Come valutare la risposta o la progressione nei pazienti in trattamento con terapie biologiche

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1 Come valutare la risposta o la progressione nei pazienti in trattamento con terapie biologiche Andrea Busolo U.O. di Radiologia Rocco De Vivo U.O. di Oncologia Medica ULSS 6 - Vicenza

2 Activity and efficacy data in metastatic RCC Trial Setting Risk groups Treatment Arms (Pts) RR Exp Arm PFS (months) OS (months) AVOREN 2007; st line CCRC 100% Favourable 27% Intermediate 56% Poor 9% beva + IFN α (327) vs Placebo + IFN α (322) CR 1% PR 30% SD 46% PD 20% CALGB ; st line CCRC 100% Favourable 26% Intermediate 64% Poor 10% Beva + IFN α (369) vs IFN α (363) ORR 25% TARGET 2007; 2009 Cytokine-pretreated 83% CCRC 100% Favourable 52% Intermediate 48% Poor 0% Sorafenib (451) vs Placebo (452) CR <1% PR 10% SD 74% PD 12% Motzer et al. 1st line Favourable 38% 2007; 2009 CCRC 100% Intermediate 56% Poor 6% Sunitinib (375) vs IFN α (375) CR 3% PR 44% SD 40% PD 7% VEG Naïve 54% Cytokine- pretreated 46% Favourable 39% Intermediate 55% Poor 3% Pazopanib (290) vs Placebo (145) CR <1% PR 30% SD 38% PD 18% Global ARCC Trial st line CCRC 80% Other 20% Favourable 0% Intermediate 26% Poor 74% Temsirolimus (209) vs IFN α (207) vs IFN α + Tem (210) CR 0% PR 8.6% SD 32.1% RECORD ; nd line CCRC 100% Favourable 29% Intermediate 56% Poor 15% Everolimus (272) vs Placebo (138) CR 0% PR 1% SD 63% PD 19%

3 Activity and efficacy data in metastatic RCC Trial Setting Risk groups Treatment Arms (Pts) RR Exp Arm PFS (months) OS (months) AVOREN 2007; st line CCRC 100% Favourable 27% Intermediate 56% Poor 9% beva + IFN α (327) vs Placebo + IFN α (322) CR 1% PR 30% SD 46% PD 20% CALGB ; st line CCRC 100% Favourable 26% Intermediate 64% Poor 10% Beva + IFN α (369) vs IFN α (363) ORR 25% TARGET 2007; 2009 Cytokine-pretreated 83% CCRC 100% Favourable 52% Intermediate 48% Poor 0% Sorafenib (451) vs Placebo (452) CR <1% PR 10% SD 74% PD 12% ORR % Motzer et al. 1st line Favourable 38% 2007; 2009 CCRC 100% Intermediate 56% Poor 6% Sunitinib (375) vs IFN α (375) CR 3% PR 44% SD 40% PD 7% VEG Naïve 54% Cytokine- pretreated 46% Favourable 39% Intermediate 55% Poor 3% Pazopanib (290) vs Placebo (145) CR <1% PR 30% SD 38% PD 18% Global ARCC Trial st line CCRC 80% Other 20% Favourable 0% Intermediate 26% Poor 74% Temsirolimus (209) vs IFN α (207) vs IFN α + Tem (210) CR 0% PR 8.6% SD 32.1% RECORD ; nd line CCRC 100% Favourable 29% Intermediate 56% Poor 15% Everolimus (272) vs Placebo (138) CR 0% PR 1% SD 63% PD 19%

4 Activity and efficacy data in metastatic RCC Trial Setting Risk groups Treatment Arms (Pts) RR Exp Arm PFS (months) OS (months) AVOREN 2007; st line CCRC 100% Favourable 27% Intermediate 56% Poor 9% beva + IFN α (327) vs Placebo + IFN α (322) CR 1% PR 30% SD 46% PD 20% CALGB ; st line CCRC 100% Favourable 26% Intermediate 64% Poor 10% Beva + IFN α (369) vs IFN α (363) ORR 25% TARGET 2007; 2009 Cytokine-pretreated 83% CCRC 100% Favourable 52% Intermediate 48% Poor 0% Sorafenib (451) vs Placebo (452) CR <1% PR 10% SD 74% PD 12% ORR % Motzer et al. 1st line Favourable 38% 2007; 2009 CCRC 100% Intermediate 56% Poor 6% Sunitinib (375) vs IFN α (375) CR 3% PR 44% SD 40% PD 7% VEG Naïve 54% Cytokine- pretreated 46% Favourable 39% Intermediate 55% Poor 3% Pazopanib (290) vs Placebo (145) CR <1% PR 30% SD 38% PD 18% Global ARCC Trial 2007 RECORD ; st line CCRC 80% Other 20% 2nd line CCRC 100% Favourable 0% Intermediate 26% Poor 74% Favourable 29% Intermediate 56% Poor 15% Temsirolimus (209) vs IFN α (207) vs IFN α + Tem (210) Everolimus (272) vs Placebo (138) CR 0% PR 8.6% SD 32.1% CR 0% PR 1% SD 63% PD 19% ORR 4.7 < 10 %

5 CLINICAL FRAME Targeted agents vs chemotherapy: no clear relation between tumor response and PFS/OS. Standard size-based response assessment with RECIST is insensitive, resulting in low response rates which do not reflect disease control measured by time to progression. Many patients who derive significant clinical benefit from these drugs never attain a RECIST defined response. RECIST measurement criteria fail to incorporate changes that occur within the tumor. Tumor volume does not always decrease significantly according to RECIST criteria under antiangiogenic drugs as they act by inhibiting tumor vessels rather than by direct cytotoxic effect on tumor cells.

6 RECIST criteria % - 30% Change in baseline sum diameters % ( SLD)

7 RECIST criteria % - 30% Change in baseline sum diameters % ( SLD) 40-70% of MRCC pts will fall in the stable disease limbo

8 If a new lesion is equivocal, continued therapy and follow-up evaluation will clarify if it represents truly new disease. If repeat scans confirm there is definitely a new lesion, then PD should be declared using the date of the initial scan.

9 Beyond RECIST

10 Including stable disease

11

12

13 Lowering the activity bar

14 PFS 11.1 mts PFS 11.5 mts PFS 5.6 mts PFS 8.3 mts -10% ( SLD) threshold clearly identify pts deriving a clinical benefit from treatment, in contrast, the ratio of the two PFS obtained with the RECIST 1.0 threshold of 30% did not yield two significant distinct groups (ratio 1.4, 95% CI ). The -10% and -30% thresholds were reached, respectively, in 93% and 64% of cases after the second cycle of treatment; thus, the responder status was detected earlier with the former than with the conventional RECIST threshold. The -10% threshold has the advantage of categorizing pts into only two groups (nonresponder vs responder), whereas RECIST subdivide pts into three groups (partial response, stable disease and progressive disease).

15 -10% seemed the most clinically relevant threshold since there could be a risk that small changes in size <10% might be due only to measurement variability instead of a true change due to therapy.

16 Quantifying changes that occur within the tumor

17

18

19

20

21 At first evaluation, Choi criteria (applied in the portal venous phase) of PR were able to define a larger population with a long PFS and OS than RECIST PR. Unfortunately, Choi criteria were not able to identify pts with clear-cutcut PD probably due to the 10% increase vs the 20% used by RECIST.

22 A combined reduction in both size and arterial phase density of RCC metastases treated with TKIs correlates with TTP, RECIST and standard Choi criteria appear inferior.

23 The mean volumetric attenuation (absolute changes in Hounsfield units) was measured using volumetric software (Oncocare, Siemens Healthcare) during the portal venous phase.

24

25 MASS Criteria are simplified SACT Criteria: assessment of lesions in limited to axial CT images without postprocessing software. The time to interpret images using MASS Criteria (~ 10 mins) was substantially less than with SACT Criteria (~ 1-2 hours), which includes volumetric attenuation measurements on an advanced 3D workstation.

26 WHERE ARE WE? QUANTITATIVE ANALYSIS QUALITATIVE ANALYSIS RECIST 1.1 M.CHOI SACT MASS DCE CT DW-MR DCE-MR SIZE STRUCTURE (ENTROPY) FUNCTION

27 WHERE ARE WE? AND QUANTITATIVE ANALYSIS %. QUALITATIVE ANALYSIS RECIST M.CHOI SACT MASS DCE CT DW-MR DCE-MR SIZE STRUCTURE (ENTROPY) FUNCTION

28 WHERE ARE WE? AND QUANTITATIVE ANALYSIS %. QUALITATIVE ANALYSIS RECIST M.CHOI SACT MASS DCE CT DW-MR DCE-MR SIZE STRUCTURE (ENTROPY) FUNCTION

29 WHERE ARE WE? QUANTITATIVE ANALYSIS. QUALITATIVE ANALYSIS RECIST M.CHOI SACT MASS DCE CT DW-MR DCE-MR SIZE STRUCTURE (ENTROPY) FUNCTION

30 WHERE ARE WE? QUANTITATIVE ANALYSIS VOLUMETRIC ASSESMENT OF ABOLUTE VALUE OF. DENSITY QUALITATIVE ANALYSIS RECIST M.CHOI SACT MASS DCE CT DW-MR DCE-MR SIZE STRUCTURE (ENTROPY) FUNCTION

31 WHERE ARE WE? QUANTITATIVE ANALYSIS. QUALITATIVE ANALYSIS RECIST M.CHOI SACT MASS DCE CT DW-MR DCE-MR SIZE STRUCTURE (ENTROPY) FUNCTION

32 WHERE ARE WE? QUANTITATIVE ANALYSIS. QUALITATIVE ANALYSIS RECIST M.CHOI SACT MASS DCE CT DW-MR DCE-MR SIZE STRUCTURE (ENTROPY) FUNCTION

33 WHERE ARE WE? QUANTITATIVE ANALYSIS STRUCTURE. QUALITATIVE ANALYSIS RECIST M.CHOI SACT MASS DCE CT DW-MR DCE-MR SIZE STRUCTURE (ENTROPY) FUNCTION

34 WHERE ARE WE? I D LIKE TO BE HERE QUANTITATIVE ANALYSIS STRUCTURE. the use of MASS criteria showed hight interobserver agreement and may predict disease outcome Smith AD, AJR 2010 QUALITATIVE ANALYSIS RECIST M.CHOI SACT MASS DCE CT DW-MR DCE-MR SIZE STRUCTURE (ENTROPY) FUNCTION

35 YES, BUT WITH STANDARDIZED EXAMS Baseline Timing of assesment Target definition Nadir Timing of scanning arterial phase, portal phase, venous phase Contrast Medium : quantity, concentration, flow

36 WE ARE HERE QUANTITATIVE ANALYSIS. QUALITATIVE ANALYSIS RECIST 1.1 M.CHOI SACT MASS DCE CT DW-MR DCE-MR SIZE STRUCTURE (ENTROPY) FUNCTION

37 WE ARE HERE QUANTITATIVE ANALYSIS?. QUALITATIVE ANALYSIS RECIST 1.1 M.CHOI SACT MASS DCE CT DW-MR DCE-MR SIZE STRUCTURE (ENTROPY) FUNCTION

38 CLEAR PROGRESSION IN A PRIMARY RESISTANT PATIENT MAR 10 JUN 10 SUN EVER JAN 11 OCT 10 SOR

39 Metastases to the liver from renal cell carcinoma: more clear enhancement during CT arterial phase with more clear decrease of it during treatment (early post-therapytherapy imaging). APR 11 MAY 11 ARTERIAL APR 11 SUN 21 days ARTERIAL MAY 11 PORTAL PORTAL

40 Metastases to the pancreas or to contralateral kidney from renal cell carcinoma: more clear enhancement during CT arterial phase

41 CLEAR RESPONSE AND CLEAR PROGRESSION BUT WHERE IS THE NADIR? FEB 08 MAY 08 OCT 08 FEB 09 SUN 50 mg SUN 37.5 mg SUN 37.5 mg SUN 37.5 mg JUL 09 OCT 09 MAR 10 JUN 10 SUN 37.5 mg SUN 37.5 mg EVER 10 mg EVER 10 mg

42 CLEAR RESPONSE AND CLEAR PROGRESSION BUT WHERE IS THE NADIR? FEB 08 MAY 08 OCT 08 FEB 09 SUN 50 mg SUN 37.5 mg SUN 37.5 mg SUN 37.5 mg JUL 09 OCT 09 MAR 10 JUN 10 SUN 37.5 mg SUN 37.5 mg EVER 10 mg EVER 10 mg

43 CLEAR RESPONSE AND CLEAR PROGRESSION BUT WHERE IS THE NADIR? FEB 08 MAY 08 OCT 08 FEB 09 SUN 50 mg SUN 37.5 mg SUN 37.5 mg SUN 37.5 mg JUL 09 OCT 09 MAR 10 JUN 10 SUN 37.5 mg SUN 37.5 mg EVER 10 mg EVER 10 mg

44 UNCLEAR PROGRESSION? SIZE AND DENSITY, NOT OR., AND ABOUT THE WASH IN? DEC 10 MAR 11 APR 11 AVG HU AVG HU AVG HU SUN 50 mg SUN 50 mg SUN 50 mg The development of resistance preceded by reemergence of remodeling or angiogenic escape) and thus of progression is consistently tumor-associated vasculature (vascular

45 THE FUTURE : IN THE FUNTIONAL IMAGING PADHANI AR, RADIOLOGY 2010

46 THE FUTURE : IN THE FUNTIONAL IMAGING? PADHANI AR, RADIOLOGY 2010

47 BIOLOGICAL PHENOMENA AND IMAGING PADHANI AR, RADIOLOGY 2010

48 DCE-CT: QUANTITATIVE VASCULAR PARAMETERS Renal carcinoma perfusion parameters ( TBF,TBV,MTT) determined with dynamic contrast-enhanced CT can help to predict biologic response to antiangiogenic drugs before beginning therapy and help detect an effect after a single cycle of treatment. Fournier LS, Radiology 2010 CT texture analysis reflecting tumor heterogeneity ( entropy ) is an independent factor associated with time to progression Goh V, Radiology 2011

49 DW MRI : AN EFFECTIVE NO RADIOESPOSING IMAGING DW-MR is useful for assessing therapy response when applied together with other functional imaging techniques Padhani A R, Magn Reson Imaging Clin N Am 2011

50 DINAMIC CONTRAST-ENHACED MRI (DCE-MRI) The analisys of the contrast distribution allow to measure the K trans (related to vascular permeability and the blood flow), a biomarker of the antivascular drugs effectivenes

51 DINAMIC CONTRAST-ENHACED MRI (DCE-MRI) Perfusion MRI is helpful in assisting for dose selection for fase II studies, in selecting subpopulations enriched for respose and in predicting patient benefit. Future challenges for imaging include correlation with clinical measures of efficacy and determining relationships with blood and serum biomarkers Padhani AR, Eur J Med Mol Imaging 2010

52 ARTERIAL SPIN LABELING MR ( ASL) A PERFUSION MR WITHOUT CONTRAST MEDIUM In a mouse model ASL provides clinically relevant information regardig tumor viability in RCC lines that respond to Sorafenib Bardach RS, Radiology 2009

53

54 Are we ready?

55 My personal practical criteria : RESPONDER: Continue Disease control Assessed with CT scan always with arterial and portal phase Slow PD Equivocal CT findings (mixed response) Worsening of clinical or lab parameters in apparent SD or response Indeterminate response: Continue but CLOSE REASSESSMENT No PD according to RECIST +/- Decrease in intratumoral contrast density or vascularity New lesion(s) OR SLD 20% (RECIST) +/- No decrease in density or in vascularity NON RESPONDER: Shift

56

2. Background This was the fourth submission for everolimus requesting listing for clear cell renal carcinoma.

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