title: Randomized phase II study of nab-paclitaxel as first-line chemotherapy in patients with HER2-negative metastatic breast cancer.
abstract: Weekly administration of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) has been shown to be a safe and effective treatment for metastatic breast cancer (MBC) in clinical studies. We conducted a multicenter, randomized, open-label phase II study to compare the efficacy and safety of weekly nab-paclitaxel and docetaxel in Japanese patients with human epidermal growth factor receptor 2-negative MBC. The primary endpoint was progression-free survival (PFS). Patients were randomized to receive nab-paclitaxel (150 mg/m2nab-paclitaxel once per week for 3 of 4 weeks; n = 100) or docetaxel (75 mg/m2docetaxel every 3 weeks; n = 100). The median PFS by independent radiologist assessment was 9.8 months (90% confidence interval [CI]: 8.5-11.2) for nab-paclitaxel and 11.2 months (90% CI: 8.4-13.8) for docetaxel (hazard ratio: 1.25, P = 0.363), and the median overall survival was 42.4 months and 34.0 months, respectively. The overall response rate was 56.1% for nab-paclitaxel and 52.5% for docetaxel. Adverse events in both treatment arms were similar to previous reports. Neutropenia was the most common adverse event in both arms, with 35.0% of patients in the nab-paclitaxel arm and 89.0% in the docetaxel arm experiencing grade 4 neutropenia. Grade 3 peripheral sensory neuropathy occurred in 22.0% of patients in the nab-paclitaxel and 5.0% in the docetaxel arm. In this study, although weekly nab-paclitaxel 150 mg/m2did not show superiority in PFS compared with docetaxel, efficacy outcomes were similar in patients treated with weekly nab-paclitaxel and docetaxel.
authors.affiliation: Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Kenji
authors.identifier: http://orcid.org/0000-0002-3514-9927
authors.initials: K
authors.lastname: Tamura
authors.affiliation: Division of Breast Oncology, Saitama Cancer Center, Saitama, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Inoue
authors.affiliation: Department of Surgery, Breast Oncology, NHO Osaka National Hospital, Osaka, Japan.
authors.forename: Norikazu
authors.initials: N
authors.lastname: Masuda
authors.affiliation: Department of Breast Surgery, Hyogo Cancer Center, Hyogo, Japan.
authors.forename: Shintaro
authors.initials: S
authors.lastname: Takao
authors.affiliation: Department of Surgery, Iwate Medical University, Iwate, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kashiwaba
authors.affiliation: Department of Breast and Endocrine Surgery, Tokai University Hospital, Kanagawa, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Tokuda
authors.affiliation: Department of Breast Oncology, Aichi Cancer Center, Aichi, Japan.
authors.forename: Hiroji
authors.initials: H
authors.lastname: Iwata
authors.affiliation: Division of Breast Surgery, Chiba Cancer Center, Chiba, Japan.
authors.forename: Naohito
authors.initials: N
authors.lastname: Yamamoto
authors.affiliation: Department of Surgery, Shikoku Cancer Center, Ehime, Japan.
authors.forename: Kenjiro
authors.initials: K
authors.lastname: Aogi
authors.affiliation: Department of Breast Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Saeki
authors.affiliation: Department of Breast and Endocrine Surgery, Osaka University Hospital, Osaka, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Nakayama
authors.affiliation: Department of Breast Surgery, Niigata Cancer Center, Niigata, Japan.
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Sato
authors.affiliation: Department of Breast Surgery, Nagoya City University Hospital, Aichi, Japan.
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Toyama
authors.affiliation: Department of Surgical Oncology, Graduate School of Medicine, Tohoku University, Miyagi, Japan.
authors.forename: Takanori
authors.initials: T
authors.lastname: Ishida
authors.affiliation: Department of Medical Oncology, Yokohama Rosai Hospital, Kanagawa, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Arioka
authors.affiliation: Department of Breast Oncology, Juntendo University Hospital, Tokyo, Japan.
authors.forename: Mitsue
authors.initials: M
authors.lastname: Saito
authors.affiliation: Department of Breast Oncology, National Kyushu Cancer Center, Fukuoka, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Ohno
authors.affiliation: Department of Breast Surgery, St. Luke's International Hospital, Tokyo, Japan.
authors.forename: Hideko
authors.initials: H
authors.lastname: Yamauchi
authors.affiliation: Department of Breast Surgery, Tokyo Medical University Hospital, Tokyo, Japan.
authors.forename: Kimito
authors.initials: K
authors.lastname: Yamada
authors.affiliation: Department of Breast Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Junichiro
authors.initials: J
authors.lastname: Watanabe
authors.affiliation: Department of Target Therapy Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ishiguro
authors.affiliation: Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Fujiwara
mesh_terms: D000328:Adult; D000368:Aged; D000418:Albumins / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage; D044466:Asian People; D001943:Breast Neoplasms / Q000188:drug therapy*; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000418:Albumins; D000077143:Docetaxel; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; C520255:130-nm albumin-bound paclitaxel; C508053:ERBB2 protein, human
keywords: albumin-bound paclitaxel; docetaxel; metastatic breast cancer; phase II; weekly regimen