Seung-Hoon Beom1, Jong Gwang Kim2, Seung Hyuk Baik3, Seong Hoon Shin4, Inkeun Park5, Young Suk Park6, Myung-Ah Lee7, Soohyeon Lee8, So-Yeon Jeon9, Sae-Won Han10, Myoung Hee Kang11, Jisu Oh12, Jin Soo Kim13, Jin Young Kim14, Mi Sun Ahn15, Dae Young Zang16, Byung-Noe Bae17, Hong Jae Jo18, Hee Kyung Kim19, Jung-Han Kim20, Ji Ae Yoon21, Dong Han Kim21,22. 1. Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea. 2. Department of Oncology/Hematology, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, 807 Hoguk-ro, Buk-gu, Daegu, 41404, Republic of Korea. jkk21c@knu.ac.kr. 3. Section of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine, Gangnam Severance Hospital, 211 Eonju-Ro, Gangnam-Gu, Seoul, South Korea. 4. Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Republic of Korea. 5. Division of Hematology-Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, 774-21 Namdongdero, Namdong-Gu, Incheon, Republic of Korea. 6. Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, Republic of Korea. 7. Division of Medical Oncology, Department of Internal Medicine, Cancer Research Institute, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. 8. Division of Oncology/Hematology, Department of Internal Medicine, Korea University Anam Hospital, 73 Goryeodae-ro Seongbuk-gu, Seoul, 02841, South Korea. 9. Department of Internal Medicine, Jeonbuk National University Medical School, Jeonju, Korea. 10. Department of Internal Medicine, Seoul National University Hospital and Seoul National University Cancer Research Institute, Seoul, Republic of Korea. 11. Division of Hematology-Oncology, Department of Internal Medicine, Gyeongsang National University Changwon Hospital, Gyeongsang National University College of Medicine, Samjeongja-ro 11, Changwon, Republic of Korea. 12. Division of Medical Oncology, Department of Internal Medicine, Yongin Severance Hospital, Yongin-si, Gyeonggi-do, Republic of Korea. 13. Department of Surgery, Chungnam National University College of Medicine, Chungnam National University Sejong Hospital, Sejong, Republic of Korea. 14. Division of Hematology and Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Dalgubeol-daero, Dalseo-gu, Daegu, Republic of Korea. 15. Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, 16499, Republic of Korea. 16. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang-si, Republic of Korea. 17. Department of Surgery, Inje University Sanggye Paik Hospital, Inje University College of Medicine, 1342 Dongil-ro, Seoul, Republic of Korea. 18. Department of Surgery, Pusan National University School of Medicine, Pusan National University Hospital, Busan, Republic of Korea. 19. Division of Oncology, Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea. 20. Department of Internal Medicine, Kangnam Sacred-Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea. 21. Medical Affairs of Oncology, Sanofi Korea, Seoul, Republic of Korea. 22. GSK Korea, Seoul, Republic of Korea.
Abstract
PURPOSE: To evaluate the safety and effectiveness of aflibercept in combination with fluorouracil, leucovorin, and irinotecan (FOLFIRI) in Korean patients with metastatic colorectal cancer (mCRC) who progressed with oxaliplatin-containing regimen. METHODS: This was a prospective observational study conducted at 22 sites across Korea between February 2018 and September 2019. Patients aged > 19 years with a diagnosis of mCRC who were prescribed aflibercept plus FOLFIRI, after progression with an oxaliplatin-containing regimen were included. Disease assessment was performed every 6 weeks. RESULTS: A total of 185 patients were included (males, 58.9%; right-sided tumors, 23.8%; and ECOG performance factor ≥ 1, 68.6%). A total of 514 adverse events (AEs) occurred in 134 patients, of which 206 (49.2%; 95% CI 42.0%, 56.4%) events were considered as adverse drug reactions (ADRs), 172 unexpected AEs (49.7%; 95% CI 42.5%, 56.9%), and 53 serious AEs (22.2%; 95% CI16.2%, 28.2%). The most common serious ADR was pneumonia (n = 2, 1.6%). The most common all grade hematological AE and non-hematological AE were neutropenia (21.6%) and nausea (16.2%), respectively. Over a median follow-up of 5.6 months, a total of five grade 5 (1.0%) AEs were reported. Median OS was 9.4 months, and median progression-free survival (PFS) was 7.3 months. The overall response rate was 14.6%. Right-sided tumor location and prior bevacizumab treatment were independent factors of poor PFS in multivariate analysis. CONCLUSION: Aflibercept in combination with FOLFIRI was effective and showed an acceptable safety profile in Korean patients with mCRC in daily clinical practice.
PURPOSE: To evaluate the safety and effectiveness of aflibercept in combination with fluorouracil, leucovorin, and irinotecan (FOLFIRI) in Korean patients with metastatic colorectal cancer (mCRC) who progressed with oxaliplatin-containing regimen. METHODS: This was a prospective observational study conducted at 22 sites across Korea between February 2018 and September 2019. Patients aged > 19 years with a diagnosis of mCRC who were prescribed aflibercept plus FOLFIRI, after progression with an oxaliplatin-containing regimen were included. Disease assessment was performed every 6 weeks. RESULTS: A total of 185 patients were included (males, 58.9%; right-sided tumors, 23.8%; and ECOG performance factor ≥ 1, 68.6%). A total of 514 adverse events (AEs) occurred in 134 patients, of which 206 (49.2%; 95% CI 42.0%, 56.4%) events were considered as adverse drug reactions (ADRs), 172 unexpected AEs (49.7%; 95% CI 42.5%, 56.9%), and 53 serious AEs (22.2%; 95% CI16.2%, 28.2%). The most common serious ADR was pneumonia (n = 2, 1.6%). The most common all grade hematological AE and non-hematological AE were neutropenia (21.6%) and nausea (16.2%), respectively. Over a median follow-up of 5.6 months, a total of five grade 5 (1.0%) AEs were reported. Median OS was 9.4 months, and median progression-free survival (PFS) was 7.3 months. The overall response rate was 14.6%. Right-sided tumor location and prior bevacizumab treatment were independent factors of poor PFS in multivariate analysis. CONCLUSION: Aflibercept in combination with FOLFIRI was effective and showed an acceptable safety profile in Korean patients with mCRC in daily clinical practice.
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