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Gastric Cancer. 2018 Sep;21(5):819-830. doi: 10.1007/s10120-018-0806-1. Epub 2018 Feb 9.

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).

Author information

1
Division of Medical Oncology, Yonsei Cancer Center, Department of Internal Medicine, Yonsei University College of Medicine, 50 Yonsei-Ro, Seodaemun-gu, Seoul, South Korea.
2
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
3
Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.
4
Division of Hematology-Oncology, Department of Internal Medicine, Gyeongsang National University Changwon Hospital, Gyeongsang National University College of Medicine, Jinju, South Korea.
5
Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
6
Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, South Korea.
7
Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.
8
Division of Hematology-Oncology, Department of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, South Korea.
9
Department of Medical Oncology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, South Korea.
10
Department of Internal Medicine, Chonbuk National University Hospital, Chonbuk National University Medical School, Jeonju, South Korea.
11
Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, South Korea.
12
Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea.
13
Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Gyeonggi, South Korea.
14
Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, South Korea.
15
Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, South Korea.
16
Division of Hematology-Oncology, Inha University Hospital and College of Medicine, Incheon, South Korea.
17
Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.
18
Department of Internal Medicine, Dongsan Medical Center, Keimyung University, Daegu, South Korea.
19
Department of Internal Medicine, Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Seoul, South Korea.
20
Division of Hematology and Oncology, Department of Internal Medicine, Korea Cancer Center Hospital Korea, Korea Institute of Radiological and Medical Sciences, Seoul, South Korea.
21
Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Chuncheon, South Korea.
22
Division of Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
23
Division of Hematology-Oncology, Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, South Korea.
24
Division of Hematology-Oncology, Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, South Korea.
25
Department of Hematology and Oncology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.
26
Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, South Korea.
27
Department of Internal Medicine, Anam Hospital, Korea University College of Medicine, Seoul, South Korea.
28
Division of Medical Oncology, Yonsei Cancer Center, Department of Internal Medicine, Yonsei University College of Medicine, 50 Yonsei-Ro, Seodaemun-gu, Seoul, South Korea. rha7655@yuhs.ac.
29
Division of Medical Oncology, Gangnam Severance Hospital, Department of Internal Medicine, Yonsei University College of Medicine, 712 Eonjuro, Gangnam-gu, Seoul, 06237, South Korea. chojy@yuhs.ac.

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

PMID:
29427038
DOI:
10.1007/s10120-018-0806-1
[Indexed for MEDLINE]

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