title: Megestrol acetate: phase II study of a single daily administration in advanced breast cancer.
abstract: A new formulation of megestrol acetate, a semisynthetic oral progestin used in the hormonal treatment of breast cancer, allows the administration of 160 mg of the drug in a single daily dose. Sixty-nine postmenopausal patients with advanced breast cancer have been treated with this regimen: five patients received megestrol acetate as first-line treatment of their metastatic disease, while all the others had been previously treated with one or more regimens of chemotherapy and/or hormone therapy. The median duration of the treatment for evaluable patients was 3 months (range 1-13+). Among 65 evaluable patients 2 complete responses and 12 partial responses (objective response rate 21.5%; 95% confidence limits 12.31%-33.49%) were observed. Median duration of response was 7 months (range 2-12+). Responses were observed both in visceral and in non-visceral sites of disease. Twenty-nine patients obtained a stabilization of disease (44.7%), and twenty-two progressed (33.8%). Median duration of stabilization was 4 months (range 3-13+). Median survival for all patients from the start of megestrol acetate was 9 months (range 1-22+). The most common side effect of therapy was weight gain, occurring in 36% of patients. Megestrol acetate on a single-daily-dose schedule can be considered as an interesting hormonal treatment for advanced breast cancer, especially in the clinical instance of patients who, after having obtained a remission or stabilization of disease with tamoxifen, need further palliative treatment.
authors.affiliation: Istituto Nazionale per la Ricerca sul Cancro, Divisione di Oncologia Medica, Genova, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Pronzato
authors.forename: F
authors.initials: F
authors.lastname: Brema
authors.forename: D
authors.initials: D
authors.lastname: Amoroso
authors.forename: G
authors.initials: G
authors.lastname: Bertelli
authors.forename: P F
authors.initials: PF
authors.lastname: Conte
authors.forename: M C
authors.initials: MC
authors.lastname: Martini
authors.forename: G
authors.initials: G
authors.lastname: Pastorino
authors.forename: R
authors.initials: R
authors.lastname: Rosso
mesh_terms: D001835:Body Weight / Q000187:drug effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000628:therapy; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008535:Megestrol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019290:Megestrol Acetate; D008593:Menopause
chemical_list: D008535:Megestrol; D019290:Megestrol Acetate