Effectiveness and Tolerability of Nab-paclitaxel in Younger versus Elderly Patients With Metastatic HR-positive/HER2-negative Breast Cancer: Results From the Noninterventional, Prospective Study NABUCCO

Clin Breast Cancer. 2020 Jun;20(3):e315-e326. doi: 10.1016/j.clbc.2019.11.003. Epub 2020 Mar 10.

Abstract

Background: There are only scarce data on treatment of elderly patients with nab-paclitaxel for metastatic breast cancer, especially from the real-world setting. Here we present data from the noninterventional study NABUCCO with special focus on taxane-induced peripheral neuropathy (TIPN) in younger and elderly patients.

Patients and methods: A total of 407 patients with HR-positive/HER2-negative metastatic breast cancer were enrolled between April 2012 and April 2015 into the prospective, multicenter, noninterventional study NABUCCO. Details on effectiveness, tolerability, and safety of nab-paclitaxel were evaluated for younger (<70 years) and elderly (≥70 years) patients.

Results: Neither median time to progression (TTP, younger 6.0 months, 95% confidence interval [CI], 5.5-7.1; elderly 6.9 months, 95% CI, 5.5-8.6) nor median overall survival (younger 16.4 months, 95% CI, 14.2-18.1; elderly 14.5 months, 95% CI, 11.9-17.4) differed by age group, also not in view of prior treatments. A multivariate regression model revealed that age did not significantly influence the TTP. TIPN was reported by 49.0% younger (44.3% common terminology criteria for adverse events [CTCAE] grade 1/2, 4.7% grade 3/4) and 45.8% elderly patients (41.1% CTCAE grade 1/2, 4.7% grade 3/4). The cumulative nab-paclitaxel dose did not correlate with the severity/grading of TIPN.

Conclusion: Treatment with nab-paclitaxel in first- or further-line of metastatic HR-positive/HER2-negative breast cancer resulted in similar effectiveness and safety, irrespective of age. Therefore, nab-paclitaxel is a valid treatment option for elderly and partially heavily pretreated patients. However, incidence of TIPN is high, influencing the patients' quality of life. A close monitoring and awareness for early TIPN symptoms is warranted.

Keywords: albumin-bound paclitaxel; breast neoplasms; health services for the aged; peripheral neuropathies; taxanes.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Albumins / administration & dosage*
  • Albumins / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Biomarkers, Tumor / analysis*
  • Biomarkers, Tumor / metabolism
  • Breast / pathology
  • Breast / surgery
  • Breast Neoplasms / diagnosis
  • Breast Neoplasms / mortality
  • Breast Neoplasms / pathology
  • Breast Neoplasms / therapy*
  • Chemotherapy, Adjuvant / adverse effects
  • Chemotherapy, Adjuvant / methods
  • Disease-Free Survival
  • Female
  • Humans
  • Mastectomy
  • Middle Aged
  • Neoplasm Staging
  • Paclitaxel / administration & dosage*
  • Paclitaxel / adverse effects
  • Peripheral Nervous System Diseases / chemically induced
  • Peripheral Nervous System Diseases / epidemiology*
  • Progression-Free Survival
  • Prospective Studies
  • Quality of Life
  • Receptor, ErbB-2 / analysis
  • Receptors, Estrogen / analysis
  • Receptors, Estrogen / metabolism
  • Receptors, Progesterone / analysis
  • Receptors, Progesterone / metabolism

Substances

  • 130-nm albumin-bound paclitaxel
  • Albumins
  • Biomarkers, Tumor
  • Receptors, Estrogen
  • Receptors, Progesterone
  • ERBB2 protein, human
  • Receptor, ErbB-2
  • Paclitaxel