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Gastric Cancer

, Volume 21, Issue 5, pp 819–830 | Cite as

Efficacy and tolerability of ramucirumab monotherapy or in combination with paclitaxel in gastric cancer patients from the Expanded Access Program Cohort by the Korean Cancer Study Group (KCSG)

  • Minkyu Jung
  • Min-Hee Ryu
  • Do Youn Oh
  • Myounghee Kang
  • Dae Young Zang
  • In Gyu Hwang
  • Keun-Wook Lee
  • Ki Hyang Kim
  • Byoung Yong Shim
  • Eun Kee Song
  • Sun Jin Sym
  • Hye Sook Han
  • Young Lee Park
  • Jin Soo Kim
  • Hyun Woo Lee
  • Moon Hee Lee
  • Dong-Hoe Koo
  • Hong Suk Song
  • Namsu Lee
  • Sung Hyun Yang
  • Dae Ro Choi
  • Young Seon Hong
  • Kyoung Eun Lee
  • Chi Hoon Maeng
  • Jin Ho Baek
  • Samyong Kim
  • Yeul Hong Kim
  • Sun Young Rha
  • Jae Yong Cho
  • Yoon-Koo Kang
Original Article
  • 353 Downloads

Abstract

Background

Ramucirumab improves survival in gastric cancer patients. The efficacy and safety of ramucirumab outside of a clinical trial were evaluated using an expanded access program (EAP).

Methods

Advanced gastric cancer patients treated with ramucirumab in combination with paclitaxel or with ramucirumab monotherapy in a Korean EAP were evaluated. Baseline characteristics were assessed for progression-free survival (PFS) and overall survival (OS), and adverse events were evaluated according to the treatment regimen.

Results

Of 265 patients, 228 received ramucirumab plus paclitaxel, and 37 received ramucirumab monotherapy. Grade 3 or 4 neutropenia was more common with ramucirumab plus paclitaxel than with ramucirumab monotherapy (46.7 vs. 8.1%). Gastrointestinal (GI) perforation developed in seven patients (3.1%) in the ramucirumab plus paclitaxel group. The overall response and disease control rates were 16.6 and 66.3% in the ramucirumab plus paclitaxel group, and 5.4 and 37.8% in the ramucirumab monotherapy group, respectively. PFS and OS were 3.8 and 8.6 months in the ramucirumab plus paclitaxel group, and 1.8 and 6.4 months in the ramucirumab monotherapy group, respectively. In multivariate analysis, alkaline phosphatase, albumin, and neutrophil-to-lymphocyte ratio (NLR) were the independent prognostic factors for PFS, while albumin, NLR, number of metastatic sites, and large amount of ascites were independent prognostic factors for OS.

Conclusion

In the Korean EAP cohort, ramucirumab showed similar efficacy to the results of the previous trials for gastric cancer. However, the level of GI perforation was slightly increased in the ramucirumab plus paclitaxel group.

Keywords

Gastric cancer Ramucirumab Second-line chemotherapy Vascular endothelial growth factor Expanded access program 

Notes

Acknowledgements

The EAP was sponsored by Lilly Company. We would like to thank the patients and investigators who participated in the Korean Ramucirumab EAP. This research was supported by the grant from the National R&D Program for Cancer Control, Ministry of Health and Welfare, Republic of Korea (Sun Young Rha, 1520190). The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Compliance with ethical standards

Conflict of interest

The authors have declared no conflicts of interest.

Human rights statement and informed consent

Each centre’s institutional review board or independent ethics committee approved the study. This program followed the guiding principles of the Declaration of Helsinki and the Good Clinical Practice Guidelines of the International Conference on Harmonization. All patients provided written informed consent.

Supplementary material

10120_2018_806_MOESM1_ESM.docx (23 kb)
Supplementary material 1 (DOCX 23 kb)

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Copyright information

© The International Gastric Cancer Association and The Japanese Gastric Cancer Association 2018

Authors and Affiliations

  • Minkyu Jung
    • 1
  • Min-Hee Ryu
    • 2
  • Do Youn Oh
    • 3
  • Myounghee Kang
    • 4
  • Dae Young Zang
    • 5
  • In Gyu Hwang
    • 6
  • Keun-Wook Lee
    • 7
  • Ki Hyang Kim
    • 8
  • Byoung Yong Shim
    • 9
  • Eun Kee Song
    • 10
  • Sun Jin Sym
    • 11
  • Hye Sook Han
    • 12
  • Young Lee Park
    • 13
  • Jin Soo Kim
    • 14
  • Hyun Woo Lee
    • 15
  • Moon Hee Lee
    • 16
  • Dong-Hoe Koo
    • 17
  • Hong Suk Song
    • 18
  • Namsu Lee
    • 19
  • Sung Hyun Yang
    • 20
  • Dae Ro Choi
    • 21
  • Young Seon Hong
    • 22
  • Kyoung Eun Lee
    • 23
  • Chi Hoon Maeng
    • 24
  • Jin Ho Baek
    • 25
  • Samyong Kim
    • 26
  • Yeul Hong Kim
    • 27
  • Sun Young Rha
    • 1
  • Jae Yong Cho
    • 28
  • Yoon-Koo Kang
    • 2
  1. 1.Division of Medical Oncology, Yonsei Cancer Center, Department of Internal MedicineYonsei University College of MedicineSeoulSouth Korea
  2. 2.Department of Oncology, Asan Medical CenterUniversity of Ulsan College of MedicineSeoulSouth Korea
  3. 3.Department of Internal Medicine, Seoul National University Hospital, Cancer Research InstituteSeoul National University College of MedicineSeoulSouth Korea
  4. 4.Division of Hematology-Oncology, Department of Internal Medicine, Gyeongsang National University Changwon HospitalGyeongsang National University College of MedicineJinjuSouth Korea
  5. 5.Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Medical CenterHallym University College of MedicineAnyangSouth Korea
  6. 6.Department of Internal MedicineChung-Ang University College of MedicineSeoulSouth Korea
  7. 7.Department of Internal Medicine, Seoul National University Bundang HospitalSeoul National University College of MedicineSeongnamSouth Korea
  8. 8.Division of Hematology-Oncology, Department of Internal Medicine, Inje University Busan Paik HospitalInje University College of MedicineBusanSouth Korea
  9. 9.Department of Medical Oncology, St. Vincent’s Hospital, College of MedicineThe Catholic University of KoreaSuwonSouth Korea
  10. 10.Department of Internal Medicine, Chonbuk National University HospitalChonbuk National University Medical SchoolJeonjuSouth Korea
  11. 11.Department of Internal Medicine, Gachon University Gil Medical CenterGachon University College of MedicineIncheonSouth Korea
  12. 12.Department of Internal Medicine, Chungbuk National University HospitalChungbuk National University College of MedicineCheongjuSouth Korea
  13. 13.Center for Gastric Cancer, Research Institute and HospitalNational Cancer CenterGoyangSouth Korea
  14. 14.Department of Internal MedicineSeoul National University Boramae Medical CenterSeoulSouth Korea
  15. 15.Department of Hematology-OncologyAjou University School of MedicineSuwonSouth Korea
  16. 16.Division of Hematology-OncologyInha University Hospital and College of MedicineIncheonSouth Korea
  17. 17.Department of Internal Medicine, Kangbuk Samsung HospitalSungkyunkwan University School of MedicineSeoulSouth Korea
  18. 18.Department of Internal Medicine, Dongsan Medical CenterKeimyung UniversityDaeguSouth Korea
  19. 19.Department of Internal Medicine, Soonchunhyang University HospitalSoonchunhyang University College of MedicineSeoulSouth Korea
  20. 20.Division of Hematology and Oncology, Department of Internal MedicineKorea Cancer Center Hospital Korea, Korea Institute of Radiological and Medical SciencesSeoulSouth Korea
  21. 21.Department of Internal Medicine, Hallym University Medical CenterHallym University College of MedicineChuncheonSouth Korea
  22. 22.Division of Oncology, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of MedicineThe Catholic University of KoreaSeoulSouth Korea
  23. 23.Division of Hematology-Oncology, Department of Internal MedicineEwha Womans University School of MedicineSeoulSouth Korea
  24. 24.Division of Hematology-Oncology, Department of Internal MedicineKyung Hee University College of MedicineSeoulSouth Korea
  25. 25.Department of Hematology and Oncology, Ulsan University HospitalUniversity of Ulsan College of MedicineUlsanSouth Korea
  26. 26.Department of Internal MedicineChungnam National University College of MedicineDaejeonSouth Korea
  27. 27.Department of Internal Medicine, Anam HospitalKorea University College of MedicineSeoulSouth Korea
  28. 28.Division of Medical Oncology, Gangnam Severance Hospital, Department of Internal MedicineYonsei University College of MedicineSeoulSouth Korea

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