Pembrolizumab plus lenvatinib for radically unresectable or metastatic renal cell carcinoma in the Japanese population

References

• Mori K, Mostafaei H, Miura N, et al. Systemic therapy for metastatic renal cell carcinoma in the first-line setting: a systematic review and network meta-analysis. Cancer Immunol Immunother Feb. 2021;70(2):265–273.
   PubMedGoogle Scholar
• Eisen T Stadler Wm EB, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007;356:125–134.
   PubMedGoogle Scholar
• Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115–124.
   PubMed Web of Science ®Google Scholar
• Rini BI, Escudier B, Tomczak P, et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011 Dec 3;378(9807):1931–1939.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Hutson TE, Cella D, et al. Pazopanib versus sunitinib in metastatic renal-cell carcinoma. N Engl J Med. 2013 Aug 22;369(8):722–731.
   PubMed Web of Science ®Google Scholar
• Choueiri TK, Halabi S, Sanford BL, et al. 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. 2017;35(6):591–597.
   PubMed Web of Science ®Google Scholar
• Yuasa T, Urasaki T, Oki R. Recent advances in medical therapy for urological cancers. Front Oncol. 2022 Apr 4;12:746922.
   PubMedGoogle Scholar
• Fujiwara R, Kageyama S, Yuasa T. Developments in personalized therapy for metastatic renal cell carcinoma. Expert Rev Anticancer Ther May. 2022;11:1–9.
   Google Scholar
• Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277–1290.
   PubMed Web of Science ®Google Scholar
• Rini BI, Plimack ER, Stus V, et al. Pembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2019 Mar 21;380(12):1116–1127.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Penkov K, Haanen J, et al. Avelumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2019 Mar 21;380(12):1103–1115.
   PubMed Web of Science ®Google Scholar
• Choueiri TK, Powles T, Burotto M, et al. Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2021 Mar 4;384(9):829–841.
   PubMed Web of Science ®Google Scholar
• Motzer R, Alekseev B, Rha SY, et al. Lenvatinib plus pembrolizumab or everolimus for advanced renal cell carcinoma. N Engl J Med. 2021;384(14):1289–1300. .
   PubMed Web of Science ®Google Scholar
• Ged Y, Lee CH. Lenvatinib plus pembrolizumab combination therapy for adult patients with advanced renal cell carcinoma. Expert Rev Anticancer Ther. 2022 Oct;22(10):1049–1059.
   PubMedGoogle Scholar
• Gillessen S, Attard G, Beer TM, et al. Management of patients with advanced prostate cancer: report of the advanced prostate cancer consensus conference 2019. Eur Urol Apr. 2020;77(4):508–547.
   PubMed Web of Science ®Google Scholar
• Eto M, Takagi T, Kimura G, et al. Lenvatinib plus pembrolizumab versus sunitinib for advanced renal cell carcinoma: Japanese patients from the CLEAR study. Cancer Med. 2023 Mar;12(6):6902–6912.
   Google Scholar
• Tamada S, Kondoh C, Matsubara N, et al. Pembrolizumab plus axitinib versus sunitinib in metastatic renal cell carcinoma: outcomes of Japanese patients enrolled in the randomized, phase III, open‑label KEYNOTE‑426 study. Int J Clin Oncol. 2022;27:154–164.
   PubMedGoogle Scholar
• Makker V, Colombo N, Casado Herráez A, et al. Lenvatinib plus pembrolizumab for advanced endometrial cancer. N Engl J Med. 2022 Feb 3;386(5):437–448.
   PubMed Web of Science ®Google Scholar
• Yonemori K, Yunokawa M, Ushijima K, et al. Lenvatinib plus pembrolizumab in Japanese patients with endometrial cancer: results from study 309/KEYNOTE-775. Cancer Sci. 2022 Oct;113(10):3489–3497.
   PubMedGoogle Scholar
• Pizzato M, Li M, Vignat J, et al. The epidemiological landscape of thyroid cancer worldwide: gLOBOCAN estimates for incidence and mortality rates in 2020. Lancet Diabetes Endocrinol Apr. 2022;10(4):264–272.
   PubMed Web of Science ®Google Scholar
• Schlumberger M, Tahara M, Wirth LJ, et al. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015;372:621–630.
   PubMed Web of Science ®Google Scholar
• Kiyota N, Schlumberger M, Muro K, et al. Subgroup analysis of Japanese patients in a phase 3 study of lenvatinib in radioiodine-refractory differentiated thyroid cancer. Cancer Sci. 2015 Dec;106(12):1714–1721.
   PubMed Web of Science ®Google Scholar
• Kudo M, Finn RS, Qin S, et al. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163–1173.
   PubMed Web of Science ®Google Scholar
• Yamashita T, Kudo M, Ikeda K, et al. REFLECT-a phase 3 trial comparing efficacy and safety of lenvatinib to sorafenib for the treatment of unresectable hepatocellular carcinoma: an analysis of Japanese subset. J Gastroenterol. 2020 Jan;55(1):113–122.
   PubMed Web of Science ®Google Scholar
• Marx A, Chan JKC, Coindre J-M, et al. The 2015 world health organization classification of tumors of the thymus: continuity and changes. J Thorac Oncol. 2015;10:1383–1395.
   PubMed Web of Science ®Google Scholar
• Sato J, Satouchi M, Itoh S, et al. Lenvatinib in patients with advanced or metastatic thymic carcinoma (REMORA): a multicentre, phase 2 trial. Lancet Oncol. 2020 Jun;21(6):843–850.
   PubMed Web of Science ®Google Scholar
• Remon J, Girard N, Novello S, et al. PECATI: a multicentric, open-label, single-arm phase ii study to evaluate the efficacy and safety of pembrolizumab and lenvatinib in pretreated B3-thymoma and thymic carcinoma patients. Clin Lung Cancer May. 2022;23(3):e243–6.
   PubMedGoogle Scholar
• Li JR, Yang CR, Cheng CL, et al. Efficacy of a protocol including heparin ointment for treatment of multikinase inhibitor-induced hand-foot skin reactions. Support Care Cancer Mar. 2013;21(3):907–911.
   PubMedGoogle Scholar
• Farr KP, Safwat A. Palmar-plantar erythrodysesthesia associated with chemotherapy and its treatment. Case Rep Oncol. 2011 Apr 11;4(1):229–235.
   PubMedGoogle Scholar
• Li J, Wang M, Zhang B, et al. Chinese consensus on management of tyrosine kinase inhibitor-associated side effects in gastrointestinal stromal tumors. World J Gastroenterol. 2018 Dec 14;24(46):5189–5202.
   PubMed Web of Science ®Google Scholar
• Arima H, Iwama S, Inaba H, et al. Management of immune-related adverse events in endocrine organs induced by immune checkpoint inhibitors: clinical guidelines of the Japan Endocrine Society. Endocr J. 2019 Jul 28;66(7):581–586.
   PubMedGoogle Scholar
• Kwon H, Roh E, Ahn CH, et al. Immune checkpoint inhibitors and endocrine disorders: a position statement from the Korean endocrine society. Endocrinol Metab (Seoul). 2022 Dec;37(6):839–850.
   PubMedGoogle Scholar
• Fukuda N, Toda K, Wang X, et al. Prognostic significance of 8 weeks’ relative dose intensity of lenvatinib in treatment of radioiodine-refractory differentiated thyroid cancer patients. Endocr J. 2021 Jun 28;68(6):639–647.
   PubMedGoogle Scholar
• Motzer RJ, Bacik J, Murphy BA, et al. Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J Clin Oncol. 2002 Jan 1;20(1):289–296.
   PubMed Web of Science ®Google Scholar
• Heng DY, Xie W, Regan MM, et al. Prognostic factors for overall survival in patients with metastatic renal cell carcinoma treated with vascular endothelial growth factor-targeted agents: results from a large, multicenter study. J Clin Oncol. 2009 Dec 1;27(34):5794–5799.
   PubMed Web of Science ®Google Scholar
• Ernst MS, Navani V, Wells JC, et al. Outcomes for International metastatic renal cell carcinoma database consortium prognostic groups in contemporary first-line combination therapies for metastatic renal cell carcinoma. Eur Urol. 2023 Jan 25;S0302-2838(23):00001–5.
   Google Scholar
• Kroeger N, Xie W, Lee JL, et al. Metastatic non-clear cell renal cell carcinoma treated with targeted therapy agents: characterization of survival outcome and application of the International mRCC database consortium criteria. Cancer. 2013;119:2999–3006.
   PubMed Web of Science ®Google Scholar
• Lee CH, Voss MH, Carlo MI, et al. Phase II trial of cabozantinib plus nivolumab in patients with non-clear-cell renal cell carcinoma and genomic correlates. J Clin Oncol. 2022;40(21):2333–2341.
   PubMed Web of Science ®Google Scholar
• Jonasch E, Donskov F, Iliopoulos O, et al. Belzutifan for renal cell carcinoma in von Hippel-Lindau disease. N Engl J Med. 2021;385(22):2036–2046.
   PubMed Web of Science ®Google Scholar
• Choueiri TK, Bauer TM, Papadopoulos KP, et al. Inhibition of hypoxia-inducible factor-2 alpha in renal cell carcinoma with belzutifan: a phase 1 trial and biomarker analysis. Nat Med. 2021;27(5):802–805.
   PubMed Web of Science ®Google Scholar
• Perets R, Bar J, Rasco DW, et al. Safety and efficacy of quavonlimab, a novel anti-CTLA-4 antibody (MK-1308), in combination with pembrolizumab in first-line advanced non-small-cell lung cancer. Ann Oncol Mar. 2021;32(3):395–403.
   PubMed Web of Science ®Google Scholar