria (self): Chugai; Honoraria (self): Eli Lilly; Honoraria (self): Nippon Kayaku; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Ono; Honoraria (self): MSD; Honoraria (self): Cmic Shift-Zero. All other authors have declared no conflicts of interest.