| General information |
| Database: | DB00443 |
| Objective: | To evaluate the efficacy and safety of trastuzumab in combination with chemotherapy versus chemotherapy alone in the firstline treatment of HER2positive advanced gastric or gastrooesophageal junction cancer. |
| Authors: | Shen L, et al |
| Title: | Trastuzumab in combination with chemotherapy versus chemotherapy alone for firstline treatment of human epidermal growth factor receptor 2positive advanced gastric or gastroesophageal junction cancer: a phase III, multicenter, randomized controlled trial, Chinese subreport]. |
| Journal: | Zhonghua Zhong Liu Za Zhi |
| Year: | 2013 |
| PMID: | 23985260 |
| Trial Design |
| Clinical Trial Id: | BO18255(TOGA) |
| Agent: | trastuzumab
|
| Target: | Receptor proteintyrosine kinase erbB2
|
| Cancer Type: | esophagusgastroesophageal junction cancer |
| Cancer Subtype: | human epidermal growth factor receptor 2positive advanced gastric or gastroesophageal junction cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | trastuzumab plus chemotherapy or chemotherapy alone. |
| Study Type: | multicenter randomizedphase III clinical trial |
| Key Patients Feature: | Chemona ve patients with measurable, nonresectable, advanced or metastatic gastric or GEJ adenocarcinoma, with human epidermal growth factor receptor 2 overexpression and/or amplification (IHC 3+, or IHC 2+ and FISH+), age more than and equal to 18 years, ECOG less than and equal to 2, left ventricle ejection fraction more than and equal to 50% and adequate organ function were eligible. |
| Biomarker: | human epidermal growth factor receptor 2positive |
| Biomark Analysis: | NA |
| Control Group Info: | trastuzumab plus chemotherapy or chemotherapy alone. |
| Treatment Info: | patients were randomly assigned ina1:1ratio to receive a chemotherapy regimen consisting of capecitabine or 5-FU plus cisplatin or chemotherapy in combination with intravenous trastuzumab. |
| Primary End Point: | overall survival |
| Secondary End Point: | NA |
| Patients Number: | 85 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | 7.2 months in the FP/H; 5.7 months in the FP group. |
| Median PFS A vs. C: | 6.8 months in the FP/H; 5.5 months in the FP group. |
| Median OS A vs. C: | 12.6 months in the FP/H group. 9.7 months in the FP group. (HR=0.72; 95% CI 0.401.92) |
| Adverse Event(agent arm): | 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. Several adverse events occurred in 3 cases of both two group, respectively. |
| Conclusions: | Addition of trastuzumab to chemotherapy is well tolerated and shows improved survival in Chinese patients with advanced gastric or gastrooesophageal 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 HER2positive advanced gastric or gastrooesophageal junction cancer. |