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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)

  • 주제(키워드) Gastric cancer , Ramucirumab , Second-line chemotherapy , Vascular endothelial growth factor , Expanded access program
  • 주제(기타) Oncology; Gastroenterology & Hepatology
  • 설명문(일반) [Jung, Minkyu; Rha, Sun Young] Yonsei Univ, Coll Med, Div Med Oncol, Yonsei Canc Ctr,Dept Internal Med, 50 Yonsei Ro, Seoul, South Korea; [Ryu, Min-Hee; Kang, Yoon-Koo] Ulsan Univ, Coll Med, Dept Oncol, Asan Med Ctr, Seoul, South Korea; [Oh, Do Youn] Seoul Natl Univ, Coll Med, Seoul Natl Univ Hosp, Dept Internal Med, Seoul, South Korea; [Kang, Myounghee] Gyeongsang Natl Univ, Coll Med, Changwon Hosp, Dept Internal Med,Div Hematol Oncol, Jinju, South Korea; [Zang, Dae Young] Hallym Univ, Coll Med, Med Ctr, Dept Internal Med,Div Hematol Oncol, Anyang, South Korea; [Hwang, In Gyu] Chung Ang Univ, Dept Internal Med, Coll Med, Seoul, South Korea; [Lee, Keun-Wook] Seoul Natl Univ, Coll Med, Bundang Hosp, Dept Internal Med, Seongnam, South Korea; [Kim, Ki Hyang] Inje Univ, Coll Med, Dept Internal Med, Busan Paik Hosp,Div Hematol Oncol, Busan, South Korea; [Shim, Byoung Yong] Catholic Univ Korea, St Vincents Hosp, Dept Med Oncol, Coll Med, Suwon, South Korea; [Song, Eun Kee] Chonbuk Natl Univ, Sch Med, Dept Internal Med, Chonbuk Natl Univ Hosp, Jeonju, South Korea; [Sym, Sun Jin] Gachon Univ, Coll Med, Dept Internal Med, Gil Med Ctr, Incheon, South Korea; [Han, Hye Sook] Chungbuk Natl Univ, Coll Med, Chungbuk Natl Univ Hosp, Dept Internal Med, Cheongju, South Korea; [Park, Young Lee] Natl Canc Ctr, Res Inst & Hosp, Ctr Gastr Canc, Goyang, Gyeonggi, South Korea; [Kim, Jin Soo] Seoul Natl Univ, Dept Internal Med, Boramae Med Ctr, Seoul, South Korea; [Lee, Hyun Woo] Ajou Univ, Dept Hematol Oncol, Sch Med, Suwon, South Korea; [Lee, Moon Hee] Inha Univ Hosp & Coll Med, Div Hematoloncol, Incheon, South Korea; [Koo, Dong-Hoe] Sungkyunkwan Univ, Sch Med, Dept Internal Med, Kangbuk Samsung Hosp, Seoul, South Korea; [Song, Hong Suk] Keimyung Univ, Dept Internal Med, Dongsan Med Ctr, Daegu, South Korea; [Lee, Namsu] Soonchunhyang Univ, Coll Med, Soonchunhyang Univ Hosp, Dept Internal Med, Seoul, South Korea; [Yang, Sung Hyun] Korea Canc Ctr Hosp Korea, Korea Inst Radiol & Med Sci, Div Hematol & Oncol, Dept Internal Med, Seoul, South Korea; [Choi, Dae Ro] Hallym Univ, Coll Med, Dept Internal Med, Med Ctr, Chunchon, South Korea; [Hong, Young Seon] Catholic Univ Korea, Seoul St Marys Hosp, Coll Med, Dept Internal Med,Div Oncol, Seoul, South Korea; [Lee, Kyoung Eun] Ewha Womans Univ, Sch Med, Div Hematoloncol, Dept Internal Med, Seoul, South Korea; [Maeng, Chi Hoon] Kyung Hee Univ, Coll Med, Div Hematoloncol, Dept Internal Med, Seoul, South Korea; [Baek, Jin Ho] Univ Ulsan, Coll Med, Ulsan Univ Hosp, Dept Hematol & Oncol, Ulsan, South Korea; [Kim, Samyong] Chungnam Natl Univ, Dept Internal Med, Coll Med, Daejeon, South Korea; [Kim, Yeul Hong] Korea Univ, Coll Med, Anam Hosp, Dept Internal Med, Seoul, South Korea; [Cho, Jae Yong] Yonsei Univ, Coll Med, Dept Internal Med, Div Med Oncol,Gangnam Severance Hosp, 712 Eonjuro, Seoul 06237, South Korea
  • 등재 SCIE, SCOPUS
  • 발행기관 SPRINGER
  • 발행년도 2018
  • URI http://www.dcollection.net/handler/ewha/000000156064
  • 본문언어 영어
  • Published As http://dx.doi.org/10.1007/s10120-018-0806-1

초록/요약

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). 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. 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. 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.

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