scholarly journals A Real-World Data Study to Evaluate Treatment Patterns, Clinical Characteristics and Survival Outcomes for First- and Second-Line Treatment in Locally Advanced and Metastatic Urothelial Cancer Patients in Germany

2018 ◽  
Vol 9 (8) ◽  
pp. 1337-1348 ◽  
Author(s):  
Günter Niegisch ◽  
Holger Gerullis ◽  
Shih-Wen Lin ◽  
Julie Pavlova ◽  
Adam Gondos ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Clinical Characteristics ◽  
Urothelial Cancer ◽  
Locally Advanced ◽  
Treatment Patterns ◽  
Survival Outcomes ◽  
Line Treatment ◽  
Second Line ◽  
Real World Data ◽  
Metastatic Urothelial Cancer

Phase II study of single-agent volasertib (BI 6727) for second-line treatment of urothelial cancer (UC).

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 253-253 ◽  
Author(s):  
W. M. Stadler ◽  
D. J. Vaughn ◽  
G. Sonpavde ◽  
N. J. Vogelzang ◽  
S. T. Tagawa ◽  
...  
Keyword(s):  
Phase Ii ◽  
Urothelial Cancer ◽  
Response Rate ◽  
Single Agent ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Mitotic Checkpoint ◽  
Line Treatment ◽  
Second Line ◽  
Metastatic Urothelial Cancer

253 Background: Polo-like kinase 1 (Plk1) controls multiple essential steps of mitosis. Volasertib (BI 6727) is a first-in-class, selective inhibitor of Plk1. In vitro, Plk1 depletion in cancer cells leads to activation of the mitotic checkpoint, prolonged mitotic arrest, and eventually apoptosis. No standard therapy exists for metastatic urothelial cancer (UC) progressing after initial chemotherapy. Thus, there is an urgent need for novel treatment options. Interim efficacy and tolerability results are presented from an open-label, single-arm, multi-center phase II trial of volasertib in patients (pts) with previously treated advanced UC. Methods: Pts progressing after one prior systemic chemotherapy for locally advanced or metastatic UC or relapsing within 2 years of adjuvant/ neoadjuvant treatment received 300 mg volasertib (2-hour intravenous infusion) on day 1 every 21 days. If well tolerated, dose escalation to 350 mg in cycle 2 was encouraged. Primary endpoint was objective tumor response, defined by RECIST. The trial follows a modified Gehan-two-stage design with an early stopping rule based on the observed response rate of the first 20 pts receiving up to 4 courses of treatment. A minimum response rate of 10% (2/20) was required to recommend additional study. Results: This trial is ongoing: 31 pts (median age 67) were treated between December 2009 and August 2010. All pts were eligible for interim safety/efficacy analysis. As of August 2010, 6 pts (19%) demonstrated a partial response, 7 pts (23%) had stable disease and 16 (52%) progressed between 3-6 weeks after study initiation. Thirteen (42%) pts remain on trial between 13-41 weeks (median time on trial 5 months) without disease progression. Major grade 3 or 4 adverse events (irrespective of drug relatedness) were neutropenia (10 pts, 32%), thrombocytopenia (7 pts, 23%), anemia (5 pts, 16%), hyponatremia (3 pts, 10%), dehydration (2 pts, 7%), and urinary tract infection (2 pts, 7%). Conclusions: Single-agent volasertib was well tolerated and demonstrates clinical activity in the second-line treatment of pts with advanced UC. The early signs of clinical benefit allows proceeding per protocol to the second stage of the trial. [Table: see text]

Utility of Prognostic Markers in Second-line Treatment of Metastatic Urothelial Cancer

2017 ◽  
Vol 29 (11) ◽  
pp. e206
Author(s):  
S.E.M. Raby ◽  
R. Conroy ◽  
J. Lyons ◽  
J. Weaver ◽  
T. Elliott ◽  
...  
Keyword(s):  
Urothelial Cancer ◽  
Prognostic Markers ◽  
Line Treatment ◽  
Second Line ◽  
Metastatic Urothelial Cancer

Nivolumab and its use in the second-line treatment of metastatic urothelial cancer

2018 ◽  
Vol 14 (26) ◽  
pp. 2683-2690
Author(s):  
Daniele Raggi ◽  
Andrea Necchi ◽  
Patrizia Giannatempo
Keyword(s):  
Urothelial Cancer ◽  
Line Treatment ◽  
Second Line ◽  
Metastatic Urothelial Cancer

Systemic Mitomycin C As Second-Line Treatment For Metastatic Urothelial Cancer

1995 ◽  
Vol 34 (7) ◽  
pp. 978-979 ◽  
Author(s):  
Lisa Sengeløv ◽  
Ole Steen Nielsen ◽  
Claus Kamby ◽  
Hans der Maase
Keyword(s):  
Mitomycin C ◽  
Urothelial Cancer ◽  
Line Treatment ◽  
Second Line ◽  
Metastatic Urothelial Cancer

Treatment (tx) characteristics of patients (pts) with locally advanced or metastatic urothelial cancer (mUC) receiving atezolizumab (atezo) monotherapy in United States clinical practice.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 381-381 ◽  
Author(s):  
Shivani K. Mhatre ◽  
Ching-Yi Chuo ◽  
Alicia K. Morgans ◽  
Osama E. Rahma ◽  
Russell Kent Pachynski ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Urothelial Cancer ◽  
Immune Checkpoint Inhibitor ◽  
Locally Advanced ◽  
Real World Data ◽  
Kaplan Meier ◽  
Study Selection ◽  
Metastatic Urothelial Cancer ◽  
The Us ◽  
Trial Setting

381 Background: Atezo (anti–PD-L1) was the first immune checkpoint inhibitor approved for mUC. Here, we describe pt characteristics, time on tx (TOT) and distribution of tx cycles for pts receiving atezo in clinical practice, to complement data from clinical trial setting. Methods: Pts diagnosed with mUC who initiated atezo monotherapy in the first-line (1L) or second-line and beyond (2L+; prior platinum tx) settings on or before Jun 30, 2017, were identified from the US-based Flatiron Health electronic health record–derived database. Tx data were analyzed through Mar 31, 2018. TOT was defined as time from first to last atezo administration, plus 1 cycle length. Median TOT was calculated by tx line using the Kaplan-Meier method. Tx cycles were calculated by the number of atezo doses received during TOT. Corresponding results from global atezo clinical trials are presented. Results: Real-world data (RWD) from 312 pts (n = 102, 1L; n = 210, 2L+) met the study selection criteria (Table). Median TOT was 3 and 3.5 months in the 1L and 2L+ settings, respectively, with 95% CIs overlapping with the trial TOT data. A median of 4 cycles (IQR, 2-7, 1L; 2-9, 2L+) was administered in both settings. Conclusions: This is the first study of RW atezo use in mUC. The TOT with atezo observed in a US RW setting and the clinical setting (IMvigor210/IMvigor211) was similar. [Table: see text]

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