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[Trastuzumab in combination with chemotherapy versus chemotherapy alone for first-line treatment of HER2-positive advanced gastric or gastroesophageal junction cancer: a Phase III, multi-center, randomized controlled trial, Chinese subreport].
- Source :
-
Zhonghua zhong liu za zhi [Chinese journal of oncology] [Zhonghua Zhong Liu Za Zhi] 2013 Apr; Vol. 35 (4), pp. 295-300. - Publication Year :
- 2013
-
Abstract
- Objective: To evaluate the efficacy and safety of trastuzumab in combination with chemotherapy versus chemotherapy alone in the first-line treatment of HER-2-positive advanced gastric or gastro-oesophageal junction cancer.<br />Methods: Fifteen Chinese research centers are involved in the BO18255 (ToGA) study. Patients with gastric or gastro-oesophageal junction cancer were eligible for inclusion if their tumor showed overexpression of HER-2 protein by immunohistochemistry +++ or FISH-positive. Patients were randomly assigned in a 1:1 ratio to receive a chemotherapy regimen consisting of capecitabine or 5-FU plus cisplatin or chemotherapy in combination with intravenous trastuzumab. The primary endpoint was overall survival.<br />Results: Eighty-five Chinese patients were enrolled in this study, of whom 84 were included in the primary analysis: trastuzumab plus chemotherapy (FP/H) (n = 36) and chemotherapy alone (FP)(n = 48). The median follow-up was 15.2 months in the FP/H group and 14.2 months in the FP group. The median survival time was 12.6 months in the FP/H group compared with 9.7 months in the FP group [hazard ratio 0.72, 95%CI (0.40; 1.29)]. Grade 3/4 adverse events were higher in the FP/H(63.9%)than FP (47.9%) groups, including neutropenia, vomiting and nausea. Two mild cardiac adverse events occurred in the FP/H group. Severe adverse events occurred in 3 cases of both two groups, respectively.<br />Conclusions: Addition of trastuzumab to chemotherapy is well tolerated and shows improved survival in Chinese patients with advanced gastric or gastro-oesophageal junction cancer. These results are consistent with the results of ToGA whole population trial. Trastuzumab in combination with chemotherapy can be considered as a new option for patients with HER-2-positive advanced gastric or gastro-oesophageal junction cancer.
- Subjects :
- Aged
Antibodies, Monoclonal, Humanized administration & dosage
Antibodies, Monoclonal, Humanized adverse effects
Antineoplastic Combined Chemotherapy Protocols adverse effects
Capecitabine
China
Cisplatin administration & dosage
Cisplatin adverse effects
Deoxycytidine administration & dosage
Deoxycytidine adverse effects
Deoxycytidine analogs & derivatives
Esophageal Neoplasms pathology
Female
Fluorouracil administration & dosage
Fluorouracil adverse effects
Fluorouracil analogs & derivatives
Follow-Up Studies
Humans
Male
Middle Aged
Nausea chemically induced
Neoplasm Staging
Neutropenia chemically induced
Remission Induction
Retrospective Studies
Stomach Neoplasms pathology
Survival Rate
Trastuzumab
Vomiting chemically induced
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Esophageal Neoplasms drug therapy
Esophagogastric Junction
Receptor, ErbB-2 metabolism
Stomach Neoplasms drug therapy
Subjects
Details
- Language :
- Chinese
- ISSN :
- 0253-3766
- Volume :
- 35
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Zhonghua zhong liu za zhi [Chinese journal of oncology]
- Publication Type :
- Academic Journal
- Accession number :
- 23985260
- Full Text :
- https://doi.org/10.3760/cma.j.issn.0253-3766.2013.04.012