1,517
Views
8
CrossRef citations to date
0
Altmetric
Oncology

An indirect treatment comparison of the efficacy of pembrolizumab versus competing regimens for the adjuvant treatment of stage III melanoma

, , , , &
Pages 135-145 | Received 22 Mar 2019, Accepted 10 Jul 2019, Published online: 15 Aug 2019

References

  • Fitzmaurice C, Allen C, Barber RM, et al. Global, regional, and national cancer incidence, mortality, years of life lost, years lived with disability, and disability-adjusted life-years for 32 cancer groups, 1990 to 2015: a systematic analysis for the global burden of disease study. JAMA Oncol. 2017;3:524–548.
  • Howlader N, Noone A, Krapcho M, et al. SEER cancer statistics review, 1975-2014. Bethesda, MD: National Cancer Institute; 2017.
  • Karimkhani C, Green AC, Nijsten T, et al. The global burden of melanoma: results from the Global Burden of Disease Study 2015. Br J Dermatol. 2017;177:134–140.
  • Gershenwald JE, Scolyer RA. Melanoma staging: American Joint Committee on Cancer (AJCC) 8th Edition and Beyond. Ann Surg Oncol. 2018;25:2105–2110.
  • Rutkowski P, Ługowska I. Follow-up in melanoma patients. Memo. 2014;7:83–86.
  • Faries MB, Thompson JF, Cochran AJ, et al. Completion dissection or observation for sentinel-node metastasis in melanoma. N Engl J Med. 2017;376:2211–2222.
  • 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. JCO. 1996;14:7–17.
  • Ives NJ, Suciu S, Eggermont AMM, et al. Adjuvant interferon-a; for the treatment of high-risk melanoma: an individual patient data meta-analysis. Eur J Cancer. 2017;82:171–183.
  • Eggermont Amc-S V, Grob JJ, Dummer R, et al. Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial. [Erratum appears in Lancet Oncol. 2015 Jun;16(6):e262; PMID: 26065611] [Clinical Trial, Phase III;Randomized Controlled Trial; Research Support, Non-U.S. Gov’t]. Lancet Oncol. 2015;16(5):522–530.
  • Weber J, Mandala M, Del Vecchio M, et al. Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma [Clinical Trial, Phase III;Comparative Study;Multicenter Study;Randomized Controlled Trial;Research Support, Non-U.S. Gov’t]. N Engl J Med. 2017;377:1824–1835.
  • 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.
  • 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. JCO. 2018;36:JCO1801219–JCO1801219.
  • Lewis K, Maio M, Mandala M, et al. BRIM8: A phase III, randomized, double-blind, placebo-controlled study of vemurafenib adjuvant therapy in patients with surgically resected, cutaneous BRAF-mutant melanoma at high risk for recurrence (NCT01667419) [Journal: Conference Abstract]. JCO. 2014;32:(15 SUPPL. 1):TPS9118–TPS9118. Conference start: 2014 May 30 Conference End: 2014 Jun 3. English.
  • Maio M, Lewis K, Demidov L, et al. Adjuvant vemurafenib in resected, BRAF V600 mutation-positive melanoma (BRIM8): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2018;19:510–520.
  • Ades AE. A chain of evidence with mixed comparisons: models for multi‐parameter synthesis and consistency of evidence. Statist Med. 2003;22:2995–3016.
  • Caldwell DM, Ades AE, Higgins J. Simultaneous comparison of multiple treatments: combining direct and indirect evidence. BMJ. 2005;331:897–900.
  • Lu G, Ades AE. Combination of direct and indirect evidence in mixed treatment comparisons. Statist Med. 2004;23:3105–3124.
  • Network NCC. Melanoma (Version 1. 2018). 2018 [updated 2017 Dec 18; cited Feb 2018]. Available from: https://www.nccn.org/patients/guidelines/melanoma/files/assets/common/downloads/files/melanoma.pdf
  • Higgins JPT, Altman DG, Gøtzsche PC, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.
  • Cope S, Zhang J, Saletan S, et al. A process for assessing the feasibility of a network meta-analysis: a case study of everolimus in combination with hormonal therapy versus chemotherapy for advanced breast cancer. BMC Med. 2014;12:1–17.
  • Jansen JP. Network meta-analysis of survival data with fractional polynomials. BMC Med Res Methodol. 2011;11:61.
  • Ouwens M, Philips Z, Jansen JP. Network meta-analysis of parametric survival curves. Res Synth Method. 2010;1:258–271.
  • Jansen JP, Cope S. Meta-regression models to address heterogeneity and inconsistency in network meta-analysis of survival outcomes. BMC Med Res Methodol. 2012;12:152–152.
  • Caraceni A, Gangeri L, Martini C, et al. Neurotoxicity of interferon-alpha in melanoma therapy: results from a randomized controlled trial [Clinical Trial;Randomized Controlled Trial]. Cancer. 1998;83:482–489.
  • Weber J, Mandala M, Del Vecchio M, et al. LBA8_PR Adjuvant therapy with nivolumab (NIVO) versus ipilimumab (IPI) after complete resection of stage III/IV melanoma: a randomized, double-blind, phase 3 trial (CheckMate 238). Ann Oncol. 2017;28:v605–v649.
  • Long GV, Hauschild A, Santinami M, et al. Adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma [Clinical Trial, Phase III;Multicenter Study;Randomized Controlled Trial; Research Support, Non-U.S. Gov’t]. N Engl J Med. 2017;377:1813–1823.
  • Hauschild A, Santinami M, Long GV, et al. LBA6_PRCOMBI-AD: adjuvant dabrafenib (D) plus trametinib (T) for resected stage III BRAF V600E/K–mutant melanoma. Ann Oncol. 2017;28:v631.
  • Coens C, Suciu S, Chiarion-Sileni V, et al. Health-related quality of life with adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): secondary outcomes of a multinational, randomised, double-blind, phase 3 trial. Lancet Oncol. 2017;18:393–403.
  • Eggermont AM, Chiarion-Sileni V, Grob JJ, et al. Prolonged survival in stage III melanoma with Ipilimumab adjuvant therapy. N Engl J Med. 2016;375:1845–1855.
  • Eggermont AMM, Chiarion-Sileni V, Grob JJ, et al. Ipilimumab (IPI) vs placebo (PBO) after complete resection of stage III melanoma: final overall survival results from the EORTC 18071 randomized, double-blind, phase 3 trial. Ann Oncol. 2016;27:LBA2_PR.
  • Eggermont Ams S, MacKie R, Ruka W, et al. Post-surgery adjuvant therapy with intermediate doses of interferon alfa 2b versus observation in patients with stage IIb/III melanoma (EORTC 18952): randomised controlled trial [Clinical Trial;Multicenter Study;Randomized Controlled Trial;Research Support, N.I.H., Extramural;Research Support, Non-U.S. Gov’t; Research Support, U.S. Gov’t, P.H.S.]. Lancet. 2005;366:1189–1196.
  • Eggermont Ams S, Rutkowski P, Kruit WH, et al. Long term follow up of the EORTC 18952 trial of adjuvant therapy in resected stage IIB-III cutaneous melanoma patients comparing intermediate doses of interferon-alpha-2b (IFN) with observation: Ulceration of primary is key determinant for IFN-sensitivity [Comparative Study;Randomized Controlled Trial;Research Support, Non-U.S. Gov’t]. Eur J Cancer. 2016;55:111–121.
  • Eggermont Ams S, Santinami M, Testori A, et al. Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomised phase III trial [Clinical Trial, Phase III;Multicenter Study;Randomized Controlled Trial;Research Support, Non-U.S. Gov’t]. Lancet. 2008;372:117–126.
  • Fusi Ac S, Busse A, Suciu S, et al. Circulating melanoma cells and distant metastasis-free survival in stage III melanoma patients with or without adjuvant interferon treatment (EORTC 18991 side study) [Clinical Trial, Phase III;Multicenter Study;Randomized Controlled Trial;Research Support, N.I.H., Extramural;Research Support, Non-U.S. Gov’t]. Eur J Cancer. 2009;45:3189–3197.
  • BottomleyAC C, Suciu S, Santinami M, et al. Adjuvant therapy with pegylated interferon alfa-2b versus observation in resected stage III melanoma: a phase III randomized controlled trial of health-related quality of life and symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group. [Erratum appears in J Clin Oncol. 2009 Sep 20;27(27):4630 Note: Dosage error in published abstract; MEDLINE/PubMed abstract corrected] [Clinical Trial, Phase III;Randomized Controlled Trial;Research Support, Non-U.S. Gov’t]. J Clin Oncol. 2009;27:2916–2923.
  • Eggermont Ams S, Testori A, Santinami M, 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 [Clinical Trial, Phase III;Multicenter Study;Randomized Controlled Trial;Research Support, Non-U.S. Gov’t]. JCO. 2012;30:3810–3818.
  • Herndon TM, Demko SG, Jiang X, et al. U.S. Food and Drug Administration Approval: peginterferon-alfa-2b for the adjuvant treatment of patients with melanoma [Multicenter Study; Randomized Controlled Trial]. Oncologist. 2012;17:1323–1328.
  • Lian B, Si L, Cui C, et al. Phase II randomized trial comparing high-dose IFN-alpha2b with temozolomide plus cisplatin as systemic adjuvant therapy for resected mucosal melanoma [Clinical Trial, Phase II;Randomized Controlled Trial;Research Support, Non-U.S. Gov’t]. Clin Cancer Res. 2013;19:4488–4498.
  • Hansson Ja S, Bastholt L, Brandberg Y, et al. Two different durations of adjuvant therapy with intermediate-dose interferon alfa-2b in patients with high-risk melanoma (Nordic IFN trial): a randomised phase 3 trial [Clinical Trial;Clinical Trial, Phase III;Randomized Controlled Trial;Research Support, Non-U.S. Gov’t]. Lancet Oncol. 2011;12:144–152.
  • Vihinen P, Tervahartiala T, Sorsa T, et al. Benefit of adjuvant interferon alfa-2b (IFN-alpha) therapy in melanoma patients with high serum MMP-8 levels [Randomized Controlled Trial;Research Support, Non-U.S. Gov’t]. Cancer Immunol Immunother. 2015;64:173–180.
  • Flaherty LE, Othus M, Atkins MB, et al. Southwest Oncology Group S0008: a phase III trial of high-dose interferon Alfa-2b versus cisplatin, vinblastine, and dacarbazine, plus interleukin-2 and interferon in patients with high-risk melanoma–an intergroup study of cancer and leukemia Group B, Children’s Oncology Group, Eastern Cooperative Oncology Group, and Southwest Oncology Group. J Clin Oncol. 2014;32:3771–3778.
  • Cascinelli N, Belli F, MacKie RM, et al. Effect of long-term adjuvant therapy with interferon alpha-2a in patients with regional node metastases from cutaneous melanoma: a randomised trial [Clinical Trial;Multicenter Study;Randomized Controlled Trial]. Lancet. 2001;358:866–869.
  • Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5:649–656.
  • Cascinelli N, Santinami M, Maurichi A, et al. World Health Organization experience in the treatment of melanoma. Surg Clin North Am. 2003;83:405–416.
  • NICE. Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease. In: Consultation A, editor. nice.org.uk: NICE; 2018.
  • Bhatia P, Friedlander P, Zakaria EA, et al. Impact of BRAF mutation status in the prognosis of cutaneous melanoma: an area of ongoing research. Ann Transl Med. 2015;3:24–24.
  • Kabirraaj Toor MRM, Jansen JP, Gooden K, et al. Comparative efficacy and safety of nivolumab versus other treatment for resected melanoma in adults: a systematic literature review and network meta-Analysis. Manchester, England: 15th International Congress of the Society for Melanoma Research. 2018. p. 76–77.
  • Koruth RS RM, Kanters S, Druyts E. Dabrafenib and trametinib combination versus other interventions as adjuvant therapy for advanced cutaneous melanoma: a network meta-analysis. Manchester, England: Proceedings of the 15th International Congress of the Society for Melanoma Research. 2018. p. 35–36.
  • Mackiewicz J, Mackiewicz A. BRAF and MEK inhibitors in the era of immunotherapy in melanoma patients. Contemp Oncol (Pozn). 2018;22:68–72.