PMID- 28547525 OWN - NLM STAT- MEDLINE DCOM- 20180416 LR - 20221207 IS - 1437-7772 (Electronic) IS - 1341-9625 (Print) IS - 1341-9625 (Linking) VI - 22 IP - 5 DP - 2017 Oct TI - Neoadjuvant chemotherapy with trastuzumab, docetaxel, and carboplatin administered every 3 weeks for Japanese women with HER2-positive primary breast cancer: efficacy and safety. PG - 880-886 LID - 10.1007/s10147-017-1136-8 [doi] AB - 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. FAU - Sugitani, Ikuko AU - Sugitani I AD - Department of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan. FAU - Ueda, Shigeto AU - Ueda S AD - Department of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan. FAU - Sakurai, Takashi AU - Sakurai T AD - Breast Center, JCHO Saitama Medical Center, 4-9-3, Kita-urawa, Urawa-ku, Saitama, 330-0074, Japan. FAU - Shigekawa, Takashi AU - Shigekawa T AD - Department of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan. FAU - Hirokawa, Eiko AU - Hirokawa E AD - Department of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan. FAU - Shimada, Hiroko AU - Shimada H AD - Department of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan. FAU - Takeuchi, Hideki AU - Takeuchi H AD - Department of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan. FAU - Matsuura, Kazuo AU - Matsuura K AD - Department of Breast Surgery, Hiroshima Prefectural Hospital, 1-5-54 Kanda, Minami-ku, Hiroshkloima-Shi, Hiroshima, 734-8530, Japan. FAU - Misumi, Misono AU - Misumi M AD - Department of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan. FAU - Fujiuchi, Nobuko AU - Fujiuchi N AD - Department of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan. FAU - Takahashi, Takao AU - Takahashi T AD - Department of Palliative Medicine, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, Japan, 350-1298. FAU - Hasebe, Takahiro AU - Hasebe T AD - Department of Pathology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan. FAU - Osaki, Akihiko AU - Osaki A AD - Department of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan. FAU - Saeki, Toshiaki AU - Saeki T AD - Department of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan. tsaeki@saitama-med.ac.jp. LA - eng PT - Clinical Trial, Phase II PT - Journal Article DEP - 20170525 PL - Japan TA - Int J Clin Oncol JT - International journal of clinical oncology JID - 9616295 RN - 0 (Taxoids) RN - 15H5577CQD (Docetaxel) RN - BG3F62OND5 (Carboplatin) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) RN - P188ANX8CK (Trastuzumab) SB - IM MH - Adult MH - Aged MH - Anorexia/chemically induced MH - Antineoplastic Combined Chemotherapy Protocols/*adverse effects/*therapeutic use MH - Asian People MH - Breast Neoplasms/*drug therapy/metabolism/pathology/surgery MH - Carboplatin/administration & dosage MH - Docetaxel MH - Female MH - Humans MH - Middle Aged MH - Neoadjuvant Therapy/adverse effects MH - Neutropenia/chemically induced MH - Receptor, ErbB-2/metabolism MH - Taxoids/administration & dosage MH - Trastuzumab/administration & dosage PMC - PMC5608788 OTO - NOTNLM OT - Breast cancer OT - Carboplatin OT - Docetaxel OT - Neoadjuvant chemotherapy OT - Trastuzumab COIS- Toshiaki Saeki received lecture fees from Chugai Pharmaceutical Co., Ltd. The other authors declare that they had no conflict of interest. EDAT- 2017/05/27 06:00 MHDA- 2018/04/17 06:00 PMCR- 2017/05/25 CRDT- 2017/05/27 06:00 PHST- 2017/03/13 00:00 [received] PHST- 2017/05/07 00:00 [accepted] PHST- 2017/05/27 06:00 [pubmed] PHST- 2018/04/17 06:00 [medline] PHST- 2017/05/27 06:00 [entrez] PHST- 2017/05/25 00:00 [pmc-release] AID - 10.1007/s10147-017-1136-8 [pii] AID - 1136 [pii] AID - 10.1007/s10147-017-1136-8 [doi] PST - ppublish SO - Int J Clin Oncol. 2017 Oct;22(5):880-886. doi: 10.1007/s10147-017-1136-8. Epub 2017 May 25.