title: 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: Medical Oncology, Centro di Riferimento Oncologico, Aviano, Italy. Electronic address: dcrivellari@cro.it.
authors: Diana
authors: D
authors: Crivellari
authors: International Breast Cancer Study Group (IBCSG) Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA; Harvard School of Public Health, Boston, MA, USA.
authors: Kathryn P
authors: KP
authors: Gray
authors: Research Unit in Medical Senology, Department of Medicine, European Institute of Oncology, Milan, Italy.
authors: Silvia
authors: S
authors: Dellapasqua
authors: Department of Medical and Biological Sciences, Medical Oncology, University of Udine, Udine, Italy.
authors: Fabio
authors: F
authors: Puglisi
authors: Quality of Life Office, International Breast Cancer Study Group Coordinating Center, Bern, Switzerland.
authors: Karin
authors: K
authors: Ribi
authors: International Breast Cancer Study Group Statistical Center, Boston, MA, USA; Frontier Science and Technology Research Foundation, Boston, MA, USA.
authors: Karen N
authors: KN
authors: Price
authors: National Institute of Oncology, Budapest, Hungary.
authors: István
authors: I
authors: Láng
authors: Department of Oncology, Ospedale Infermi Rimini and Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Rimini, Italy.
authors: Lorenzo
authors: L
authors: Gianni
authors: Medical Oncology, Centro di Riferimento Oncologico, Aviano, Italy.
authors: Simon
authors: S
authors: Spazzapan
authors: Medical Oncology, Ospedale di Circolo and Fondazione Macchi, Varese, Italy.
authors: Graziella
authors: G
authors: Pinotti
authors: Medical Oncology, Spital STS AG, Thun, Switzerland.
authors: Jean-Marc
authors: JM
authors: Lüthi
authors: International Breast Cancer Study Group (IBCSG) Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA; Harvard School of Public Health, Boston, MA, USA; Frontier Science and Technology Research Foundation, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
authors: Richard D
authors: RD
authors: Gelber
authors: International Breast Cancer Study Group (IBCSG) Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
authors: Meredith M
authors: MM
authors: Regan
authors: Research Unit in Medical Senology, Department of Medicine, European Institute of Oncology, Milan, Italy.
authors: Marco
authors: M
authors: Colleoni
authors: Unité de Onco-Gynécologie médicale, Departement de Médecine Hôpitaux, Universitaires de Genève, Genève, Switzerland.
authors: Monica
authors: M
authors: Castiglione-Gertsch
authors: International Breast Cancer Study Group Coordinating Center, Bern, Switzerland.
authors: Rudolf
authors: R
authors: Maibach
authors: International Breast Cancer Study Group Coordinating Center, Bern, Switzerland; Department of Medical Oncology, Inselspital, Bern, Switzerland.
authors: Manuela
authors: M
authors: Rabaglio
authors: International Breast Cancer Study Group and University of Sydney, Sydney, Australia.
authors: Alan S
authors: AS
authors: Coates
authors: Department of Medicine, European Institute of Oncology, Milan, Italy.
authors: Aron
authors: A
authors: Goldhirsch
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000453:epidemiology / Q000235:genetics / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D015897:Comorbidity; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008081:Liposomes; D008408:Mastectomy; D015412:Mastectomy, Segmental; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011788:Quality of Life
chemical_list: D000903:Antibiotics, Antineoplastic; D008081:Liposomes; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin