Table 7.

FT of the ESMO-MCBS for the treatment of urothelial cancer at the Medical University of Vienna

Analysed treatment	Setting	Primary EP	PFS control	PFS gain	PFS HR	OS control	OS gain	OS HR	Adjustment/ remark	MCBS	MCBS- FT
Cisplatin + gemcitabine versus MVAC von der Maase et al, JCO45 von der Maase et al , JCO46 Roberts et al, Ann Oncol47	First-line advanced or metastatic disease	Non-inferiority	–	–	Non-significant	–	–	Non-significant	Less toxicity with new combination	−	4
Cisplatin + gemcitabine ± paclitaxel (EORTC 30987) Bellmunt et al, JCO48	First-line advanced or metastatic disease	OS	7.6 months	0.7 months	0.87 (0.74–1.03)	12.7 months	3.1 months	Non-significant	Increase in response rate	−	NA
High-dose intensified MVAC versus classic MVAC Sternberg et al, JCO49 Sternberg et al , Eur J Cancer50	First-line advanced or metastatic disease	OS		–		14.9 months	0.2 months	0.76 (0.58–0.99)	Score based on 3 year OS (+>5%)	–	3
Vinflunine versus best supportive care Bellmunt et al , JCO51 Bellmunt et al, Ann Oncol52	Second-line treatment after platin-based treatment	OS				4.6 months	2.3 months	Non-significant		–	NA

EP, endpoint; ESMO, European Society for Medical Oncology; FT, field testing; MCBS, Magnitude of Clinical Benefit Score; MVAC, methotrexate, vinblastine, doxorubicin, cisplatin; OS, overall survival; PFS, progression-free survival.