La metodologia della ricerca clinica: aspetti salienti per l oncologo
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1 La metodologia della ricerca clinica: aspetti salienti per l oncologo Valter Torri Lab. Metodologia della Ricerca Clinica Dipartimento di Oncologia IRCCS Istituto Mario Negri - Milano
2 Controllo di confondimento e bias Confondimento Randomizzazione
3 Qualità dell evidenza
4 Disegno Dimensione dello studio Arruolamento Conduzione Valutazione degli endpoint Analisi statistica Random error Selection bias Performance bias Attrition bias Detection bias Selection bias
5 Evoluzione degli metodologia Anni 2000 : personalized medicine Anni 90: simple large
6 Evoluzione degli metodologia Anni 2000 : personalized medicine Anni 90: simple large Effetti moderati Pochi endpoints Issues: Power Disegni fattoriali I.P.D. Meta-analysis BM prognostici (tranne ER/PGR)
7 Evoluzione degli metodologia Anni 2000 : personalized medicine Anni 90: simple large Effetti moderati Pochi endpoints Issues: Power Disegni fattoriali I.P.D. Meta-analysis BM prognostici (tranne ER/PGR) Effetti attesi importanti Endpoint surrogati Enrichment Cross-over Disegni adattivi Umbrella trials Real life evidence Biomarker predittivi / biopsia liquida
8 I pazienti Paclitaxel Carboplatin Alone or with Bevacizumab for Non Small-Cell Lung Cancer A.Sandler, M.D., et al. N Engl J Med 2006; 355: pop. target restrizioni
9 Scelta del braccio di controllo Pubblicati Pubblicati Accrual
10 Scelta degli endpoints: ALK inh.
11 Scelta degli endpoints: PD-1 inh.
12 Typical survival curves observed in clinical trials YES NO NO Correlation with late benefit
13 Limitaton: reliability of interim analysis
14 Analisi di sottogruppi
15 Molteplicità di endpoint Stage IIIB/IV adenocarcinoma of the lung EGFR mutation (Del19 and/or L858R) in the tumor tissue* No prior treatment for advanced/ metastatic disease ECOG PS 0/1 1:1 Afatinib 40 mg once daily Stratified by Mutation type (Del19/L858R) Brain metastases (present/absent) Gefitinib 250 mg once daily Primary endpoints: PFS (independent) TTF OS Secondary endpoints: ORR Time to response Duration of response Duration of disease control Tumor shrinkage HRQoL Safety Treatment beyond progression allowed if deemed beneficial by investigator RECIST assessment performed at Weeks 4, 8 and every 8 weeks thereafter until Week 64, and every 12 weeks thereafter *Central or local test Dose modification to 50, 30, 20 mg permitted in line with prescribing information Lux-lung 7: Study Design Park K, et al. Lancet Oncol 2016
16 Molteplicità di endpoint Afatinib significantly improved PFS of patients with EGFRm+ NSCLC relative to gefitinib. Results are consistent across subgroups Afatinib treatment was associated with a significant improvement in response rate and TTF The improvement in efficacy was observed in both Del19 and L858R populations OS data immature (current HR: 0.87, 95%CI: ) AEs in both groups were consistent with previous experience, and were manageable leading to equally low rates of treatment discontinuation LUX-Lung 7 confirms the benefit of irreversible ErbB blockade with afatinib over reversible EGFR inhibition with gefitinib in treatment of EGFRm+ NSCLC Lux-lung 7: Park K, et al. Lancet Oncol 2016
17 Co-primary & multiple endpoints Willi Maurer & Frank Bretz (2013) Multiple Testing in Group Sequential Trials Using Graphical Approaches, Statistics in Biopharmaceutical Research, 5:4,
18 Selection & Evaluation bias Analisi ITT vs PP IRB vs Local
19 Global Appraisal Validity Precision of results Risk/Benefit profile D absolute vs relative NNT/NNH
20 Conclusioni Studi moderni in genere di buona qualità formale Randomizzazione Mascheramento ITT Attenzione ad altri aspetti sostanziali Scelta braccio controllo Scelta endpoint Scelta misure riassuntive Maturità dei dati Valutazione di contesto
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