Randomized phase II trial of nimotuzumab plus irinotecan versus irinotecan alone as second-line therapy for patients with advanced gastric canceropen access
- Authors
- Satoh, T.[Satoh, T.]; Lee, K.H.[Lee, K.H.]; Rha, S.Y.[Rha, S.Y.]; Sasaki, Y.[Sasaki, Y.]; Park, S.H.[Park, Se Hoon]; Komatsu, Y.[Komatsu, Y.]; Yasui, H.[Yasui, H.]; Kim, T.-Y.[Kim, T.-Y.]; Yamaguchi, K.[Yamaguchi, K.]; Fuse, N.[Fuse, N.]; Yamada, Y.[Yamada, Y.]; Ura, T.[Ura, T.]; Kim, S.-Y.[Kim, S.-Y.]; Munakata, M.[Munakata, M.]; Saitoh, S.[Saitoh, S.]; Nishio, K.[Nishio, K.]; Morita, S.[Morita, S.]; Yamamoto, E.[Yamamoto, E.]; Zhang, Q.[Zhang, Q.]; Kim, J.-M.[Kim, J.-M.]; Kim, Y.H.[Kim, Y.H.]; Sakata, Y.[Sakata, Y.]
- Issue Date
- 2015
- Keywords
- Nimotuzumab; Anti-EGFR; Irinotecan; Second-line therapy; Advanced gastric cancer
- Citation
- Gastric Cancer, v.18, no.4, pp.824 - 832
- Journal Title
- Gastric Cancer
- Volume
- 18
- Number
- 4
- Start Page
- 824
- End Page
- 832
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/49296
- DOI
- 10.1007/s10120-014-0420-9
- Abstract
- Background: This multicenter, randomized phase II trial was conducted to compare the efficacy and safety of nimotuzumab plus irinotecan (N-IRI) versus irinotecan alone (IRI) in patients with advanced gastric cancer (AGC) showing disease progression after previous 5-fluorouracil-based therapy. Methods: Irinotecan-naive patients (n = 82) received N-IRI (nimotuzumab 400 mg weekly plus irinotecan 150 mg/m2 biweekly) or IRI (irinotecan 150 mg/m2 biweekly) until disease progression. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were overall survival (OS), response rate (RR), safety, tolerability, and the correlation between efficacy and tumor epidermal growth factor receptor (EGFR) expression. Results: Of 83 patients, 40 and 43 patients were randomly assigned to the N-IRI and IRI groups, respectively. In the N-IRI/IRI treatment group, median PFS was 73.0/85.0 days (P = 0.5668), and median OS and RR at 18 months were 250.5/232.0 days (P = 0.9778) and 18.4/10.3 %, respectively. Median PFS and OS in the EGFR 2+/3+ subgroups were 118.5/59.0 and 358.5/229.5 days, respectively. The RR was 33.3/0.0 % in the N-IRI/IRI treatment group. The incidence of grade 3 or higher adverse events was 77.5/64.3 %. No adverse events of grade 3 or higher skin rash or grade 3 or higher infusion-related reaction were reported. Conclusions: There was no superiority of N-IRI over IRI alone in terms of PFS in 5-fluorouracil-refractory AGC patients. However, N-IRI showed potential improvement in the EGFR 2+/3+ subgroup based on improved RR, PFS, and OS. © 2014, The Author(s).
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Collections - Medicine > Department of Medicine > 1. Journal Articles
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