Traitement de 2ème ligne du cancer colorectal métastatique : nouvelles données cliniques en 2018
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1 GR DIG 2017 Traitement de 2ème ligne du cancer colorectal métastatique : nouvelles données cliniques en décembre 2017 Benoist Chibaudel Oncologie Médicale Institut Hospitalier Franco-Britannique, Levallois - France
2 Disclosures Honoraria/consulting: Sanofi, Lilly, Roche, Bayer Travels: Roche, Sanofi, Amgen, Merck, Lilly «Sanofi ne recommande en aucun cas l usage des produits en dehors de leurs indications approuvées par leurs AMM [«par leur marquage CE» s il s agit de dispositifs médicaux (DM)]. Merci de consulter le résumé des caractéristiques du produit [«la notice technique» pour les DM) avant de les prescrire. Les informations ci-après sont fournies pour un usage médical et scientifique uniquement, et sont destinées exclusivement aux participants de cette manifestation scientifique.»
3 2 ème ligne du cancer colorectal métastatique Où en est-on?
4 Bevacizumab (TML) All RAS Second-line Treatment Sequencing in MCRC Second-line phase III trials Antiangiogenic agents Aflibercept (VELOUR) All RAS Ramucirumab (RAISE) All RAS Anti-EGFR mab Panitumumab (181) KRAS WT Bennouna J et al, Lancet Oncol 2013 Van Cutsem E et al, JCO 2012 Tabernero J et al, Lancet Oncol 2015 Peeters et al, JCO 2010
5 Bevacizumab (TML) All RAS Second-line phase III trials Antiangiogenic agents Aflibercept (VELOUR) All RAS Ramucirumab (RAISE) All RAS Anti-EGFR mab Panitumumab (181) KRAS WT Bennouna J et al, Lancet Oncol 2013 Van Cutsem E et al, JCO 2012 Tabernero J et al, Lancet Oncol 2015 Peeters et al, JCO 2010
6 Bevacizumab (TML) All RAS Second-line phase III trials Antiangiogenic agents Aflibercept (VELOUR) All RAS Ramucirumab (RAISE) All RAS Anti-EGFR mab Panitumumab (181) KRAS WT OS L2 1 year PFS L2 ½ ye ar Bennouna J et al, Lancet Oncol 2013 Van Cutsem E et al, JCO 2012 Tabernero J et al, Lancet Oncol 2015 Peeters et al, JCO 2010
7 2 ème ligne du cancer colorectal métastatique Quelle direction prendre?
8 Second-line direct comparison Antiangiogenics or anti-egfr in second-line PRODIGE 18 (KRAS ex.2) Randomized phase II, N = 130 Primary endpoint : 4m-PFS FOLFOX / FOLFIRI + bevacizumab FOLFOX / FOLFIRI + cetuximab Hiret S et al, ASCO 2016 (abs 3514)
9 Second-line direct comparison Antiangiogenics or anti-egfr in second-line PRODIGE 18 PFS OS Hiret S et al, ASCO 2016 (abs 3514)
10 Second-line direct comparison Antiangiogenics or anti-egfr in second-line SPIRITT (KRAS ex.2) Randomized phase II, N = 182 Primary endpoint : PFS FOLFOX + bevacizumab FOLFIRI + bevacizumab FOLFIRI + panitumumab Hecht et al, CCR 2015
11 Second-line direct comparison Antiangiogenics or anti-egfr in second-line SPIRITT (KRAS ex.2) PFS BEV+CT PAN+CT ( ) ( ) HR 1.06 OS BEV+CT 21.4 ( ) HR 1.01 PAN+CT 18.0 ( ) Hecht et al, CCR 2015
12 Second-line strategy trial Antiangiogenics or anti-egfr in second-line COMETS (KRAS) Randomized phase II, N = 110 Primary endpoint : PFS Cascinu et al, ESMO 2015
13 Second-line strategy trial Antiangiogenics or anti-egfr in second-line COMETS PFS OS Cascinu et al, ESMO 2015
14 Second-line phase III trials 1 0,95 Tumor biology : KRAS status No benefit HR PFS 0,9 0,85 0,8 0,75 Bevacizumab (TML) Aflibercept (VELOUR) Ramucirumab (RAISE) Panitumumab (181) KRAS mut. 0,7 0,65 KRAS wt. 0,6 0,55 High benefit 0,5 0,5 0,55 0,6 0,65 0,7 0,75 0,8 0,85 0,9 0,95 1 HR OS
15 2 ème ligne du cancer colorectal métastatique Quel anti-angiogénique et pour qui?
16
17 Key differences between anti-ang Safety Profile CTCAE G3-4, % Bev. (TML) Ramucirumab (RAISE) Aflibercept (VELOUR) Any Hypertension Diarrhea Asthenia Mucositis Neutropenia Art. thrombosis < (1) Van Cutsem et al, JCO 2012 (2) Bennouna et al, Lancet Oncol 2012 (3) Tabernero et al, Lancet Oncol 2015
18 Key differences between anti-ang Association between safety and efficacy The highest response rate (19%) was achieved with FOLFIRI-aflibercept. The highest incidence of grade 3-4 hypertension (19%) was observed with FOLFIRI-aflibercept. Bev. (TML) Ram. (RAISE) Afli. (VELOUR) Afli. 14 RR, % HTA (G3-4), % RR (%) Bev. Ram. r = P = HTA(%) (1) Van Cutsem et al, JCO 2012 (2) Bennouna et al, Lancet Oncol 2012 (3) Tabernero et al, Lancet Oncol 2015 Chibaudel B, unpublished data
19 Criteria for sequencing anti-vegf agents Prior first-line regimen Bevacizumab-based first-line Bevacizumab-naïve patients FOLFOX + bev. FOLFIRI + bev. FOLFOX +/- anti-egfr FOLFIRI +/- anti-egfr Bevacizumab Bennouna, Lancet Oncol 2012 Giantonio, JCO nd -line Aflibercept Van Cutsem, JCO 2012 Van Cutsem, JCO 2012 Ramucirumab Tabernero, Lancet Oncol 2015
20 Criteria for sequencing anti-vegf agents Prior use of bev. (or not) in first-line? Prior bevacizumab Bevacizumab-naïve HR PFS HR OS HR PFS HR OS TML (bev.) VELOUR (afli.) RAISE (ram.) Bennouna et al, Lancet Oncol 2012 Van Cutsem et al, JCO 2012 Tabernero et al, Lancet Oncol 2015
21 Criteria for sequencing anti-vegf agents Tumor biology : KRAS status Tejpar S et al, ASCO 2017 (abs 3538)
22 Criteria for sequencing anti-vegf agents Tumor biology : BRAF status FOLFIRI-aflibercept FOLFIRI-placebo HR OS 0.42 HR PFS 0.59 Tejpar S et al, ASCO 2017 (abs 3538)
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