title: Concurrent gemcitabine and radiotherapy for the treatment of muscle-invasive bladder cancer: A pooled individual data analysis of eight phase I-II trials.
abstract: Although radical cystectomy is still considered the standard of care for most localized muscle-invasive bladder cancer (MIBC) patients, bladder-sparing strategies with chemoradiotherapy have demonstrated comparable local control and survival rates when adjusting for tumor stage. We present a pooled analysis of individual patient data out of published trials with gemcitabine-based chemoradiotherapy for MIBC.
  
  
  
  Individual patient data were collected from Institutions that enrolled patients into trials that evaluated gemcitabine-based chemoradiotherapy for MIBC.
  
  
  
  We identified eight studies published on gemcitabine-based radiochemotherapy and 190 patients were included in this analysis. A complete response (CR) was observed in 166 patients (93%). After a median follow up of 44.5months, 36 patients (18.9%) presented a bladder recurrence and 14 subsequently underwent cystectomy. The 5-year overall survival (OS), disease-specific survival (DSS), and cystectomy-free survival (CFS) rates were 59%, 80.9%, and 93.3%, respectively. The achievement of CR after chemoradiotherapy was the main prognostic variable which was associated with improved OS, DSS, and CFS. The treatment was well tolerated.
  
  
  
  This pooled analysis strengthens the evidence that chemoradiotherapy regimens with concurrent gemcitabine are feasible and well tolerated. Prospective randomized controlled trials are on-going to definitively assess the efficacy of gemcitabine-based chemoradiotherapy for MIBC.
authors.affiliation: Medical Oncology Department, Santa Chiara Hospital, Trento, Italy. Electronic address: orazio.caffo@apss.tn.it.
authors.forename: Orazio
authors.initials: O
authors.lastname: Caffo
authors.affiliation: Clinical Oncology Department, The Christie NHS Foundation Trust and University of Manchester, Manchester Academic Health Sciences Centre, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Thompson
authors.affiliation: Ludwig Boltzmann Institute for Applied Cancer Research, ACR-ITR VIEnna, Austria; University of Warwick, Coventry, UK.
authors.forename: Maria
authors.initials: M
authors.lastname: De Santis
authors.affiliation: Institute of Oncology, Ljubljana, Slovenia.
authors.forename: Borut
authors.initials: B
authors.lastname: Kragelj
authors.affiliation: Department of Radiation Oncology, University of Michigan, Ann Arbor, USA.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Hamstra
authors.affiliation: Department of Radiation Oncology, Institut régional du Cancer de Montpellier, Inserm U1194, Montpellier, France.
authors.forename: David
authors.initials: D
authors.lastname: Azria
authors.affiliation: Radiation Oncology Department, Santa Chiara Hospital, Trento, Italy.
authors.forename: Gianni
authors.initials: G
authors.lastname: Fellin
authors.affiliation: Epidemiology & Clinical Trials Office, General Hospital, Mirano, Italy.
authors.forename: Giovanni L
authors.initials: GL
authors.lastname: Pappagallo
authors.affiliation: Medical Oncology Department, Santa Chiara Hospital, Trento, Italy.
authors.forename: Enzo
authors.initials: E
authors.lastname: Galligioni
authors.affiliation: Clinical Oncology Department, The Christie NHS Foundation Trust and University of Manchester, Manchester Academic Health Sciences Centre, UK.
authors.forename: Ananya
authors.initials: A
authors.lastname: Choudhury
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D059248:Chemoradiotherapy / Q000379:methods; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D015653:Cystectomy; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013223:Statistics as Topic; D001749:Urinary Bladder Neoplasms / Q000401:mortality / Q000628:therapy*; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine
keywords: Conservative treatment; Gemcitabine; Infiltrating bladder cancer; Pooled analysis; Radiochemotherapy