Adjuvant pegylated liposomal doxorubicin for older women with endocrine nonresponsive breast cancer who are NOT suitable for a "standard chemotherapy regimen": the CASA randomized trial

Breast. 2013 Apr;22(2):130-137. doi: 10.1016/j.breast.2013.01.015. Epub 2013 Feb 28.

Abstract

There is no optimal treatment for breast cancers lacking estrogen (ER) and progesterone (PgR) receptors in elderly women with co-morbidities that prevent use of "standard chemotherapy regimens" such as AC or CMF. The CASA trial studied pegylated liposomal doxorubicin (PLD) and low dose, metronomic cyclophosphamide + methotrexate (CM) for older (>65), vulnerable women with operable, ER and PgR-negative breast cancer. After two years the trial closed early, due to slow and inadequate accrual, with 77 patients (38:PLD, 36:CM, 3:nil). Sixty-eight percent completed PLD; 83% completed CM (both 16 weeks). Patients on PLD reported worse quality of life, cognitive and physical functioning than non-PLD regimens (primarily CM). At a median follow-up of 42 months, 81% of randomized patients remained free of any breast cancer recurrence. Based on our limited experience, PLD and CM may be reasonable options for further study for elderly vulnerable patients with endocrine nonresponsive breast cancer.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antibiotics, Antineoplastic / administration & dosage*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / epidemiology
  • Breast Neoplasms / genetics
  • Breast Neoplasms / surgery
  • Chemotherapy, Adjuvant
  • Comorbidity
  • Doxorubicin / administration & dosage
  • Doxorubicin / analogs & derivatives*
  • Female
  • Humans
  • Liposomes
  • Mastectomy
  • Mastectomy, Segmental
  • Neoplasm Recurrence, Local / epidemiology
  • Polyethylene Glycols / administration & dosage*
  • Quality of Life

Substances

  • Antibiotics, Antineoplastic
  • Liposomes
  • liposomal doxorubicin
  • Polyethylene Glycols
  • Doxorubicin