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Randomized phase III study comparing Paclitaxel/Cisplatin/ Gemcitabine and Gemcitabine/Cisplatin in patients with locally advanced or metastatic urothelial cancer without prior systemic therapy : EORTC Intergroup Study 30987
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Bellmunt, Joaquim, von der Maase, Hans, Mead, Graham M., Skoneczna, Iwona, De Santis, Maria, Daugaard, Gedske, Boehle, A., Chevreau, C., Paz-Ares, Luis, Laufman, L. R., Winquist, E., Raghavan, D., Marreaud, Sandrine, Collette, S., Sylvester, Richard and de Wit, Ronald (2012) Randomized phase III study comparing Paclitaxel/Cisplatin/ Gemcitabine and Gemcitabine/Cisplatin in patients with locally advanced or metastatic urothelial cancer without prior systemic therapy : EORTC Intergroup Study 30987. Journal of Clinical Oncology, Volume 30 (Number 10). pp. 1107-1113. doi:10.1200/JCO.2011.38.6979 ISSN 0732-183X.
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Official URL: http://dx.doi.org/10.1200/JCO.2011.38.6979
Abstract
Purpose The combination of gemcitabine plus cisplatin (GC) is a standard regimen in patients with locally advanced or metastatic urothelial cancer. A phase I/II study suggested that a three-drug regimen that included paclitaxel had greater antitumor activity and might improve survival.
Patients and Methods We conducted a randomized phase III study to compare paclitaxel/cisplatin/gemcitabine (PCG) with GC in patients with locally advanced or metastatic urothelial carcinoma. Primary outcome was overall survival (OS). Secondary outcomes were progression-free survival (PFS), overall response rate, and toxicity.
Results From 2001 to 2004, 626 patients were randomly assigned; 312 patients were assigned to PCG, and 314 patients were assigned to GC. After a median follow-up of 4.6 years, the median OS was 15.8 months on PCG versus 12.7 months on GC (hazard ratio [HR], 0.85; P = .075). OS in the subgroup of all eligible patients was significantly longer on PCG (3.2 months; HR, 0.82; P = .03), as was the case in patients with bladder primary tumors. PFS was not significantly longer on PCG (HR, 0.87; P = .11). Overall response rate was 55.5% on PCG and 43.6% on GC (P = .0031). Both treatments were well tolerated, with more thrombocytopenia and bleeding on GC than PCG (11.4% v 6.8%, respectively; P = .05) and more febrile neutropenia on PCG than GC (13.2% v 4.3%, respectively; P < .001).
Conclusion The addition of paclitaxel to GC provides a higher response rate and a 3.1-month survival benefit that did not reach statistical significance. Novel approaches will be required to obtain major improvements in survival of incurable urothelial cancer.
Item Type: | Journal Article | ||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Cancer Research Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Journal or Publication Title: | Journal of Clinical Oncology | ||||
Publisher: | American Society of Clinical Oncology | ||||
ISSN: | 0732-183X | ||||
Official Date: | 1 April 2012 | ||||
Dates: |
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Volume: | Volume 30 | ||||
Number: | Number 10 | ||||
Page Range: | pp. 1107-1113 | ||||
DOI: | 10.1200/JCO.2011.38.6979 | ||||
Status: | Peer Reviewed | ||||
Publication Status: | Published | ||||
Access rights to Published version: | Restricted or Subscription Access |
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