Entry Detail
| General information | |
| Database: | DB00657 |
| Objective: | In this study, they investigated the effect of lapatinib plus capecitabine treatment in human epidermal growth factor receptor 2positive breast cancer patients with brain metastasis. |
| Authors: | Kaplan MA, et al |
| Title: | Clinical outcomes in patients who received lapatinib plus capecitabine combination therapy for human epidermal growth factor receptor 2positive breast cancer with brain metastasis and a comparison of survival with those who received trastuzumabbased therapy: a study by the Anatolian Society of Medical Oncology. |
| Journal: | Breast Cancer. |
| Year: | 2014 |
| PMID: | 23335064 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | lapatinib |
| Target: | Epidermal growth factor receptor Receptor proteintyrosine kinase erbB2 |
| Cancer Type: | advanced cancer with brain metastasis |
| Cancer Subtype: | brain metastases from human epidermal growth factor receptor 2-positive breast cancerhuman epidermal growth factor receptor 2positive breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | lapatinib plus capecitabine combination therapy |
| Study Type: | retrospective study |
| Key Patients Feature: | NA |
| Biomarker: | human epidermal growth factor receptor 2positive |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Of 405 metastatic breast cancer patients with brain metastases at referral centers in Turkey, 46 were treated with lapatinib plus capecitabine only after the development of brain metastasis. Patients who only received trastuzumabbased therapy after the development of brain metastases were accepted as the historic control group for survival analyses (n = 65). |
| Primary End Point: | safety and efficacy |
| Secondary End Point: | NA |
| Patients Number: | 46 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | 0.684 |
| Median Time to Progression: | 11.9 months (0-69 months) |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Grade 34 toxicity was observed in eight patients (17.3 %). Median overall survival (OS) in patients treated with lapatinib plus capecitabine was significantly increased compared to that in patients treated with trastuzumabbased therapy (19.1 vs. 12 months, respectively, p = 0.039). The incidence of cerebral death was slightly decreased in patients who received lapatinib plus capecitabine compared to those who received trastuzumabbased therapy (32 vs. 43.4 %, p = 0.332). |
| Conclusions: | Although this retrospective multicenter study had several limitations, the results suggest that undergoing lapatinib plus capecitabine therapy after the diagnosis of brain metastasis may further improve survival compared to undergoing only trastuzumabbased therapy. |