PropertyValue
?:abstract
  • BACKGROUND: Chemotherapy-induced peripheral neuropathy is commonly observed in patients treated with nanoparticle albumin–bound paclitaxel (nab-PTX). We conducted a multicenter randomized controlled study to evaluate the optimal dose of nab-PTX. METHODS: We compared three different doses of q3w nab-PTX (Standard: 260 mg/m(2) [SD260] vs Medium: 220 mg/m(2) [MD220] vs Low: 180 mg/m(2) [LD180]) in patients with HER2-negative metastatic breast cancer (MBC). Primary endpoint was progression-free survival (PFS). Grade 3/4 neuropathy rates in the three doses were estimated using the logistic regression model. The optimal dose was selected in two steps. Initially, if the hazard ratio (HR) for PFS was <0.75 or >1.33, the inferior dose was excluded, and we proceeded with the non-inferior dose. Then, if the estimated incidence rate of grade 3/4 neurotoxicity exceeded 10%, that dose was also excluded. RESULTS: One hundred forty-one patients were randomly assigned to SD260 (n = 47), MD220 (n = 46), and LD180 (n = 48) groups, and their median PFS was 6.66, 7.34, and 6.82 months, respectively. The HRs were 0.73 (95% confidence interval [CI]: 0.42–1.28) in MD220 vs SD260, 0.77 (95% CI 0.47–1.28) in LD180 vs SD260, and 0.96 (95% CI 0.56–1.66) in LD180 vs MD220. SD260 was inferior to MD220 and was excluded. The estimated incidence rate of grade 3/4 neurotoxicity was 29.5% in SD260, 14.0% in MD220, and 5.9% in LD180. The final selected dose was LD180. CONCLUSIONS: Intravenous administration of low-dose nab-PTX at 180 mg/m(2) q3w may be the optimal therapy with meaningful efficacy and favorable toxicity in patients with MBC.
is ?:annotates of
?:creator
?:doi
  • 10.1016/j.breast.2020.12.002
?:doi
?:journal
  • Breast
?:license
  • cc-by-nc-nd
?:pdf_json_files
  • document_parses/pdf_json/065ee62b09aed793339960366e09c2d20fe8c636.json
?:pmc_json_files
  • document_parses/pmc_json/PMC7753189.xml.json
?:pmcid
?:pmid
?:pmid
  • 33341707.0
?:publication_isRelatedTo_Disease
?:sha_id
?:source
  • Medline; PMC
?:title
  • Randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel in patients with metastatic breast cancer
?:type
?:year
  • 2020-12-09

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