scholarly journals 800TiP Meet-URO 12: A randomized phase II trial of niraparib versus best supportive care (BSC) as maintenance treatment in patients with locally advanced or metastatic urothelial cancer (UC) whose disease did not progress after completion of first-line platinum-based chemotherapy

2020 ◽  
Vol 31 ◽  
pp. S607
Author(s):  
F. Vignani ◽  
A. Hamzaj ◽  
U. De Giorgi ◽  
R. Tambaro ◽  
U. Basso ◽  
...  
2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4526-4526
Author(s):  
Alicia K. Morgans ◽  
Osama E. Rahma ◽  
Shivani K. Mhatre ◽  
Ching-Yi Chuo ◽  
Jessica Davies ◽  
...  

4526 Background: Approval of anti–PD-L1/anti–PD-1 CPI agents has changed the mUC tx landscape, but real-world (RW) tx patterns are not well described. Here, we describe pt characteristics, time on tx (TOT), tx-cycle distribution, relative dose intensity (RDI) and subsequent tx for pts receiving atezolizumab (atezo), nivolumab (nivo) or pembrolizumab (pembro) monotherapy. Methods: Pts diagnosed with mUC who completed atezo, nivo or pembro in the first-line (1L) or prior-platinum second-line and beyond (2L+) settings by April 30, 2018, were identified from the US-based Flatiron Health electronic health record–derived database. TOT was defined as time from first to last CPI administration + 1 cycle, tx cycles as number of CPI doses received during TOT and RDI as ratio of actual to planned dose per week to reflect any dose interruption. Results: RW data from pts receiving atezo, nivo and pembro were analyzed (Table). Up to 38% of pts had ECOG PS > 1. Median TOT ranged from 2.1-2.8 mo, with overlapping 95% CIs; mean TOT ranged from 2.7-4.1 mo. Over 50% of pts had ≤ 4 tx cycles. 21%-38% of pts did not have RDI within 95%-105% of the labeled dose. Most common subsequent txs were platinum-based chemotherapy combinations with gemcitabine or taxanes (post–1L CPI) and taxane monotherapy or other CPI monotherapy/combinations (post–2L+ CPI). Conclusions: Here, we present the largest analysis of RW CPI use in mUC to date. Overall, this unadjusted descriptive analysis showed relative comparability of pt and tx characteristics and TOT across CPI-treated groups. Insights into RW tx allow for an understanding of how clinical trial data translate to broader pt populations, including those with ECOG PS > 1, and may be useful for practitioners. [Table: see text]


2021 ◽  
Vol 9 ◽  
pp. 232470962110356
Author(s):  
Balraj Singh ◽  
Parminder Kaur ◽  
Sachin Gupta ◽  
Nirmal Guragai ◽  
Michael Maroules

Bladder cancer is the most common urinary tract malignancy. Platinum-based chemotherapy is the first line of treatment in locally advanced or metastatic bladder cancer. Immunotherapy has become a novel therapy option in a broad variety of malignancies including bladder cancer. Immunotherapy is approved as first line of treatment in patients who are ineligible for platinum-based chemotherapy and second-line treatment for metastatic urothelial cancer who progressed after platinum-based treatments. We present the case of an 83-year-old female with metastatic bladder cancer who was chemotherapy ineligible and had complete response with immune checkpoint inhibitor pembrolizumab.


Author(s):  
M. Sotelo ◽  
T. Alonso-Gordoa ◽  
P. Gajate ◽  
E. Gallardo ◽  
R. Morales-Barrera ◽  
...  

Abstract Background The studies IMvigor 210 cohort 2 and IMvigor211 evaluated the efficacy of atezolizumab in patients with locally advanced or metastatic urothelial cancer (mUC) upon progression to platinum-based chemotherapy worldwide. Yet, the real impact of this drug in specific geographical regions is unknown. Materials and methods We combined individual-level data from the 131 patients recruited in Spain from IMvigor210 cohort 2 and IMvigor211 in a pooled analysis. Efficacy and safety outcomes were assessed in the overall study population and according to PD-L1 expression on tumour-infiltrating immune cells. Results Full data were available for 127 patients; 74 (58%) received atezolizumab and 53 (42%) chemotherapy. Atezolizumab patients had a numerically superior median overall survival although not reaching statistical significance (9.2 months vs 7.7 months). No statistically significant differences between arms were observed in overall response rates (20.3% vs 37.0%) or progression-free survival (2.1 months vs 5.3 months). Nonetheless, median duration of response was superior for the immunotherapy arm (non-reached vs 6.4 months; p = 0.005). Additionally, among the responders, the 12-month survival rates seemed to favour atezolizumab (66.7% vs 19.9%). When efficacy was analyzed based on PD-L1 expression status, no significant differences were found. Treatment-related adverse events of any grade occurred more frequently in the chemotherapy arm [46/57 (81%) vs 44/74 (59%)]. Conclusion Patients who achieved an objective response on atezolizumab presented a longer median duration of response and numerically superior 12 month survival rates when compared with chemotherapy responders along with a more favorable safety profile. PD-L1 expression did not discriminate patients who might benefit from atezolizumab.


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