AI Article Synopsis
- Lapatinib, an oral drug targeting EGFR and HER2, shows effectiveness as a single agent or with chemotherapy for metastatic breast cancer (MBC) that overexpresses HER2.
- A phase II trial evaluated lapatinib combined with paclitaxel in untreated HER2-overexpressing MBC patients, focusing on overall response rate (ORR) and other efficacy and safety measures.
- The results indicated a 51% ORR by independent review, with manageable side effects, suggesting the combination is a promising first-line treatment option for this patient group.
Article Abstract
Introduction: Lapatinib, an orally active tyrosine kinase inhibitor of epidermal growth factor receptor ErbB1 (EGFR) and ErbB2 (HER2), has activity as monotherapy and in combination with chemotherapy in HER2-overexpressing metastatic breast cancer (MBC).
Methods: This phase II single-arm trial assessed the safety and efficacy of first-line lapatinib in combination with paclitaxel in previously untreated patients with HER2-overexpressing MBC. The primary endpoint was the overall response rate (ORR). Secondary endpoints were the duration of response (DoR), time to response, time to progression, progression-free survival (PFS), overall survival, and the incidence and severity of adverse events. All endpoints were investigator- and independent review committee (IRC)-assessed.
Results: The IRC-assessed ORR was 51% (29/57 patients with complete or partial response) while the investigator-assessed ORR was 77% (44/57). As per the IRC, the median DoR was 39.7 weeks, and the median PFS was 47.9 weeks. The most common toxicities were diarrhea (56%), neutropenia (44%), rash (40%), fatigue (25%), and peripheral sensory neuropathy (25%).
Conclusions: First-line lapatinib plus paclitaxel for HER2-overexpressing MBC produced an encouraging ORR with manageable toxicities. This combination may be useful in first-line treatment for patients with HER2-overexpressing MBC and supports the ongoing evaluation of this combination as first-line therapy in HER2-overexpressing MBC.
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| http://dx.doi.org/10.1159/000318043 | DOI Listing |
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