La sequenza terapeutica nel paziente con NSCLC avanzato in base all istologia e alla caratterizzazione molecolare: Impatto sulla pratica clinica?
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- Cora Anderson
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1 La sequenza terapeutica nel paziente con NSCLC avanzato in base all istologia e alla caratterizzazione molecolare: Impatto sulla pratica clinica? GRUPPO A Luca Toschi (former Vanesa Gregorc)
2
3 Who are oncogene addicted NSCLC patients?
4 Lung Cancer Consortium Mutation - 16 US cancer centers - Test 10 driver mutations in 1007 lung adenocarcinomas - 63%: oncogenic driver
5 NGS in never/light smokers with lung ADC with negative non-ngs tests coding exons of 287 cancerrelated genes introns of 19 frequently rearranged genes Drilon, CCR 2015
6 Today Who are oncogene addicted NSCLC in clinical practice? EGFR-mutant ALK rearranged
7 Horn L, et al. J Clin Oncol, 27 (26):4232-5, 2009
8 6 patients with concomitant EGFR mutation and EML4-ALK translocation % of the overall population % of EGFR-mutated patients % patients of patients with concomitant with EML4-ALK EGFR and translocation KRAS mutation % of the overall population - 6.8% of EGFR-mutated patients - 3.2% of KRAS-mutated patients 7 patients with concomitant EML4-ALK translocation and KRAS mutation % of the overall population % of patients with EML4-ALK translocation - 3.2% of KRAS-mutated patients MINI10.01: Frequency of concomitant EGFR, EML4-ALK or KRAS alterations in NSCLC patients and correlation with response to treatment Paola Ulivi WLCC 2015
9 NSCLC EGFR-mutato La prima linea è definita? EGFR TKI: prima scelta rispetto a CT
10 1st line: EGFR-TKIs vs CT Author Study N (EGFR mut. +) EGFR-TKI ORR Median PFS* Mok IPASS 261 Gefitinib 71.2% vs. 47.3% 9.8 vs. 6.4 months Lee First-SIGNAL 42 Gefitinib 84.6% vs. 37.5% 8.4 vs. 6.7 months Mitsudomi WJTOG Gefitinib 62.1% vs. 32.2% 9.2 vs. 6.3 months Maemondo NEJGSG Gefitinib 73.7% vs. 30.7% 10.8 vs. 5.4 months Zhou OPTIMAL 154 Erlotinib 83% vs. 36% 13.1 vs. 4.6 months Rosell EURTAC 175 Erlotinib 58% vs. 15% 9.7 vs. 5.2 months Yang LUX-Lung Afatinib 56.1% vs. 22.6% 11.1 vs. 6.9 months Wu LUX-Lung Afatinib 66.9% vs 23.0% 11.0 vs 5.6 months *Primary endpoint
11 NSCLC EGFR-mutato La prima linea è definita? EGFR TKI: prima scelta rispetto a CT Quale TKI scegliere? ECOG PS, eta, interazioni farmacologiche Dubbi: tipo di mutazione; mutazioni non comuni Criticità: aspetti metodologici
12 Toxicity with EGFR TKIs Landi L, Expert Opin Pharmacother 2014
13 PFS with TKIs better for del19 than L858R Del19 HR: 0.24 p for interaction < L858R HR: 0.48 Lee et al. JCO 2015
14 Afatinib activity in uncommon mutations L861Q (ex 21) G719 (ex 18) S768I (ex 20) other T790M alone or in combination Exon 20 insertions RR 27% PFS 10.7 RR 2% PFS 2.9 RR 2% PFS 2.7 Yang et al. Lancet Oncol 2015
15 EURTAC: PFS according to T790M and treatment T790M detected in 65.2% of patient (detection threshold 1/5000) 9.7 months 6.0 months Costa et al. Clinical Cancer Research 2014
16 NSCLC EGFR-mutato alla progressione Opportunità di trattamento ma numerose criticità Definizione di PD (radiologica, clinica?): quando switch?
17 ASPIRATION: erlotinib beyond PD EGFR TKI EGFR TKI Advance stage NSCLC with EGFR Mutation N=207 PFS 1: 11.0 months PD By RECIST N=171 PD By doctor Discretion N=93 PFS 2: 14.1 months Park et al.esmo 2014
18 PFS benefit in oligoprogressive EGFR+/ALK+ patients continuing TKI + local therapy (n=65) All patients: +6.2m ecns: +4.0m CNS: +7.1m Weickhardt et al. JTO 7: , 2012
19 NSCLC EGFR-mutato alla progressione Opportunità di trattamento ma numerose criticità Definizione di PD (radiologica, clinica?): quando switch? Identificazione T790M (tessuto vs sangue)
20 Rebiopsy in 155 pts with acquired resistance to gefitinib or erlotinib Yu et al. Clin Cancer Res 2013
21 Wu et al. Oncotarget 2016
22 Rebiopsy N=100 advanced NSCLC with indication for rebiopsy Rebiopsy not possible in 19.5% of cases Inadequate sample in 25.6% of cases Rebiopsy useful for guiding treatment in 30.4% (25/82) Complications were infrequent Lung Cancer 2014
23 NSCLC EGFR-mutato alla progressione Opportunità di trattamento ma numerose criticità Definizione di PD (radiologica, clinica?): quando switch? Identificazione T790M (tessuto vs sangue) Disponibilità del farmaco Approvazione basata su fase I Gestione T790M-negativi: locoregional, CT
24 NSCLC ALK-traslocato
25 Crizotinib Superior to Standard Chemotherapy 1 st Line therapy 2nd Line therapy Profile 1014: Crizotinib vs. Platinum/Pemetrexed Profile 1007: Crizotinib vs. Chemotherapy PFS probability (%) Crizotinib (N=172) Chemotherapy (N=172) Events, n (%) 100 (58) 137 (80) Median, months HR (95% CI) 0.45 ( ) P b < No. at risk Crizotinib Chemotherapy Time (months) ORR: Crizotinib 74% vs. Chemo 45% ORR: Crizotinib 65% vs. Chemo 20% Solomon et at, NEJM 2014 Shaw et al., NEJM 2013
26 NSCLC ALK-traslocato La prima linea è definita? Idealmente SI, praticamente NO: CT Seconda linea: crizotinib Praticamente SI, idealmente NO Terza linea Definizione di PD (radiologica, clinica?): quando switch?
27 Crizotinib Beyond Progression 16.4 mo vs 3.9 mo; HR 0.27 Ou et al; Ann Oncol 2014
28 Several Mechanisms of Crizotinib Resistance Unknown Bypass Target gene alteration 28% ALK amplification ALK mutation EGFR activation CKIT amplification Unknown L1196M G1206Y S1206Y 1151Tins L1152R C11525Y
29 NSCLC ALK-traslocato La prima linea è definita? Idealmente SI, praticamente NO: CT Seconda linea: crizotinib Praticamente SI, idealmente NO Terza linea Definizione di PD (radiologica, clinica?): quando switch? No ruolo per la rebiopsia nella pratica clinica ma futuri sviluppi possibili
30 Acquired resistance to ALK inhibitors: a dynamic process
31 NSCLC ALK-traslocato La prima linea è definita? Idealmente si, praticamente no: CT Seconda linea: crizotinib Praticamente si, idealmente no Terza linea Definizione di PD (radiologica, clinica?): quando switch? No ruolo per la rebiopsia nella pratica clinica ma futuri sviluppi possibili Ceritinib EAP Clinical trial
32 ALK TKI Sponsor ROS1 Activity Status Ongoing Studies Reference Ceritinib Novartis Yes FDA approved (29 Apr 2014) Phase 3 Shaw et al., NEJM 2014; Kim et al., ASCO 2014 Alectinib Roche No FDA approved (11 Dec 2015) Phase 3 Expanded access Seto et al., Lancet Onc 2013; Gadgeel et al., Lancet Onc 2014 AP26113 Ariad Yes Investigational Phase 2 Gettinger et al., ASCO 2014 X-396 Xcovery Yes Investigational Phase 1 Horn et al., ASCO 2014 TSR-011 Tesaro Unk Investigational Phase 1/2 Weiss et al., WCLC 2013 Entrectinib Ignyta Yes Investigational Phase 1 De Braud et al., ASCO 2014 CEP Teva Unk Investigational Phase 1 NCT Lorlatinib Pfizer Yes Investigational Phase 1/2 Zou et al., EORTC- AACR-NCI 2013
33 NSCLC ALK-traslocato La prima linea è definita? Idealmente si, praticamente no: CT Seconda linea: crizotinib Praticamente si, idealmente no Terza linea Definizione di PD (radiologica, clinica?): quando switch? No ruolo per la rebiopsia nella pratica clinica ma futuri sviluppi possibili Ceritinib EAP Clinical trial Metastasi cerebrali: timing RT?
34 Grazie
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