Les actualités PEC des cancers bronchiques au stade précoce - DAVID.PLANCHARD GUSTAVE ROUSSY Head of Thoracic Group Villejuif - FRANCE
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les actualités PEC des cancers bronchiques au stade précoce DAVID.PLANCHARD GUSTAVE ROUSSY Head of Thoracic Group Villejuif - FRANCE M-MA-00000097
Le contenu et l’interprétation de ces diapositives reflètent le point de vue Les informations présentées pourraient comporter des données relatives à des produits non enregistrés ou à des indications non La cadre de cette présentation est scientifique et nullement promotionnel.
Pour toute information médicale sur les produits Roche, veuillez nous contacter à l’adresse : email: morocco.medinfo@roche.com, par téléphone : 05 22 95 90 00 ou par fax : 05 22 95 90 01 Pour toute notification d’évènements indésirables, veuillez nous contacter à l’adresse : email: morocco.drug_safety@roche.com, par téléphone : 06 61 05 31 70/ 05 22 95 90 58 ou par fax : 05 22 95 90 59 Roche Maroc S.A. Ivoire 05, Casablanca Marina Bvd Sidi Mohamed Ben Abdellah Casablanca, MAROC
DISCLOSURE SLIDE Consulting, advisory role or lectures: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly, Merck, Novartis, Pfizer, prIME Oncology, Peer CME, Roche, Samsung Honoraria: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Merck, Novartis, Pfizer, prIME Oncology, Peer CME, Roche, Samsung Clinical trials research as principal or co-investigator (Institutional financial interests): AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, Pfizer, Roche, Medimmun, Sanofi-Aventis, Taiho Pharma, Novocure, Daiichi Sankyo Travel, Accommodations, Expenses: AstraZeneca, Roche, Novartis, prIME Oncology, Pfizer
4 questions in early-stage NSCLC : PORT in completely resected early-stage N2 NSCLC ? Targeted therapy in completely resected early-stage ? IO in completely resected early-stage ? IO in unresectable early-stage ?
Postoperative cisplatin-based chemotherapy significantly improves survival LACE meta-analysis 5-year absolute benefit of 5.4% from chemotherapy Stage IA: No Adj therapy recommended HR:0.89 Stage IB: Not for routine use (8th TNM > 4cm : T2b ou T3, T4 : IIA-IIIA) Stage IIA/B and IIIA: Adjuvant cisplatin- based chemoT recommended HR:0.84 Jean-Pierre Pignon et al, JCO 2008
Postoperative radiotherapy In a meta-analysis of rather old studies PORT found to be detrimental if given to patients with N0 and N1 disease The case for unexpected N2 disease discovered at surgery is less clear, and currently evaluated in a large clinical trial Cochrane Database Syst Rev 2005
IMPACT OF POSTOPERATIVE RADIATION THERAPY ON SURVIVAL IN PATIENTS WITH COMPLETE RESECTION (pN2) 4483 resected pts N2 30.552 pts treated for stages II–IIIA SURVIVAL IN PATIENTS WITH COMPLETE National Cancer Data Base in National Cancer Database RESECTION AND STAGE I, II, OR IIIA (ANITA trial) N2 pN2 Post-op RT CT +PORT OS: 45.2 v 40.7 months Cliff G. Robinson et al, JCO 2015 Christopher D. Corso et al, JTO 2015 Douillard JY et al, Radiation onco 2008
C.Le Pechoux et al ESMO 2020
30.5 vs 22.8mo C.Le Pechoux et al ESMO 2020
C.Le Pechoux et al ESMO 2020
3Y: 66.5 vs 68.5% C.Le Pechoux et al ESMO 2020
C.Le Pechoux et al ESMO 2020
4 questions in early-stage NSCLC : PORT in completely resected early-stage N2 NSCLC ? Not recommended Targeted therapy in completely resected early-stage ? IO in completely resected early-stage ? IO in unresectable early-stage ?
ADJUVANT trial stage II–IIIA (N1–N2) Adjuvant gefitinib led to significantly longer DFS compared in patients with completely resected stage II–IIIA (N1–N2) EGFR-mutant NSCLC DFS (ITT population)(update at 3 and 5 years) HR: 0.56 - duration of benefit with gefitinib after 24 months might be limited and overall Zhong W.Z et al, lancet 2018 Zhong WZ et al, JCO 2020
Overall survival (ITT population) HR: 0.92 Zhong WZ et al, JCO 2020
Stage IB-IIIA Slide 5 Ramalingam SS et al, NEJM 2020
DFS stage II IIIA stage IB IIIA HR: 0.17 HR: 0.20 Ramalingam SS et al, NEJM 2020
DFS by disease stage stage IB stage II stage IIIA HR: 0.39 HR: 0.17 HR: 0.12 Ramalingam SS et al, NEJM 2020
DFS assessment with and without adjuvant chemoT Received adjuvant chemoT no adjuvant chemoT HR: 0.16 HR: 0.23 Ramalingam SS et al, NEJM 2020
ADJUVANT trial II–IIIA (N1–N2) ADAURA stage II IIIA HR: 0.56 HR: 0.17 Ramalingam SS et al, NEJM 2020
Type of disease recurrence Masahiro Tsuboi et al, ESMO 2020
Sites of disease recurrence CNS DFS in the overall population Masahiro Tsuboi et al, ESMO 2020
Post Hoc Analysis of the ADJUVANT Trial (CTONG 1104) ChemoT disease-free survival (CNS) 24% HR: 0.75 Gefitinib ChemoT Gef 27% Song-Tao Xu et al, JTO 2018
EGFR and ALK Stage IB-IIIA NSCLC The ALCHEMIST Screening Trial ALINA Trial (ALK-Alectinib)
4 questions in early-stage NSCLC : PORT in completely resected early-stage N2 NSCLC ? Not recommended Targeted therapy in completely resected early-stage ? EGFRmut – Osimertinib: resounding justification for the rapid implementation of this approach into clinical practice IO in completely resected early-stage ? IO in unresectable early-stage ?
Neoadjuvant IO monotherapy
Neoadjuvant Chemo IO trials
Benjamin Besse et al, ESMO 2020
Partial response (RECIST1.1) :7% Benjamin Besse et al, ESMO 2020
MPR 14% Benjamin Besse et al, ESMO 2020
Benjamin Besse et al, ESMO 2020
Benjamin Besse et al, ESMO 2020
Marie Wislez et al, ESMO 2020
Marie Wislez et al, ESMO 2020
Marie Wislez et al, ESMO 2020
IO in adjuvant, phase 3 on going… Strategy Trial Clinical Treatment Patients target Primary phase endoint Adjuvant IB (>4cm) -IIIA ANVIL 3 Nivo vs 714 DFS Observation OS Adjuvant IB (>4cm) -IIIA PEARLS 3 Pembro vs 1380 DFS Placebo -IIIA Impower010 3 Atezo vs BSC 1127 DFS Adjuvant IB (>4cm) -IIA BR31 3 Durva vs 1100 DFS placebo
4 questions in early-stage NSCLC : PORT in completely resected early-stage N2 NSCLC ? Not recommended Targeted therapy in completely resected early-stage ? EGFRmut – Osimertinib: resounding justification for the rapid implementation of this approach into clinical practice IO in completely resected early-stage ? Not yet in clinical practice IO in unresectable early-stage ?
Unresectable stage III: Concurrent is superior to sequential CT-RT Concomitant a standard of care Progression-free Overall Survival3 Survival3 Sequential CRT Concurrent CRT Sequential CRT Concurrent CRT 25% 23.8% 25% 20% 18.1% 20% 15.1% 16% 15% 15% 13.1% 11.6% 10.6% 9.4% 10% 10% 5% 5% 0% 0% 3 Years 5 Years 3 Years 5 Years Overall survival: absolute benefit 2 years 3 years 5 years 5.3% 5.7% 4.5% Concomitant CRT is the standard of care for unresectable stage III NSCLC Anne Auperin et al, JCO 2010
PACIFIC Trial - durvalumab vs Placebo post RTCT UPDATED PFS mPFS 17.2 vs 5.6 mo Corinne Faivre-Finn et al, ESMO 2020; JTO 2021
UPDATED OS mOS: 47.5 vs 29.1 mo Corinne Faivre-Finn et al, ESMO 2020; JTO 2021
Stages I-III: immunotherapy trials Replacing chemotherapy with IO trials ? Concurrent immunotherapy + CTRT Trials SBRT – immunotherapy trials (consolidation) A.S.Tsao, ASCO 2019
4 questions in early-stage NSCLC : PORT in completely resected early-stage N2 NSCLC ? Not recommended Targeted therapy in completely resected early-stage ? EGFRmut – Osimertinib: resounding justification for the rapid implementation of this approach into clinical practice IO in completely resected early-stage ? Not yet in clinical practice IO in unresectable early-stage ? Consolidation with Durvalumab as a standard
MERCI ! @dplanchard Benjamin BESSE Thierry LE CHEVALIER Jean-Charles SORIA Fabrice BARLESI Charles NALTET Anas GAZZAH Pernelle LAVAUD Cécile LE PECHOUX Angéla BOTTICELLA Antonin LEVY
Pour toute information médicale sur les produits Roche, veuillez nous contacter à l’adresse : email: morocco.medinfo@roche.com, par téléphone : 05 22 95 90 00 ou par fax : 05 22 95 90 01 Pour toute notification d’évènements indésirables, veuillez nous contacter à l’adresse : email: morocco.drug_safety@roche.com, par téléphone : 06 61 17 83 67/ 05 22 95 90 58 ou par fax : 05 22 95 90 59 Roche Maroc S.A. Ivoire 05, Casablanca Marina Bvd Sidi Mohamed Ben Abdellah Casablanca, MAROC
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