ASCO 2018: Relapse-Free Survival of Clinical T2-4N0 Urothelial Bladder Carcinoma After Radical Cystectomy, with or without Perioperative Chemotherapy: Endpoints for Clinical Trial Design.
Chicago, IL (UroToday.com) Results from several prospective trials have led to neoadjuvant chemotherapy followed by radical cystectomy being considered the gold-standard treatment for patients with muscle-invasive bladder cancer (MIBC)1 2.
In a meta-analysis of 886 patients analyzed after neoadjuvant chemotherapy and radical cystectomy, the pathological complete response rate was 28.6%, leading to a relative risk for OS of 0.45 (95%CI 0.36-0.56) compared to those that did not achieve complete response3. However, data from 19 centers outside of a clinical trial suggested that pathologic complete response rates may lower in the real-world setting (23.9-24.5%) compared to clinical trials 4. As such, the full benefit of neoadjuvant therapy may not be captured via pathologic complete response rates.
ASCO 2018: Optimization of PD-L1 Algorithm for Predicting OS in Patients with Urothelial Cancer Treated with Durvalumab
Chicago, IL (UroToday.com) Durvalumab is an anti-programmed cell death ligand-1 (PD-L1) immune checkpoint inhibitor that has been tested in patients with advanced urothelial bladder cancer. In a phase I/II open-label study, 191 patients who had progressed on or were ineligible for chemotherapy were administered durvalumab IV 10 mg/kg every two weeks for up to 12 months or until progression or unacceptable side effects . Over a median follow-up was 5.8 months (range, 0.4-25.9), the ORR was 17.8% (95%CI 12.7%-24.0%), including 7 complete responses.
ASCO 2018: Tailoring of Chemotherapy to Fit Patients with Metastatic Urothelial Cancer
Chicago, IL (UroToday.com) At the precision therapy in the treatment of advanced urothelial cancer session, Arlene Siefker-Radtke, MD, discussed systematic chemotherapy for these patients and how it best fits into the treatment paradigm.
ASCO 2018: Targeted Therapies in Advanced Urothelial Cancer
Chicago, IL (UroToday.com) Evan Yu, MD, from the Fred Hutchinson Cancer Center provided a presentation of the role of precision therapy in the treatment of advanced urothelial cancer. RANGE was a phase III trial first presented at the ESMO 2017 Clinical Congress, a phase III randomized controlled trial assessing docetaxel with or without ramucirumab in platinum refractory advanced or metastatic urothelial carcinoma 1.
ASCO 2018: Immunotherapy-Based Approaches for Advanced Urothelial Cancer
Chicago, IL (UroToday.com) At the precision therapy for the treatment of advanced urothelial cancer session at ASCO 2018, Sandy Srinivas, MD, presented on the role of immunotherapy-based approaches in this disease space.
Starting with the FDA approval of cisplatin in 1978 for metastatic bladder cancer, there have been few exciting advances with regards to systemic therapy for bladder cancer until the recent approval of atezolizumab in 2016, quickly followed by four more immunotherapy options in 2017 (pembrolizumab, nivolumab, durvalumab, avelumab).
ASCO 2018: SPEAR-Bladder (Study Informing Treatment Pathway Decision in Bladder Cancer): First-Through Third-Line Time to Treatment Failure in the US
Chicago, IL (UroToday.com) Over the last three years, there have been exciting developments for immunotherapy for patients with advanced and metastatic urothelial carcinoma, stemming from several phase II and phase III trials [1-7]. This has resulted in FDA approval for several immunotherapy agents, including pembrolizumab, avelumab, durvalumab, atezolizumab, and nivolumab, in the second line and cisplatin ineligible first-line setting. Gurjyot K. Doshi, MD, and colleagues presented results of their analysis assessing time to treatment failure among patients with metastatic urothelial carcinoma treated with systemic chemotherapy and immunotherapy regimens in the US community oncology setting.
ASCO 2018: Bladder Cancer and Germ Cell Tumors
Chicago, IL (UroToday.com) Matthew Galsky, MD gave a concise summary of the 3-oral abstracts presented in this session and he began with summarizing the two bladder cancer abstracts. Survival of patients with muscle invasive bladder cancer (MIBC) remains suboptimal, despite neoadjuvant chemotherapy and cystectomy.
Abstract 4506 was a single arm, phase II study analyzing two cycles of Atezolizumab prior to radical cystectomy among patients with T2-4N0M0 transitional cell carcinoma. The primary endpoints included pathological complete response occurring in ≥20% of patients, and increase in CD8 count. Adverse events were assessed as well. Overall, there were 74 patients receiving Atezolizumab, and 67 underwent subsequent radical cystectomy. The results demonstrated that almost 30% of the patients had pathological complete response (T0 disease), 40% were PD-L1 positive patients, and 16% were PD-L1 negative patients.