Le nuove tossicità in oncologia: come cambia l informazione al paziente
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1 Ospedale Sacro Cuore- Don Calabria U.O.C. Oncologia - Cancer Care Center Negrar (VR) Le nuove tossicità in oncologia: come cambia l informazione al paziente Cosa dice il medico, cosa sente il paziente Università degli Studi di Palermo Scuola di Specializzazione in Oncologia Medica Daniele Galanti
2 Le nuove tossicità in oncologia: come cambia l informazione al paziente Understand the science Break it down Treat patient, NOT disease Get personalized Have a dialog
3 Understand the science: old vs new chemioterapia target therapies immunoterapia
4 Understand the science: tossicità della chemioterapia
5 Understand the science: immune checkpoint inhibitors Cancer Biology
6 Understand the science: tossicità della immunoterapia Anti-CTLA4 IrAEs: Overall incidence of all grade iraes up to 72%, high-grade iraes was 24% The risk of developing iraes was dosage-dependent (for high-grade RR 3,10 p=0,0008 with IPI 10 mg/kg vs 3 mg/kg) Anti-PD1/PDL1 IrAEs: In general grade of iraes is mild to moderate; grade 3-4 adverse drug reaction is <2% The risk of developing iraes was NO dosage-dependent The rates of any-grade and grade 3 to 4 treatment-related AEs in patients who had received prior anti-ctla4 are similar to the rates in the naïve population A delayed effect of immune checkpoint antibodies cannot be ruled out, sometimes up to 1 year after the start of the anti-pd-1 treatment Champiat, Annals 2016 Hodi FS, NEJM 2010; Robert C, NEJM 2011; Bertrand, BMC 2015 Michot, EJC 2016; Boutros, Nat Rev Clin Oncol 2016; Weber JS, JCO 2017
7 Understand the science: tossicità della immunoterapia
8 Understand the science: tossicità della immunoterapia
9 Understand the science: tossicità della immunoterapia (anti-pd1). J Clin Oncol 2012; 30: Cancer Treatment Reviews 45 (2016) 7 18
10 Understand the science: tossicità della immunoterapia
11 Understand the science: immunoterapia di combinazione
12 Understand the science: immunoterapia di combinazione
13 Understand the science: immunoterapia di combinazione Annals of Oncology 28 (Supplement 4): iv119 iv142, 2017
14 Break it down: l educazione del paziente
15 Break it down: l educazione del paziente Communication is the key!! Red flag symptoms: Diarrhea (more than 2 loose stools in 24 h) Bloody diarrhea Fever greater than 38 C Profound fatigue Production of yellow or green sputum Shortness of breath Skin rash New simptoms high level of suspicion Workup depends on organ system involved
16 Treat patient, NOT disease: grading delle tossicità immuno-relate
17 Treat patient, NOT disease: grading delle tossicità immuno-relate
18 Treat patient, NOT disease: trattamento delle tossicità immuno-relate
19 Treat patient, NOT disease: trattamento delle tossicità immuno-relate
20 Treat patient, NOT disease: trattamento delle tossicità immuno-relate
21 Treat patient, NOT disease: trattamento delle tossicità immuno-relate
22 Treat patient, NOT disease: trattamento delle tossicità immuno-relate Creare forum multidiscipilinari per discutere dei pazienti con IrAEs con oncologi e specialisti non oncologi Creare expertise negli IrAEs negli specialisti non oncologi Proporre iniziative cliniche relative agli IrAEs Presented By Julie Brahmer at 2018 ASCO Annual Meeting
23 Get personalized: valutazione basale del paziente
24 Get personalized: screening per IrAEs
25 Get personalized: screening per IrAEs e biomarkers Increase of eosinophil absolute count (AEC) from B/L to week 4 and 7 associated with IrAEs (p=0.032 and p=0.007) As continuous variables at W4, absolute and relative eosinophil count associated with iraes (p=0.018 and p=0.275) Pts treated with ipilimumab for metastatic melanoma (n=52) Higher IL17 serum levels for pts wih colitis vs no IrAEs Correlation between increase of IL17 serum level and development of colitis symptoms Correlation between decrease of IL17 serum level and resolution of colitis symptoms
26 Get personalized: IrAEs come markers di risposta??
27 Get personalized: IrAEs come markers di risposta?? (HR= 0.51; 95%CI,0.32to0.82; P<.005 (HR=0.25; 95%CI, 0.10 to 0.61; P<.003)
28 Get personalized: IrAEs «eccezionali» Pharmacol Ther Jan;181:
29 Have a dialog: P.R.O.-C.T.C.A.E. P.R.O.- C.T.C.A.E. a e u o e r d v t p t m r i v e i o c m m t e n e r o o i e r t n t m n n r s s t e e o i e s d s l a o g y
30 Have a dialog: P.R.O.-C.T.C.A.E. P.R.O.-C.T.C.A.E. rappresentano un sistema di registrazione e di misurazione degli eventi avversi (AEs) così come vengono riportati dai pazienti P.R.O.-C.T.C.A.E. registrano e misurano frequenza, severità e impatto sulla qualità di vita (ADL, IADL) di 78 tossicità sintomatiche dei trattamenti oncologici medici e radianti nei trials clinici attraverso 124 items P.R.O.-C.T.C.A.E. non devono essere utilizzati in sostituzione dei C.T.C.A.E. ma in aggiunta ai C.T.C.A.E. Frequenza, severità e impatto sulla qualità di vita degli AEs riportati vengono valutati con uno score da 0 a 4 relativamente alla settimana precedente la somministrazione dei questionari di valutazione Gli AEs vengono riportati: - attraverso sistemi informatici di connessione Internet - attraverso sistemi vocali interattivi - attraverso questionari cartacei
31 Have a dialog: P.R.O.-C.T.C.A.E by MSKCC & NCI
32 Have a dialog: P.R.O.-C.T.C.A.E.
33 Have a dialog: P.R.O.-C.T.C.A.E. N=940 pts initiating or undergoing CT, RT or both 122/124 (98%) PRO-CTCAE items were associated in the expected direction with the QLQ-C30 HRQOL summary score 107/124 items demonstrated meaningful correlation (Pearson r.1) 124/124 (100%) PRO-CTCAE items were associated in the expected direction with one or more QLQLC30 scales (114/124 demonstrating meaningful correlation; 111/124 coefficients reaching statistical significance) items that were likely to impact physical functioning had the strongest correlations with the QLQ- C30 physical functioning scale items likely to impact cognitive functioning had the strongest correlations with the QLQ-C30 cognitive functioning scale correlation between PRO-CTCAE and PS
34 Have a dialog: P.R.O.-C.T.C.A.E. N=940 pts initiating or undergoing CT, RT or both
35 Have a dialog: P.R.O.-C.T.C.A.E.
36 Grazie per l attenzione
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