title: A phase II multicenter study of two different dosages of pemetrexed given in combination with cyclophosphamide as first-line treatment in patients with locally advanced or metastatic breast cancer.
abstract: Pemetrexed/cyclophosphamide was evaluated as first-line treatment for patients with locally advanced/metastatic breast cancer. In this randomized phase II study (NCT00190671), therapy consisted of either 600 mg/m(2) (P600) or 1,800 mg/m(2) (P1800) pemetrexed, followed by 600 mg/m(2) cyclophosphamide, every 21 days; 103 females (42 P600; 61 P1800) were enrolled. P600 was discontinued, as response rate (19.1%) was lower than targeted. In the P1800 arm, 20 patients had partial response (32.8%; 95% CI: 21.0-44.6) and 26 (42.6%) had stable disease. Median progression-free survival was 6.3 months (range: 0.3-31.1). P1800 plus cyclophosphamide 600 represents a regimen of reasonable efficacy and acceptable tolerability.
authors.affiliation: LBI-ACR VIEnna and ACR-ITR VIEnna/CEADDP, Center for Oncology and Hematology, Kaiser Franz Josef-Spital, Vienna, Austria. christian.dittrich@toc.lbg.ac.at
authors.forename: Christian
authors.initials: C
authors.lastname: Dittrich
authors.forename: Ewa
authors.initials: E
authors.lastname: Solska
authors.forename: Alexey
authors.initials: A
authors.lastname: Manikhas
authors.forename: Alexandru
authors.initials: A
authors.lastname: Eniu
authors.forename: Sergei
authors.initials: S
authors.lastname: Tjulandin
authors.forename: Rodica
authors.initials: R
authors.lastname: Anghel
authors.forename: Luna
authors.initials: L
authors.lastname: Musib
authors.forename: Bente
authors.initials: B
authors.lastname: Frimodt-Moller
authors.forename: Yushan
authors.initials: Y
authors.lastname: Liu
authors.forename: Kurt
authors.initials: K
authors.lastname: Krejcy
authors.forename: István
authors.initials: I
authors.lastname: Láng
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D005971:Glutamates / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000493:pharmacokinetics; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D000068437:Pemetrexed; D021241:Spectrometry, Mass, Electrospray Ionization
chemical_list: D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine; D003520:Cyclophosphamide