Jong Seok Lee1, Ki Hyeong Lee2, Eun Kyung Cho3, Dong-Wan Kim4, Sang-We Kim5, Joo-Hang Kim6, Byoung Chul Cho7, Jin Hyoung Kang8, Ji-Youn Han9, Young Joo Min10, Keunchil Park11. 1. 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. 2. Chungbuk National University Hospital, 776, 1 Sunhwan-Ro, Seowon-Gu, Cheongju-Si, Chungcheongbuk-Do, 28644, Republic of Korea. Electronic address: kihlee@chungbuk.ac.kr. 3. Gachon University Gil Medical Center, 21, Namdongdae-Ro 774 Beon-Gil, Namdong-Gu, Incheon, 21565, Republic of Korea. Electronic address: ekcho@gilhospital.com. 4. Seoul National University Hospital, 101, Daehak-Ro, Jongno-Gu, Seoul, 03080, Republic of Korea. Electronic address: kimdw@snu.ac.kr. 5. Asan Medical Center, 88, Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea. Electronic address: swkim@amc.seoul.kr. 6. Yonsei University Severance Hospital, 50-1, Yonsei-Ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea. Electronic address: kim123@cha.ac.kr. 7. Yonsei University Severance Hospital, 50-1, Yonsei-Ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea. Electronic address: cbc1971@yuhs.ac. 8. 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. 9. National Cancer Center, 323, Ilsan-Ro, Ilsandong-Gu, Goyang-Si, Gyeonggi-Do, 10408, Republic of Korea. Electronic address: jymama@ncc.re.kr. 10. Ulsan University Hospital, 877, Bangeojinsunhwangdo-Ro, Dong-Gu, Ulsan, 44055, Republic of Korea. Electronic address: yjmin65@gmail.com. 11. Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-Ro, Gangnam-Gu, Seoul, 06351, Republic of Korea. Electronic address: kpark@skku.edu.
Abstract
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.
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.
Authors: Yucai Wang; Shouhao Zhou; Fang Yang; Xinyue Qi; Xin Wang; Xiaoxiang Guan; Chan Shen; Narjust Duma; Jesus Vera Aguilera; Ashish Chintakuntlawar; Katharine A Price; Julian R Molina; Lance C Pagliaro; Thorvardur R Halfdanarson; Axel Grothey; Svetomir N Markovic; Grzegorz S Nowakowski; Stephen M Ansell; Michael L Wang Journal: JAMA Oncol Date: 2019-07-01 Impact factor: 31.777
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