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
	atezolizumab alone
	IMvigor-130 (At-arm B vs Ch-armC), 2020 Lancet 2020; 395:1547-1557 NCT02807636	RCT	mUC - L1 - all population	atezolizumab (B)	chemotherapy (C) gemcitabine plus platine	patients with untreated locally advanced or metastatic urothelial carcinoma	360 / 400	some concern	inconclusive	inconclusive 2 % increase in deaths (OS) (PE) statistically significant 62 % decrease in objective responses (ORR)
	durvalumab alone
	DANUBE (D vs C - all population), 2020 Urologe A 2016; 55:1097-8 Lancet Oncol 2020 Sep 21;S1470-2045(20)30541-6. NCT02516241	RCT	mUC - L1 - all population	durvalumab	platine based chemotherpy (SOC) cisplatine plus gemcitabine	first line in Patients with Stage IV Urothelial Cancer.	346 / 344	some concern	inconclusive	statistically significant 64 % decrease in objective responses (ORR)
	durvalumab plus tremelimumab
	DANUBE (DT vs C - all population), 2020 Urologe A 2016; 55:1097-8 Lancet Oncol 2020 Sep 21;S1470-2045(20)30541-6. NCT02516241	RCT	mUC - L1 - all population	durvalumab plus tremelimumab	platine based chemotherpy	first line in Patients with Stage IV Urothelial Cancer.	342 / 344	some concern	inconclusive	inconclusive 15 % decrease in deaths (OS) (PE) statistically significant 41 % decrease in objective responses (ORR)
	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 placebo plus SoC
	atezolizumab plus SoC
	IMvigor-130 (At-arm A vs Pl-arm C), 2020 Lancet 2020; 395:1547-1557 NCT02807636	RCT	mUC - L1 - all population	atezolizumab (A) plus gemcitabine and platine	placebo (C) plus gemcitabine and platine	patients with untreated locally advanced or metastatic urothelial carcinoma	451 / 400	some concern	conclusif	inconclusive 17 % decrease in deaths (OS) (PE) demonstrated 18 % 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 - L1 - PDL1 positive metastatic/advanced UC (mUC) - 1st Line (L1) mUC - L1 - PDL1 positive
versus gemcitabine plus platin
	durvalumab alone
	DANUBE (D vs C - PDL1>25%), 2020 Urologe A 2016; 55:1097-8 Lancet Oncol 2020 Sep 21;S1470-2045(20)30541-6. NCT02516241	RCT	mUC - L1 - PDL1 positive	durvalumab	platine based chemotherapy (gemcitabine)	first line in Patients with Stage IV Urothelial Cancer whose tumours express high levels of PD-L1.	209 / 207	some concern	inconclusive	inconclusive 11 % decrease in deaths (OS) (PE) statistically significant 59 % decrease in objective responses (ORR)
	durvalumab plus tremelimumab
	DANUBE (DT vs C - PDL1>25%), 2020 Urologe A 2016; 55:1097-8 Lancet Oncol 2020 Sep 21;S1470-2045(20)30541-6. NCT02516241	RCT	mUC - L1 - PDL1 positive	durvalumab plus tremelimumab	platine based chemotherpy (SOC)	first line in Patients with Stage IV Urothelial Cancer with PDL1 high expression level	205 / 207	some concern	suggested	suggested 26 % decrease in deaths (OS)

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

mUC - L1 - PDL1 positive metastatic/advanced UC (mUC) - 1st Line (L1) mUC - L1 - PDL1 positive