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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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机构： [1]Weill Cornell Med Coll, Meyer Canc Ctr, Med Oncol Solid Tumor Program, New York, NY USA; [2]Genentech Inc, San Francisco, CA 94080 USA; [3]Sun Yat Sen Univ, Canc Ctr, State Key Lab Oncol South China, Guangzhou, Guangdong, Peoples R China; [4]Collaborat Innovat Ctr Canc Med, Guangzhou, Guangdong, Peoples R China; [5]Fudan Univ, Zhongshan Hosp, Shanghai, Peoples R China; [6]Roche China Holding Ltd, Shanghai, Peoples R China; [7]Seoul Natl Univ, Coll Med, Seoul, South Korea; [8]Hosp Sirio Libanes, Sao Paulo, Brazil; [9]F Hoffmann La Roche Ltd, Basel, Switzerland; [10]Univ Autonoma Barcelona, Vall dHebron Univ Hosp, Barcelona, Spain; [11]Univ Autonoma Barcelona, Inst Oncol VHIO, Barcelona, Spain; [12]New York Presbyterian, Weill Cornell Med, Sandra & Edward Meyer Canc Ctr, Hematol Oncol, 1305 York Ave,Room Y1247, New York, NY 10021 USA

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Purpose 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

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出版当年[2017]版：

大类 | 1 区

医学

小类 | 1 区肿瘤学

最新[2023]版：

大类 | 1 区

医学

小类 | 1 区肿瘤学

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第一作者机构： [1]Weill Cornell Med Coll, Meyer Canc Ctr, Med Oncol Solid Tumor Program, New York, NY USA;

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通讯机构： [1]Weill Cornell Med Coll, Meyer Canc Ctr, Med Oncol Solid Tumor Program, New York, NY USA; [12]New York Presbyterian, Weill Cornell Med, Sandra & Edward Meyer Canc Ctr, Hematol Oncol, 1305 York Ave,Room Y1247, New York, NY 10021 USA

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