Neoadjuvant chemotherapy with trastuzumab, docetaxel, and carboplatin administered every 3 weeks for Japanese women with HER2-positive primary breast cancer: efficacy and safety

• Published in: International journal of clinical oncology 2017-10, Vol.22 (5), p.880-886
• Main Authors: Sugitani, Ikuko, Ueda, Shigeto, Sakurai, Takashi, Shigekawa, Takashi, Hirokawa, Eiko, Shimada, Hiroko, Takeuchi, Hideki, Matsuura, Kazuo, Misumi, Misono, Fujiuchi, Nobuko, Takahashi, Takao, Hasebe, Takahiro, Osaki, Akihiko, Saeki, Toshiaki
• Format: Article
• Language: English
• Subjects: Adult; Aged; Anemia; Anorexia; Anorexia - chemically induced; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Asian Continental Ancestry Group; Biopsy; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - metabolism; Breast Neoplasms - pathology; Breast Neoplasms - surgery; Cancer Research; Carboplatin; Carboplatin - administration & dosage; Chemotherapy; Diarrhea; Drug therapy; Epidermal growth factor; ErbB-2 protein; Exanthema; Female; Hematology; Humans; Immunotherapy; Invasiveness; Lymph nodes; Medicine; Medicine & Public Health; Middle Aged; Monoclonal antibodies; Neoadjuvant Therapy - adverse effects; Neutropenia; Neutropenia - chemically induced; Oncology; Original; Original Article; Receptor, ErbB-2 - metabolism; Safety; Surgery; Surgical Oncology; Targeted cancer therapy; Taxoids - administration & dosage; Thrombocytopenia; Toxicity; Trastuzumab; Trastuzumab - administration & dosage; UMIN; UMIN000013513; Women
• ISSN: 1341-9625; 1437-7772
• DOI: 10.1007/s10147-017-1136-8

Background This phase II neoadjuvant study evaluated the efficacy and safety of a triweekly regimen of docetaxel and carboplatin in combination with trastuzumab (TCbH) in Japanese women with human epidermal growth factor receptor type2 (HER2)-positive primary breast cancer. Methods Patients with HER2-positive, stage I–III invasive breast cancer received six courses of trastuzumab (8 mg/kg loading dose, then 6 mg/kg, day 1), docetaxel (75 mg/m 2 , day 1), and carboplatin (area under the curve: 6, day 1) every 3 weeks. The primary endpoint was pathological complete response (pCR) of both breast and axillary lymph node disease. Results Fifty patients were enrolled in this study. Median age was 58 (range 32–75) years. All patients underwent definitive surgery. Thirty-three (66%) patients completed the chemotherapy course, while the treatment was delayed or discontinued in the other 17 (34%) patients because of adverse events (AEs). The pCR rate was 52%; the overall response rate was 66%. Grade 3/4 AEs due to nonhematological toxicity were anorexia (4%), diarrhea (2%), and rash (2%), and those due to hematological toxicity were neutropenia (36%), anemia (12%), and thrombocytopenia (2%). Conclusion Although the triweekly six-course regimen of TCbH achieved a high pCR rate, hematological AEs frequently occurred during the latter part of the chemotherapy course. One-third of patients experienced delayed or discontinued chemotherapy. Clinical registration number: http://www.umin.org.au UMIN000013513.