Cited 89 times in
Randomized phase II trial of nimotuzumab plus irinotecan versus irinotecan alone as second-line therapy for patients with advanced gastric cancer
DC Field | Value | Language |
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dc.contributor.author | 라선영 | - |
dc.date.accessioned | 2016-02-04T11:58:47Z | - |
dc.date.available | 2016-02-04T11:58:47Z | - |
dc.date.issued | 2015 | - |
dc.identifier.issn | 1436-3291 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/141623 | - |
dc.description.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/m(2) biweekly) or IRI (irinotecan 150 mg/m(2) 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. | - |
dc.description.statementOfResponsibility | open | - |
dc.format.extent | 824~832 | - |
dc.relation.isPartOf | GASTRIC CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adenocarcinoma/drug therapy* | - |
dc.subject.MESH | Adenocarcinoma/genetics | - |
dc.subject.MESH | Adenocarcinoma/mortality | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Antibodies, Monoclonal, Humanized/administration & dosage | - |
dc.subject.MESH | Antibodies, Monoclonal, Humanized/adverse effects | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols/therapeutic use* | - |
dc.subject.MESH | Camptothecin/administration & dosage | - |
dc.subject.MESH | Camptothecin/adverse effects | - |
dc.subject.MESH | Camptothecin/analogs & derivatives | - |
dc.subject.MESH | DNA Mutational Analysis | - |
dc.subject.MESH | Disease-Free Survival | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Genes, ras/genetics | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Immunohistochemistry | - |
dc.subject.MESH | In Situ Hybridization, Fluorescence | - |
dc.subject.MESH | Kaplan-Meier Estimate | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Neoplasm Recurrence, Local/drug therapy* | - |
dc.subject.MESH | Neoplasm Recurrence, Local/genetics | - |
dc.subject.MESH | Neoplasm Recurrence, Local/mortality | - |
dc.subject.MESH | Polymerase Chain Reaction | - |
dc.subject.MESH | Receptor, Epidermal Growth Factor/biosynthesis | - |
dc.subject.MESH | Receptor, Epidermal Growth Factor/genetics | - |
dc.subject.MESH | Receptor, ErbB-2/biosynthesis | - |
dc.subject.MESH | Salvage Therapy/methods | - |
dc.subject.MESH | Stomach Neoplasms/drug therapy* | - |
dc.subject.MESH | Stomach Neoplasms/genetics | - |
dc.subject.MESH | Stomach Neoplasms/mortality | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Randomized phase II trial of nimotuzumab plus irinotecan versus irinotecan alone as second-line therapy for patients with advanced gastric cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학) | - |
dc.contributor.googleauthor | Taroh Satoh | - |
dc.contributor.googleauthor | Kyung Hee Lee | - |
dc.contributor.googleauthor | Sun Young Rha | - |
dc.contributor.googleauthor | Yasutsuna Sasaki | - |
dc.contributor.googleauthor | Se Hoon Park | - |
dc.contributor.googleauthor | Yoshito Komatsu | - |
dc.contributor.googleauthor | Hirofumi Yasui | - |
dc.contributor.googleauthor | Tae-You Kim | - |
dc.contributor.googleauthor | Kensei Yamaguchi | - |
dc.contributor.googleauthor | Nozomu Fuse | - |
dc.contributor.googleauthor | Yasuhide Yamada | - |
dc.contributor.googleauthor | Takashi Ura | - |
dc.contributor.googleauthor | Si-Young Kim | - |
dc.contributor.googleauthor | Masaki Munakata | - |
dc.contributor.googleauthor | Soh Saitoh | - |
dc.contributor.googleauthor | Kazuto Nishio | - |
dc.contributor.googleauthor | Satoshi Morita | - |
dc.contributor.googleauthor | Eriko Yamamoto | - |
dc.contributor.googleauthor | Qingwei Zhang | - |
dc.contributor.googleauthor | Jung-mi Kim | - |
dc.contributor.googleauthor | Yeul Hong Kim | - |
dc.contributor.googleauthor | Yuh Sakata | - |
dc.identifier.doi | 10.1007/s10120-014-0420-9 | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A01316 | - |
dc.relation.journalcode | J00916 | - |
dc.identifier.eissn | 1436-3305 | - |
dc.identifier.pmid | 25185971 | - |
dc.subject.keyword | Advanced gastric cancer | - |
dc.subject.keyword | Anti-EGFR | - |
dc.subject.keyword | Irinotecan | - |
dc.subject.keyword | Nimotuzumab | - |
dc.subject.keyword | Second-line therapy | - |
dc.contributor.alternativeName | Rha, Sun Young | - |
dc.contributor.affiliatedAuthor | Rha, Sun Young | - |
dc.rights.accessRights | free | - |
dc.citation.volume | 18 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 824 | - |
dc.citation.endPage | 832 | - |
dc.identifier.bibliographicCitation | GASTRIC CANCER, Vol.18(4) : 824-832, 2015 | - |
dc.identifier.rimsid | 30773 | - |
dc.type.rims | ART | - |
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