Skip to main content
Top
Published in: Advances in Therapy 2/2017

Open Access 01-02-2017 | Original Research

Relative Efficacy of Granulocyte-Macrophage Colony-Stimulating Factor, Dacarbazine, and Glycoprotein 100 in Metastatic Melanoma: An Indirect Treatment Comparison

Authors: Casey Quinn, Qiufei Ma, Amber Kudlac, Stephen Palmer, Beth Barber, Zhongyun Zhao

Published in: Advances in Therapy | Issue 2/2017

Login to get access

Abstract

Introduction

Advances in the treatment of metastatic melanoma have been achieved in recent years: immunotherapies and targeted therapies have demonstrated survival benefits over older agents such as granulocyte-macrophage colony-stimulating factor (GM-CSF), dacarbazine, and glycoprotein peptide vaccine (gp100) in pivotal phase 3 trials. It is important to compare therapies to guide the treatment decision-making process, and establishing the relationship between older agents can strengthen the networks of evidence for newer therapies. We report the outcome of an indirect comparison of GM-CSF, dacarbazine, and gp100 in metastatic melanoma through meta-analysis of absolute treatment effect.

Methods

A systematic literature review identified trials for inclusion in the meta-analysis. A valid network meta-analysis was not feasible: treatment-specific meta-analysis was conducted. A published algorithm was used to adjust overall survival estimates from trials of GM-CSF, dacarbazine, and gp100 for heterogeneity in baseline prognostic factors. Survival estimates were compared in three patient groups: stage IIIB–IV M1c, stage IIIB–IV M1a, and stage IV M1b/c.

Results

One trial of GM-CSF, four of dacarbazine, and one of gp100 were included in the analysis. After adjusting for differences in baseline prognostic factors, median overall survival (OS) in all patient groups was longer for those receiving GM-CSF than for those receiving dacarbazine or gp100. The observed survival over time for GM-CSF was similar to the adjusted survival for dacarbazine and greater than for gp100 in all patient groups.

Conclusion

The relative treatment effect of GM-CSF, dacarbazine, and gp100 has been reliably estimated by adjusting for differences in baseline prognostic factors. Results suggest that OS with GM-CSF is at least as good as with dacarbazine and greater than with gp100. Given the role of these agents as controls in phase 3 trials of new immunotherapies and targeted agents, these results can be used to contextualize the efficacy of newer therapies.

Funding

Amgen Inc.
Literature
3.
go back to reference Dummer R, Hauschild A, Guggenheim M, Jost L, Pentheroudakis G, ESMO Guidelines Working Group. Melanoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010;21(Suppl 5):v194–7.CrossRefPubMed Dummer R, Hauschild A, Guggenheim M, Jost L, Pentheroudakis G, ESMO Guidelines Working Group. Melanoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010;21(Suppl 5):v194–7.CrossRefPubMed
4.
go back to reference Dummer R, Hauschild A, Lindenblatt N, Pentheroudakis G, Keilholz U, ESMO Guidelines Committee. Cutaneous melanoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26(Suppl 5):v126–32.CrossRefPubMed Dummer R, Hauschild A, Lindenblatt N, Pentheroudakis G, Keilholz U, ESMO Guidelines Committee. Cutaneous melanoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26(Suppl 5):v126–32.CrossRefPubMed
5.
go back to reference National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Melanoma. Version 2.2016 ed2016. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Melanoma. Version 2.2016 ed2016.
6.
go back to reference Colombino M, Capone M, Lissia A, et al. BRAF/NRAS mutation frequencies among primary tumors and metastases in patients with melanoma. J Clin Oncol. 2012;30(20):2522–9.CrossRefPubMed Colombino M, Capone M, Lissia A, et al. BRAF/NRAS mutation frequencies among primary tumors and metastases in patients with melanoma. J Clin Oncol. 2012;30(20):2522–9.CrossRefPubMed
7.
8.
go back to reference Robert C, Thomas L, Bondarenko I, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011;364(26):2517–26.CrossRefPubMed Robert C, Thomas L, Bondarenko I, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011;364(26):2517–26.CrossRefPubMed
9.
go back to reference Hauschild A, Grob JJ, Demidov LV, et al. Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2012;380(9839):358–65.CrossRefPubMed Hauschild A, Grob JJ, Demidov LV, et al. Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2012;380(9839):358–65.CrossRefPubMed
10.
go back to reference McArthur GA, Chapman PB, Robert C, et al. Safety and efficacy of vemurafenib in BRAF(V600E) and BRAF(V600K) mutation-positive melanoma (BRIM-3): extended follow-up of a phase 3, randomised, open-label study. Lancet Oncol. 2014;15(3):323–32.CrossRefPubMedPubMedCentral McArthur GA, Chapman PB, Robert C, et al. Safety and efficacy of vemurafenib in BRAF(V600E) and BRAF(V600K) mutation-positive melanoma (BRIM-3): extended follow-up of a phase 3, randomised, open-label study. Lancet Oncol. 2014;15(3):323–32.CrossRefPubMedPubMedCentral
11.
go back to reference Andtbacka RH, Kaufman HL, Collichio F, et al. Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol. 2015;33(25):2780–8.CrossRefPubMed Andtbacka RH, Kaufman HL, Collichio F, et al. Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol. 2015;33(25):2780–8.CrossRefPubMed
13.
14.
go back to reference Quinn C, Ma Q, Kudlac A, Palmer S, Barber B, Zhao Z. Indirect treatment comparison of talimogene laherparepvec compared with ipilimumab and vemurafenib for the treatment of patients with metastatic melanoma. Adv Ther. 2016;33:643–57.CrossRefPubMedPubMedCentral Quinn C, Ma Q, Kudlac A, Palmer S, Barber B, Zhao Z. Indirect treatment comparison of talimogene laherparepvec compared with ipilimumab and vemurafenib for the treatment of patients with metastatic melanoma. Adv Ther. 2016;33:643–57.CrossRefPubMedPubMedCentral
15.
go back to reference Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336(7650):924–6.CrossRefPubMedPubMedCentral Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336(7650):924–6.CrossRefPubMedPubMedCentral
16.
go back to reference Cope S, Zhang J, Saletan S, Smiechowski B, Jansen JP, Schmid P. 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;12:93.CrossRefPubMedPubMedCentral Cope S, Zhang J, Saletan S, Smiechowski B, Jansen JP, Schmid P. 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;12:93.CrossRefPubMedPubMedCentral
17.
go back to reference Alemayehu D, Alvir JM, Jones B, Willke RJ. Statistical issues with the analysis of nonrandomized studies in comparative effectiveness research. J Manag Care Pharm. 2011;17(9 Suppl A):S22–6.PubMed Alemayehu D, Alvir JM, Jones B, Willke RJ. Statistical issues with the analysis of nonrandomized studies in comparative effectiveness research. J Manag Care Pharm. 2011;17(9 Suppl A):S22–6.PubMed
18.
go back to reference Korn EL, Liu PY, Lee SJ, et al. Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials. J Clin Oncol. 2008;26(4):527–34.CrossRefPubMed Korn EL, Liu PY, Lee SJ, et al. Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials. J Clin Oncol. 2008;26(4):527–34.CrossRefPubMed
20.
go back to reference Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst. 1959;22(4):719–48.PubMed Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst. 1959;22(4):719–48.PubMed
21.
go back to reference Deeks JJ, Higgins JPT, Altman DG. Analysing data and undertaking meta-analyses. In: Higgins JP, Green S, editors. Cochrane handbook for systematic reviews of interventions: Cochrane book series. Chichester: Wiley; 2008. Deeks JJ, Higgins JPT, Altman DG. Analysing data and undertaking meta-analyses. In: Higgins JP, Green S, editors. Cochrane handbook for systematic reviews of interventions: Cochrane book series. Chichester: Wiley; 2008.
22.
go back to reference Guyot P, Ades AE, Ouwens MJ, Welton NJ. Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves. BMC Med Res Methodol. 2012;12:9.CrossRefPubMedPubMedCentral Guyot P, Ades AE, Ouwens MJ, Welton NJ. Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves. BMC Med Res Methodol. 2012;12:9.CrossRefPubMedPubMedCentral
23.
go back to reference Jones C, Zhao Z, Barber B, Bagijn M, Corrie P, Saltman D. Treatment patterns in advanced melanoma: findings from a survey of European oncologists. Eur J Cancer Care. 2015;24:862–6.CrossRef Jones C, Zhao Z, Barber B, Bagijn M, Corrie P, Saltman D. Treatment patterns in advanced melanoma: findings from a survey of European oncologists. Eur J Cancer Care. 2015;24:862–6.CrossRef
24.
go back to reference Kotapati S, Dequen P, Ouwens MJ et al. Overall survival (OS) in the management of pretreated patients with unresectable stage III/IV melanoma: a systematic literature review and meta-analysis. J Clin Oncol. 2011;29:Abstract 8580. Kotapati S, Dequen P, Ouwens MJ et al. Overall survival (OS) in the management of pretreated patients with unresectable stage III/IV melanoma: a systematic literature review and meta-analysis. J Clin Oncol. 2011;29:Abstract 8580.
25.
go back to reference Daponte A, Signoriello S, Maiorino L, et al. Phase III randomized study of fotemustine and dacarbazine versus dacarbazine with or without interferon-alpha in advanced malignant melanoma. J Transl Med. 2013;11:38.CrossRefPubMedPubMedCentral Daponte A, Signoriello S, Maiorino L, et al. Phase III randomized study of fotemustine and dacarbazine versus dacarbazine with or without interferon-alpha in advanced malignant melanoma. J Transl Med. 2013;11:38.CrossRefPubMedPubMedCentral
26.
go back to reference Chapman PB, Hauschild A, Robert C, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011;364(26):2507–16.CrossRefPubMedPubMedCentral Chapman PB, Hauschild A, Robert C, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011;364(26):2507–16.CrossRefPubMedPubMedCentral
27.
go back to reference Lawson DH, Tarhini AA et al. Phase III cooperative study of yeast-derived granulocyte macrophage colonystimulating factor (GM-CSF) versus placebo as adjuvant treatment of patients with completely resected stage III-IV melanoma. J Clin Oncol 2010;28(suppl):Abstract 8504). Lawson DH, Tarhini AA et al. Phase III cooperative study of yeast-derived granulocyte macrophage colonystimulating factor (GM-CSF) versus placebo as adjuvant treatment of patients with completely resected stage III-IV melanoma. J Clin Oncol 2010;28(suppl):Abstract 8504).
28.
go back to reference Ravaud A, Delaunay M, Chevreau C, et al. Granulocyte-macrophage colony-stimulating factor alone or with dacarbazine in metastatic melanoma: a randomized phase II trial. British J Cancer. 2001;85(10):1467–71.CrossRef Ravaud A, Delaunay M, Chevreau C, et al. Granulocyte-macrophage colony-stimulating factor alone or with dacarbazine in metastatic melanoma: a randomized phase II trial. British J Cancer. 2001;85(10):1467–71.CrossRef
29.
go back to reference Patel PM, Suciu S, Mortier L, et al. Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: Final results of a randomised phase III study (EORTC 18032). European J Cancer. 2011;47:1476–83.CrossRef Patel PM, Suciu S, Mortier L, et al. Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: Final results of a randomised phase III study (EORTC 18032). European J Cancer. 2011;47:1476–83.CrossRef
Metadata
Title
Relative Efficacy of Granulocyte-Macrophage Colony-Stimulating Factor, Dacarbazine, and Glycoprotein 100 in Metastatic Melanoma: An Indirect Treatment Comparison
Authors
Casey Quinn
Qiufei Ma
Amber Kudlac
Stephen Palmer
Beth Barber
Zhongyun Zhao
Publication date
01-02-2017
Publisher
Springer Healthcare
Published in
Advances in Therapy / Issue 2/2017
Print ISSN: 0741-238X
Electronic ISSN: 1865-8652
DOI
https://doi.org/10.1007/s12325-016-0464-9

Other articles of this Issue 2/2017

Advances in Therapy 2/2017 Go to the issue