Safety and efficacy evaluation of albumin-bound paclitaxel

Sara Cecco, Maria Aliberti, Paolo Baldo, Elisa Giacomin, Roberto Leone

Research output: Contribution to journalArticlepeer-review


Introduction: Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is a novel solvent-free formulation of paclitaxel, which was developed to avoid toxicities associated with Cremophor EL® vehicle used in solvent-based paclitaxel. It is approved as monotherapy for treatment of metastatic breast cancer (MBC) in Europe and the US; in combination therapy for non-small-cell lung cancer (NSCLC) and for first-line treatment of advanced pancreatic cancer (PC) only in the US. The European Medicines Agency has recently released only a positive opinion for use of nab-paclitaxel in PC. Areas covered: This review reports the clinical findings and the safety data of nab-paclitaxel for MBC, NSCLC and PC. Expert opinion: In MBC, nab-paclitaxel has demonstrated a good safety and an efficacy profile compared with other taxanes, but no strong data on overall survival are available. Considering the role of markers or predictive factors for nab-paclitaxel effectiveness in the metastatic setting would be useful. In PC, nab-paclitaxel and gemcitabine represent a new therapeutic choice with significant improvement in survival. In a Phase III study with NSCLC patients, nab-paclitaxel showed better results in a subgroup of patients with squamous histology, for whom results with conventional therapies are still poor and improved therapeutic options are needed.

Original languageEnglish
Pages (from-to)511-520
Number of pages10
JournalExpert Opinion on Drug Safety
Issue number4
Publication statusPublished - 2014


  • Adverse drug reaction
  • Albumin-bound paclitaxel
  • Metastatic breast cancer
  • Pancreatic cancer
  • Squamous lung cancer

ASJC Scopus subject areas

  • Pharmacology (medical)


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