Preoperative chemotherapy plus trastuzumab, lapatinib, or both in human epidermal growth factor receptor 2-positive operable breast cancer: Results of the randomized phase III CHER-LB study Full Text
Journal of Clinical Oncology,
Guarneri V et al. – The primary end point of the study was met, with a relative increase of 80% in the pCR rate achieved with chemotherapy plus trastuzumab and lapatinib compared with chemotherapy plus either trastuzumab or lapatinib. These data add further evidence supporting the superiority of a dual-HER2 inhibition for the treatment of HER2-positive breast cancer.Methods
- In the three arms, chemotherapy consisted of weekly paclitaxel (80 mg/m2) for 12 weeks followed by fluorouracil, epirubicin, and cyclophosphamide for four courses every 3 weeks.
- The patients randomly assigned to arm A received a 4-mg loading dose of trastuzumab followed by 2 mg weekly; in arm B patients received lapatinib 1,500 mg orally (PO) daily; and in arm C, patients received trastuzumab and lapatinib 1,000 mg PO daily.
- A total of 121 patients were randomly assigned.
- Diarrhea and dermatologic and hepatic toxicities were observed more frequently in patients receiving lapatinib.
- No episodes of congestive heart failure were observed.
- The rates of breast-conserving surgery were 66.7%, 57.9%, and 68.9% in arms A, B and C, respectively.
- The pCR rates were 25% (90% CI, 13.1% to 36.9%) in arm A, 26.3% (90% CI, 14.5% to 38.1%) in arm B, and 46.7% (90% CI, 34.4% to 58.9%) in arm C (exploratory P = .019).