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.

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.

• Authors: Diana Crivellari, Kathryn P Gray, Silvia Dellapasqua, Fabio Puglisi, Karin Ribi, Karen N Price, István Láng, Lorenzo Gianni, Simon Spazzapan, Graziella Pinotti, Jean-Marc Lüthi, Richard D Gelber, Meredith M Regan, Marco Colleoni, Monica Castiglione-Gertsch, Rudolf Maibach, Manuela Rabaglio, Alan S Coates, Aron Goldhirsch
• Journal: Breast (Edinburgh, Scotland) (Breast) Vol. 22 Issue 2 Pg. 130-137 (Apr 2013) ISSN: 1532-3080 [Electronic] Netherlands
• PMID: 23453899 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
• Copyright: Copyright © 2013 Elsevier Ltd. All rights reserved.

Chemical References

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

Topics

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