PMID- 30032838 OWN - NLM STAT- MEDLINE DCOM- 20190625 LR - 20190625 IS - 1872-8332 (Electronic) IS - 0169-5002 (Linking) VI - 122 DP - 2018 Aug TI - Nivolumab in advanced non-small-cell lung cancer patients who failed prior platinum-based chemotherapy. PG - 234-242 LID - S0169-5002(18)30399-4 [pii] LID - 10.1016/j.lungcan.2018.05.023 [doi] AB - OBJECTIVES: To investigate the efficacy and safety of nivolumab in Korean patients with stage IIIB/IV or recurrent non-small-cell lung cancer (NSCLC) who failed platinum-based chemotherapy. MATERIALS AND METHODS: In this multicenter, open-label, Phase II study, 100 patients with stage IIIB or IV squamous (n = 44) or non-squamous (n = 56) NSCLC received nivolumab 3 mg/kg every 2 weeks for 6 weeks per treatment cycle. Patients continued treatment until disease progression or intolerable adverse events (AEs), and then entered a follow-up phase. The primary efficacy endpoint was the centrally assessed objective response rate (ORR). RESULTS: The ORR was 20.0% (95% confidence interval [CI]: 13.3-28.9%) in the total population, 15.9% (7/44 patients; 95% CI: 7.9-29.4%) in patients with squamous NSCLC, and 23.2% (13/56 patients; 95% CI: 14.1-35.8%) in patients with non-squamous NSCLC. Median overall survival was 13.9 (95% CI: 10.8-18.5) months in the total population, 12.3 (95% CI: 8.2-18.5) months in squamous NSCLC, and 16.3 (95% CI: 10.8, -) months in non-squamous NSCLC. Median progression-free survival was 2.8 (95% CI: 1.4-5.7), 2.6 (95% CI: 1.3-5.7), and 5.3 (95% CI: 1.4-7.1) months in the total, squamous, and non-squamous NSCLC populations, respectively. The median duration of response was 11.7 (95% CI: 5.6, -), 12.0 (95% CI: 4.8, -), and 12.1 (95% CI: 3.0, -) months in the total, squamous, and non-squamous NSCLC populations, respectively. The most frequent AEs were decreased appetite, dyspnea, and cough in 43 (43.0%), 32 (32.0%), and 29 (29.0%) patients, respectively. The most common Grade >/=3 AE was pneumonia, occurring in 7.0% of patients. Common treatment-related AEs included decreased appetite (14.0%) and pruritus (6.0%), neither of which was Grade >/=3. CONCLUSION: The efficacy and safety of nivolumab in Korean patients with advanced or recurrent squamous or non-squamous NSCLC are consistent with previous reports. CI - Copyright (c) 2018 The Authors. Published by Elsevier B.V. All rights reserved. FAU - Lee, Jong Seok AU - Lee JS AD - Seoul National University Bundang Hospital, 82, Gumi-Ro, 173 Beon-Gil, Bundang-Gu, Seongnam-Si, Gyeonggi-Do, 13620, Republic of Korea. Electronic address: jslee@snubh.org. FAU - Lee, Ki Hyeong AU - Lee KH AD - Chungbuk National University Hospital, 776, 1 Sunhwan-Ro, Seowon-Gu, Cheongju-Si, Chungcheongbuk-Do, 28644, Republic of Korea. Electronic address: kihlee@chungbuk.ac.kr. FAU - Cho, Eun Kyung AU - Cho EK AD - Gachon University Gil Medical Center, 21, Namdongdae-Ro 774 Beon-Gil, Namdong-Gu, Incheon, 21565, Republic of Korea. Electronic address: ekcho@gilhospital.com. FAU - Kim, Dong-Wan AU - Kim DW AD - Seoul National University Hospital, 101, Daehak-Ro, Jongno-Gu, Seoul, 03080, Republic of Korea. Electronic address: kimdw@snu.ac.kr. FAU - Kim, Sang-We AU - Kim SW AD - Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea. Electronic address: swkim@amc.seoul.kr. FAU - Kim, Joo-Hang AU - Kim JH AD - Yonsei University Severance Hospital, 50-1, Yonsei-Ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea. Electronic address: kim123@cha.ac.kr. FAU - Cho, Byoung Chul AU - Cho BC AD - Yonsei University Severance Hospital, 50-1, Yonsei-Ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea. Electronic address: cbc1971@yuhs.ac. FAU - Kang, Jin Hyoung AU - Kang JH AD - Seoul St. Mary's Hospital, The Catholic University of Korea, 222, Banpo-Daero, Seocho-Gu, Seoul, 06591, Republic of Korea. Electronic address: jinkang@catholic.ac.kr. FAU - Han, Ji-Youn AU - Han JY AD - National Cancer Center, 323, Ilsan-Ro, Ilsandong-Gu, Goyang-Si, Gyeonggi-Do, 10408, Republic of Korea. Electronic address: jymama@ncc.re.kr. FAU - Min, Young Joo AU - Min YJ AD - Ulsan University Hospital, 877, Bangeojinsunhwangdo-Ro, Dong-Gu, Ulsan, 44055, Republic of Korea. Electronic address: yjmin65@gmail.com. FAU - Park, Keunchil AU - Park K AD - Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-Ro, Gangnam-Gu, Seoul, 06351, Republic of Korea. Electronic address: kpark@skku.edu. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20180524 PL - Ireland TA - Lung Cancer JT - Lung cancer (Amsterdam, Netherlands) JID - 8800805 RN - 0 (Antineoplastic Agents) RN - 0 (Platinum Compounds) RN - 31YO63LBSN (Nivolumab) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents/*therapeutic use MH - Carcinoma, Non-Small-Cell Lung/*drug therapy/epidemiology/mortality MH - Drug Resistance, Neoplasm MH - Drug-Related Side Effects and Adverse Reactions/*epidemiology MH - Female MH - Follow-Up Studies MH - Humans MH - Korea/epidemiology MH - Lung Neoplasms/*drug therapy/epidemiology/mortality MH - Male MH - Middle Aged MH - Neoplasm Recurrence, Local MH - Neoplasm Staging MH - Nivolumab/*therapeutic use MH - Platinum Compounds/therapeutic use MH - Pneumonia/*epidemiology/etiology MH - Prospective Studies MH - Survival Analysis OTO - NOTNLM OT - Nivolumab OT - Non-small cell lung cancer OT - Programmed cell death-1 EDAT- 2018/07/24 06:00 MHDA- 2019/06/27 06:00 CRDT- 2018/07/24 06:00 PHST- 2017/06/28 00:00 [received] PHST- 2018/02/16 00:00 [revised] PHST- 2018/05/22 00:00 [accepted] PHST- 2018/07/24 06:00 [entrez] PHST- 2018/07/24 06:00 [pubmed] PHST- 2019/06/27 06:00 [medline] AID - S0169-5002(18)30399-4 [pii] AID - 10.1016/j.lungcan.2018.05.023 [doi] PST - ppublish SO - Lung Cancer. 2018 Aug;122:234-242. doi: 10.1016/j.lungcan.2018.05.023. Epub 2018 May 24.