PMID- 35344080 OWN - NLM STAT- MEDLINE DCOM- 20230307 LR - 20230307 IS - 1432-1335 (Electronic) IS - 0171-5216 (Linking) VI - 149 IP - 3 DP - 2023 Mar TI - Safety and effectiveness of aflibercept in combination with FOLFIRI in Korean patients with metastatic colorectal cancer who received oxaliplatin-containing regimen. PG - 1131-1143 LID - 10.1007/s00432-022-03946-x [doi] AB - 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. CI - (c) 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature. FAU - Beom, Seung-Hoon AU - Beom SH AD - Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea. FAU - Kim, Jong Gwang AU - Kim JG AUID- ORCID: 0000-0002-7615-5864 AD - 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. FAU - Baik, Seung Hyuk AU - Baik SH AD - 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. FAU - Shin, Seong Hoon AU - Shin SH AD - Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Republic of Korea. FAU - Park, Inkeun AU - Park I AD - Division of Hematology-Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, 774-21 Namdongdero, Namdong-Gu, Incheon, Republic of Korea. FAU - Park, Young Suk AU - Park YS AD - Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, Republic of Korea. FAU - Lee, Myung-Ah AU - Lee MA AD - 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. FAU - Lee, Soohyeon AU - Lee S AD - Division of Oncology/Hematology, Department of Internal Medicine, Korea University Anam Hospital, 73 Goryeodae-ro Seongbuk-gu, Seoul, 02841, South Korea. FAU - Jeon, So-Yeon AU - Jeon SY AD - Department of Internal Medicine, Jeonbuk National University Medical School, Jeonju, Korea. FAU - Han, Sae-Won AU - Han SW AD - Department of Internal Medicine, Seoul National University Hospital and Seoul National University Cancer Research Institute, Seoul, Republic of Korea. FAU - Kang, Myoung Hee AU - Kang MH AD - 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. FAU - Oh, Jisu AU - Oh J AD - Division of Medical Oncology, Department of Internal Medicine, Yongin Severance Hospital, Yongin-si, Gyeonggi-do, Republic of Korea. FAU - Kim, Jin Soo AU - Kim JS AD - Department of Surgery, Chungnam National University College of Medicine, Chungnam National University Sejong Hospital, Sejong, Republic of Korea. FAU - Kim, Jin Young AU - Kim JY AD - Division of Hematology and Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Dalgubeol-daero, Dalseo-gu, Daegu, Republic of Korea. FAU - Ahn, Mi Sun AU - Ahn MS AD - Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, 16499, Republic of Korea. FAU - Zang, Dae Young AU - Zang DY AD - Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang-si, Republic of Korea. FAU - Bae, Byung-Noe AU - Bae BN AD - Department of Surgery, Inje University Sanggye Paik Hospital, Inje University College of Medicine, 1342 Dongil-ro, Seoul, Republic of Korea. FAU - Jo, Hong Jae AU - Jo HJ AD - Department of Surgery, Pusan National University School of Medicine, Pusan National University Hospital, Busan, Republic of Korea. FAU - Kim, Hee Kyung AU - Kim HK AD - Division of Oncology, Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea. FAU - Kim, Jung-Han AU - Kim JH AD - Department of Internal Medicine, Kangnam Sacred-Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea. FAU - Yoon, Ji Ae AU - Yoon JA AD - Medical Affairs of Oncology, Sanofi Korea, Seoul, Republic of Korea. FAU - Kim, Dong Han AU - Kim DH AD - Medical Affairs of Oncology, Sanofi Korea, Seoul, Republic of Korea. AD - GSK Korea, Seoul, Republic of Korea. LA - eng PT - Journal Article PT - Observational Study DEP - 20220327 PL - Germany TA - J Cancer Res Clin Oncol JT - Journal of cancer research and clinical oncology JID - 7902060 RN - 15C2VL427D (aflibercept) RN - 04ZR38536J (Oxaliplatin) RN - XT3Z54Z28A (Camptothecin) RN - 2S9ZZM9Q9V (Bevacizumab) RN - U3P01618RT (Fluorouracil) RN - Q573I9DVLP (Leucovorin) SB - IM MH - Male MH - Humans MH - Oxaliplatin/therapeutic use MH - *Colorectal Neoplasms/pathology MH - Camptothecin/therapeutic use MH - *Colonic Neoplasms/drug therapy MH - Bevacizumab/therapeutic use MH - *Rectal Neoplasms/drug therapy MH - Fluorouracil/therapeutic use MH - Leucovorin/therapeutic use MH - Antineoplastic Combined Chemotherapy Protocols/therapeutic use MH - Republic of Korea OTO - NOTNLM OT - Acquired resistance OT - Anti-VEGF agents OT - Chemotherapy OT - Colorectal cancer EDAT- 2022/03/29 06:00 MHDA- 2023/03/08 06:00 CRDT- 2022/03/28 12:16 PHST- 2021/08/12 00:00 [received] PHST- 2022/02/04 00:00 [accepted] PHST- 2022/03/29 06:00 [pubmed] PHST- 2023/03/08 06:00 [medline] PHST- 2022/03/28 12:16 [entrez] AID - 10.1007/s00432-022-03946-x [pii] AID - 10.1007/s00432-022-03946-x [doi] PST - ppublish SO - J Cancer Res Clin Oncol. 2023 Mar;149(3):1131-1143. doi: 10.1007/s00432-022-03946-x. Epub 2022 Mar 27.