metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
mUC - L1 - all population metastatic/advanced UC (mUC) - 1st Line (L1) mUC - L1 - all population
versus gemcitabine plus platin
	pembrolizumab plus SoC
	KEYNOTE-361 (PC vs C), 2021 Annals of Oncology Lancet Oncol 2021 May 26;S1470-2045(21)00152-2. NCT02853305	RCT	mUC - L1 - all population	pembrolizumab plus chemotherapy	chemotherapy alone (cisplatine or carbo plus gemcitabine)	patients with histologically or cytologically confirmed unresectable/metastatic urothelial carcinoma, who received no prior systemic chemotherapy for advanced urothelial cancer	351 / 352	some concern	inconclusive	inconclusive 14 % decrease in deaths (OS) (PE) suggested 22 % decrease in progression or deaths (PFS) (PE)
versus Standard of Care (SoC)
	pembrolizumab alone
	KEYNOTE-361 (P vs C), 2021 Annals of Oncology Lancet Oncol 2021 May 26;S1470-2045(21)00152-2. NCT02853305	RCT	mUC - L1 - all population	pembrolizumab	chemotherapy alone (cisplatine or carbo plus gemcitabine)	patients with histologically or cytologically confirmed unresectable/metastatic urothelial carcinoma, who received no prior systemic chemotherapy for advanced urothelial cancer	307 / 352	some concern	inconclusive	statistically significant 35 % increase in progression or deaths (PFS) statistically significant 47 % decrease in objective responses (ORR)
mUC - L2 - all population metastatic/advanced UC (mUC) - 2nd Line (L2) mUC - L2 - all population
versus Standard of Care (SoC)
	pembrolizumab alone
	KEYNOTE-045 (all population), 2017 N Engl J Med 2017;376:1015-1026 Urologe A 2015; 54:1287-90 Int. J. Clin. Oncol. 2020; 25:165-174 Ann. Oncol. 2019; 30:970-976 J Clin Oncol 2018 Jun 1;36(16):1579-1587. NCT02256436	RCT	mUC - L2 - all population	pembrolizumab	chemotherapy (ICC) : paclitaxel, docetaxel, or vinflunine	patients with advanced urothelial carcinoma that progressed during or after the receipt of platinumbased chemotherapy treated as second-line therapy	270 / 272	some concern	conclusif	demonstrated 27 % decrease in deaths (OS) (PE) inconclusive 2 % decrease in progression or deaths (PFS) (PE) suggested 30 % decrease in deaths (OS) (extension) demonstrated 1.1-fold increase in objective responses (ORR) (PE) more...
mUC - L2 - PDL1 positive metastatic/advanced UC (mUC) - 2nd Line (L2) mUC - L2 - PDL1 positive
versus Standard of Care (SoC)
	pembrolizumab alone
	KEYNOTE-045 (PDL1 CPS >10%), 2017 N Engl J Med 2017;376:1015-1026 Urologe A 2015; 54:1287-90 Int. J. Clin. Oncol. 2020; 25:165-174 Ann. Oncol. 2019; 30:970-976 NCT02256436	RCT	mUC - L2 - PDL1 positive	pembrolizumab	chemotherapy (ICC)	as second-line therapy in patients with advanced urothelial carcinoma that progressed during or after the receipt of platinumbased chemotherapy.=> only PDL1 CPS >10%	74 / 90	some concern	conclusif	demonstrated 43 % decrease in deaths (OS) (PE) inconclusive 11 % decrease in progression or deaths (PFS) (PE)

mUC - L1 - all population metastatic/advanced UC (mUC) - 1st Line (L1) mUC - L1 - all population

mUC - L2 - all population metastatic/advanced UC (mUC) - 2nd Line (L2) mUC - L2 - all population

mUC - L2 - PDL1 positive metastatic/advanced UC (mUC) - 2nd Line (L2) mUC - L2 - PDL1 positive