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(1)

Novità in tema di carcinoma della

vescica

Marco MARUZZO

UOC Oncologia Medica 1

Dip. Oncologia Clinica e Sperimentale Istituto Oncologico Veneto, IOV IRCCS, Padova

Regione del Veneto

(2)

Agenda

 Natural history and epidemiology

 Patterns of care

 Perioperative treatments

 Adjuvant treatments

 Treatments for metastatic disease

 2016 news: have we moved the bar?

(3)

Incidence by age and probability aged-based

Galsky, JGO 2014

Taylor, JA Nat Clin Pract Urol 2009

(4)

Patterns of care

Booth, Urol Oncol 2014

(5)

Perioperative treatments

Grossman, NEJM 2003

(6)

Perioperative treatments: News in 2016

GU Symposium 2016, abs 365

A Randomized Phase II Study of CO-eXpression ExtrapolatioN (COXEN)-Directed Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer

(7)

Adjuvant treaments

(8)

Adjuvant treaments: 2016 news

GU Symposium 2016, abs 356

No significant differences in DFS across the study arms, but chemo arm was not originally planned, the statistical

assumptions are unclear

A RCT comparing adj RT vs Chemo plus RT vs Chemo alone after Cx

(9)

Adjuvant treaments: 2016 news

A Study of Adjuvant Nivolumab Versus Placebo Post-Surgical Removal of High Risk Invasive Urothelial Carcinoma (CheckMate 274)

Treatment with nivolumab will extend disease-free survival, compared with placebo, as adjuvant

therapy in all randomized patients and in patients with PD-L1 expressing tumors with high risk residual disease after radical resection of MIBC.

(10)

Metastatic disease: patterns of care

Porter, Urol Oncol 2009

(11)

Metastatic disease treatment 1L

von der Maase, JCO 2005

(12)

Metastatic disease: cisplatin unfit pts

Galsky, JCO 2011 De Santis, JCO 2011

(13)

Metastatic disease treatment 2L

Bellmunt, JCO 2009

(14)

Metastatic disease: immunotheraphy is here!

(15)

Atezolizumab in platium-treated mUC (1)

(16)

Atezolizumab in platium-treated mUC (2)

(17)

Atezolizumab in platium-treated mUC (3)

(18)

Atezolizumab in platium-treated mUC: safety

(19)

Atezolizumab in platinum-unift mUC (1)

(20)

Atezolizumab in platinum-unift mUC (2)

(21)

Atezolizumab in platinum-unift mUC (3)

(22)

Nivolumab in mUC (1)

(23)

Nivolumab in mUC (2)

(24)

Nivolumab in mUC (3)

(25)

Nivolumab in mUC (4)

(26)

Nivolumab in mUC (5)

(27)

Pembrolizumab in mUC (1)

(28)

Pembrolizumab in mUC (2)

(29)

Avelumab in mUC (1)

(30)

Avelumab in mUC (1)

(31)

Darvalumab in mUC (1)

(32)

Darvalumab in mUC (2)

(33)

Darvalumab in mUC (3)

(34)

Have we moved the bar?

Presented By Elizabeth Plimack at 2016 ASCO Annual Meeting

(35)

Post platinum ORR

Presented By Elizabeth Plimack at 2016 ASCO Annual Meeting

(36)

Front line therapy for cisplatin-unfit patients

Presented By Elizabeth Plimack at 2016 ASCO Annual Meeting

(37)

Progression outside of the target lesions

(38)

Take home messages

• Atezolizumab: 2016 new standard of care in mUC

• If you respond, you tend to continue doing it

• Well tolerated drug

• Even PD-L1 “low” patients can respond

• For clisplatin unfit patients, atezolizumab performs well

• Early development for nivolumab and darvalumab

• Need for phase III trials and comparative trials vs chemotherapy

• Which IT drug to use and in which sequence?

• Open questions: optimal duration? biomarkers?

(39)

Conclusions: moving the bar

Neo-adj Adjuvant M+ 1L M+ 2L M+ >2L

MVAC Cis-base CT MVAC Vinflunina Paclitaxel

Cis-Gem Cis-Gem

Carbo-Gem*

Up to now

Neo-adj Adjuvant M+ 1L M+ 2L M+ >2L

MVAC Cis-base CT MVAC Atezolizumab Vinflunina Cis-Gem (Chemo+RT) Cis-Gem (Nivolumab) Paclitaxel

(Nivolumab) Carbo-Gem*

(Atezolizumab)

2016 news

(40)

Future development in UC

(41)

marco.maruzzo@ioveneto.it

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