Characterization and management of adverse reactions from the CLEAR study in advanced renal cell carcinoma treated with lenvatinib plus pembrolizumab

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About the authors

R. Motzer

Memorial Sloan Kettering Cancer Center

Author for correspondence.
Email: motzerr@mskcc.org

Department of Medicine

United States

S. George

Roswell Park Comprehensive Cancer Center

Department of Medicine

United States

J. R. Merchan

University of Miami Sylvester Comprehensive Cancer Center

Department of Medicine

United States

T. E. Hutson

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Department of Medical Oncology

United States

X. Song

Clinical Research, Merck & Co., Inc.

Рауэй, штат Нью-Джерси, США 

United States

R. F. Perini

Clinical Research, Merck & Co., Inc.

Рауэй, штат Нью-Джерси, США 

United States

R. Xie

Biostatistics, Eisai Inc.

Натли, штат Нью-Джерси, США 

United States

U. Bapat

Clinical Research, Eisai Inc.

Натли, штат Нью-Джерси, США 

United States

J. Puente

Hospital Clinico Universitario San Carlos

Department of Medical Oncology

Spain

References

  1. Motzer R., Alekseev B., Rha S.Y. et al. Lenvatinib plus pembrolizumab or everolimus for advanced renal cell carcinoma. N Engl J Med 2021;384(14):1289–300. doi: 10.1056/NEJMoa2035716
  2. Lenvima® (lenvatinib) [prescribing information]. Nutley, NJ, USA: Eisai Inc., 2021.
  3. Kisplyx 4 mg and 10 mg hard capsules [summary of product characteristics]. Frankfurt am Main, Germany: Eisai GmbH, 2021.
  4. Keytruda® (pembrolizumab) [prescribing information]. Whitehouse Station, NJ, USA: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., 2022.
  5. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry: adverse reactions section of labeling for human prescription drug and biological products – content and format 2006. Accessed June 1, 2022. Available at: https://www.fda.gov/media/72139/download.
  6. Sher A.F., Golshani G.M., Wu S. Fatal adverse events associated with pembrolizumab in cancer patients: a meta-analysis. Cancer Invest 2020;38(2):130–8. doi: 10.1080/07357907.2020.1721521
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  8. Opdivo® (nivolumab) [prescribing information]. Princeton, NJ, USA: Bristol Myers Squibb Company, 2022.
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  11. Bavencio® (avelumab) [prescribing information]. Rockland, MA, USA: EMD Serono, Inc., 2022.
  12. Rini B.I., Plimack E.R., Stus V. et al. Pembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med 2019;380(12):1116–27. doi: 10.1056/nejmoa1816714
  13. Choueiri T.K., Powles T., Burotto M. et al. Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med 2021;384(9):829–41. doi: 10.1056/nejmoa2026982
  14. Motzer R.J., Tannir N.M., McDermott D.F. et al. Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma. N Engl J Med 2018;378(14):1277–90. doi: 10.1056/NEJMoa1712126
  15. Motzer R.J., Penkov K., Haanen J. et al. Avelumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med 2019;380(12):1103–15. doi: 10.1056/nejmoa1816047
  16. Bianchi L., Rossi L., Tomao F. et al. Thyroid dysfunction and tyrosine kinase inhibitors in renal cell carcinoma. Endocr Relat Cancer 2013;20(5):R233–45. doi: 10.1530/erc-13-0201
  17. Rizzo A., Mollica V., Santoni M. et al. Risk of selected gastrointestinal toxicities in metastatic renal cell carcinoma patients treated with immuno-TKI combinations: a meta-analysis. Expert Rev Gastroenterol Hepatol 2021;15(10):1225–32. doi: 10.1080/17474124.2021.1948328
  18. Schlumberger M., Tahara M., Wirth L.J. et al. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med 2015;372(7):621–30. doi: 10.1056/nejmoa1406470
  19. Kudo M., Finn R.S., 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;391(10126):1163–73. doi: 10.1016/S0140-6736(18)30207-1
  20. Makker V., Colombo N., Casado Herráez A. et al. Lenvatinib plus pembrolizumab for advanced endometrial cancer. N Engl J Med 2022;386(5):437–48. doi: 10.1056/nejmoa2108330
  21. Motzer R.J., Hutson T.E., Glen H. et al. Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial. Lancet Oncol 2015;16(15):1473–82. doi: 10.1016/s1470-2045(15)00290-9
  22. Motzer R.J., Taylor M.H., Evans T.R.J. et al. Lenvatinib dose, efficacy, and safety in the treatment of multiple malignancies. Expert Rev Anticancer Ther 2022;22(4):383–400. doi: 10.1080/14737140.2022.2039123

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