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Concurrent gemcitabine and radiotherapy for the treatment of muscle-invasive bladder cancer : a pooled individual data analysis of eight phase I–II trials
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Caffo, Orazio, Thompson, Catherine, De Santis, Maria, Kragelj, Borut, Hamstra, Daniel A., Azria, David, Fellin, Gianni, Pappagallo, Giovanni L., Galligioni, Enzo and Choudhury, Ananya (2016) Concurrent gemcitabine and radiotherapy for the treatment of muscle-invasive bladder cancer : a pooled individual data analysis of eight phase I–II trials. Radiotherapy and Oncology, 121 (2). pp. 193-198. doi:10.1016/j.radonc.2016.09.006 ISSN 0167-8140.
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Official URL: http://dx.doi.org/10.1016/j.radonc.2016.09.006
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 44.5 months, 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.
| Item Type: | Journal Article | ||||||||||
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Journal or Publication Title: | Radiotherapy and Oncology | ||||||||||
| Publisher: | Elsevier Science BV | ||||||||||
| ISSN: | 0167-8140 | ||||||||||
| Official Date: | November 2016 | ||||||||||
| Dates: |
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| Volume: | 121 | ||||||||||
| Number: | 2 | ||||||||||
| Page Range: | pp. 193-198 | ||||||||||
| DOI: | 10.1016/j.radonc.2016.09.006 | ||||||||||
| Status: | Peer Reviewed | ||||||||||
| Publication Status: | Published | ||||||||||
| Access rights to Published version: | Restricted or Subscription Access |
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