Publications
Detailed Information
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
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Shah, Manish A. | - |
dc.contributor.author | Xu, Rui-hua | - |
dc.contributor.author | Bang, Yung-Jue | - |
dc.contributor.author | Hoff, Paulo M. | - |
dc.contributor.author | Liu, Tianshu | - |
dc.contributor.author | Herraez-Baranda, Luis A. | - |
dc.contributor.author | Xia, Fan | - |
dc.contributor.author | Garg, Amit | - |
dc.contributor.author | Shing, Mona | - |
dc.contributor.author | Tabernero, Josep | - |
dc.date.accessioned | 2021-01-31T11:11:41Z | - |
dc.date.available | 2021-01-31T11:11:41Z | - |
dc.date.created | 2018-09-12 | - |
dc.date.issued | 2017-08 | - |
dc.identifier.citation | Journal of Clinical Oncology, Vol.35 No.22, pp.2558-2567 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.other | 53338 | - |
dc.identifier.uri | https://hdl.handle.net/10371/173097 | - |
dc.description.abstract | 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 | - |
dc.language | 영어 | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 방영주 | - |
dc.identifier.doi | 10.1200/JCO.2016.71.6852 | - |
dc.citation.journaltitle | Journal of Clinical Oncology | - |
dc.identifier.wosid | 000406473900017 | - |
dc.identifier.scopusid | 2-s2.0-85026757787 | - |
dc.citation.endpage | 2567 | - |
dc.citation.number | 22 | - |
dc.citation.startpage | 2558 | - |
dc.citation.volume | 35 | - |
dc.identifier.sci | 000406473900017 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Bang, Yung-Jue | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | EXPOSURE-RESPONSE | - |
dc.subject.keywordPlus | CANCER | - |
dc.subject.keywordPlus | ANTIBODY | - |
- Appears in Collections:
- Files in This Item:
- There are no files associated with this item.
Item View & Download Count
Items in S-Space are protected by copyright, with all rights reserved, unless otherwise indicated.