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Preoperative chemotherapy plus trastuzumab, lapatinib, or both in human epidermal growth factor receptor 2-positive operable breast cancer: Results of the randomized phase II CHER-LOB study
- Publication Year :
- 2012
-
Abstract
- Purpose This is a noncomparative, randomized, phase II trial of preoperative taxane-anthracycline in combination with trastuzumab, lapatinib, or combined trastuzumab plus lapatinib in patients with human epidermal growth factor receptor 2 (HER2) –positive, stage II to IIIA operable breast cancer. The primary aim was to estimate the percentage of pathologic complete response (pCR; no invasive tumor in breast and axillary nodes). Patients and 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. Results 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). Conclusion 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.
- Subjects :
- Oncology
medicine.medical_specialty
Cancer Research
Cyclophosphamide
Paclitaxel
Receptor, ErbB-2
medicine.medical_treatment
Socio-culturale
Breast Neoplasms
Lapatinib
Loading dose
Antineoplastic Combined Chemotherapy Protocols
Drug Administration Schedule
Epirubicin
Female
Fluorouracil
Humans
Middle Aged
Neoadjuvant Therapy
Quinazolines
ErbB-2
Breast cancer
Trastuzumab
Internal medicine
medicine
skin and connective tissue diseases
Chemotherapy
Antineoplastic Combined Chemotherapy Protocol
business.industry
Quinazoline
medicine.disease
business
Breast Neoplasm
Receptor
medicine.drug
Human
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....3d032a97273c7b720d5fc5fb616cc6e7