Difference between revisions of "Malignant pleural mesothelioma - null regimens"

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===References===
 
===References===
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# '''MS01:''' Muers MF, Stephens RJ, Fisher P, Darlison L, Higgs CM, Lowry E, Nicholson AG, O'Brien M, Peake M, Rudd R, Snee M, Steele J, Girling DJ, Nankivell M, Pugh C, Parmar MK; MS01 Trial Management Group. Active symptom control with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma (MS01): a multicentre randomised trial. Lancet. 2008 May 17;371(9625):1685-94. [https://doi.org/10.1016/S0140-6736(08)60727-8 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2431123/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/18486741/ PubMed] [https://clinicaltrials.gov/ct2/show/NCT00075699 Clinical Trial Registry]
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# '''MS01:''' Muers MF, Stephens RJ, Fisher P, Darlison L, Higgs CM, Lowry E, Nicholson AG, O'Brien M, Peake M, Rudd R, Snee M, Steele J, Girling DJ, Nankivell M, Pugh C, Parmar MK; MS01 Trial Management Group. Active symptom control with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma (MS01): a multicentre randomised trial. Lancet. 2008 May 17;371(9625):1685-94. [https://doi.org/10.1016/S0140-6736(08)60727-8 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2431123/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/18486741/ PubMed] [https://clinicaltrials.gov/study/NCT00075699 Clinical Trial Registry]
  
 
=Maintenance after first-line therapy=
 
=Maintenance after first-line therapy=
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===References===
 
===References===
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# '''JMEW:''' Jassem J, Ramlau R, Santoro A, Schuette W, Chemaissani A, Hong S, Blatter J, Adachi S, Hanauske A, Manegold C. Phase III trial of pemetrexed plus best supportive care compared with best supportive care in previously treated patients with advanced malignant pleural mesothelioma. J Clin Oncol. 2008 Apr 1;26(10):1698-704. [https://doi.org/10.1200/jco.2006.09.9887 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/18375898/ PubMed] [https://clinicaltrials.gov/ct2/show/NCT00190762 Clinical Trial Registry]
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# '''JMEW:''' Jassem J, Ramlau R, Santoro A, Schuette W, Chemaissani A, Hong S, Blatter J, Adachi S, Hanauske A, Manegold C. Phase III trial of pemetrexed plus best supportive care compared with best supportive care in previously treated patients with advanced malignant pleural mesothelioma. J Clin Oncol. 2008 Apr 1;26(10):1698-704. [https://doi.org/10.1200/jco.2006.09.9887 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/18375898/ PubMed] [https://clinicaltrials.gov/study/NCT00190762 Clinical Trial Registry]
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# '''DETERMINE:''' Maio M, Scherpereel A, Calabrò L, Aerts J, Cedres Perez S, Bearz A, Nackaerts K, Fennell DA, Kowalski D, Tsao AS, Taylor P, Grosso F, Antonia SJ, Nowak AK, Taboada M, Puglisi M, Stockman PK, Kindler HL. Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial. Lancet Oncol. 2017 Sep;18(9):1261-1273. Epub 2017 Jul 17. [https://doi.org/10.1016/S1470-2045(17)30446-1 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28729154/ PubMed] [https://clinicaltrials.gov/ct2/show/NCT01843374 Clinical Trial Registry]
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# '''DETERMINE:''' Maio M, Scherpereel A, Calabrò L, Aerts J, Cedres Perez S, Bearz A, Nackaerts K, Fennell DA, Kowalski D, Tsao AS, Taylor P, Grosso F, Antonia SJ, Nowak AK, Taboada M, Puglisi M, Stockman PK, Kindler HL. Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial. Lancet Oncol. 2017 Sep;18(9):1261-1273. Epub 2017 Jul 17. [https://doi.org/10.1016/S1470-2045(17)30446-1 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28729154/ PubMed] [https://clinicaltrials.gov/study/NCT01843374 Clinical Trial Registry]
  
 
==Placebo==
 
==Placebo==
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===References===
 
===References===
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# '''VANTAGE-014:''' Krug LM, Kindler HL, Calvert H, Manegold C, Tsao AS, Fennell D, Öhman R, Plummer R, Eberhardt WE, Fukuoka K, Gaafar RM, Lafitte JJ, Hillerdal G, Chu Q, Buikhuisen WA, Lubiniecki GM, Sun X, Smith M, Baas P. Vorinostat in patients with advanced malignant pleural mesothelioma who have progressed on previous chemotherapy (VANTAGE-014): a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Oncol. 2015 Apr;16(4):447-56. Epub 2015 Mar 20. Erratum in: Lancet Oncol. 2015 May;16(5):e199. [https://doi.org/10.1016/S1470-2045(15)70056-2 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25800891/ PubMed] [https://clinicaltrials.gov/ct2/show/NCT00128102 Clinical Trial Registry]
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# '''VANTAGE-014:''' Krug LM, Kindler HL, Calvert H, Manegold C, Tsao AS, Fennell D, Öhman R, Plummer R, Eberhardt WE, Fukuoka K, Gaafar RM, Lafitte JJ, Hillerdal G, Chu Q, Buikhuisen WA, Lubiniecki GM, Sun X, Smith M, Baas P. Vorinostat in patients with advanced malignant pleural mesothelioma who have progressed on previous chemotherapy (VANTAGE-014): a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Oncol. 2015 Apr;16(4):447-56. Epub 2015 Mar 20. Erratum in: Lancet Oncol. 2015 May;16(5):e199. [https://doi.org/10.1016/S1470-2045(15)70056-2 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25800891/ PubMed] [https://clinicaltrials.gov/study/NCT00128102 Clinical Trial Registry]
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# '''CONFIRM<sub>meso</sub>:''' Fennell DA, Ewings S, Ottensmeier C, Califano R, Hanna GG, Hill K, Danson S, Steele N, Nye M, Johnson L, Lord J, Middleton C, Szlosarek P, Chan S, Gaba A, Darlison L, Wells-Jordan P, Richards C, Poile C, Lester JF, Griffiths G; CONFIRM trial investigators. Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial. Lancet Oncol. 2021 Nov;22(11):1530-1540. Epub 2021 Oct 14. [https://doi.org/10.1016/s1470-2045(21)00471-x link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8560642/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34656227/ PubMed] [https://clinicaltrials.gov/ct2/show/NCT03063450 Clinical Trial Registry]
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# '''CONFIRM<sub>meso</sub>:''' Fennell DA, Ewings S, Ottensmeier C, Califano R, Hanna GG, Hill K, Danson S, Steele N, Nye M, Johnson L, Lord J, Middleton C, Szlosarek P, Chan S, Gaba A, Darlison L, Wells-Jordan P, Richards C, Poile C, Lester JF, Griffiths G; CONFIRM trial investigators. Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial. Lancet Oncol. 2021 Nov;22(11):1530-1540. Epub 2021 Oct 14. [https://doi.org/10.1016/s1470-2045(21)00471-x link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8560642/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34656227/ PubMed] [https://clinicaltrials.gov/study/NCT03063450 Clinical Trial Registry]
  
 
[[Category:Mesothelioma regimens]]
 
[[Category:Mesothelioma regimens]]

Revision as of 01:41, 25 June 2023

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. While not clinically relevant, these references provide further insight into the historical development of the treatment landscape. See the main MPM page for current regimens.


Advanced or metastatic disease, first-line therapy

Best supportive care

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Muers et al. 2008 (MS01) 2001-2006 Phase 3 (C) 1. MVP Did not meet primary endpoint of OS
2. Vinorelbine Might have inferior OS

No antineoplastic treatment; used as a comparator arm and here for reference purposes only.

References

  1. MS01: Muers MF, Stephens RJ, Fisher P, Darlison L, Higgs CM, Lowry E, Nicholson AG, O'Brien M, Peake M, Rudd R, Snee M, Steele J, Girling DJ, Nankivell M, Pugh C, Parmar MK; MS01 Trial Management Group. Active symptom control with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma (MS01): a multicentre randomised trial. Lancet. 2008 May 17;371(9625):1685-94. link to original article contains dosing details in manuscript link to PMC article PubMed Clinical Trial Registry

Maintenance after first-line therapy

Best supportive care

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Buikhuisen et al. 2013 (NVALT 5) 2004-2009 Phase 3 (C) Thalidomide Did not meet primary endpoint of TTP

No antineoplastic treatment after first-line therapy.

Preceding treatment

References

  1. NVALT 5: Buikhuisen WA, Burgers JA, Vincent AD, Korse CM, van Klaveren RJ, Schramel FM, Pavlakis N, Nowak AK, Custers FL, Schouwink JH, Gans SJ, Groen HJ, Strankinga WF, Baas P. Thalidomide versus active supportive care for maintenance in patients with malignant mesothelioma after first-line chemotherapy (NVALT 5): an open-label, multicentre, randomised phase 3 study. Lancet Oncol. 2013 May;14(6):543-51. Epub 2013 Apr 12. link to original article PubMed ISRCTN13632914

Advanced or metastatic disease, subsequent lines of therapy

Best supportive care

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Jassem et al. 2008 (JMEW) 2001-2004 Phase 3 (C) Pemetrexed Seems to have inferior PFS
Maio et al. 2017 (DETERMINE) 2013-2014 Randomized Phase 2b (C) Tremelimumab Did not meet primary endpoint of OS

No antineoplastic treatment.

References

  1. JMEW: Jassem J, Ramlau R, Santoro A, Schuette W, Chemaissani A, Hong S, Blatter J, Adachi S, Hanauske A, Manegold C. Phase III trial of pemetrexed plus best supportive care compared with best supportive care in previously treated patients with advanced malignant pleural mesothelioma. J Clin Oncol. 2008 Apr 1;26(10):1698-704. link to original article contains dosing details in manuscript PubMed Clinical Trial Registry
  2. DETERMINE: Maio M, Scherpereel A, Calabrò L, Aerts J, Cedres Perez S, Bearz A, Nackaerts K, Fennell DA, Kowalski D, Tsao AS, Taylor P, Grosso F, Antonia SJ, Nowak AK, Taboada M, Puglisi M, Stockman PK, Kindler HL. Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial. Lancet Oncol. 2017 Sep;18(9):1261-1273. Epub 2017 Jul 17. link to original article PubMed Clinical Trial Registry

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Krug et al. 2015 (VANTAGE-014) 2005-2011 Phase 3 (C) Vorinostat Did not meet primary endpoint of OS
Fennell et al. 2021 (CONFIRMmeso) 2017-2020 Phase 3 (C) Nivolumab Inferior OS

No active antineoplastic treatment. Note that CONFIRM should not be confused with the trial by the same name in breast cancer.

References

  1. VANTAGE-014: Krug LM, Kindler HL, Calvert H, Manegold C, Tsao AS, Fennell D, Öhman R, Plummer R, Eberhardt WE, Fukuoka K, Gaafar RM, Lafitte JJ, Hillerdal G, Chu Q, Buikhuisen WA, Lubiniecki GM, Sun X, Smith M, Baas P. Vorinostat in patients with advanced malignant pleural mesothelioma who have progressed on previous chemotherapy (VANTAGE-014): a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Oncol. 2015 Apr;16(4):447-56. Epub 2015 Mar 20. Erratum in: Lancet Oncol. 2015 May;16(5):e199. link to original article PubMed Clinical Trial Registry
  2. CONFIRMmeso: Fennell DA, Ewings S, Ottensmeier C, Califano R, Hanna GG, Hill K, Danson S, Steele N, Nye M, Johnson L, Lord J, Middleton C, Szlosarek P, Chan S, Gaba A, Darlison L, Wells-Jordan P, Richards C, Poile C, Lester JF, Griffiths G; CONFIRM trial investigators. Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial. Lancet Oncol. 2021 Nov;22(11):1530-1540. Epub 2021 Oct 14. link to original article contains dosing details in abstract link to PMC article PubMed Clinical Trial Registry
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