title: Taxane-induced peripheral neuropathy and health-related quality of life in postoperative breast cancer patients undergoing adjuvant chemotherapy: N-SAS BC 02, a randomized clinical trial.
abstract: OBJECTIVE
  To elucidate whether adjuvant taxane monotherapy is a feasible and tolerable for postoperative breast cancer patients, we evaluated the severity of chemotherapy-induced peripheral neuropathy (CIPN) and the relative tolerability of regimens by health-related quality of life (HRQOL) assessment in node-positive breast cancer patients treated with taxane-containing regimens.
  
  
  METHODS
  We evaluated CIPN and HRQOL in the first 300 patients enrolled in a larger (1,060 total) multicenter phase III trial randomized to one of four adjuvant regimens: (1) anthracycline-cyclophosphamide followed by paclitaxel (ACP), (2) AC followed by docetaxel (ACD), (3) paclitaxel alone (PTX), or (4) docetaxel alone (DTX). CIPN was assessed by the Patient Neurotoxicity Questionnaire (PNQ) and the National Cancer Institute Common Toxicity Criteria, and HRQOL by Functional Assessment of Cancer Therapy-General (FACT-G). CIPN and HRQOL scores were compared between ACP and ACD vs. PTX and DTX, and ACP and PTX vs. ACD and DTX.
  
  
  RESULTS
  PNQ sensory scores were significantly higher in patients treated with taxane monotherapy compared to treatment with AC followed by taxane (P = .003). No significant differences in PNQ sensory scores were observed between the ACP and PTX vs. ACD and DTX regimens (P = .669). Regardless of taxane regimen, PNQ severity scores for CIPN appear to be largely reversible within 1 year of adjuvant treatment. No significant difference in FACT-G scores was observed between any regimens during the study treatments.
  
  
  CONCLUSIONS
  Patient-reported CIPN was significantly more severe with single-agent adjuvant taxane compared to AC followed by taxane treatment; however, the HRQOL findings support that single-agent taxane treatment is tolerable.
authors.affiliation: Department of Biomedical Sciences, College of Life Sciences, Ritsumeikan University, 1-1-1 Noji-Higashi, Kusatsu, Shiga 525-8577, Japan. k-shimoz@sk.ritsumei.ac.jp
authors.forename: Kojiro
authors.initials: K
authors.lastname: Shimozuma
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Ayano
authors.initials: A
authors.lastname: Takeuchi
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Aranishi
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Katsumasa
authors.initials: K
authors.lastname: Kuroi
authors.forename: Shozo
authors.initials: S
authors.lastname: Ohsumi
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Makino
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Katsumata
authors.forename: Masaru
authors.initials: M
authors.lastname: Kuranami
authors.forename: Kimito
authors.initials: K
authors.lastname: Suemasu
authors.forename: Toru
authors.initials: T
authors.lastname: Watanabe
authors.forename: Frederick H
authors.initials: FH
authors.lastname: Hausheer
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D017322:Clinical Trials, Phase II as Topic; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008875:Middle Aged; D020258:Neurotoxicity Syndromes; D017239:Paclitaxel / Q000009:adverse effects; D010292:Paresthesia / Q000139:chemically induced; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D043823:Taxoids / Q000009:adverse effects*
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel