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Randomized phase II trial of nimotuzumab plus irinotecan versus irinotecan alone as second-line therapy for patients with advanced gastric cancer

DC FieldValueLanguage
dc.contributor.author라선영-
dc.date.accessioned2016-02-04T11:58:47Z-
dc.date.available2016-02-04T11:58:47Z-
dc.date.issued2015-
dc.identifier.issn1436-3291-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/141623-
dc.description.abstractBACKGROUND: 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.statementOfResponsibilityopen-
dc.format.extent824~832-
dc.relation.isPartOfGASTRIC CANCER-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAdenocarcinoma/drug therapy*-
dc.subject.MESHAdenocarcinoma/genetics-
dc.subject.MESHAdenocarcinoma/mortality-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAntibodies, Monoclonal, Humanized/administration & dosage-
dc.subject.MESHAntibodies, Monoclonal, Humanized/adverse effects-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols/therapeutic use*-
dc.subject.MESHCamptothecin/administration & dosage-
dc.subject.MESHCamptothecin/adverse effects-
dc.subject.MESHCamptothecin/analogs & derivatives-
dc.subject.MESHDNA Mutational Analysis-
dc.subject.MESHDisease-Free Survival-
dc.subject.MESHFemale-
dc.subject.MESHGenes, ras/genetics-
dc.subject.MESHHumans-
dc.subject.MESHImmunohistochemistry-
dc.subject.MESHIn Situ Hybridization, Fluorescence-
dc.subject.MESHKaplan-Meier Estimate-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHNeoplasm Recurrence, Local/drug therapy*-
dc.subject.MESHNeoplasm Recurrence, Local/genetics-
dc.subject.MESHNeoplasm Recurrence, Local/mortality-
dc.subject.MESHPolymerase Chain Reaction-
dc.subject.MESHReceptor, Epidermal Growth Factor/biosynthesis-
dc.subject.MESHReceptor, Epidermal Growth Factor/genetics-
dc.subject.MESHReceptor, ErbB-2/biosynthesis-
dc.subject.MESHSalvage Therapy/methods-
dc.subject.MESHStomach Neoplasms/drug therapy*-
dc.subject.MESHStomach Neoplasms/genetics-
dc.subject.MESHStomach Neoplasms/mortality-
dc.subject.MESHTreatment Outcome-
dc.titleRandomized phase II trial of nimotuzumab plus irinotecan versus irinotecan alone as second-line therapy for patients with advanced gastric cancer-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학)-
dc.contributor.googleauthorTaroh Satoh-
dc.contributor.googleauthorKyung Hee Lee-
dc.contributor.googleauthorSun Young Rha-
dc.contributor.googleauthorYasutsuna Sasaki-
dc.contributor.googleauthorSe Hoon Park-
dc.contributor.googleauthorYoshito Komatsu-
dc.contributor.googleauthorHirofumi Yasui-
dc.contributor.googleauthorTae-You Kim-
dc.contributor.googleauthorKensei Yamaguchi-
dc.contributor.googleauthorNozomu Fuse-
dc.contributor.googleauthorYasuhide Yamada-
dc.contributor.googleauthorTakashi Ura-
dc.contributor.googleauthorSi-Young Kim-
dc.contributor.googleauthorMasaki Munakata-
dc.contributor.googleauthorSoh Saitoh-
dc.contributor.googleauthorKazuto Nishio-
dc.contributor.googleauthorSatoshi Morita-
dc.contributor.googleauthorEriko Yamamoto-
dc.contributor.googleauthorQingwei Zhang-
dc.contributor.googleauthorJung-mi Kim-
dc.contributor.googleauthorYeul Hong Kim-
dc.contributor.googleauthorYuh Sakata-
dc.identifier.doi10.1007/s10120-014-0420-9-
dc.admin.authorfalse-
dc.admin.mappingfalse-
dc.contributor.localIdA01316-
dc.relation.journalcodeJ00916-
dc.identifier.eissn1436-3305-
dc.identifier.pmid25185971-
dc.subject.keywordAdvanced gastric cancer-
dc.subject.keywordAnti-EGFR-
dc.subject.keywordIrinotecan-
dc.subject.keywordNimotuzumab-
dc.subject.keywordSecond-line therapy-
dc.contributor.alternativeNameRha, Sun Young-
dc.contributor.affiliatedAuthorRha, Sun Young-
dc.rights.accessRightsfree-
dc.citation.volume18-
dc.citation.number4-
dc.citation.startPage824-
dc.citation.endPage832-
dc.identifier.bibliographicCitationGASTRIC CANCER, Vol.18(4) : 824-832, 2015-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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