Safety of pembrolizumab for resected stage III melanoma

References

• Hodi FS, O’Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363:711–723.
   PubMed Web of Science ®Google Scholar
• Robert C, Thomas L, Bondarenko I, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011;364:2517–2526.
   PubMed Web of Science ®Google Scholar
• Maio M, Grob -J-J, Aamdal S, et al. Five-year survival rates for treatment-naive patients with advanced melanoma who received ipilimumab plus dacarbazine in a phase III trial. J Clin Oncol. 2015;33:1191–1196.
   PubMed Web of Science ®Google Scholar
• Robert C, Ribas A, Schachter J, et al. Pembrolizumab versus ipilimumab in advanced melanoma (KEYNOTE-006): post-hoc 5-year results from an open-label, multicentre, randomised, controlled, phase 3 study. Lancet Oncol. 2019;20:1239–1251.
   PubMed Web of Science ®Google Scholar
• Robert C, Long GV, Brady B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015;372:320–330.
   PubMed Web of Science ®Google Scholar
• Postow MA, Chesney J, Pavlick AC, et al. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med. 2015;372:2006–2017.
   PubMed Web of Science ®Google Scholar
• Hamid O, Robert C, Daud A, et al. Safety and tumor responses with lambrolizumab (Anti–PD-1) in melanoma. N Engl J Med. 2013;369:134–144.
   PubMed Web of Science ®Google Scholar
• Hamid O, Robert C, Daud A, et al. Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. Ann Oncol. 2019;30:582–588.
   PubMed Web of Science ®Google Scholar
• Gershenwald JE, Scolyer RA. Melanoma staging: American Joint Committee on Cancer (AJCC) 8th edition and beyond. Ann Surg Oncol. 2018;25:2105–2110.
   PubMed Web of Science ®Google Scholar
• Eggermont AMM, Blank CU, Mandala M, et al. Prognostic and predictive value of AJCC-8 staging in the phase III EORTC1325/KEYNOTE-054 trial of pembrolizumab vs placebo in resected high-risk stage III melanoma. Eur J Cancer. 2019;116:148–157.
   PubMed Web of Science ®Google Scholar
• Kirkwood JM, Strawderman MH, Ernstoff MS, et al. Interferon alfa-2b adjuvant therapy of high-risk resected cutaneous melanoma: the Eastern Cooperative Oncology group trial EST 1684. J Clin Oncol. 1996;14:7–17.
   PubMed Web of Science ®Google Scholar
• Eggermont AMM, Suciu S, Testori A, et al. Long-term results of the randomized phase III trial EORTC 18991 of adjuvant therapy with pegylated interferon Alfa-2b versus observation in resected stage III melanoma. J Clin Oncol. 2012;30:3810–3818.
   PubMed Web of Science ®Google Scholar
• Mocellin S, Lens MB, Pasquali S, et al. Interferon alpha for the adjuvant treatment of cutaneous melanoma. Cochrane Skin Group, editor. Cochrane Database Syst Rev [Internet]. 2013 [[cited 2020 May 19]]. DOI:https://doi.org/10.1002/14651858.CD008955.pub2.
   Google Scholar
• Eggermont AMM, Chiarion-Sileni V, Grob -J-J, et al. Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2015;16:522–530.
   PubMed Web of Science ®Google Scholar
• Tarhini AA, Lee SJ, Hodi FS, et al. Phase III study of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon Alfa-2b for resected high-risk melanoma: North American intergroup E1609. J Clin Oncol. 2020;38:567–575.
   PubMed Web of Science ®Google Scholar
• Weber J, Mandala M, Del Vecchio M, et al. Adjuvant nivolumab versus ipilimumab in resected stage III or IV melanoma. N Engl J Med. 2017;377:1824–1835.
   PubMed Web of Science ®Google Scholar
• Research C for DE and. FDA grants regular approval to nivolumab for adjuvant treatment of melanoma. FDA [Internet]. 2019 cited 2020 Apr 10. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-nivolumab-adjuvant-treatment-melanoma
   Google Scholar
• Eggermont AMM, Blank CU, Mandala M, et al. Adjuvant pembrolizumab versus placebo in resected stage III melanoma. N Engl J Med. 2018;378:1789–1801.
   PubMed Web of Science ®Google Scholar
• Research C for DE and. FDA approves pembrolizumab for adjuvant treatment of melanoma. FDA [Internet]. 2019 cited 2020 Apr 10. Available from: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-adjuvant-treatment-melanoma
   Google Scholar
• Patnaik A, Kang SP, Rasco D, et al. Phase I study of pembrolizumab (MK-3475; anti–PD-1 monoclonal antibody) in patients with advanced solid tumors. Clin Cancer Res. 2015;21:4286–4293.
   PubMed Web of Science ®Google Scholar
• Merck & Co. Inc. Keytruda [prescribing information] [Internet]. [ cited 2020 May 10]. Available from: https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
   Google Scholar
• Elassaiss‐Schaap J, Rossenu S, Lindauer A, et al. Using model-based “Learn and Confirm” to reveal the pharmacokinetics-pharmacodynamics relationship of pembrolizumab in the KEYNOTE-001 trial. CPT Pharmacomet Syst Pharmacol. 2017;6:21–28.
   PubMedGoogle Scholar
• Robert C, Schachter J, Long GV, et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med. 2015;372:2521–2532.
   PubMed Web of Science ®Google Scholar
• Ribas A, Puzanov I, Dummer R, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol. 2015;16:908–918.
   PubMed Web of Science ®Google Scholar
• Herbst RS, Baas P, Kim D-W, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet. 2016;387:1540–1550.
   PubMed Web of Science ®Google Scholar
• 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;375:1823–1833.
   PubMed Web of Science ®Google Scholar
• Research C for DE and. FDA approves new dosing regimen for pembrolizumab. FDA [Internet]. 2020 [cited 2020 May 16]. Available from: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-new-dosing-regimen-pembrolizumab
   Google Scholar
• Faries MB, Thompson JF, Cochran AJ, et al. Completion dissection or observation for sentinel-node metastasis in melanoma. N Engl J Med. 2017;376:12.
   Web of Science ®Google Scholar
• Leiter U, Stadler R, Mauch C, et al. Complete lymph node dissection versus no dissection in patients with sentinel lymph node biopsy positive melanoma (DeCOG-SLT): a multicentre, randomised, phase 3 trial. Lancet Oncol. 2016;17:757–767.
   PubMed Web of Science ®Google Scholar
• Verver D, van Klaveren D, van Akkooi ACJ, et al. Risk stratification of sentinel node–positive melanoma patients defines surgical management and adjuvant therapy treatment considerations. Eur J Cancer. 2018;96:25–33.
   PubMed Web of Science ®Google Scholar
• Eggermont AM, Blank CU, Mandalà M, et al. Pembrolizumab versus placebo after complete resection of high-risk stage III melanoma: new recurrence-free survival results from the EORTC 1325-MG/Keynote 054 double-blinded phase III trial at three-year median follow-up. J Clin Oncol. 2020;38:10000.
   Web of Science ®Google Scholar
• Eggermont AMM, Kicinski M, Blank CU, et al. Association between immune-related adverse events and recurrence-free survival among patients with stage III melanoma randomized to receive pembrolizumab or placebo: a secondary analysis of a randomized clinical trial. JAMA Oncol. 2020;6:519.
   PubMed Web of Science ®Google Scholar
• Lebbé C, Weber JS, Maio M, et al. Survival follow-up and ipilimumab retreatment of patients with advanced melanoma who received ipilimumab in prior phase II studies. Ann Oncol. 2014;25:2277–2284.
   PubMed Web of Science ®Google Scholar
• Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med. 2015;373:23–34.
   PubMed Web of Science ®Google Scholar
• Blank CU, Rozeman EA, Fanchi LF, et al. Neoadjuvant versus adjuvant ipilimumab plus nivolumab in macroscopic stage III melanoma. Nat Med. 2018;24:1655–1661.
   PubMed Web of Science ®Google Scholar
• Eggermont AMM, Chiarion-Sileni V, Grob -J-J, et al. Prolonged survival in stage III melanoma with ipilimumab adjuvant therapy. N Engl J Med. 2016;375:1845–1855.
   PubMed Web of Science ®Google Scholar
• Meropol NJ, Egleston BL, Buzaglo JS, et al. Cancer patient preferences for quality and length of life. Cancer. 2008;113:3459–3466.
   PubMed Web of Science ®Google Scholar
• Coens C, Bottomley A, Blank CU, et al. Health-related quality-of-life results for pembrolizumab versus placebo after complete resection of high-risk stage III melanoma from the EORTC 1325-MG/Keynote 054 trial: an international randomized double-blind phase III trial. Ann Oncol. 2018;29:viii456.
   Web of Science ®Google Scholar
• Higham CE, Chatzimavridou-Grigoriadou V, Fitzgerald CT, et al. Adjuvant immunotherapy: the sting in the tail. Eur J Cancer. 2020;132:207–210.
   PubMed Web of Science ®Google Scholar
• Michielin O, van Akkooi ACJ, Ascierto PA, et al. Cutaneous melanoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019;30:1884–1901.
   PubMed Web of Science ®Google Scholar
• Long GV, Hauschild A, Santinami M, et al. Adjuvant dabrafenib plus trametinib in stage III BRAF -mutated melanoma. N Engl J Med. 2017;377:1813–1823.
   PubMed Web of Science ®Google Scholar
• Luke JJ, Ascierto PA, Carlino MS, et al. KEYNOTE-716: phase II study of adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma. Future Oncol. 2020;16:4429–4438.
   PubMed Web of Science ®Google Scholar