| General information |
| Database: | DB01084 |
| Objective: | Phase III EGF104900 data demonstrated that lapatinib plus trastuzumab significantly improved progression free survival (PFS) and clinical benefit rate versus lapatinib monotherapy, offering a chemotherapyfree option for patients with heavily pretreated human epidermal growth factor receptor 2 (human epidermal growth factor receptor 2) positive metastatic breast cancer (MBC). Final planned overall survival (OS) analysis from EGF104900 is reported here. |
| Authors: | Blackwell KL, et al |
| Title: | Overall survival benefit with lapatinib in combination with trastuzumab for patients with human epidermal growth factor receptor 2positive metastatic breast cancer: final results from the EGF104900 Study. |
| Journal: | J Clin Oncol. |
| Year: | 2012 |
| PMID: | 22689807 |
| Trial Design |
| Clinical Trial Id: | NCT00320385 |
| Agent: | lapatinib, trastuzumab
|
| Target: | NA
|
| Cancer Type: | breast cancer |
| Cancer Subtype: | human epidermal growth factor receptor 2positive advanced breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | lapatinib+ trastuzumab |
| Study Type: | final results from the EGFI04900 Study |
| Key Patients Feature: | Patients with human epidermal growth factor receptor 2positive MBC whose disease progressed during prior trastuzumabbased therapies |
| Biomarker: | human epidermal growth factor receptor 2 |
| Biomark Analysis: | Multiple baseline factors, including Eastern Cooperative Oncology Group performance status of 0, nonvisceral disease, < three metastatic sites, and less time from initial diagnosis until random assignment, were associated with improved OS. |
| Control Group Info: | lapatinib monotherapy versus lapatinib+ trastuzumab |
| Treatment Info: | patients were randomly assigned to receive lapatinib monotherapy or lapatinib in combination with trastuzumab |
| Primary End Point: | PFS, OS, toxicity |
| Secondary End Point: | NA |
| Patients Number: | 291 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | lapatinib plus trastuzumab continued to show superiority to lapatinib monotherapy in PFS (hazard ratio [HR], 0.74; 95% CI, 0.58 to 0.94; P = .011) |
| Median OS A vs. C: | lapatinib plus trastuzumab versus lapatinib monotherapy offered significant OS benefit (HR, 0.74; 95% CI, 0.57 to 0.97; P = .026).Improvements in absolute OS rates were 10% at 6 months and 15% at 12 months in the combination arm compared with the monotherapy arm |
| Adverse Event(agent arm): | Incidence of adverse events was consistent with previously reported rates. |
| Conclusions: | These data demonstrated a significant 4.5month median OS advantage with the lapatinib and trastuzumab combination and support dual human epidermal growth factor receptor 2 blockade in patients with heavily pretreated human epidermal growth factor receptor 2positive MBC. |