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HELOISE: Phase IIIb Randomized Multicenter Study Comparing Standard-of-Care and Higher-Dose Trastuzumab Regimens Combined With Chemotherapy as First-Line Therapy in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

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dc.contributor.authorShah, Manish A.-
dc.contributor.authorXu, Rui-hua-
dc.contributor.authorBang, Yung-Jue-
dc.contributor.authorHoff, Paulo M.-
dc.contributor.authorLiu, Tianshu-
dc.contributor.authorHerraez-Baranda, Luis A.-
dc.contributor.authorXia, Fan-
dc.contributor.authorGarg, Amit-
dc.contributor.authorShing, Mona-
dc.contributor.authorTabernero, Josep-
dc.date.accessioned2021-01-31T11:11:41Z-
dc.date.available2021-01-31T11:11:41Z-
dc.date.issued2017-08-
dc.identifier.citationJournal of Clinical Oncology, Vol.35 No.22, pp.2558-2567-
dc.identifier.issn0732-183X-
dc.identifier.other53338-
dc.identifier.urihttps://hdl.handle.net/10371/173097-
dc.description.abstractPurpose To compare standard-of-care (SoC) trastuzumab plus chemotherapy with higher-dose (HD) trastuzumab plus chemotherapy to investigate whether HD trastuzumab increases trastuzumab serum trough concentration (C-trough) levels and increases overall survival (OS) in first-line human epidermal growth factor receptor 2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. Patients and Methods Patients with Eastern Cooperative Oncology Group performance status 2, no prior gastrectomy, and >= two metastatic sites were randomly assigned at a one-to-one ratio to loading-dose trastuzumab 8 mg/kg followed by SoC trastuzumab maintenance 6 mg/kg every 3 weeks or loading-dose trastuzumab 8 mg/kg followed by HD trastuzumab maintenance 10 mg/kg every 3 weeks until progression; treatment in each arm was combined with cisplatin 80 mg/m(2) plus capecitabine 800 mg/m(2) twice per day in cycles 1 to 6. The primary objective was HD trastuzumab OS superiority (all randomly assigned patients [full-analysis set]). Final results are from an interim analysis for futility (boundary hazard ratio [HR] >= 0.95) at 125 deaths. Results At clinical cutoff, 248 patients had been randomly assigned. A marked increase in mean trastuzumab C-trough was observed after the first HD trastuzumab cycle versus SoC trastuzumab. In the full-analysis set, median OS was 12.5 months in the SoC trastuzumab arm and 10.6 months in the HD trastuzumab arm (stratified HR, 1.24; 95% CI, 0.86 to 1.78; P = .2401). Results were similar in the per-protocol set (cycle 1 trastuzumab C-trough, 12 mu g/mL). Safety was comparable between arms. Conclusion HD trastuzumab maintenance dosing was associated with higher trastuzumab concentrations, no increased efficacy, and no new safety signals. HELOISE confirms standard-dose trastuzumab (loading dose of 8 mg/kg followed by 6 mg/kg maintenance dose every 3 weeks) with chemotherapy as the SoC for first-line treatment of human epidermal growth factor receptor 2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. (C) 2017 by American Society of Clinical Oncology-
dc.titleHELOISE: Phase IIIb Randomized Multicenter Study Comparing Standard-of-Care and Higher-Dose Trastuzumab Regimens Combined With Chemotherapy as First-Line Therapy in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma-
dc.typeArticle-
dc.contributor.AlternativeAuthor방영주-
dc.identifier.doi10.1200/JCO.2016.71.6852-
dc.citation.journaltitleJournal of Clinical Oncology-
dc.identifier.scopusid2-s2.0-85026757787-
dc.citation.endpage2567-
dc.citation.number22-
dc.citation.startpage2558-
dc.citation.volume35-
dc.identifier.urlhttps://ascopubs.org/doi/10.1200/JCO.2016.71.6852-
dc.identifier.rimsid53338-
dc.identifier.sci000406473900017-
dc.contributor.affiliatedAuthorBang, Yung-Jue-
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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