Nanoparticle albumin-bound paclitaxel/liposomal-encapsulated doxorubicin in HER2-negative metastatic breast cancer patients

Alessandra Fabi, Gianluigi Ferretti, Paola Malaguti, Simona Gasparro, Cecilia Nisticò, Grazia Arpino, Paola Papaldo, Michelangelo Russillo, Giovanna Catania, Francesco Schettini, Diana Giannarelli, Francesco Cognetti

Research output: Contribution to journalArticlepeer-review

Abstract

Aim: To investigate the toxicity of nab-paclitaxel (wNP)/nonpegylated liposome-encapsulated doxorubicin (wNPLD) combination in HER2-negative metastatic breast cancer (MBC) patients as first-line treatment. Materials & methods: Phase I, single-arm study in metastatic breast cancer patients naive to previous chemotherapy for advanced disease. A 3 + 3 dose-escalation design was used to determine the safety. Primary endpoints were the identification of dose-limiting toxicity and maximum tolerated dose. Results: In total, 12 patients (mean age: 52 years; median metastatic sites: 2) were enrolled and 97 cycles were completed. Maximum tolerated dose was wNP + wNPLD 25 mg/m2. The most common adverse events were neutropenia, nausea, diarrhea and mucositis. The objective response rate was 68% (response mean duration: 12.6 months). Conclusion: wNP/wNPLD combination constitutes an active regimen with mild toxicity.

Original languageEnglish
Pages (from-to)1629-1637
Number of pages9
JournalFuture Oncology
Volume16
Issue number22
DOIs
Publication statusPublished - Aug 2020

Keywords

  • advanced breast cancer
  • dose-limiting toxicity
  • HER2
  • nanoparticle

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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