title: High-dose medroxyprogesterone acetate in advanced breast cancer. Clinical and pharmacokinetic study with a combined oral and intramuscular regimen.
abstract: Seventy-five patients with advanced and intensively pretreated breast cancer received high-dose medroxyprogesterone acetate (MPA) using a schedule consisting of an intramuscular (IM) loading dose (1 g MPA IM days 1 to 10) and an oral maintenance treatment (200 mg/day three times a day) thereafter. A reinduction was performed in part of the responding patients at time of early relapse (1 g MPA IM for 10 consecutive days). MPA serum levels above 100 ng/ml were achieved during induction treatment and maintained for 3 to 4 months during the oral phase of therapy before decreasing to approximately 50 ng/ml. Two complete remissions (duration, 17.2 and 62 months), 15 partial remissions (median duration, 7 months), and 21 cases of disease stabilization (median duration, 5.5 months) were achieved. The median survival time was significantly longer for responders (19.9 months) than nonresponders (4.8 months). Although a higher proportion of postmenopausal patients responded, the remission duration in premenopausal women was remarkably long. Favorable sites of response were soft tissue, lymph nodes, and bone lesions. Reinduction treatment yielded a second response (two partial remissions, three no change) in five of six patients indicating that high-dose conditions were necessary to maintain response. This schedule allows to restrict higher doses of MPA on a long-term basis to responding patients.
authors.affiliation: Innere Universität und Poliklinik (Tumorforschung), Westdeutsches Tumorzentrum, FRG.
authors.forename: R
authors.initials: R
authors.lastname: Becher
authors.forename: A A
authors.initials: AA
authors.lastname: Miller
authors.forename: K
authors.initials: K
authors.lastname: Höffken
authors.forename: U
authors.initials: U
authors.lastname: Gerhold
authors.forename: H
authors.initials: H
authors.lastname: Hirche
authors.forename: C G
authors.initials: CG
authors.lastname: Schmidt
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000556:secondary; D001943:Breast Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008525:Medroxyprogesterone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D017258:Medroxyprogesterone Acetate; D008593:Menopause; D008875:Middle Aged
chemical_list: D000970:Antineoplastic Agents; D017258:Medroxyprogesterone Acetate; D008525:Medroxyprogesterone