title: Phase II study of MTX-HSA in combination with cisplatin as first line treatment in patients with advanced or metastatic transitional cell carcinoma.
abstract: OBJECTIVE
  To assess the efficacy, tolerability and safety of MTX-HSA (methotrexate (MTX) covalently linked to human serum albumin (HSA)) combined with cisplatin as first line therapy for advanced bladder cancer.
  
  
  METHODS
  Patients (pat) were treated with a loading dose of 110 mg/m(2) of MTX-HSA followed by a weekly dose of 40 mg/m(2) starting on day 8. Cisplatin was given on day 2 of each 28 day cycle at a dose of 75 mg/m(2).
  
  
  RESULTS
  Tumor response evaluation was possible in 7 patients. Complete response (CR) and partial response (PR) was observed in 1 patient each (overall response rate: 29%). Key toxicities included CTC Grade (G) 3/4 stomatitis in 6 patients, vomiting G3 in 1 patient, fatigue G3 in 1 patient and thrombocytopenia G3 in 3 patients.
  
  
  CONCLUSIONS
  The combination of MTX-HSA with cisplatin is feasible and shows antitumor activity against urothelial carcinomas combined with an acceptable toxicity profile.
authors.affiliation: Medizinische Abteilung, AK St. Georg, Lohmühlenstrasse 5, Hamburg 20099, Germany. Studiensekretariat.Medizin1@ak-st.georg.lbk-hh.de
authors.forename: C
authors.initials: C
authors.lastname: Bolling
authors.forename: T
authors.initials: T
authors.lastname: Graefe
authors.forename: C
authors.initials: C
authors.lastname: Lübbing
authors.forename: F
authors.initials: F
authors.lastname: Jankevicius
authors.forename: S
authors.initials: S
authors.lastname: Uktveris
authors.forename: A
authors.initials: A
authors.lastname: Cesas
authors.forename: W-H
authors.initials: WH
authors.lastname: Meyer-Moldenhauer
authors.forename: H
authors.initials: H
authors.lastname: Starkmann
authors.forename: M
authors.initials: M
authors.lastname: Weigel
authors.forename: K
authors.initials: K
authors.lastname: Burk
authors.forename: A-R
authors.initials: AR
authors.lastname: Hanauske
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D008875:Middle Aged; D012709:Serum Albumin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D012709:Serum Albumin; C040811:methotrexate-serum albumin; D002945:Cisplatin; D008727:Methotrexate