Concurrent gemcitabine and radiotherapy for the treatment of muscle-invasive bladder cancer: A pooled individual data analysis of eight phase I-II trials

Radiother Oncol. 2016 Nov;121(2):193-198. doi: 10.1016/j.radonc.2016.09.006. Epub 2016 Oct 5.

Abstract

Purpose: 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.

Methods and materials: Individual patient data were collected from Institutions that enrolled patients into trials that evaluated gemcitabine-based chemoradiotherapy for MIBC.

Results: 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.

Conclusion: 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.

Keywords: Conservative treatment; Gemcitabine; Infiltrating bladder cancer; Pooled analysis; Radiochemotherapy.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antimetabolites, Antineoplastic / therapeutic use*
  • Chemoradiotherapy* / methods
  • Clinical Trials, Phase I as Topic
  • Clinical Trials, Phase II as Topic
  • Cystectomy
  • Deoxycytidine / analogs & derivatives*
  • Deoxycytidine / therapeutic use
  • Female
  • Gemcitabine
  • Humans
  • Male
  • Middle Aged
  • Statistics as Topic
  • Urinary Bladder Neoplasms / mortality
  • Urinary Bladder Neoplasms / therapy*

Substances

  • Antimetabolites, Antineoplastic
  • Deoxycytidine
  • Gemcitabine