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

doi:10.1007/s10120-018-0806-1

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 YangDae 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

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

21 Scopus citations

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.

Original language	English
Pages (from-to)	819-830
Number of pages	12
Journal	Gastric Cancer
Volume	21
Issue number	5
DOIs	https://doi.org/10.1007/s10120-018-0806-1
State	Published - 1 Sep 2018

Bibliographical note

Funding Information:
Acknowledgements The EAP was sponsored by Lilly Company. We

Funding Information:
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. The authors have declared no conflicts of interest.

Funding Information:
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.

Publisher Copyright:
© 2018, The International Gastric Cancer Association and The Japanese Gastric Cancer Association.

Keywords

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

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10.1007/s10120-018-0806-1

Cite this

Jung, M., Ryu, M. H., Oh, D. Y., Kang, M., Zang, D. Y., Hwang, I. G., Lee, K. W., Kim, K. H., Shim, B. Y., Song, E. K., Sym, S. J., Han, H. S., Park, Y. L., Kim, J. S., Lee, H. W., Lee, M. H., Koo, D. H., Song, H. S., Lee, N., ... Kang, Y. K. (2018). 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). Gastric Cancer, 21(5), 819-830. https://doi.org/10.1007/s10120-018-0806-1

@article{772cc77e33d44b47b5d2f1d5c6894f9a,

title = "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)",

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

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

note = "Funding Information: Acknowledgements The EAP was sponsored by Lilly Company. We Funding Information: 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. The authors have declared no conflicts of interest. Funding Information: 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. Publisher Copyright: {\textcopyright} 2018, The International Gastric Cancer Association and The Japanese Gastric Cancer Association.",

year = "2018",

month = sep,

day = "1",

doi = "10.1007/s10120-018-0806-1",

language = "English",

volume = "21",

pages = "819--830",

journal = "Gastric Cancer",

issn = "1436-3291",

publisher = "Springer Japan",

number = "5",

}

Jung, M, Ryu, MH, Oh, DY, Kang, M, Zang, DY, Hwang, IG, Lee, KW, Kim, KH, Shim, BY, Song, EK, Sym, SJ, Han, HS, Park, YL, Kim, JS, Lee, HW, Lee, MH, Koo, DH, Song, HS, Lee, N, Yang, SH, Choi, DR, Hong, YS, Lee, KE, Maeng, CH, Baek, JH, Kim, S, Kim, YH, Rha, SY, Cho, JY & Kang, YK 2018, '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)', Gastric Cancer, vol. 21, no. 5, pp. 819-830. https://doi.org/10.1007/s10120-018-0806-1

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). / Jung, Minkyu; Ryu, Min Hee; Oh, Do Youn et al.
In: Gastric Cancer, Vol. 21, No. 5, 01.09.2018, p. 819-830.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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)

AU - Jung, Minkyu

AU - Ryu, Min Hee

AU - Oh, Do Youn

AU - Kang, Myounghee

AU - Zang, Dae Young

AU - Hwang, In Gyu

AU - Lee, Keun Wook

AU - Kim, Ki Hyang

AU - Shim, Byoung Yong

AU - Song, Eun Kee

AU - Sym, Sun Jin

AU - Han, Hye Sook

AU - Park, Young Lee

AU - Kim, Jin Soo

AU - Lee, Hyun Woo

AU - Lee, Moon Hee

AU - Koo, Dong Hoe

AU - Song, Hong Suk

AU - Lee, Namsu

AU - Yang, Sung Hyun

AU - Choi, Dae Ro

AU - Hong, Young Seon

AU - Lee, Kyoung Eun

AU - Maeng, Chi Hoon

AU - Baek, Jin Ho

AU - Kim, Samyong

AU - Kim, Yeul Hong

AU - Rha, Sun Young

AU - Cho, Jae Yong

AU - Kang, Yoon Koo

N1 - Funding Information: Acknowledgements The EAP was sponsored by Lilly Company. We Funding Information: 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. The authors have declared no conflicts of interest. Funding Information: 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. Publisher Copyright: © 2018, The International Gastric Cancer Association and The Japanese Gastric Cancer Association.

PY - 2018/9/1

Y1 - 2018/9/1

N2 - 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.

AB - 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.

KW - Expanded access program

KW - Gastric cancer

KW - Ramucirumab

KW - Second-line chemotherapy

KW - Vascular endothelial growth factor

UR - http://www.scopus.com/inward/record.url?scp=85041824623&partnerID=8YFLogxK

U2 - 10.1007/s10120-018-0806-1

DO - 10.1007/s10120-018-0806-1

M3 - Article

C2 - 29427038

AN - SCOPUS:85041824623

SN - 1436-3291

VL - 21

SP - 819

EP - 830

JO - Gastric Cancer

JF - Gastric Cancer

IS - 5

ER -

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)

Abstract

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Keywords

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