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Clinical Trial
. 2012 Apr 1;30(10):1107-13.
doi: 10.1200/JCO.2011.38.6979. Epub 2012 Feb 27.

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

Joaquim Bellmunt  1 , Hans von der Maase, Graham M Mead, Iwona Skoneczna, Maria De Santis, Gedske Daugaard, Andreas Boehle, Christine Chevreau, Luis Paz-Ares, Leslie R Laufman, Eric Winquist, Derek Raghavan, Sandrine Marreaud, Sandra Collette, Richard Sylvester, Ronald de Wit
Affiliations
Clinical Trial

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

Joaquim Bellmunt et al. J Clin Oncol. .

Erratum in

  • Errata.
    [No authors listed] [No authors listed] J Clin Oncol. 2018 Mar 10;36(8):833. doi: 10.1200/JCO.2018.78.0759. J Clin Oncol. 2018. PMID: 31329711 Free PMC article.

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.

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Conflict of interest statement

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Figures

Fig 1.
Fig 1.
Flow chart of the study population. Eligibility before the database lock was assessed by the study coordinator (J.B.) and thereafter reviewed by the statisticians (R.S. and S.C.) and the clinical research physician (S.M.). ITT, intent to treat.
Fig 2.
Fig 2.
Overall duration of survival in the intent-to-treat patient population. O, number of observed events.
Fig 3.
Fig 3.
Overall duration of survival in the eligible patients. O, number of observed events.
Fig 4.
Fig 4.
Duration of progression-free survival. O, number of observed events.
See this image and copyright information in PMC

References

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