Difference between revisions of "Malignant pleural mesothelioma - null regimens"
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==Best supportive care== | ==Best supportive care== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
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''No antineoplastic treatment; used as a comparator arm and here for reference purposes only.'' | ''No antineoplastic treatment; used as a comparator arm and here for reference purposes only.'' | ||
| − | + | </div> | |
===References=== | ===References=== | ||
# '''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] [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 NCT00075699] | # '''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] [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 NCT00075699] | ||
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=Maintenance after first-line therapy= | =Maintenance after first-line therapy= | ||
==Best supportive care== | ==Best supportive care== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| Line 51: | Line 51: | ||
|[[#Thalidomide_monotherapy_999|Thalidomide]] | |[[#Thalidomide_monotherapy_999|Thalidomide]] | ||
|style="background-color:#ffffbf"|Did not meet primary endpoint of TTP | |style="background-color:#ffffbf"|Did not meet primary endpoint of TTP | ||
| + | |- | ||
| + | |[https://doi.org/10.1016/s1470-2045(24)00191-8 Aerts et al. 2024 (DENIM)] | ||
| + | |2018-06-21 to 2021-06-10 | ||
| + | |style="background-color:#1a9851"|Phase 3 (C) | ||
| + | |[[#MesoPher_monotherapy_777|MesoPher]] | ||
| + | |style="background-color:#ffffbf"|Did not meet primary endpoint of OS | ||
|- | |- | ||
|} | |} | ||
''No antineoplastic treatment after first-line therapy.'' | ''No antineoplastic treatment after first-line therapy.'' | ||
| + | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
| − | *First-line [[Regimen_classes#Pemetrexed-containing_regimen|pemetrexed-containing chemotherapy]] x 4 | + | *NVALT 5: First-line [[Regimen_classes#Pemetrexed-containing_regimen|pemetrexed-containing chemotherapy]] x 4 |
| + | *DENIM: First-line [[Malignant_pleural_mesothelioma#Carboplatin_.26_Pemetrexed|Carboplatin & Pemetrexed]] or [[Malignant_pleural_mesothelioma#Cisplatin_.26_Pemetrexed|Cisplatin & Pemetrexed]] x 4 to 6 | ||
| + | </div></div> | ||
===References=== | ===References=== | ||
# '''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. [https://doi.org/10.1016/S1470-2045(13)70125-6 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23583604/ PubMed] ISRCTN13632914 | # '''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. [https://doi.org/10.1016/S1470-2045(13)70125-6 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23583604/ PubMed] ISRCTN13632914 | ||
| + | #'''DENIM:''' Aerts JG, Belderbos R, Baas P, Scherpereel A, Bezemer K, Enninga I, Meijer R, Willemsen M, Berardi R, Fennell D, Kerstens R, Cornelissen R, van Meerbeeck JP; DENIM team. Dendritic cells loaded with allogeneic tumour cell lysate plus best supportive care versus best supportive care alone in patients with pleural mesothelioma as maintenance therapy after chemotherapy (DENIM): a multicentre, open-label, randomised, phase 2/3 study. Lancet Oncol. 2024 Jul;25(7):865-878. Epub 2024 Jun 4. [https://doi.org/10.1016/s1470-2045(24)00191-8 link to original article] [https://pubmed.ncbi.nlm.nih.gov/38848742/ PubMed] [https://clinicaltrials.gov/study/NCT03610360 NCT03610360] | ||
=Advanced or metastatic disease, subsequent lines of therapy= | =Advanced or metastatic disease, subsequent lines of therapy= | ||
==Best supportive care== | ==Best supportive care== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| Line 84: | Line 94: | ||
|} | |} | ||
''No antineoplastic treatment.'' | ''No antineoplastic treatment.'' | ||
| − | + | </div> | |
===References=== | ===References=== | ||
# '''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] [https://pubmed.ncbi.nlm.nih.gov/18375898/ PubMed] [https://clinicaltrials.gov/study/NCT00190762 NCT00190762] | # '''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] [https://pubmed.ncbi.nlm.nih.gov/18375898/ PubMed] [https://clinicaltrials.gov/study/NCT00190762 NCT00190762] | ||
| Line 90: | Line 100: | ||
==Placebo== | ==Placebo== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| Line 112: | Line 122: | ||
|- | |- | ||
|} | |} | ||
| − | ''No active antineoplastic treatment. Note that CONFIRM | + | ''No active antineoplastic treatment. Note that we have renamed CONFIRM to avoid confusion with the trial by the same name in breast cancer.'' |
| − | + | </div> | |
===References=== | ===References=== | ||
# '''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 NCT00128102] | # '''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 NCT00128102] | ||
Latest revision as of 18:24, 4 July 2024
The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main MPM page for regimens that include active anticancer treatment.
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
- 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 link to PMC article PubMed NCT00075699
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 |
| Aerts et al. 2024 (DENIM) | 2018-06-21 to 2021-06-10 | Phase 3 (C) | MesoPher | Did not meet primary endpoint of OS |
No antineoplastic treatment after first-line therapy.
Preceding treatment
- NVALT 5: First-line pemetrexed-containing chemotherapy x 4
- DENIM: First-line Carboplatin & Pemetrexed or Cisplatin & Pemetrexed x 4 to 6
References
- 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
- DENIM: Aerts JG, Belderbos R, Baas P, Scherpereel A, Bezemer K, Enninga I, Meijer R, Willemsen M, Berardi R, Fennell D, Kerstens R, Cornelissen R, van Meerbeeck JP; DENIM team. Dendritic cells loaded with allogeneic tumour cell lysate plus best supportive care versus best supportive care alone in patients with pleural mesothelioma as maintenance therapy after chemotherapy (DENIM): a multicentre, open-label, randomised, phase 2/3 study. Lancet Oncol. 2024 Jul;25(7):865-878. Epub 2024 Jun 4. link to original article PubMed NCT03610360
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
- 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 PubMed NCT00190762
- 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 NCT01843374
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 we have renamed CONFIRM to avoid confusion with the trial by the same name in breast cancer.
References
- 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 NCT00128102
- 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 link to PMC article PubMed NCT03063450