Applying adjuvant therapy for melanoma into clinical practice

References

• Gershenwald JE, Scolyer RA, Hess KR, et al. Melanoma staging: evidence-based changes in the American Joint Committee on Cancer eighth edition cancer staging manual. CA Cancer J Clin. 2017;67(6):472–492.
   PubMed Web of Science ®Google Scholar
• Hsueh EC, Essner R, Foshag LJ, et al. Prolonged survival after complete resection of disseminated melanoma and active immunotherapy with a therapeutic cancer vaccine. J Clin Oncol. 2002;20(23):4549–4554.
   PubMed Web of Science ®Google Scholar
• Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Five-year survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2019;381(16):1535–1546.
   PubMed Web of Science ®Google Scholar
• Eggermont AM, Chiarion-Sileni V, Grob JJ, 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(5):522–530.
   PubMed Web of Science ®Google Scholar
• Eggermont AMM, Chiarion-Sileni V, Grob JJ, et al. Adjuvant ipilimumab versus placebo after complete resection of stage III melanoma: long-term follow-up results of the European Organisation for Research and Treatment of Cancer 18071 double-blind phase 3 randomised trial. Eur J Cancer. 2019;119:1–10.
   PubMed Web of Science ®Google Scholar
• Eggermont AMM, Blank CU, Mandala M, et al. Longer follow-up confirms recurrence-free survival benefit of adjuvant pembrolizumab in high-risk stage III melanoma: updated results from the EORTC 1325-MG/KEYNOTE-054 trial. J Clin Oncol. 2020;JCO2002110. DOI:10.1200/JCO.20.02110
   PubMed Web of Science ®Google Scholar
• Ascierto PA, Del Vecchio M, Mandala M, et al. Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Oncol. 2020. DOI:10.1016/S1470-2045(20)30494-0
   PubMedGoogle Scholar
• Hauschild A, Dummer R, Schadendorf D, et al. Longer follow-up confirms relapse-free survival benefit with adjuvant dabrafenib plus trametinib in patients with resected BRAF V600-mutant stage III melanoma. J Clin Oncol. 2018;36(35):3441–3449.
   PubMed Web of Science ®Google Scholar
• Dummer R, Hauschild A, Santinami M, et al. Five-year analysis of adjuvant dabrafenib plus trametinib in stage III melanoma. N Engl J Med. 2020;383(12):1139–1148.
   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(19):1813–1823.
   PubMed Web of Science ®Google Scholar
• Hauschild A, Dummer R, Santinami M, et al. Long-term benefit of adjuvant dabrafenib + trametinib (D+T) in patients (pts) with resected stage III BRAF V600–mutant melanoma: five-year analysis of COMBI-AD. J Clin Oncol. 2020;38(15_suppl): 10001-10001. DOI:10.1200/JCO.2020.38.15_suppl.10001
   PubMed Web of Science ®Google Scholar
• Hauschild A, Dummer R, Schadendorf D, et al. longer follow-up confirms relapse-free survival benefit with adjuvant dabrafenib plus trametinib in patients with resected BRAF V600-mutant stage III melanoma. J Clin Oncol. 2018;36(35):3441-3449.
   Web of Science ®Google Scholar
• Garbe C, Keim U, Suciu S, et al. Prognosis of patients with stage III melanoma according to American joint committee on cancer version 8: a reassessment on the basis of 3 independent stage III melanoma cohorts. J Clin Oncol. 2020;38(22):2543–2551.
   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
• Eggermont AM, Blank CU, Mandala 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(15_suppl): 10000-10000. DOI:10.1200/JCO.2020.38.15_suppl.10000
   PubMed Web of Science ®Google Scholar
• Michielin O, van Akkooi A, Lorigan P, et al. ESMO consensus conference recommendations on the management of locoregional melanoma: under the auspices of the ESMO Guidelines Committee. Ann Oncol. 2020. DOI:10.1016/j.annonc.2020.07.005
   Web of Science ®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(19):1789–1801.
   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(19):1824–1835.
   PubMed Web of Science ®Google Scholar
• Owen CN, Shoushtari AN, Chauhan D, et al. Management of early melanoma recurrence despite adjuvant anti-PD-1 antibody therapy. Ann Oncol. 2020;31(8):1075–1082.
   PubMed Web of Science ®Google Scholar
• Bhave P, Pallan L, Atkinson V, et al. Melanoma recurrence after adjuvant targeted therapy: a multicenter analysis. J Clin Oncol. 2020;38(15_suppl): 10016-10016. DOI:10.1200/JCO.2020.38.15_suppl.10016
   Web of Science ®Google Scholar
• Saab KR, Mooradian MJ, Wang DY, et al. Tolerance and efficacy of BRAF plus MEK inhibition in patients with melanoma who previously have received programmed cell death protein 1-based therapy. Cancer. 2019;125(6):884–891.
   PubMed Web of Science ®Google Scholar
• Da Silva IP, Ahmed T, Lo S, et al. Ipilimumab (IPI) alone or in combination with anti-PD-1 (IPI+PD1) in patients (pts) with metastatic melanoma (MM) resistant to PD1 monotherapy. J Clin Oncol. 2020;38(15_suppl):10005-10005.
   Web of Science ®Google Scholar
• Tsang VHM, McGrath RT, Clifton-Bligh RJ, et al. Checkpoint inhibitor-associated autoimmune diabetes is distinct from type 1 diabetes. J Clin Endocrinol Metab. 2019;104(11):5499–5506.
   PubMed 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(4):519.
   Web of Science ®Google Scholar
• Zhao X, Suryawanshi S, Hruska M, et al. Assessment of nivolumab benefit-risk profile of a 240-mg flat dose relative to a 3-mg/kg dosing regimen in patients with advanced tumors. Ann Oncol. 2017;28(8):2002–2008.
   PubMed Web of Science ®Google Scholar
• Long GV, Tykodi SS, Schneider JG, et al. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018;29(11):2208–2213.
   PubMed Web of Science ®Google Scholar
• Lala M, Li TR, de Alwis DP, et al. A six-weekly dosing schedule for pembrolizumab in patients with cancer based on evaluation using modelling and simulation. Eur J Cancer. 2020;131:68–75.
   PubMed Web of Science ®Google Scholar
• Lala M, Akala O, Chartash E, et al. Abstract CT042: Pembrolizumab 400 mg Q6W dosing: first clinical outcomes data from Keynote-555 cohort B in metastatic melanoma patients. Cancer Res August 15. 2020;80(16 Supplement) CT042.
   Google Scholar
• Rozeman EA, Menzies AM, van Akkooi ACJ, et al. Identification of the optimal combination dosing schedule of neoadjuvant ipilimumab plus nivolumab in macroscopic stage III melanoma (OpACIN-neo): a multicentre, phase 2, randomised, controlled trial. Lancet Oncol. 2019;20(7):948–960.
   PubMed Web of Science ®Google Scholar
• Leiter U, Stadler R, Mauch C, et al. Final analysis of DeCOG-SLT trial: no survival benefit for complete lymph node dissection in patients with melanoma with positive sentinel node. J Clin Oncol. 2019;37(32):3000–3008.
   PubMed Web of Science ®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(23):2211–2222.
   PubMed Web of Science ®Google Scholar
• Farrow NE, Raman V, Williams TP, et al. Adjuvant therapy is effective for melanoma patients with a positive sentinel lymph node biopsy who forego completion lymphadenectomy. Ann Surg Oncol. 2020. Online ahead of print.
   Web of Science ®Google Scholar
• D’Angelo SP, Larkin J, Sosman JA, et al. Efficacy and safety of nivolumab alone or in combination with ipilimumab in patients with mucosal melanoma: a pooled analysis. J Clin Oncol. 2017;35(2):226–235.
   PubMed Web of Science ®Google Scholar
• Menzies AM, Johnson DB, Ramanujam S, et al. Anti-PD-1 therapy in patients with advanced melanoma and preexisting autoimmune disorders or major toxicity with ipilimumab. Ann Oncol. 2017;28(2):368–376.
   PubMed Web of Science ®Google Scholar
• Amaria RN, Prieto PA, Tetzlaff MT, et al. Neoadjuvant plus adjuvant dabrafenib and trametinib versus standard of care in patients with high-risk, surgically resectable melanoma: a single-centre, open-label, randomised, phase 2 trial. Lancet Oncol. 2018;19(2):181–193.
   PubMed Web of Science ®Google Scholar
• Amaria RN, Reddy SM, Tawbi HA, et al. Neoadjuvant immune checkpoint blockade in high-risk resectable melanoma. Nat Med. 2018;24(11):1649–1654.
   PubMed Web of Science ®Google Scholar
• Huang AC, Orlowski RJ, Xu X, et al. A single dose of neoadjuvant PD-1 blockade predicts clinical outcomes in resectable melanoma. Nat Med. 2019;25(3):454–461.
   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(11):1655–1661.
   PubMed Web of Science ®Google Scholar
• Long GV, Saw RPM, Lo S, et al. Neoadjuvant dabrafenib combined with trametinib for resectable, stage IIIB-C, BRAF(V600) mutation-positive melanoma (NeoCombi): a single-arm, open-label, single-centre, phase 2 trial. Lancet Oncol. 2019;20(7):961–971.
   PubMed Web of Science ®Google Scholar
• Amaria RN, Menzies AM, Burton EM, et al. Neoadjuvant systemic therapy in melanoma: recommendations of the International Neoadjuvant Melanoma Consortium. Lancet Oncol. 2019;20(7):e378–e89.
   PubMed Web of Science ®Google Scholar
• Zimmer L, Livingstone E, Hassel JC, et al. Adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus placebo in patients with resected stage IV melanoma with no evidence of disease (IMMUNED): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2020;395(10236):1558–1568.
   PubMed Web of Science ®Google Scholar