Adjuvant Cisplatin-Based Chemotherapy for High-Risk Bladder Cancer

Summary and Comment |
February 5, 2015

Adjuvant Cisplatin-Based Chemotherapy for High-Risk Bladder Cancer

  1. Robert Dreicer, MD, MS, FACP, FASCO

Overall survival was similar with either adjuvant or deferred treatment.

  1. Robert Dreicer, MD, MS, FACP, FASCO

Level 1 evidence supports the role of cisplatin-based neoadjuvant chemotherapy for patients undergoing cystectomy for muscle-invasive transitional cell cancer of the bladder. However, the use of adjuvant chemotherapy remains attractive to many clinicians given that patients are often referred following cystectomy.

To evaluate the effectiveness of adjuvant versus deferred cisplatin-based chemotherapy following cystectomy, European investigators conducted an intergroup, phase III, randomized, open-label study involving fit patients with pT3–pT4 or N+ M0 urothelial carcinoma of the bladder. All patients underwent radical cystectomy and bilateral lymphadenectomy and within 90 days were randomized to receive either four cycles of adjuvant chemotherapy or six cycles of deferred chemotherapy at relapse. Patients received one of three chemotherapy regimens: methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC); high-dose MVAC; or gemcitabine plus cisplatin. The trial was closed due to poor accrual after 284 of the planned 660 patients were recruited.

At a median follow-up of 7 years, the percentages of patients who died in the adjuvant and deferred treatment groups were 47% and 57%, respectively. Adjuvant treatment did not improve overall survival (the primary endpoint), although it did improve progression-free survival (PFS; 3.11 vs. 0.99 years; hazard ratio, 0.54; P<0.0001). Myelosuppression was common with both treatments; one patient in each group died from toxicity.


What has historically been a U.S. problem of accruing patients for bladder cancer studies has unfortunately spread to Europe; this trial was closed prematurely because of poor accrual and was thus significantly underpowered. The PFS benefit is intriguing but not definitive. Although new therapeutics are on the horizon, neoadjuvant cisplatin-based chemotherapy remains the standard of care for the majority of fit patients with adequate renal function.

Editor Disclosures at Time of Publication

  • Disclosures for Robert Dreicer, MD, MS, FACP, FASCO at time of publication Consultant / Advisory board Millenium; Dendreon; Medivation; Janssen; Roche Speaker's bureau Bayer Editorial boards Urology; Clinical Genitourinary Cancer; Current Urology Reports Leadership positions in professional societies National Cancer Institute (Co-Chair, GU Oncology Steering Committee)


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