Risk of selected gastrointestinal toxicities in metastatic renal cell carcinoma patients treated with immuno-TKI combinations: a meta-analysis

References

• Chowdhury N, Drake CG. Kidney cancer: an overview of current therapeutic approaches. Urol Clin North Am. 2020;47(4):419–431.
   PubMed Web of Science ®Google Scholar
• Escudier B, Porta C, Schmidinger M, et al. ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019 May 1;30(5):706–720.
   PubMed Web of Science ®Google Scholar
• Rizzo A, Rosellini M, Marchetti A, et al. Determinants of treatment for first-line immune-based combinations in metastatic renal cell carcinoma: a critical overview of recent evidence. Immunotherapy. 2021 Jun;13(8):685–692. Epub 2021 Apr 7. PMID: 33823678.
   PubMed Web of Science ®Google Scholar
• Massari F, Mollica V, Rizzo A, et al. Safety evaluation of immune-based combinations in patients with advanced renal cell carcinoma: a systematic review and meta-analysis. Expert Opin Drug Saf. 2020;19(10):1329–1338.
   PubMed Web of Science ®Google Scholar
• Powles T, Plimack ER, Soulières D, et al. Pembrolizumab plus axitinib versus sunitinib monotherapy as first-line treatment of advanced renal cell carcinoma (KEYNOTE-426): extended follow-up from a randomised, open-label, phase 3 trial. Lancet Oncol. 2020;21(12):1563–1573.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Choueiri TK, Powles T, et al. Nivolumab + cabozantinib (NIVO+CABO) versus sunitinib (SUN) for advanced renal cell carcinoma (aRCC): outcomes by sarcomatoid histology and updated trial results with extended follow-up of CheckMate 9ER. J Clin Oncol. 2021;39(suppl 6_suppl):abstr 308.
   Web of Science ®Google Scholar
• Choueiri TK, Motzer RJ, Rini BI, et al. Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma. Ann Oncol. 2020;31(8):1030–1039.
   PubMed Web of Science ®Google Scholar
• Motzer R, Alekseev B, Rha SY, et al. CLEAR trial investigators. lenvatinib plus pembrolizumab or everolimus for advanced renal cell carcinoma. N Engl J Med. 2021 Feb:13. DOI:https://doi.org/10.1056/NEJMoa2035716
   Google Scholar
• Lalani AA, McGregor BA, Albiges L, et al. Systemic treatment of metastatic clear cell renal cell carcinoma in 2018: current paradigms, use of immunotherapy, and future directions. Eur Urol. 2019 Jan;75(1):100–110.
   PubMed Web of Science ®Google Scholar
• Santoni M, Massari F, Di Nunno V, et al. Immunotherapy in renal cell carcinoma:latest evidence and clinical implications. Drugs Context. 2018 Jun 5;7:212528. PMID: 29899754; PMCID: PMC5992965.
   PubMedGoogle Scholar
• Kennedy LB, Salama AKS. A review of cancer immunotherapy toxicity. CA Cancer J Clin. 2020 Mar;70(2):86–104. Epub 2020 Jan 16. PMID: 31944278.
   PubMed Web of Science ®Google Scholar
• Rzeniewicz K, Larkin J, Menzies AM, et al. Immunotherapy use outside clinical trial populations: never say never? Ann Oncol. 2021 Mar;24:S0923-7534(21)01078–4. Epub ahead of print. PMID: 33771665.
   Google Scholar
• Kroeze SG, Fritz C, Hoyer M, et al. Toxicity of concurrent stereotactic radiotherapy and targeted therapy or immunotherapy: a systematic review. Cancer Treat Rev. 2017 Feb;53:25–37. Epub 2016 Dec 19. PMID: 28056412.
   PubMed Web of Science ®Google Scholar
• Jannin A, Penel N, Ladsous M, et al. Tyrosine kinase inhibitors and immune checkpoint inhibitors-induced thyroid disorders. Crit Rev Oncol Hematol. 2019 Sep;141:23–35. Epub 2019 May 31. PMID: 31202955.
   PubMed Web of Science ®Google Scholar
• Hussaini S, Chehade R, Boldt RG, et al. Association between immune-related side effects and efficacy and benefit of immune checkpoint inhibitors - A systematic review and meta-analysis. Cancer Treat Rev. 2021 Jan;92:102134. Epub 2020 Dec 3. PMID: 33302134.
   PubMed Web of Science ®Google Scholar
• Samaan MA, Pavlidis P, Papa S, et al. Gastrointestinal toxicity of immune checkpoint inhibitors: from mechanisms to management. Nat Rev Gastroenterol Hepatol. 2018 Apr;15(4):222–234. Epub 2018 Mar 7. PMID: 29512649.
   PubMed Web of Science ®Google Scholar
• Moher D, Liberati A, Tetzlaff J, et al. PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097.
   PubMed Web of Science ®Google Scholar
• Higgins JPT, Thomas J, Chandler J, et al. Cochrane hand-book for systematic reviews of interventions. 2nd. Chichester UK: John Wiley & Sons; 2019.
   Google Scholar
• Higgins JP, Altman DG, Gøtzsche PC, et al. cochrane bias methods group; cochrane statistical methods group the cochrane collaboration’s tool for assessing risk of bias in randomised trials. BMJ 2011;343(oct18 2):d5928.
   PubMed Web of Science ®Google Scholar
• Rajha E, Chaftari P, Kamal M, et al. Gastrointestinal adverse events associated with immune checkpoint inhibitor therapy. Gastroenterol Rep (Oxf). 2019 Dec 17;8(1):25–30. PMID: 32104583; PMCID: PMC7034236.
   PubMed Web of Science ®Google Scholar
• Thompson JA, Schneider BJ, Brahmer J, et al. NCCN Guidelines Insights: management of Immunotherapy-Related Toxicities, Version 1.2020. J Natl Compr Canc Netw. 2020 Mar;18(3):230–241. PMID: 32135517.
   PubMed Web of Science ®Google Scholar
• Rizzo A, Mollica V, Santoni M, et al. Impact of clinicopathological features on survival in patients treated with first-line immune checkpoint inhibitors plus tyrosine kinase inhibitors for renal cell carcinoma: a meta-analysis of randomized clinical trials. Eur Urol Focus. 2021 Mar;10:S2405-4569(21)00058–4. Epub ahead of print. PMID: 33714725.
   Google Scholar
• Rassy E, Flippot R, Albiges L. Tyrosine kinase inhibitors and immunotherapy combinations in renal cell carcinoma. Ther Adv Med Oncol. 2020 Mar 18;12:1758835920907504.
   Web of Science ®Google Scholar
• An MW, Duong Q, Le-Rademacher J, et al. Principles of good clinical trial design. J Thorac Oncol. 2020 Aug;15(8):1277–1280. Epub 2020 May 15. PMID: 32417343; PMCID: PMC7390662.
   PubMed Web of Science ®Google Scholar
• Yan F, Thall PF, Lu KH, et al. Phase I-II clinical trial design: a state-of-the-art paradigm for dose finding. Ann Oncol. 2018 Mar 1;29(3):694–699. . PMID: 29267863; PMCID: PMC5888967.
   PubMed Web of Science ®Google Scholar
• Wilson MK, Karakasis K, Oza AM. Outcomes and endpoints in trials of cancer treatment: the past, present, and future. Lancet Oncol. 2015 Jan;16(1):e32–42. . Epub 2014 Dec 29. PMID: 25638553.
   PubMed Web of Science ®Google Scholar
• Ladanie A, Schmitt AM, Speich B, et al. Clinical trial evidence supporting US food and drug administration approval of novel cancer therapies between 2000 and 2016. JAMA Network Open. 2020 Nov 2;3(11):e2024406. PMID: 33170262; PMCID: PMC7656288.
   PubMed Web of Science ®Google Scholar
• Ainsworth C. Assessing the robustness of direct meta-analysis in the presence of heterogeneity. J Comp Eff Res. 2018 Oct;7(10):1009–1025. Epub 2018 Aug 22. PMID: 30130972.
   PubMed Web of Science ®Google Scholar
• Albiges L, Powles T, Staehler M, et al. 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. 2019 Aug;76(2):151–156. PMID: 31151678.
   PubMed Web of Science ®Google Scholar
• Powles T. ESMO Guidelines Committee. Electronic address: [email protected]. Recent eUpdate to the ESMO Clinical Practice Guidelines on renal cell carcinoma on cabozantinib and nivolumab for first-line clear cell renal cancer: renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2021 Mar;32(3):422–423. Epub 2020 Nov 30. PMID: 33271289.
   PubMed Web of Science ®Google Scholar
• Dougan M, Blidner AG, Choi J, et al. Multinational Association of Supportive Care in Cancer (MASCC) 2020 clinical practice recommendations for the management of severe gastrointestinal and hepatic toxicities from checkpoint inhibitors. Support Care Cancer. 2020 Dec;28(12):6129–6143. . Epub 2020 Aug 27. PMID: 32856210.
   PubMed Web of Science ®Google Scholar
• Dougan M. Gastrointestinal and Hepatic Complications of Immunotherapy: current Management and Future Perspectives. Curr Gastroenterol Rep. 2020 Mar 17;22(4):15. . PMID: 32185493.
   PubMedGoogle Scholar
• Rizzo A, Mollica V, Dall’Olio FG, et al. Quality of life assessment in renal cell carcinoma Phase II and III clinical trials published between 2010 and 2020: a systematic review. Future Oncol. 2021 Apr;21. Epub ahead of print. PMID: 33880963. https://doi.org/10.2217/fon-2021-0069
   Google Scholar