Difference between revisions of "Melanoma - historical"

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=Adjuvant thereapy=
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==Bevacizumab monotherapy {{#subobject:1jg8aec|Regimen=1}}==
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{| class="wikitable" style="float:right; margin-left: 5px;"
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|-
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|[[#top|back to top]]
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===Regimen {{#subobject:f8e1tg|Variant=1}}===
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{| class="wikitable sortable" style="width: 100%; text-align:center;"
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!style="width: 20%"|Study
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!style="width: 20%"|Years of enrollment
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!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
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!style="width: 20%"|Comparator
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
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|-
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|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70110-X/fulltext Corrie et al. 2014 (AVAST-M)]
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|2007-2012
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|style="background-color:#1a9851"|Phase III (E-esc)
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|[[Melanoma_-_null_regimens#Observation|Observation]]
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|style="background-color:#ffffbf"|Did not meet primary endpoint of OS<sup>1</sup> (HR 0.98, 95% CI 0.82-1.16)
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|-
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====Preceding treatment====
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*[[Surgery#Melanoma_surgery|Surgery]]
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====Targeted therapy====
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*[[Bevacizumab (Avastin)]] 7.5 mg/kg IV once on day 1
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'''21-day cycle for 18 cycles (1 year)'''
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===References===
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# '''AVAST-M:''' Corrie PG, Marshall A, Dunn JA, Middleton MR, Nathan PD, Gore M, Davidson N, Nicholson S, Kelly CG, Marples M, Danson SJ, Marshall E, Houston SJ, Board RE, Waterston AM, Nobes JP, Harries M, Kumar S, Young G, Lorigan P. Adjuvant bevacizumab in patients with melanoma at high risk of recurrence (AVAST-M): preplanned interim results from a multicentre, open-label, randomised controlled phase 3 study. Lancet Oncol. 2014 May;15(6):620-30. Epub 2014 Apr 15. Erratum in: Lancet Oncol. 2014 Aug;15(9):e365. Lancet Oncol. 2014 Jun;15(7):e253. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70110-X/fulltext link to original article] [https://pubmed.ncbi.nlm.nih.gov/24745696 PubMed] ISRCTN81261306
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## '''Update:''' Corrie PG, Marshall A, Nathan PD, Lorigan P, Gore M, Tahir S, Faust G, Kelly CG, Marples M, Danson SJ, Marshall E, Houston SJ, Board RE, Waterston AM, Nobes JP, Harries M, Kumar S, Goodman A, Dalgleish A, Martin-Clavijo A, Westwell S, Casasola R, Chao D, Maraveyas A, Patel PM, Ottensmeier CH, Farrugia D, Humphreys A, Eccles B, Young G, Barker EO, Harman C, Weiss M, Myers KA, Chhabra A, Rodwell SH, Dunn JA, Middleton MR; AVAST-M Investigators, Nathan P, Lorigan P, Dziewulski P, Holikova S, Panwar U, Tahir S, Faust G, Thomas A, Corrie P, Sirohi B, Kelly C, Middleton M, Marples M, Danson S, Lester J, Marshall E, Ajaz M, Houston S, Board R, Eaton D, Waterston A, Nobes J, Loo S, Gray G, Stubbings H, Gore M, Harries M, Kumar S, Goodman A, Dalgleish A, Martin-Clavijo A, Marsden J, Westwell S, Casasola R, Chao D, Maraveyas A, Marshall E, Patel P, Ottensmeier C, Farrugia D, Humphreys A, Eccles B, Dega R, Herbert C, Price C, Brunt M, Scott-Brown M, Hamilton J, Hayward RL, Smyth J, Woodings P, Nayak N, Burrows L, Wolstenholme V, Wagstaff J, Nicolson M, Wilson A, Barlow C, Scrase C, Podd T, Gonzalez M, Stewart J, Highley M, Wolstenholme V, Grumett S, Goodman A, Talbot T, Nathan K, Coltart R, Gee B, Gore M, Farrugia D, Martin-Clavijo A, Marsden J, Price C, Farrugia D, Nathan K, Coltart R, Nathan K, Coltart R. Adjuvant bevacizumab for melanoma patients at high risk of recurrence: survival analysis of the AVAST-M trial. Ann Oncol. 2018 Aug 1;29(8):1843-1852. Erratum in: Ann Oncol. 2019 Dec 1;30(12):2013-2014. Erratum in: Ann Oncol. 2019 Dec;30(12):2013-2014. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6096737/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30010756 PubMed]
  
 
=Metastatic or unresectable disease=
 
=Metastatic or unresectable disease=

Revision as of 16:27, 14 April 2021

The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the NCCN Guidelines. Is there a regimen missing from this list? See the main melanoma page for current regimens.

20 regimens on this page
34 variants on this page


Adjuvant thereapy

Bevacizumab monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Corrie et al. 2014 (AVAST-M) 2007-2012 Phase III (E-esc) Observation Did not meet primary endpoint of OS1 (HR 0.98, 95% CI 0.82-1.16)

Preceding treatment

Targeted therapy

21-day cycle for 18 cycles (1 year)

References

  1. AVAST-M: Corrie PG, Marshall A, Dunn JA, Middleton MR, Nathan PD, Gore M, Davidson N, Nicholson S, Kelly CG, Marples M, Danson SJ, Marshall E, Houston SJ, Board RE, Waterston AM, Nobes JP, Harries M, Kumar S, Young G, Lorigan P. Adjuvant bevacizumab in patients with melanoma at high risk of recurrence (AVAST-M): preplanned interim results from a multicentre, open-label, randomised controlled phase 3 study. Lancet Oncol. 2014 May;15(6):620-30. Epub 2014 Apr 15. Erratum in: Lancet Oncol. 2014 Aug;15(9):e365. Lancet Oncol. 2014 Jun;15(7):e253. link to original article PubMed ISRCTN81261306
    1. Update: Corrie PG, Marshall A, Nathan PD, Lorigan P, Gore M, Tahir S, Faust G, Kelly CG, Marples M, Danson SJ, Marshall E, Houston SJ, Board RE, Waterston AM, Nobes JP, Harries M, Kumar S, Goodman A, Dalgleish A, Martin-Clavijo A, Westwell S, Casasola R, Chao D, Maraveyas A, Patel PM, Ottensmeier CH, Farrugia D, Humphreys A, Eccles B, Young G, Barker EO, Harman C, Weiss M, Myers KA, Chhabra A, Rodwell SH, Dunn JA, Middleton MR; AVAST-M Investigators, Nathan P, Lorigan P, Dziewulski P, Holikova S, Panwar U, Tahir S, Faust G, Thomas A, Corrie P, Sirohi B, Kelly C, Middleton M, Marples M, Danson S, Lester J, Marshall E, Ajaz M, Houston S, Board R, Eaton D, Waterston A, Nobes J, Loo S, Gray G, Stubbings H, Gore M, Harries M, Kumar S, Goodman A, Dalgleish A, Martin-Clavijo A, Marsden J, Westwell S, Casasola R, Chao D, Maraveyas A, Marshall E, Patel P, Ottensmeier C, Farrugia D, Humphreys A, Eccles B, Dega R, Herbert C, Price C, Brunt M, Scott-Brown M, Hamilton J, Hayward RL, Smyth J, Woodings P, Nayak N, Burrows L, Wolstenholme V, Wagstaff J, Nicolson M, Wilson A, Barlow C, Scrase C, Podd T, Gonzalez M, Stewart J, Highley M, Wolstenholme V, Grumett S, Goodman A, Talbot T, Nathan K, Coltart R, Gee B, Gore M, Farrugia D, Martin-Clavijo A, Marsden J, Price C, Farrugia D, Nathan K, Coltart R, Nathan K, Coltart R. Adjuvant bevacizumab for melanoma patients at high risk of recurrence: survival analysis of the AVAST-M trial. Ann Oncol. 2018 Aug 1;29(8):1843-1852. Erratum in: Ann Oncol. 2019 Dec 1;30(12):2013-2014. Erratum in: Ann Oncol. 2019 Dec;30(12):2013-2014. link to PMC article PubMed

Metastatic or unresectable disease

BCG & Dacarbazine

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BCG & DTIC: Bacillus Calmette-Guérin & Dimethyl Triazeno Imidazole Carboxamide (Dacarbazine)

Regimen

Study Evidence
Gutterman et al. 1974 Non-randomized

Immunotherapy

Chemotherapy

References

  1. Gutterman JU, Mavligit G, Gottlieb JA, Burgess MA, McBride CE, Einhorn L, Freireich EJ, Hersh EM. Chemoimmunotherapy of disseminated malignant melanoma with dimethyl triazeno imidazole carboxamide and Bacillus Calmette--Guérin. N Engl J Med. 1974 Sep 19;291(12):592-7. link to original article PubMed

BHD

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BHD: BCNU (Carmustine), Hydroxyurea, Dacarbazine

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Costanzi et al. 1984 (SWOG S7727) NR Phase III (C) 1. BHD & Levamisole
2. DTIC & Dactinomycin
Seems not superior

Chemotherapy

References

  1. SWOG S7727: Costanzi JJ, Fletcher WS, Balcerzak SP, Taylor S, Eyre HJ, O'Bryan RM, Al-Sarraf M, Frank J. Combination chemotherapy plus levamisole in the treatment of disseminated malignant melanoma: a Southwest Oncology Group study. Cancer. 1984 Feb 15;53(4):833-6. link to original article PubMed

BVD

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BVD: BCNU (Carmustine), Vincristine, Dacarbazine

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Jelić et al. 2002 NR Phase III (C) 1. BVD; high-dose
2. Bleomycin, Cisplatin, Vindesine
3. Carmustine & Procarbazine
Seems not superior

Chemotherapy

References

  1. Jelić S, Babovic N, Kovcin V, Milicevic N, Milanovic N, Popov I, Radosavljevic D. Comparison of the efficacy of two different dosage dacarbazine-based regimens and two regimens without dacarbazine in metastatic melanoma: a single-centre randomized four-arm study. Melanoma Res. 2002 Feb;12(1):91-8. link to original article PubMed

CDB

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CDB: Cisplatin, Dacarbazine, BCNU (Carmustine)

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Creagan et al. 1999 1991-1996 Phase III (C) CDB & Tamoxifen Seems not superior
Rusthoven et al. 1996 1992-1995 Phase III (E-de-esc) CDB & Tamoxifen Seems not superior
Ridolfi et al. 2002 1997-1999 Phase III (C) Cisplatin, Dacarbazine, IL-2, IFN alfa-2b +/- Carmustine Seems not superior

Chemotherapy

References

  1. Rusthoven JJ, Quirt IC, Iscoe NA, McCulloch PB, James KW, Lohmann RC, Jensen J, Burdette-Radoux S, Bodurtha AJ, Silver HK, Verma S, Armitage GR, Zee B, Bennett K; National Cancer Institute of Canada Clinical Trials Group. Randomized, double-blind, placebo-controlled trial comparing the response rates of carmustine, dacarbazine, and cisplatin with and without tamoxifen in patients with metastatic melanoma. J Clin Oncol. 1996 Jul;14(7):2083-90. link to original article PubMed
  2. Creagan ET, Suman VJ, Dalton RJ, Pitot HC, Long HJ, Veeder MH, Vukov AM, Rowland KM, Krook JE, Michalak JC. Phase III clinical trial of the combination of cisplatin, dacarbazine, and carmustine with or without tamoxifen in patients with advanced malignant melanoma. J Clin Oncol. 1999 Jun;17(6):1884-90. link to original article PubMed
  3. Ridolfi R, Chiarion-Sileni V, Guida M, Romanini A, Labianca R, Freschi A, Lo Re G, Nortilli R, Brugnara S, Vitali P, Nanni O; Italian Melanoma Intergroup. Cisplatin, dacarbazine with or without subcutaneous interleukin-2, and interferon alpha-2b in advanced melanoma outpatients: results from an Italian multicenter phase III randomized clinical trial. J Clin Oncol. 2002 Mar 15;20(6):1600-7. link to original article contains verified protocol PubMed

Cisplatin, Dacarbazine, Interferon alfa-2b

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Keilholz et al. 2005 (EORTC 18951) 1995-2000 Phase III (C) Cisplatin, Dacarbazine, IFN, IL-2 Seems not superior

Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm.

Chemotherapy

Immunotherapy

28-day cycle for up to 4 cycles

References

  1. EORTC 18951: Keilholz U, Punt CJ, Gore M, Kruit W, Patel P, Lienard D, Thomas J, Proebstle TM, Schmittel A, Schadendorf D, Velu T, Negrier S, Kleeberg U, Lehman F, Suciu S, Eggermont AM. Dacarbazine, cisplatin, and interferon-alfa-2b with or without interleukin-2 in metastatic melanoma: a randomized phase III trial (18951) of the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol. 2005 Sep 20;23(27):6747-55. link to original article PubMed

Cisplatin, Dacarbazine, Tamoxifen

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Rosenberg et al. 1999 1993-1997 Phase III (C) Cisplatin, Dacarbazine, Tamoxifen, then IFN & IL-2 Seems not superior

Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm.

Chemotherapy

Hormonotherapy

References

  1. Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Seipp CA, Einhorn JH, White DE, Steinberg SM. Prospective randomized trial of the treatment of patients with metastatic melanoma using chemotherapy with cisplatin, dacarbazine, and tamoxifen alone or in combination with interleukin-2 and interferon alfa-2b. J Clin Oncol. 1999 Mar;17(3):968-75. link to original article PubMed

Dacarbazine & Tamoxifen

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Cocconi et al. 1992 1983-1988 Phase III (E-esc) Dacarbazine Seems to have superior OS

Chemotherapy

Hormonotherapy

References

  1. Cocconi G, Bella M, Calabresi F, Tonato M, Canaletti R, Boni C, Buzzi F, Ceci G, Corgna E, Costa P, Lottici R, Papadia F, Sofra MC, Bacchi M. Treatment of metastatic malignant melanoma with dacarbazine plus tamoxifen. N Engl J Med. 1992 Aug 20;327(8):516-23. link to original article PubMed