Bladder articles Flashcards
1
Q
BCa Lit
EV 302
6
A
- EV+ P improves OS by 15 months in untreated UC
- Enfortumab is a antibody to Nectin-4 and vedotin is a payload drug
- RCT 886pts with unresectable for locally advanced UC +/- M1
- EV+ P vs G/C or Gem/Carbo
- mOS 31.5 vs 16.1 months, PFS 12.5 vs 6.3 months
- 67% ORR and 29% CR
JCO 2024
Powles, Thomas et al. “Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer.” The New England journal of medicine vol. 390,10 (2024): 875-888. doi:10.1056/NEJMoa2312117
2
Q
BCa lit
RAZOR
4
A
- Robotic cystectomy is non-inferior to open cystectomy
- RCT 350 pts; open vs robotic RC
- 2y PFS was 72%
- AEs in 69% vs 67% (UTI and Ileus)
Lancet 2018
3
Q
BCa lit
SWOG 8710
A
- NAC MVAC before RC improves OS
- Occult micrometastases are a major problem, 7 negative NAC trials
- RCT 300 pts with cN0M0 with RC vs NAC MVAC
- 38% pT0, 5y OS 57% vs 43%
- ~33% pre-op AEs, no change in post-op AEs
NEJM 2003
4
Q
BCa lit
VESPER
4
A
- ddMVAC vs Gem/Cis as peri-op chemo for MIBC
- RCT 500 pts; ddMVAC vs G/C (88% NAC)
- ypT0 42% vs 36% for ddMVAC
- similar toxicity but GI and fatigue were worse with ddMVAC
JCO 2020
5
Q
BCa lit
IMvigor 210
4
A
- Atezolizumab for cis-ineligible pts with advanced UC
- Single arm Phase 2, 123 pts
- ORR 23%, CR 9%
- mOS 16m
Lancet 2017
6
Q
BCa lit
KEYNOTE 052
4
A
- Pembro is first line for cis-ineligible pts with advanced UC
- Single arm Phase 2, 370 pts
- ORR 24%, CR 20%
- mOS 11.3m
Lancet Onc 2017
7
Q
BCa lit
KEYNOTE 045
5
A
- Pembro is option for progression through platinum chemo
- RCT 542 pts with advanced US that progressed or recurred after platinum
- Pembro vs 2nd line chemo
- OS 10m vs 7m, higher if PDl-1 score over 10%
- fewer AEs
NEJM 2017
8
Q
BCa lit
BLC 2001
4
A
- Erdafitinib is option for progression through chemo +/- ICI
- Alterations in FGFR may be associated with lower sensitivity to ICI
- Phase 2, 99pts with progression AND alterations of FGFR gene
- 40% ORR, mOS 14m
NEJM 2019
9
Q
BCa lit
JAVELIN Bladder
A
- Avelumab maintenance prolongs survival after G/C for advanced US
- RCT 700 pts with advanced or unresectable UC (SD during G/C)
- Avelumab maintenance vs observation
- OS at 1y 71 vs 58% with 60% in PDL1 pts
NEJM 2020
10
Q
BCa lit
EV 301
6
A
- EV improves OS by 4 months in UC that progressed through chemo and ICI
- Enfortumab is a antibody to Nectin-4 and vedotin is a payload drug
- RCT 608pts with unresectable for locally advanced UC +/- M1
- EV vs additional chemo
- mOS 13 vs 9 months, PFS 3.7 vs 2 months
- 44% ORR and 12% CR
NEJM 2021
11
Q
BCa lit
CheckMate 274
5
A
- Adjuvant Nivolumab improved DFS after RC +/- NAC for MIBC
- RCT 709 pts with MIBC s/p RC (44% NAC)
- Adjuvant nivo vs placebo
- mDFS 21 vs 11m with 6m DFS 75 vs 60%
- G3 AEs 18 vs 7% with 2 ICI deaths
NEJM 2021
12
Q
BCa lit
IMvigor 010
6
A
- Adjuvant atezolizumab only improved DFS and OS in HR pts with ctDNA after RC or NUx
- RCT 809 HRpts with UC s/p RC or NUx +/- NAC
- adjuvant atezolizuman vs placebo
- negative trial
- 214pts with ctDNA mDFS 5.9 vs 4.4 and mOS 26 vs 16
- first trial to used ctDNA as biomarker for adjuvant therapy
Nature 2021
