Recent advancements in the treatment of metastatic clear cell renal cell carcinoma: A review of the evidence using second-generation p-values

Maia, 2018, Current systemic therapies for metastatic renal cell carcinoma in older adults: a comprehensive review, J. Geriatr. Oncol., 9, 265, 10.1016/j.jgo.2017.11.011 Atkins, 2018, Current and emerging therapies for first-line treatment of metastatic clear cell renal cell carcinoma, Cancer Treat. Rev., 70, 127, 10.1016/j.ctrv.2018.07.009 Tannir, 2018, Second-line treatment landscape for renal cell carcinoma: a comprehensive review, Oncologist, 23, 540, 10.1634/theoncologist.2017-0534 Choueiri, 2017, Systemic therapy for metastatic renal-cell carcinoma, N. Engl. J. Med., 376, 354, 10.1056/NEJMra1601333 Snapinn, 2011, On the clinical meaningfulness of a treatment's effect on a time-to-event variable, Stat. Med., 30, 2341, 10.1002/sim.4256 Senn, 2013, Seven myths of randomisation in clinical trials, Stat. Med., 32, 1439, 10.1002/sim.5713 Kent, 2018, Personalized evidence based medicine: predictive approaches to heterogeneous treatment effects, BMJ, 363, k4245, 10.1136/bmj.k4245 Greenland, 2016, Statistical tests, P values, confidence intervals, and power: a guide to misinterpretations, Eur. J. Epidemiol., 31, 337, 10.1007/s10654-016-0149-3 Blume, 2018, Second-generation p-values: improved rigor, reproducibility, & transparency in statistical analyses, PLoS One, 13, 10.1371/journal.pone.0188299 Blume, 2019, An introduction to second-generation p-Values, Am. Stat., 73, 157, 10.1080/00031305.2018.1537893 Fisher, 2000, Long-term survival update for high-dose recombinant interleukin-2 in patients with renal cell carcinoma, Cancer J. Sci. Am., 6, S55 Fyfe, 1995, Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy, J. Clin. Oncol., 13, 688, 10.1200/JCO.1995.13.3.688 Fishman, 2019, Overall survival by clinical risk category for high dose interleukin-2 (HD IL-2) treated patients with metastatic renal cell cancer (mRCC): data from the PROCLAIM(SM) registry, J. Immunother. Cancer, 7, 84, 10.1186/s40425-019-0567-3 Rini, 2016, Society for immunotherapy of cancer consensus statement on immunotherapy for the treatment of renal cell carcinoma, J. Immunother. Cancer, 4, 81, 10.1186/s40425-016-0180-7 Shen, 2013, The VHL/HIF axis in clear cell renal carcinoma, Semin. Cancer Biol., 23, 18, 10.1016/j.semcancer.2012.06.001 Lai, 2018, Crosstalk between VEGFR and other receptor tyrosine kinases for TKI therapy of metastatic renal cell carcinoma, Cancer Cell Int., 18, 31, 10.1186/s12935-018-0530-2 Ghosh, 2016, Genetics of renal cancer: focus on MTOR, Aging (Albany NY), 8, 421, 10.18632/aging.100937 Rini, 2008, Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206, J. Clin. Oncol., 26, 5422, 10.1200/JCO.2008.16.9847 Rini, 2010, Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206, J. Clin. Oncol., 28, 2137, 10.1200/JCO.2009.26.5561 Escudier, 2007, Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial, Lancet, 370, 2103, 10.1016/S0140-6736(07)61904-7 Escudier, 2010, Phase III trial of bevacizumab plus interferon alfa-2a in patients with metastatic renal cell carcinoma (AVOREN): final analysis of overall survival, J. Clin. Oncol., 28, 2144, 10.1200/JCO.2009.26.7849 Escudier, 2007, Sorafenib in advanced clear-cell renal-cell carcinoma, N. Engl. J. Med., 356, 125, 10.1056/NEJMoa060655 Escudier, 2009, Sorafenib for treatment of renal cell carcinoma: final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial, J. Clin. Oncol., 27, 3312, 10.1200/JCO.2008.19.5511 Hudes, 2007, Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma, N. Engl. J. Med., 356, 2271, 10.1056/NEJMoa066838 Bukowski, 2004, Prognostic factors in patients with advanced renal cell carcinoma: development of an international kidney cancer working group, Clin. Cancer Res., 10, 6310S, 10.1158/1078-0432.CCR-050000 Tannir, 2019, Temsirolimus versus Pazopanib (TemPa) in patients with advanced clear-cell renal cell carcinoma and poor-risk features: a randomized phase II trial, Eur. Urol. Oncol. Motzer, 2007, Sunitinib versus interferon alfa in metastatic renal-cell carcinoma, N. Engl. J. Med., 356, 115, 10.1056/NEJMoa065044 Motzer, 2009, Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma, J. Clin. Oncol., 27, 3584, 10.1200/JCO.2008.20.1293 Sternberg, 2010, Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial, J. Clin. Oncol., 28, 1061, 10.1200/JCO.2009.23.9764 Sternberg, 2013, A randomised, double-blind phase III study of pazopanib in patients with advanced and/or metastatic renal cell carcinoma: final overall survival results and safety update, Eur. J. Cancer, 49, 1287, 10.1016/j.ejca.2012.12.010 Motzer, 2013, Pazopanib versus sunitinib in metastatic renal-cell carcinoma, N. Engl. J. Med., 369, 722, 10.1056/NEJMoa1303989 Schmidinger, 2015, First-line treatment of metastatic renal cell carcinoma after COMPARZ and PISCES, Curr. Opin. Urol., 25, 395, 10.1097/MOU.0000000000000207 Motzer, 2008, Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial, Lancet, 372, 449, 10.1016/S0140-6736(08)61039-9 Motzer, 2010, Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors, Cancer, 116, 4256, 10.1002/cncr.25219 Hu-Lowe, 2008, Nonclinical antiangiogenesis and antitumor activities of axitinib (AG-013736), an oral, potent, and selective inhibitor of vascular endothelial growth factor receptor tyrosine kinases 1, 2, 3, Clin. Cancer Res., 14, 7272, 10.1158/1078-0432.CCR-08-0652 Hutson, 2013, Axitinib versus sorafenib as first-line therapy in patients with metastatic renal-cell carcinoma: a randomised open-label phase 3 trial, Lancet Oncol., 14, 1287, 10.1016/S1470-2045(13)70465-0 Rini, 2011, Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial, Lancet, 378, 1931, 10.1016/S0140-6736(11)61613-9 Motzer, 2013, Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: overall survival analysis and updated results from a randomised phase 3 trial, Lancet Oncol., 14, 552, 10.1016/S1470-2045(13)70093-7 Jonasch, 2019, NCCN guidelines updates: management of metastatic kidney cancer, J. Natl. Compr. Cancer Netw., 17, 587 Choueiri, 2015, Cabozantinib versus everolimus in advanced renal-cell carcinoma, N. Eng. J. Med., 373, 1814, 10.1056/NEJMoa1510016 Choueiri, 2016, Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial, Lancet Oncol., 17, 917, 10.1016/S1470-2045(16)30107-3 Motzer, 2018, Long-term follow-up of overall survival for cabozantinib versus everolimus in advanced renal cell carcinoma, Br. J. Cancer, 118, 1176, 10.1038/s41416-018-0061-6 Choueiri, 2017, Cabozantinib versus sunitinib as initial targeted therapy for patients with metastatic renal cell carcinoma of poor or intermediate risk: the Alliance A031203 CABOSUN trial, J. Clin. Oncol., 35, 591, 10.1200/JCO.2016.70.7398 Choueiri, 2018, Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): progression-free survival by independent review and overall survival update, Eur. J. Cancer, 94, 115, 10.1016/j.ejca.2018.02.012 Motzer, 2015, Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial, Lancet Oncol., 16, 1473, 10.1016/S1470-2045(15)00290-9 Motzer, 2016, Independent assessment of lenvatinib plus everolimus in patients with metastatic renal cell carcinoma, Lancet Oncol., 17, e4, 10.1016/S1470-2045(15)00543-4 Wei, 2018, Fundamental mechanisms of immune checkpoint blockade therapy, Cancer Discov., 8, 1069, 10.1158/2159-8290.CD-18-0367 Pichler, 2019, Renal cell carcinoma with sarcomatoid features: finally new therapeutic hope?, Cancers (Basel), 11, 11, 10.3390/cancers11030422 Motzer, 2015, Nivolumab versus everolimus in advanced renal-cell carcinoma, N. Engl. J. Med., 373, 1803, 10.1056/NEJMoa1510665 Centanni, 2019, Clinical pharmacokinetics and pharmacodynamics of immune checkpoint inhibitors, Clin. Pharmacokinet., 58, 835, 10.1007/s40262-019-00748-2 Escudier, 2017, Treatment beyond progression in patients with advanced renal cell carcinoma treated with nivolumab in checkmate 025, Eur. Urol., 72, 368, 10.1016/j.eururo.2017.03.037 Motzer, 2018, Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma, N. Engl. J. Med., 378, 1277, 10.1056/NEJMoa1712126 Motzer, 2019, Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended follow-up of efficacy and safety results from a randomised, controlled, phase 3 trial, Lancet Oncol., 20, 1370, 10.1016/S1470-2045(19)30413-9 Brookes, 2001, Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives, Health Technol. Assess., 5, 1, 10.3310/hta5330 Albiges, 2019, Updated european association of urology guidelines on renal cell carcinoma: immune checkpoint inhibition is the new backbone in first-line treatment of metastatic clear-cell renal cell carcinoma, Eur. Urol., 76, 151, 10.1016/j.eururo.2019.05.022 Rini, 2019, Pembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma, N. Engl. J. Med., 380, 1116, 10.1056/NEJMoa1816714 Motzer, 2019, Avelumab plus axitinib versus sunitinib for advanced renal-cell carcinoma, N. Engl. J. Med., 380, 1103, 10.1056/NEJMoa1816047 Amrhein, 2019, Inferential statistics as descriptive statistics: there is no replication crisis if we don't expect replication, Am. Stat., 73, 262, 10.1080/00031305.2018.1543137 Sharpe, 2018, The diverse functions of the PD1 inhibitory pathway, Nat. Rev. Immunol., 18, 153, 10.1038/nri.2017.108 Korn, 2011, Overall survival as the outcome for randomized clinical trials with effective subsequent therapies, J. Clin. Oncol., 29, 2439, 10.1200/JCO.2011.34.6056 Mejean, 2018, Sunitinib alone or after nephrectomy in metastatic renal-cell carcinoma, N. Engl. J. Med., 379, 417, 10.1056/NEJMoa1803675 Motzer, 2018, Cytoreductive nephrectomy - Patient Selection is key, N. Engl. J. Med., 379, 481, 10.1056/NEJMe1806331 Bhindi, 2019, Systematic review of the role of cytoreductive nephrectomy in the targeted therapy era and beyond: an individualized approach to metastatic renal cell carcinoma, Eur. Urol., 75, 111, 10.1016/j.eururo.2018.09.016 Lyon, 2019, Complete surgical metastasectomy for renal cell carcinoma in the post-cytokine era, J. Urol., 10.1097/01.JU.0000555651.43215.9d Apollonio, 2019, The role of metastasectomy in advanced renal cell carcinoma, Expert Rev. Anticancer Ther., 19, 603, 10.1080/14737140.2019.1625772 Shah, 2019, Outcomes of patients with metastatic clear-cell renal cell carcinoma treated with second-line VEGFR-TKI after first-line immune checkpoint inhibitors, Eur. J. Cancer, 114, 67, 10.1016/j.ejca.2019.04.003 Auvray, 2019, Second-line targeted therapies after nivolumab-ipilimumab failure in metastatic renal cell carcinoma, Eur. J. Cancer, 108, 33, 10.1016/j.ejca.2018.11.031 Nadal, 2016, Safety and clinical activity of vascular endothelial growth factor receptor (VEGFR)-tyrosine kinase inhibitors after programmed cell death 1 inhibitor treatment in patients with metastatic clear cell renal cell carcinoma, Ann. Oncol., 27, 1304, 10.1093/annonc/mdw160