Entry Detail
| General information | |
| Database: | DB01056 |
| Objective: | Adjuvant lapatinib for women with earlystage human epidermal growth factor receptor 2positive breast cancer |
| Authors: | Paul E Goss |
| Title: | Adjuvant lapatinib for women with earlystage human epidermal growth factor receptor 2positive breast cancer: a randomised, controlled, phase 3 trial. |
| Journal: | Lancet Oncol. |
| Year: | 2013 |
| PMID: | 23234763 |
| Trial Design | |
| Clinical Trial Id: | NCT00374322 |
| Agent: | lapatinib |
| Target: | Epidermal growth factor receptor Receptor proteintyrosine kinase erbB2 |
| Cancer Type: | breast cancer |
| Cancer Subtype: | breast cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a placebocontrolled, multicentre, randomisedphase III trial. |
| Key Patients Feature: | Women outpatients from 405 centres in 33 countries with human epidermal growth factor receptor 2positive earlybreast cancer who had previously received adjuvant chemotherapy but not trastuzumab |
| Biomarker: | human epidermal growth factor receptor 2positive |
| Biomark Analysis: | Central review of human epidermal growth factor receptor 2 status showed that only 2490 (79%) of the randomised women were human epidermal growth factor receptor 2positive. 157 (13%) of 1230 confirmed human epidermal growth factor receptor 2positive patients in the lapatinib group and in 208 (17%) of 1260 in the placebo group had a diseasefree survival event (HR 0.82, 95% 0.671.00; p=0.04). |
| Control Group Info: | placebo |
| Treatment Info: | daily lapatinib (1500 mg) or daily placebo for 12 months. |
| Primary End Point: | diseasefree survival in the intentiontotreat population. |
| Secondary End Point: | NA |
| Patients Number: | 3147 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 210 (13%) diseasefree survival events had occurred in the lapatinib group versus 264 (17%) in the placebo group (hazard ratio [HR] 0.83, 95% CI 0.70-1.00; p=0.053). |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | 1450 (92%) of 1573 patients who took lapatinib and 1193 (76%) of 1574 patients who took placebo reported any adverse event (p=0.003), mainly of grade 1 or 2. Diarrhoea, rash, nausea, fatigue, and hepatobiliary events were more common in the lapatinib group than in the placebo group (table 3). Overall, 99 (6%) patients taking lapatinib and 77 (5%) patients taking placebo had serious adverse events (28 [1.8%] vs 10 [<1%] had infections; 16 [1%] vs 14 [<1%] neoplasms; 17 [1%] vs 8 [<1%] gastrointestinal disorders; and 7 [<1%] vs 7 [<1%] cardiac events). Eight serious hepatobiliary events (<1%) occurred in the lapatinib group versus none in the placebo group. Occurrence of cardiac events did not diff er signifi cantly between groups (table 3). No statistically signifi cant (p<0.05) or clinically meaningful diff erences existed be ttheyen groups for summary qualityoflife scores relative to baseline (data not shown). No deaths were related to lapatinib treatment. |
| Conclusions: | Our data show that there was no signifi cant diff erence in diseasefree survival bettheyen groups when analysed in the intentiontotreat population. Hotheyver, exploratory analyses restricted to patients who had human epidermal growth factor receptor 2positive disease confi rmed by central fl uorescence insitu hybridisation review suggested marginal benefi t with lapatinib in terms of diseasefree survival. Thus lapatinib might be an option for women with human epidermal growth factor receptor 2positive breast cancer who do not or cannot receive adjuvant trastuzumab. |