Jin-Hyoung Kang1, Ki-Hyeong Lee2, Dong-Wan Kim3, Sang-We Kim4, Hye Ryun Kim5, Joo-Hang Kim6, Jin-Hyuk Choi7, Ho Jung An8, Jin-Soo Kim9, Joung-Soon Jang10, Bong-Seog Kim11, Heung Tae Kim12. 1. The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, South Korea. 2. Chungbuk National University Hospital, Cheongju, South Korea. 3. Seoul National University Hospital, Seoul, South Korea. 4. Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. 5. Yonsei Cancer Center, Division of Medical Oncology, Yonsei University College of Medicine, Seoul, South Korea. 6. CHA University Bundang Medical Center, Seongnam, South Korea. 7. Ajou University Hospital, Suwon, South Korea. 8. The Catholic University of Korea St. Vincent's Hospital, Seoul, South Korea. 9. Seoul National University Boramae Medical Center, Seoul, South Korea. 10. Chung-Ang University College of Medicine, Seoul, South Korea. 11. Veterans Health Service Medical Center, Seoul, South Korea. 12. National Cancer Center, Goyang, South Korea. htkim@ncc.re.kr.
Abstract
BACKGROUND: This study compared the efficacy/safety of the camptothecin analogues belotecan and topotecan for sensitive-relapsed small-cell lung cancer (SCLC). METHODS:One-hundred-and-sixty-four patients were randomised (1:1) to receive five consecutive daily intravenous infusions of topotecan (1.5 mg/m2) or belotecan (0.5 mg/m2), every 3 weeks, for six cycles. Main outcomes were objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), tolerability and toxicity. The study statistical plan was non-inferiority design with ORR as the endpoint. RESULTS: In the belotecan vs. topotecan groups, ORR (primary endpoint) was 33% vs. 21% (p = 0.09) and DCR was 85% vs. 70% (p = 0.030). PFS was not different between groups. Median OS was significantly longer with belotecan than with topotecan (13.2 vs. 8.2 months, HR = 0.69, 95% CI: 0.48-0.99), particularly in patients aged <65 years, with more advanced disease (i.e., extensive-stage disease, time to relapse: 3-6 months), or Eastern Cooperative Oncology Group performance status 1 or 2. More belotecan recipients completed all treatment cycles (53% vs. 35%; p = 0.022). CONCLUSIONS: The efficacy/safety of belotecan warrants further evaluation in Phase 3 trials. Belotecan potentially offers an alternative to topotecan for sensitive-relapsed SCLC, particularly in patients aged <65 years, with more advanced disease, or poor performance.
RCT Entities:
BACKGROUND: This study compared the efficacy/safety of the camptothecin analogues belotecan and topotecan for sensitive-relapsed small-cell lung cancer (SCLC). METHODS: One-hundred-and-sixty-four patients were randomised (1:1) to receive five consecutive daily intravenous infusions of topotecan (1.5 mg/m2) or belotecan (0.5 mg/m2), every 3 weeks, for six cycles. Main outcomes were objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), tolerability and toxicity. The study statistical plan was non-inferiority design with ORR as the endpoint. RESULTS: In the belotecan vs. topotecan groups, ORR (primary endpoint) was 33% vs. 21% (p = 0.09) and DCR was 85% vs. 70% (p = 0.030). PFS was not different between groups. Median OS was significantly longer with belotecan than with topotecan (13.2 vs. 8.2 months, HR = 0.69, 95% CI: 0.48-0.99), particularly in patients aged <65 years, with more advanced disease (i.e., extensive-stage disease, time to relapse: 3-6 months), or Eastern Cooperative Oncology Group performance status 1 or 2. More belotecan recipients completed all treatment cycles (53% vs. 35%; p = 0.022). CONCLUSIONS: The efficacy/safety of belotecan warrants further evaluation in Phase 3 trials. Belotecan potentially offers an alternative to topotecan for sensitive-relapsed SCLC, particularly in patients aged <65 years, with more advanced disease, or poor performance.
Authors: Jan A Stratmann; Radha Timalsina; Akin Atmaca; Vivian Rosery; Nikolaj Frost; Jürgen Alt; Cornelius F Waller; Niels Reinmuth; Gernot Rohde; Felix C Saalfeld; Aaron Becker von Rose; Fabian Acker; Lukas Aspacher; Miriam Möller; Martin Sebastian Journal: Ther Adv Med Oncol Date: 2022-06-04 Impact factor: 5.485
Authors: Cristina Pangua; Jacobo Rogado; Gloria Serrano-Montero; José Belda-Sanchís; Beatriz Álvarez Rodríguez; Laura Torrado; Nuria Rodríguez De Dios; Xabier Mielgo-Rubio; Juan Carlos Trujillo; Felipe Couñago Journal: World J Clin Oncol Date: 2022-06-24