title: Pegylated liposomal doxorubicin as third-line chemotherapy in patients with metastatic transitional cell carcinoma of urothelial tract: results of a phase II study.
abstract: Until the recent approval of vinflunine, no standard second-line chemotherapy existed for advanced transitional cell carcinoma (TCC). Few data exist about third-line chemotherapy for metastatic disease. Although administered in up-front regimens, anthracyclines were never evaluated beyond second-line treatment. This study assessed the activity of pegylated liposomal doxorubicin (PLD) in patients with advanced TCC previously treated with two chemotherapy regimens. From May 2005 to June 2009, 23 patients with metastatic TCC were recruited: median age was 62 years (49-76 years) with a median ECOG PS of 1. Patients received PLD 35 mg/m(2) every 21 days. All patients were evaluable for efficacy and toxicity. No patient showed complete response. Three patients (13 %) had partial response; seven patients (30 %) showed stable disease for a disease control rate of 43 %. The median time to progression (TTP) was 4.1 months with a median survival time (MST) of 6.3 months. Treatment was well tolerated: no patient developed grade 4 toxicities. This is the first study which evaluated the role of anthracyclines as third-line chemotherapy in metastatic TCC. Despite its manageable profile of toxicity, PLD showed modest activity. Beyond second-line chemotherapy, supportive care still represents the best therapeutic option for patients with metastatic TCC.
authors.affiliation: Clinical Oncology Unit, Istituto Neurotraumatologico Italiano (I.N.I.) Grottaferrata, via di S.Anna snc, 00046 Rome, Grottaferrata, Italy. antoniorozzi@virgilio.it
authors.forename: Antonio
authors.initials: A
authors.lastname: Rozzi
authors.forename: Daniele
authors.initials: D
authors.lastname: Santini
authors.forename: Margherita
authors.initials: M
authors.lastname: Salerno
authors.forename: Francesca
authors.initials: F
authors.lastname: Bordin
authors.forename: Andrea
authors.initials: A
authors.lastname: Mancuso
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Minniti
authors.forename: Chiara
authors.initials: C
authors.lastname: Nardoni
authors.forename: Michela
authors.initials: M
authors.lastname: Corona
authors.forename: Pina Tiziana
authors.initials: PT
authors.lastname: Falbo
authors.forename: Federica
authors.initials: F
authors.lastname: Recine
authors.forename: Gaetano
authors.initials: G
authors.lastname: Lanzetta
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D004317:Doxorubicin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D016879:Salvage Therapy / Q000379:methods*; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology
chemical_list: D000970:Antineoplastic Agents; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin