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1 1ª línea continuum of care: maximizando la SG en CCRm RAS wt (Cetuximab) Ramon Salazar Institut Català d Oncologia
2 Sequence of treatment Chemotherapy sequence (folfiri/folfox) 1 Detrimental effect when Panitumumab (PACCE) 2 or Cetuximab (CAIRO-2) 3 were added to CT+Bevacizumab Biological sequence (EGFR versus VEGF targeted) Before Sideness Left versus Right sideness New Molecular Subtypes New treatment avenues Molecular Dx & Liquid Biopsies EGFR emergent resistant clones 1.- Tournigand,et al. JCO Hecht, et al. JCO Tol et al, NEJM 2009
3 Meta-analysis PEAK / FIRE-3 / CALGB 1º end point: OS (before sideness) pts RAS wt: 170 p p p Study level data Heinemann V, Rivera F et al. EJC, 2016
4 Meta-analysis PEAK / FIRE-3 / CALGB PFS (before sideness) pts RAS wt: 170 p p p Study level data Heinemann V, Rivera F, et al. EJC, 2016
5 Meta-analysis PEAK / FIRE-3 / CALGB (before sideness) RR pts RAS wt: 170 p p p Study level data Heinemann V, Rivera F, et al. EJC, 2016
6 Biological sequencing Considerations for sequencing anti-egfr and anti-vegf therapy in mcrc Tumour shrinkage Anti-EGFR mabs may be more effective at rapidly debulking tumours than anti-vegf mabs Tumour and stromal cell genetics/epigenetics Tumour cells are less (epi)genetically stable than stromal cells so it may be preferable to use tumour cell-targeted drugs (e.g. an anti-egfr mab) early Invasion and metastasis In preclinical models, VEGF inhibition has been reported to promote invasion and metastasis; therefore, it may be preferable to reserve VEGF mab therapy for later lines Sensitivity to second-line therapy Anti-EGFR-resistant cells may remain sensitive to anti-vegf mab therapy whereas anti-vegf-resistant cells may become simultaneously resistant to anti-egfr therapy* Wainberg ZA, Drakaki A. Expert Opin Biol Ther 2015;15: *Via hypoxia-dependent resistance mechanisms; controversial model; contrary data exist.
7 Outline Selection of treatment EGFR versus VEGF targeted sequence Detrimental effect when Panitumumab (PACCE) 1 or Cetuximab (CAIRO-2) 2 were added to CT+Bevacizumab Left versus Right sideness New Molecular Subtypes New treatment avenues Molecular Dx & Liquid Biopsies EGFR emergent resistant clones 1.- Hecht, et al. JCO Tol et al, NEJM 2009
8 There are multiple differences between the right and left colon and Embryologic origin 1 their associated tumors Function 2 Microbiome 3 Midgut Hindgut Metabolism Fermentation Proteolysis Degradation Processing Almost inactive metabolically Waste reservoir Biofilm positive Biofilm negative Epigenetic 2,4,5 Genetic 4,6 Methylation MSI-High BRAF mt See slide notes for references. 9
9 CIMP-high, MSI-high and CMS distribution varies between colorectal Right colon locations Left colorectum +++ MSI-high 1,2 +++ CIMP-high 1,2 +++ CMS Serrated pathway 2 Right colon +++ MT BRAF 1,2 MT KRAS 1 Colon +++ CIN CMS EREG expression 2 MT KRAS 1 EGFR expression 1 HER2 amplification EGFR expression 1 Molecular heterogeneity may be captured by the anatomical location of the tumour 1. Yamauchi M, et al. Gut 2012;61:847 54; 2. Missiaglia E, et al. Ann Oncol 2014;25: ; 3. Guinney J, et al. Nat Med 2015;21: (and Supplementary Figure 10). +++ denotes that a molecular or morphological subtype is more prevalent compared with other colorectal segments. CIN expression and serrated pathway data are not available for rectal tumours. CIMP, CpG island methylator phenotype; CIN, chromosomal instability; CMS, Consensus Molecular Subtypes; MSI, microsatellite instability.
10 CRYSTAL (FOLFIRI vs FOLFIRI + Cetuximab) Tumor location analysis RAS WT Left-sided Right-sided Clear poor prognostic effect of rightsided tumor location in both arms RAS wt Erb + CT (n=142) CT alone (n=138) Erb + CT (n=33) CT alone (n=51) ORR PFS % OR (95% CI) 3.99 ( ) 1.45 ( ) p-value < Median, months HR (95% CI) 0.50 ( ) 0.87 ( ) p-value < Median, months No difference in outcomes between arms in right-sided tumors, but conclusions are limited by small sample size OS HR (95% CI) 0.65 ( ) 1.08 ( ) p-value CT = FOLFIRI; Erb, cetuximab PFS & OS benefit in left-sided mcrc with cetuximab + CT vs CT alone Tejpar S, et al. JAMA Oncol 2016; epub 10 Oct 2016; Van Cutsem E, et al. Oral presentation at ESMO
11 RR in CRYSTAL in Left and Right Tumors RAS wt ORR CET + CT (n=142) Left-sided CT alone (n=138) CET + CT (n=33) Right-sided CT alone (n=51) % OR (95% CI) 3.99 ( ) 1.45 ( ) p-value < CT = FOLFIRI; CET =cetuximab 1. Tejpar S, et al. JAMA Oncol 2016; epub 10 Oct 2016; 2. Van Cutsem E, et al. Oral presentation at ESMO
12 FIRE-3 (FOLFIRI + cetuximab vs FOLFIRI + bevacizumab) Tumor location analysis RAS/BRAF WT Unprecedented OS benefit with cetuximab + CT vs bevacizumab + CT in left-sided RAS/BRAF wt mcrc 1 Left-sided Right-sided Data consistent w RAS wt subgroup analysis RAS/BRAF wt Erb + CT (n=143) Bev + CT (n=139) Erb + CT (n=28) Bev + CT (n=37) ORR PFS OS % OR p-value Median, months HR p-value Median, months HR p-value Borderline-significant increase in PFS with bevacizumab, but no significant difference in OS or ORR. However, conclusions are limited by small sample size CT = FOLFIRI; Erb, cetuximab; bev, bevacizumab 1. Heinemann V, et al. Oral presentation at ESMO
13 FIRE-3: análisis de 2ª línea según la localización tumoral Cetuximab + QT como elección de 1ªlínea para CCRm RAS wt 1 de lado izquierdo RAS wt PFS2 OS2 Localización Tumoral Lado Izquierdo Lado Derecho 1ª línea tratamiento Cetux + FOLFIRI (n=170*) Bev + FOLFIRI (n=139*) Cetux + FOLFIRI (n=40*) Bev + FOLFIRI (n=62*) Mediana, meses HR (95% CI) 0.65 ( ) 1.02 ( ) p-value Mediana, meses HR (95% CI) 0.65 ( ) 1.02 ( ) p-value Diferencia significativa en PFS2 y OS2 tras 1ª línea Cetuximab + FOLFIRI vs 1ª línea bevacizumab + FOLFIRI en CCRm RAS wt de lado izquierdo No hubo diferencias en los resultados de 2ª línea en CCRm de lado derecho; no obstante, las conclusiones son limitadas por el pequeño tamaño muestral Los datos confirman el impacto pronóstico de la localización tumoral en las líneas de tratamiento *Patients with known primary tumor location who received 2nd line therapy. FIRE-3 did not meet its primary endpoint of significantly improving ORR in patients with KRAS (exon 2) wt mcrc based on investigators read 6 ; The OS benefit of cetuximab plus chemotherapy vs bevacizumab plus chemotherapy demonstrated for RAS wt mcrc patients in the FIRE-3 study 7 could not be confirmed in the CALGB/SWOG study 8 1. Modest DP, et al. ASCO 2017 (Abstract No. 3525); 16
14 CALGB/SWOG (CT + cetuximab vs CT + bevacizumab) Tumor location analysis RAS WT RAS wt CET + CT (n=173) Left-sided Bev + CT (n=152) CET + CT (n=71) Right-sided Bev + CT (n=78) PFS OS HR (95% CI) 0.84 ( ) 1.64 ( ) p-value Treatment tumor location interaction (pvalue)* Median, months HR (95% CI) 0.77 ( ) 1.36 ( ) p-value Treatment tumor location interaction (pvalue)* Clear poor prognostic effect of right-sided tumor location on OS in both arms Longer PFS with bevacizumab vs cetuximab, and non sig difference in OS between arms, in right-sided tumors; conclusions are limited by small sample size Significant OS benefit with cetuximab + CT vs bevacizumab + CT in leftsided RAS wt mcrc Significant treatment tumor location interaction for PFS and OS CT = Investigator s choice of FOLFIRI or mfolfox6 *Adjusted for biologic, protocol CT, prior adjuvant therapy, prior RT, age, sex, synchronous disease, in place primary, liver metastases 17 Venook AP, et al. Oral presentation at ESMO 2016
15 Meta-analyses support the preferential use of anti-egfr + CT over bevacizumab + CT for LS tumors Holch meta-analysis of OS 1 LEFT Meta-analysis OS Arnold meta-analysis of OS 2 1st line CT + anti-egfr vs CT + bevacizumab in patients with LS tumors* 1st/2nd line CT + anti-egfr vs CT ± bevacizumab in patients with LS tumors* 86% of LS anti-egfr + CT-treated patients in the head-to-head trials vs bevacizumab + CT received cetuximab + CT FE, fixed-effects model; RE, random-effects model *FIRE-3 did not meet its primary endpoint of significantly improving ORR in patients with KRAS (exon 2) wt mcrc based on investigators read; 3 the OS benefit of cetuximab plus chemotherapy vs bevacizumab plus chemotherapy demonstrated for patients with RAS wt mcrc in the FIRE-3 study 4 could not be confirmed in the CALGB/SWOG study 5 1. Holch JW, et al. Eur J Cancer 2017;70:87 98; 2. Arnold D, et al. Ann Oncol 2017; epub Apr 12. doi: /annonc/mdx175; 3. Heinemann V, et al. Lancet Oncol 2014;15: ; 4. Stintzing S, et al. Lancet Oncol 2016;17: ; 5. Venook A, et al. JAMA. 2017;317:
16 LEFT Meta-analysis ORR Meta-analyses support the preferential use of anti-egfr + CT over bevacizumab + CT for LS tumors Holch meta-analysis of ORR 1 1st line CT + anti-egfr vs CT + bevacizumab in patients with LS tumors* Arnold meta-analysis of ORR 2 1st/2nd line CT + anti-egfr vs CT ± bevacizumab in patients with LS tumors* FE, fixed-effects model; RE, random-effects model *FIRE-3 did not meet its primary endpoint of significantly improving ORR in patients with KRAS (exon 2) wt mcrc based on investigators read; 3 the OS benefit of cetuximab plus chemotherapy vs bevacizumab plus chemotherapy demonstrated for patients with RAS wt mcrc in the FIRE-3 study 4 could not be confirmed in the CALGB/SWOG study 5 1. Holch JW, et al. Eur J Cancer 2017;70:87 98; 2. Arnold D, et al. Ann Oncol 2017; epub Apr 12. doi: /annonc/mdx175; 3. Heinemann V, et al. Lancet Oncol 2014;15: ; 4. Stintzing S, et al. Lancet Oncol 2016;17: ; 5. Venook A, et al. JAMA. 2017;317:
17 No PFS benefit for CT + anti-egfr vs CT ± bevacizumab for RS tumors Holch meta-analysis of PFS 1 RIGHT Meta-analysis PFS Arnold meta-analysis of PFS 2 1st line CT + anti-egfr vs CT + bevacizumab in patients with RS tumors* 1st/2nd line CT + anti-egfr vs CT ± bevacizumab in patients with RS tumors* FE, fixed-effects model; RE, random-effects model *FIRE-3 did not meet its primary endpoint of significantly improving ORR in patients with KRAS (exon 2) wt mcrc based on investigators read; 3 the OS benefit of cetuximab plus chemotherapy vs bevacizumab plus chemotherapy demonstrated for patients with RAS wt mcrc in the FIRE-3 study 4 could not be confirmed in the CALGB/SWOG study 5 1. Holch JW, et al. Eur J Cancer 2017;70:87 98; 2. Arnold D, et al. Ann Oncol 2017; epub Apr 12. doi: /annonc/mdx175; 3. Heinemann V, et al. Lancet Oncol 2014;15: ; 4. Stintzing S, et al. Lancet Oncol 2016;17: ; 5. Venook A, et al. JAMA. 2017;317:
18 RIGHT Meta-analysis OS No significant difference in OS for CT + anti-egfr vs CT ± bevacizumab for RS tumors Holch meta-analysis of OS 1 1st line CT + anti-egfr vs CT + bevacizumab in patients with RS tumors* Arnold meta-analysis of OS 2 1st/2nd line CT + anti-egfr vs CT ± bevacizumab in patients with RS tumors* FE, fixed-effects model; RE, random-effects model *FIRE-3 did not meet its primary endpoint of significantly improving ORR in patients with KRAS (exon 2) wt mcrc based on investigators read; 3 the OS benefit of cetuximab plus chemotherapy vs bevacizumab plus chemotherapy demonstrated for patients with RAS wt mcrc in the FIRE-3 study 4 could not be confirmed in the CALGB/SWOG study 5 1. Holch JW, et al. Eur J Cancer 2017;70:87 98; 2. Arnold D, et al. Ann Oncol 2017; epub Apr 12. doi: /annonc/mdx175; 3. Heinemann V, et al. Lancet Oncol 2014;15: ; 4. Stintzing S, et al. Lancet Oncol 2016;17: ; 5. Venook A, et al. JAMA. 2017;317:
19 RIGHT Meta-analysis ORR Cetuximab + CT is effective in patients with RS tumors: ORR numerically favors anti-egfr + CT over bevacizumab + CT Holch meta-analysis of ORR 1 1st line CT + anti-egfr vs CT + bevacizumab in patients with RS tumors* Arnold meta-analysis of ORR 2 1st/2nd line CT + anti-egfr vs CT ± bevacizumab in patients with RS tumors* FE, fixed-effects model; RE, random-effects model *FIRE-3 did not meet its primary endpoint of significantly improving ORR in patients with KRAS (exon 2) wt mcrc based on investigators read; 3 the OS benefit of cetuximab plus chemotherapy vs bevacizumab plus chemotherapy demonstrated for patients with RAS wt mcrc in the FIRE-3 study 4 could not be confirmed in the CALGB/SWOG study 5 1. Holch JW, et al. Eur J Cancer 2017;70:87 98; 2. Arnold D, et al. Ann Oncol 2017; epub Apr 12. doi: /annonc/mdx175; 3. Heinemann V, et al. Lancet Oncol 2014;15: ; 4. Stintzing S, et al. Lancet Oncol 2016;17: ; 5. Venook A, et al. JAMA. 2017;317:
20 WCGIC 2017 The Left versus Right cancer story: What is the truth? WCGIC 2017, Session XIX: Colorectal cancer, Controversy debate: Updates on treatment algorithms in mcrcin 2017 The left versus right colon cancer story: What is the truth: Axel Grothey, MD
21 CMS1-4 in CALGB & Fire-3
22 Proposed taxonomy of colorectal cancer Prognosis Drug response prediction Inmune checkpoints blockade Oncogene drivers Amplifications Metabolism & DNA damage TGF- inhibition + Inmune checkpoint blockade
23 CALGB Slide 18 Presented By Heinz-Josef Lenz at 2017 ASCO Annual Meeting
24 Fire-3 FOLFIRI cetuximab vs. FOLFIRI bevacizumab Presented By Sebastian Stintzing at 2017 ASCO Annual Meeting
25 Institut Català d Oncologia ICO l Hospitalet Hospital Duran i Reynals Gran Via de l Hospitalet, l Hospitalet de Llobregat ICO Badalona Hospital Germans Trias i Pujol Ctra. del Canyet s/n Badalona ICO Girona Hospital Doctor Trueta Av. França s/n Girona
26 BACK up slides.
27 Sensitivity to 2 nd -line therapy Putative mechanisms of decreased anti-egfr mab efficacy after anti-vegf exposure Putative effect of VEGF pathway inhibition: Hypoxia-induced EGFR-independent RAS signal activation 1 Hypoxia-induced EMT transition 2 sensitivity to EGFR inhibition Aggressive/invasive cell characteristics VEGF-A VEGF-A-induced resistance to anti-egfr 3 in WT KRAS/NRAS colon cancer cell lines VEGFR2/Stat-3-dependent Adapted from Zaniboni A, Formica V. Cancer Chemother Pharmacol 2016 [Epub ahead of print]. 1. Zang M, et al. PLoS One 2010;5:e10966; 2. Zhou J, et al. Oncotarget 2015;6: ; 3. Derangère V, et al. Oncotarget 2016;7: EMT, epithelial-mesenchymal transition;
28 Digital PCR allows high sensitivity and quantitative results Conventional PCR Digital PCR Wild-type DNA Mutant DNA Partitioning of DNA into many individual reactions Relative signal readout Digital signal readout Vogelstein et al. PNAS 1999; mod. Diehl et al Curr Opin Oncol. 2007
29 RAS mutants: MEK inhibition leads to PI3K/AKT activation by relieving a negative feedback on ERBB receptors 1 Turke A et al. Cancer Research 2012
30
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