title: Oral metronomic chemo-hormonal-therapy of metastatic breast cancer with cyclophosphamide and megestrol acetate.
abstract: Metronomic chemotherapy is an anticancer strategy which uses conventional cytotoxic drugs administered at very low dose in close intervals. We have designed a phase II trial to investigate the safety and antitumor activity of the newest metronomic chemo-hormonal-therapy with daily cyclophosphamide and twice daily megestrol acetate (mCM regimen) in patients with metastatic pretreated breast cancer.Twenty-nine pretreated post-menopausal patients with multiple metastatic sites were enrolled. four patients had a triple negative status, nineteen a positive hormonal ER and PgR status, and three ERB-B2 over-expression. Patients received treatment with cyclophosphamide (50 mg/daily day 1-21/q28) and fractionated megestrol acetate (80 mg twice a day). The overall objective response rate was 31.0%, disease control rate 41.3%, mean time to tumor progression 7.4 months (CI 95%, 3.8-10.88, range 1-48 months) and mean overall survival 13.4 months (CI 95%, 7.24-17.18, range 1-53 months). The mCM regimen was active and well tolerated.
authors.affiliation: Section of Medical Oncology, Department Giorgio Segre of Pharmacology, Siena University School of Medicine, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Licchetta
authors.forename: P
authors.initials: P
authors.lastname: Correale
authors.forename: C
authors.initials: C
authors.lastname: Migali
authors.forename: C
authors.initials: C
authors.lastname: Remondo
authors.forename: E
authors.initials: E
authors.lastname: Francini
authors.forename: A
authors.initials: A
authors.lastname: Pascucci
authors.forename: A
authors.initials: A
authors.lastname: Magliocca
authors.forename: A
authors.initials: A
authors.lastname: Guarnieri
authors.forename: V
authors.initials: V
authors.lastname: Savelli
authors.forename: A
authors.initials: A
authors.lastname: Piccolomini
authors.forename: A F
authors.initials: AF
authors.lastname: Carli
authors.forename: G
authors.initials: G
authors.lastname: Francini
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy* / Q000473:pathology; D018275:Carcinoma, Lobular / Q000188:drug therapy* / Q000473:pathology; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D019290:Megestrol Acetate / Q000008:administration & dosage; D008875:Middle Aged; D009367:Neoplasm Staging; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D003520:Cyclophosphamide; D019290:Megestrol Acetate