| General information |
| Database: | DB00444 |
| Objective: | The Trastuzumab for Gastric Cancer (ToGA) study is the first international trial to include Japanese patients with human epidermal growth factor 2 (human epidermal growth factor receptor 2) positive advanced/metastatic gastric or gastroesophageal junction cancer. ToGA showed that trastuzumab plus chemotherapy (capecitabine/cisplatin or 5fluorouracil/cisplatin) improved overall survival in the overall population (hazard ratio 0.74). Regional differences in outcome in favor of Japanese populations were observed in other studies; therefore, subgroup analyses of ToGA may contribute to the evaluation of the potential benefits of this regimen in Japanese patients. |
| Authors: | Sawaki A, et al |
| Title: | Efficacy of trastuzumab in Japanese patients with human epidermal growth factor receptor 2positive advanced gastric or gastroesophageal junction cancer: a subgroup analysis of the Trastuzumab for Gastric Cancer (ToGA) study. |
| Journal: | Gastric Cancer. |
| Year: | 2012 |
| PMID: | 22179434 |
| Trial Design |
| Clinical Trial Id: | NA |
| 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 + chemotherapy(capecitabine/cisplatin or 5fluorouracil/cisplatin) |
| Study Type: | a subgroup analysis of a phase III multicenter randomized trial |
| Key Patients Feature: | Japanese patients with human epidermal growth factor 2 (human epidermal growth factor receptor 2) positive advanced/metastatic gastric or gastroesophageal junction cancer. |
| Biomarker: | human epidermal growth factor receptor 2positive |
| Biomark Analysis: | NA |
| Control Group Info: | chemotherapy alone. |
| Treatment Info: | They performed subgroup analyses on 101 Japanese patients enrolled into ToGA (trastuzumab plus chemotherapy, n = 51; chemotherapy, n = 50). |
| Primary End Point: | overall survival |
| Secondary End Point: | NA |
| Patients Number: | 101 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The objective response rate was 64.4% (95% CI 48.8-78.1%) in the trastuzumab plus XP arm and 58.5% (95% CI 42.1-73.7%) in the XP arm. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 6.2 months (95% CI 5-7 months) in the trastuzumab plus XP arm and 5.6 months (95% CI 5-7 months) in the XP arm (HR 0.92, 95% CI 0.60-1.43). |
| Median OS A vs. C: | 15.9 months (95% confidence interval 12-25) for trastuzumab plus chemotherapy and 17.7 months (95% confidence interval 12-24) for chemotherapy (hazard ratio 1.00; 95% confidence interval 0.59-1.69). |
| Adverse Event(agent arm): | Grade 3/4 adverse events occurred in 43 patients (84%) in the trastuzumab plus XP arm and 36 patients (72%) in the XP arm. Treatment was discontinued due to adverse events for one patient (2%) in the trastuzumab plus XP arm and four patients (8%) in the XP arm. Deaths due to adverse events occurred in two patients in the trastuzumab plus XP arm: one due to cardiac failure and unstable angina and the other due to gastrointestinal perforation. The case of cardiac failure and unstable angina was attributed to an adverse event likely related to trastuzumab. |
| Conclusions: | After adjusting for imbalanced patient backgrounds bettheyen arms, overall survival of Japanese patients with human epidermal growth factor 2 positive advancedmetastatic gastric or gastroesophageal junction cancer who received trastuzumab plus chemotherapy was improved compared with patients who received chemotherapy alone. |