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Safety and effectiveness of aflibercept in combination with FOLFIRI in Korean patients with metastatic colorectal cancer who received oxaliplatin-containing regimen

  • Original Article – Clinical Oncology
  • Published:
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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.

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Availability of data material

Qualified researchers may request access to patient-level data and related documents [including, e.g., the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications]. Patient-level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access can be found at https://www.clinicalstudydatarequest.com.

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Acknowledgements

The authors would like to thank the study participants, their families and caregivers who were involved in this study. Authors also thank Pravin Bolshete and Sapna Patil of Sqarona Medical Communications LLP, Mumbai for medical writing assistance which was paid for by Sanofi. Editorial support was also provided by Anahita Gouri and Rohan Mitra from Sanofi India.

Funding

The study was funded by Sanofi-Aventis Korea Co, Ltd.

Author information

Author notes

  1. Dong Han Kim

    Present address: GSK Korea, Seoul, Republic of Korea

Authors and Affiliations

  1. Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea

    Seung-Hoon Beom

  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

    Jong Gwang Kim

  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

    Seung Hyuk Baik

  4. Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Republic of Korea

    Seong Hoon Shin

  5. Division of Hematology-Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, 774-21 Namdongdero, Namdong-Gu, Incheon, Republic of Korea

    Inkeun Park

  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

    Young Suk Park

  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

    Myung-Ah Lee

  8. Division of Oncology/Hematology, Department of Internal Medicine, Korea University Anam Hospital, 73 Goryeodae-ro Seongbuk-gu, Seoul, 02841, South Korea

    Soohyeon Lee

  9. Department of Internal Medicine, Jeonbuk National University Medical School, Jeonju, Korea

    So-Yeon Jeon

  10. Department of Internal Medicine, Seoul National University Hospital and Seoul National University Cancer Research Institute, Seoul, Republic of Korea

    Sae-Won Han

  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

    Myoung Hee Kang

  12. Division of Medical Oncology, Department of Internal Medicine, Yongin Severance Hospital, Yongin-si, Gyeonggi-do, Republic of Korea

    Jisu Oh

  13. Department of Surgery, Chungnam National University College of Medicine, Chungnam National University Sejong Hospital, Sejong, Republic of Korea

    Jin Soo Kim

  14. Division of Hematology and Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Dalgubeol-daero, Dalseo-gu, Daegu, Republic of Korea

    Jin Young Kim

  15. Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, 16499, Republic of Korea

    Mi Sun Ahn

  16. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang-si, Republic of Korea

    Dae Young Zang

  17. Department of Surgery, Inje University Sanggye Paik Hospital, Inje University College of Medicine, 1342 Dongil-ro, Seoul, Republic of Korea

    Byung-Noe Bae

  18. Department of Surgery, Pusan National University School of Medicine, Pusan National University Hospital, Busan, Republic of Korea

    Hong Jae Jo

  19. Division of Oncology, Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea

    Hee Kyung Kim

  20. Department of Internal Medicine, Kangnam Sacred-Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea

    Jung-Han Kim

  21. Medical Affairs of Oncology, Sanofi Korea, Seoul, Republic of Korea

    Ji Ae Yoon & Dong Han Kim

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  1. Seung-Hoon Beom
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Contributions

Conceived and designed the analysis: S-HB, JGK, JAY, DHK. Collected the data: S-HB, JGK, SHB, SHS, IP, YSP, M-AL, SL, S-YJ, S-WH, MHK, JO, JSK, JYK, MSA, DYZ, B-NB, HJJ, HKK, J-HK. Contributed data or analysis tools: JGK, S-HB, JAY, DHK. Performed the analysis: JGK, S-HB, JAY, DHK. Wrote the paper: S-HB, JGK. Supervision and revision of the manuscript: S-HB, JGK, SHB, SHS, IP, YSP, M-AL, SL, S-YJ, S-WH, MHK, JO, JSK, JYK, MSA, DYZ, B-NB, HJJ, HKK, J-HK, JAY, DHK.

Corresponding author

Correspondence to Jong Gwang Kim.

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Conflict of interest

Ji Ae Yoon and Dong Han Kim are employees of Sanofi, and Ji Ae Yoon holds stock option. All other authors have no conflict of interest to declare.

Ethical approval

The study protocol was approved by an independent ethics committee or institutional review board at each study site. The study was conducted in accordance with the International Conference on Harmonization Good Clinical Practices, applicable local regulatory requirements and principles that have their origin in the Declaration of Helsinki.

Consent to participate

Written informed consent was obtained from each participant before any study-related procedure.

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Not applicable.

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Beom, SH., Kim, J.G., Baik, S.H. et al. Safety and effectiveness of aflibercept in combination with FOLFIRI in Korean patients with metastatic colorectal cancer who received oxaliplatin-containing regimen. J Cancer Res Clin Oncol 149, 1131–1143 (2023). https://doi.org/10.1007/s00432-022-03946-x

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  • Issue Date:

  • DOI: https://doi.org/10.1007/s00432-022-03946-x

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