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.
- VernacularTitle:曲妥珠单抗联合化疗一线治疗人表皮生长因子受体2阳性无法手术的局部进展期或转移性胃或胃食管结合部腺癌的多中心随机对照Ⅲ期临床试验中国亚组报告
- Author:
Lin SHEN
1
;
Jian-ming XU
;
Feng-yi FENG
;
Shun-chang JIAO
;
Li-wei WANG
;
Jin LI
;
Zhong-Zhen GUAN
;
Shu-kui QIN
;
Jie-jun WANG
;
Shi-ying YU
;
Ya-jie WANG
;
Ye-ning JIN
;
Min TAO
;
Lei-zhen ZHENG
;
Liang-xi PAN
Author Information
- Publication Type:Journal Article
- MeSH: Aged; Antibodies, Monoclonal, Humanized; administration & dosage; adverse effects; Antineoplastic Combined Chemotherapy Protocols; adverse effects; therapeutic use; Capecitabine; China; Cisplatin; administration & dosage; adverse effects; Deoxycytidine; administration & dosage; adverse effects; analogs & derivatives; Esophageal Neoplasms; drug therapy; pathology; Esophagogastric Junction; Female; Fluorouracil; administration & dosage; adverse effects; analogs & derivatives; Follow-Up Studies; Humans; Male; Middle Aged; Nausea; chemically induced; Neoplasm Staging; Neutropenia; chemically induced; Receptor, ErbB-2; metabolism; Remission Induction; Retrospective Studies; Stomach Neoplasms; drug therapy; pathology; Survival Rate; Trastuzumab; Vomiting; chemically induced
- From: Chinese Journal of Oncology 2013;35(4):295-300
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo 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.
METHODSFifteen 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.
RESULTSEighty-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.
CONCLUSIONSAddition 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.