1. Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Trastuzumab Followed by 5-Fluorouracil/Epirubicin/Cyclophosphamide for HER2-positive Operable Breast Cancer: A Multicenter Phase II Trial
- Author
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Kenji Tezuka, Kosei Hirakawa, Shigehito Yamagata, Mao Tokumoto, Minoru Takada, Takeo Nishimori, Katsumi Ikeda, Shinya Tokunaga, Hidemi Kawajiri, Yoshinari Ogawa, Yoko Mizuyama, Takeshi Sunami, Tsutomu Takashima, Shinichiro Kashiwagi, Masaichi Ohira, Tetsuro Ishikawa, Shinzoh Kudoh, Satoru Noda, and Shigehiko Nishimura more...
- Subjects
Adult ,Oncology ,Cancer Research ,medicine.medical_specialty ,Paclitaxel ,Cyclophosphamide ,Receptor, ErbB-2 ,medicine.medical_treatment ,Breast Neoplasms ,Loading dose ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Breast cancer ,Trastuzumab ,Albumins ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Clinical endpoint ,Humans ,Medicine ,skin and connective tissue diseases ,Aged ,Epirubicin ,Chemotherapy ,business.industry ,General Medicine ,Middle Aged ,medicine.disease ,Neoadjuvant Therapy ,Treatment Outcome ,chemistry ,030220 oncology & carcinogenesis ,Female ,Fluorouracil ,business ,medicine.drug - Abstract
Aim This study was conducted in order to evaluate the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus trastuzumab followed by 5-fluorouracil/ epirubicin/cyclophosphamide (FEC) in a neoadjuvant chemotherapy (NAC) setting for patients with human epidermal growth factor receptor 2 (HER2)-positive operable breast cancer. Patients and methods Each patient received four cycles of 260 mg/m2 nab-paclitaxel with 6 mg/kg trastuzumab (8 mg/kg as the loading dose) every 3 weeks (q3w) followed by four cycles of FEC (500/100/500 mg/m2) q3w. The primary endpoint was pathological complete response (pCR) rate. Results Twenty-nine patients were analyzed for the efficacy and safety of this treatment. All patients completed four cycles of nab-paclitaxel and trastuzumab, and 28 patients completed four cycles of FEC. Twenty-seven patients subsequently underwent surgery. The pCR rate was 74.0%. The most frequent toxicity was sensory neuropathy (96.6%), but grade 3 neuropathy rate was 3.4%. Conclusion Nab-paclitaxel plus trastuzumab followed by FEC in patients with HER2-positive operable breast cancer is considerably effective and well tolerated. more...
- Published
- 2019
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