Phase 2 prospective open label study of neoadjuvant nab-paclitaxel,trastuzumab, and pertuzumab in patients with HER2-positive primary breast cancer |
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| Authors: | Sayeh M Lavasani MD George Somlo MD Susan E Yost PhD Paul H Frankel PhD Christopher Ruel MS Yujie Cui MS Mireya Murga BS Aileen Tang RN Norma Martinez RN Laura Kruper MD Lusine Tumyan MD Daniel Schmolze MD Christina Yeon MD Yuan Yuan MD PhD James R Waisman MD Joanne Mortimer MD |
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| Institution: | 1. Department of Medical Oncology & Therapeutic Research, City of Hope National Medical Center, Duarte, California, USA;2. Department of Biostatistics, City of Hope National Medical Center, Duarte, California, USA;3. Department of Surgery, City of Hope National Medical Center, Duarte, California, USA;4. Department of Diagnostic Radiology, City of Hope National Medical Center, Duarte, California, USA;5. Department of Pathology, City of Hope National Medical Center, Duarte, California, USA |
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| Abstract: | Background The objective of this study was to evaluate the safety and efficacy of nab-paclitaxel, trastuzumab, and pertuzumab as neoadjuvant therapy (NAT) in patients with human epidermal growth factor receptor 2 HER2+ breast cancer (HER2+ BC) to determine pathologic complete response (pCR), invasive disease-free survival (iDFS), and overall survival. Methods Forty-five patients with HER2+ BC Stages II–III were to be enrolled from 2013 to 2017. Patients were treated with weekly nab-paclitaxel (100 mg/m2 intravenously), weekly trastuzumab (4 mg/kg loading dose, then 2 mg/kg), and six cycles of pertuzumab (840 mg loading dose, then 420 mg intravenously day 1 every 21 days). Results Median follow-up was 60 months (95% CI, 32.3–55.6) and pCR was 29/45 (64%). The 5-year iDFS for patients who achieved pCR (N = 29) was 96.3% (95% CI, 76.5–99.5) and non-pCR patients (N = 16) was 74.3% (95% CI, 39.1–91.0). The 5-year overall survival (N = 45) was 94.1% (95% CI, 77.6–98.5). Based on hormonal status, the 5-year iDFS for HR+ pCR patients (N = 14) was 92.3% (95% CI, 56.6–98.9) and for HR? (N = 15) was 100% (p = .3). Conclusions This anthracycline/carboplatin-free regimen with nab-paclitaxel achieved a pCR rate of 64% in patients with HER2+ BC. The 5-year iDFS in patients with and without pCR was 96.3% and 74.3%, respectively. The pCR rate is comparable with docetaxel, carboplatin, trastuzumab, and pertuzumab therapy in the NAT setting, but with fewer treatment-associated toxicities. This finding suggests the possibility of safe avoidance of anthracyclines and carboplatin as components of NAT in patients with HER2+ BC. |
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| Keywords: | HER2-positive nab-paclitaxel neoadjuvant pertuzumab primary and locally-advanced breast cancer trastuzumab |
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