5 Références

     

[1] Brose MS, Nutting CM, Jarzab B, et al. Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial. The Lancet 2014;384:319–28 10.1016/S0140-6736(14)60421-9 [24768112]

[2] Isbary G, Staab TR, Amelung VE, et al. Effect of Crossover in Oncology Clinical Trials on Evidence Levels in Early Benefit Assessment in Germany. Value Health 2018;21:698–706 10.1016/j.jval.2017.09.010 [29909875]

[3] Prasad V, Grady C. The misguided ethics of crossover trials. Contemporary Clinical Trials 2014;37:167–69 10.1016/j.cct.2013.12.003 [24365533]

[4] Reck M, Rodríguez-Abreu D, Robinson AG, et al. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med 2016;375:1823–33 10.1056/NEJMoa1606774 [27718847]

[5] Mok TSK, Wu Y-L, Kudaba I, et al. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. The Lancet 2019;393:1819–30 10.1016/S0140-6736(18)32409-7 [30955977]

[6] Jönsson L, Sandin R, Ekman M, et al. Analyzing overall survival in randomized controlled trials with crossover and implications for economic evaluation. Value Health 2014;17:707–13 10.1016/j.jval.2014.06.006 [25236994]

[7] Morden JP, Lambert PC, Latimer N, et al. Assessing methods for dealing with treatment switching in randomised controlled trials: a simulation study. BMC Med Res Methodol 2011;11:4 10.1186/1471-2288-11-4 [21223539]

[8] Latimer NR, Abrams KR. NICE DSU Technical Support Document 16: Adjusting Survival Time Estimates in the Presence of Treatment Switching. London 2014.

[9] Korn EL, Freidlin B, Abrams JS. Overall survival as the outcome for randomized clinical trials with effective subsequent therapies. JCO 2011;29:2439–42 10.1200/JCO.2011.34.6056 [21555691]

[10] Diaz J, Sternberg CN, Mehmud F, et al. Overall Survival Endpoint in Oncology Clinical Trials: Addressing the Effect of Crossover--The Case of Pazopanib in Advanced Renal Cell Carcinoma. Oncology 2016;90:119–26 10.1159/000443647 [26901053]

[11] Brose M, Jarzab B, Elisei R, et al. Final overall survival analysis of patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer (RAI-rDTC) treated with sorafenib in the phase 3 DECISION trial: An exploratory crossover adjustment analyses. Annals of Oncology 2016;27:vi329 10.1093/annonc/mdw376.06

[12] Brose MS, Jarzab B, Elisei R, et al. Updated overall survival analysis of patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer (RAI-rDTC) treated with sorafenib on the phase 3 DECISION trial. JCO 2014;32:6060 10.1200/jco.2014.32.15_suppl.6060

[13] Haslam A, Prasad V. When is crossover desirable in cancer drug trials and when is it problematic? Annals of Oncology 2018;29:1079–81 10.1093/annonc/mdy116 [29648572]

[14] Soria J-C, Ohe Y, Vansteenkiste J, et al. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med 2018;378:113–25 10.1056/NEJMoa1713137 [29151359]

[15] Mok TS, Wu Y-L, Ahn M-J, et al. Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. N Engl J Med 2017;376:629–40 10.1056/NEJMoa1612674 [27959700]