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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
| − | !style="width: 25%"|Study | + | ! style="width: 25%" |Study |
| − | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]] |
| − | !style="width: 25%"|Comparator | + | ! style="width: 25%" |Comparator |
| − | !style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] |
|- | |- | ||
|[http://jco.ascopubs.org/content/21/14/2636.long Vogelzang et al. 2003 (JMCH)] | |[http://jco.ascopubs.org/content/21/14/2636.long Vogelzang et al. 2003 (JMCH)] | ||
| − | |style="background-color:#1a9851"|Phase III (E-RT) | + | | style="background-color:#1a9851" |Phase III (E-RT) |
|[[#Cisplatin_monotherapy|Cisplatin]] | |[[#Cisplatin_monotherapy|Cisplatin]] | ||
| − | |style="background-color:#91cf60"|Seems to have superior OS | + | | style="background-color:#91cf60" |Seems to have superior OS |
|- | |- | ||
|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01238-6/abstract Zalcman et al. 2016 (MAPS)] | |[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01238-6/abstract Zalcman et al. 2016 (MAPS)] | ||
| − | |style="background-color:#1a9851"|Phase III (C) | + | | style="background-color:#1a9851" |Phase III (C) |
|[[#Cisplatin.2C_Pemetrexed.2C_Bevacizumab|PCB]] | |[[#Cisplatin.2C_Pemetrexed.2C_Bevacizumab|PCB]] | ||
| − | |style="background-color:#fc8d59"|Seems to have inferior OS | + | | style="background-color:#fc8d59" |Seems to have inferior OS |
|- | |- | ||
|[https://doi.org/10.1200/JCO.2017.72.9012 Grosso et al. 2017 (LUME-Meso)] | |[https://doi.org/10.1200/JCO.2017.72.9012 Grosso et al. 2017 (LUME-Meso)] | ||
| − | |style="background-color:#1a9851"|Phase II/III (C) | + | | style="background-color:#1a9851" |Phase II/III (C) |
|Cisplatin, Nintedanib, Pemetrexed | |Cisplatin, Nintedanib, Pemetrexed | ||
| style="background-color:#ffffbf" |Seems not superior (*) | | style="background-color:#ffffbf" |Seems not superior (*) | ||
| Line 33: | Line 33: | ||
''Note: JMCH did not specify the total number of cycles and some patients did receive more than 6 cycles. Reported efficacy for LUME-Meso is based on the 2019 update.'' | ''Note: JMCH did not specify the total number of cycles and some patients did receive more than 6 cycles. Reported efficacy for LUME-Meso is based on the 2019 update.'' | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
| + | |||
*[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV over 2 hours once on day 1, '''given second, 30 minutes after pemetrexed''' | *[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV over 2 hours once on day 1, '''given second, 30 minutes after pemetrexed''' | ||
*[[Pemetrexed (Alimta)]] 500 mg/m<sup>2</sup> IV over 10 minutes once on day 1, '''given first''' | *[[Pemetrexed (Alimta)]] 500 mg/m<sup>2</sup> IV over 10 minutes once on day 1, '''given first''' | ||
====Supportive medications==== | ====Supportive medications==== | ||
| + | |||
*Folic acid 350 to 1000 mcg PO once per day, starting 1 to 3 weeks before [[Pemetrexed (Alimta)]], to continue throughout therapy | *Folic acid 350 to 1000 mcg PO once per day, starting 1 to 3 weeks before [[Pemetrexed (Alimta)]], to continue throughout therapy | ||
*[[Cyanocobalamin (Vitamin B12)]] 1000 mcg IM once 1 to 3 weeks before [[Pemetrexed (Alimta)]], then 1000 mcg IM once every 9 weeks | *[[Cyanocobalamin (Vitamin B12)]] 1000 mcg IM once 1 to 3 weeks before [[Pemetrexed (Alimta)]], then 1000 mcg IM once every 9 weeks | ||
| Line 44: | Line 46: | ||
===References=== | ===References=== | ||
| − | # '''JMCH:''' Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. [http://jco.ascopubs.org/content/21/14/2636.long link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/12860938 PubMed] | + | |
| − | ## '''Update:''' Manegold C, Symanowski J, Gatzemeier U, Reck M, von Pawel J, Kortsik C, Nackaerts K, Lianes P, Vogelzang NJ. Second-line (post-study) chemotherapy received by patients treated in the phase III trial of pemetrexed plus cisplatin versus cisplatin alone in malignant pleural mesothelioma. Ann Oncol. 2005 Jun;16(6):923-7. Epub 2005 Apr 11. [http://annonc.oxfordjournals.org/content/16/6/923.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/15824080 PubMed] | + | #'''JMCH:''' Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. [http://jco.ascopubs.org/content/21/14/2636.long link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/12860938 PubMed] |
| + | ##'''Update:''' Manegold C, Symanowski J, Gatzemeier U, Reck M, von Pawel J, Kortsik C, Nackaerts K, Lianes P, Vogelzang NJ. Second-line (post-study) chemotherapy received by patients treated in the phase III trial of pemetrexed plus cisplatin versus cisplatin alone in malignant pleural mesothelioma. Ann Oncol. 2005 Jun;16(6):923-7. Epub 2005 Apr 11. [http://annonc.oxfordjournals.org/content/16/6/923.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/15824080 PubMed] | ||
<!-- # '''Abstract:''' Gerard Zalcman, Julien Mazières, Jacques Margery, Laurent Greillier, Clarisse Audigier-Valette, Denis Moro-Sibilot, Oliver Molinier, Romain Corre, Isabelle Monnet, Valérie Gounant, Henri Janicot, Radj Gervais, Chrystele Locher, Bernard Milleron, Quan Tran, Marie Paule Lebitasy, Franck Morin, Christian Creveuil, Jean-Jacques Parienti, Arnaud Scherpereel, French Cooperative Thoracic Intergroup (IFCT). Bevacizumab 15mg/kg plus cisplatin-pemetrexed (CP) triplet versus CP doublet in Malignant Pleural Mesothelioma (MPM): Results of the IFCT-GFPC-0701 MAPS randomized phase 3 trial. J Clin Oncol 33, 2015 (suppl; abstr 7500) [http://meetinglibrary.asco.org/content/150191-156 link to abstract] --> | <!-- # '''Abstract:''' Gerard Zalcman, Julien Mazières, Jacques Margery, Laurent Greillier, Clarisse Audigier-Valette, Denis Moro-Sibilot, Oliver Molinier, Romain Corre, Isabelle Monnet, Valérie Gounant, Henri Janicot, Radj Gervais, Chrystele Locher, Bernard Milleron, Quan Tran, Marie Paule Lebitasy, Franck Morin, Christian Creveuil, Jean-Jacques Parienti, Arnaud Scherpereel, French Cooperative Thoracic Intergroup (IFCT). Bevacizumab 15mg/kg plus cisplatin-pemetrexed (CP) triplet versus CP doublet in Malignant Pleural Mesothelioma (MPM): Results of the IFCT-GFPC-0701 MAPS randomized phase 3 trial. J Clin Oncol 33, 2015 (suppl; abstr 7500) [http://meetinglibrary.asco.org/content/150191-156 link to abstract] --> | ||
| − | # '''MAPS:''' Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Rivière F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-14. Epub 2015 Dec 21. Erratum in: Lancet. 2016 Apr 2;387(10026):e24. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01238-6/abstract link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/26719230 PubMed] | + | #'''MAPS:''' Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Rivière F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-14. Epub 2015 Dec 21. Erratum in: Lancet. 2016 Apr 2;387(10026):e24. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01238-6/abstract link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/26719230 PubMed] |
| − | # '''LUME-Meso:''' Grosso F, Steele N, Novello S, Nowak AK, Popat S, Greillier L, John T, Leighl NB, Reck M, Taylor P, Planchard D, Sørensen JB, Socinski MA, von Wangenheim U, Loembé AB, Barrueco J, Morsli N, Scagliotti G. Nintedanib plus pemetrexed/cisplatin in patients with malignant pleural mesothelioma: Phase II results from the randomized, placebo-controlled LUME-Meso trial. J Clin Oncol. 2017 Nov 1;35(31):3591-3600. Epub 2017 Sep 11. [https://doi.org/10.1200/JCO.2017.72.9012 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/28892431 PubMed] | + | #'''LUME-Meso:''' Grosso F, Steele N, Novello S, Nowak AK, Popat S, Greillier L, John T, Leighl NB, Reck M, Taylor P, Planchard D, Sørensen JB, Socinski MA, von Wangenheim U, Loembé AB, Barrueco J, Morsli N, Scagliotti G. Nintedanib plus pemetrexed/cisplatin in patients with malignant pleural mesothelioma: Phase II results from the randomized, placebo-controlled LUME-Meso trial. J Clin Oncol. 2017 Nov 1;35(31):3591-3600. Epub 2017 Sep 11. [https://doi.org/10.1200/JCO.2017.72.9012 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/28892431 PubMed] |
| − | ## '''Update:''' Scagliotti GV, Gaafar R, Nowak AK, Nakano T, van Meerbeeck J, Popat S, Vogelzang NJ, Grosso F, Aboelhassan R, Jakopovic M, Ceresoli GL, Taylor P, Orlandi F, Fennell DA, Novello S, Scherpereel A, Kuribayashi K, Cedres S, Sørensen JB, Pavlakis N, Reck M, Velema D, von Wangenheim U, Kim M, Barrueco J, Tsao AS. Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2019 Jul;7(7):569-580. Epub 2019 May 15. [https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(19)30139-0/fulltext link to original article] [https://pubmed.ncbi.nlm.nih.gov/31103412 PubMed] | + | ##'''Update:''' Scagliotti GV, Gaafar R, Nowak AK, Nakano T, van Meerbeeck J, Popat S, Vogelzang NJ, Grosso F, Aboelhassan R, Jakopovic M, Ceresoli GL, Taylor P, Orlandi F, Fennell DA, Novello S, Scherpereel A, Kuribayashi K, Cedres S, Sørensen JB, Pavlakis N, Reck M, Velema D, von Wangenheim U, Kim M, Barrueco J, Tsao AS. Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2019 Jul;7(7):569-580. Epub 2019 May 15. [https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(19)30139-0/fulltext link to original article] [https://pubmed.ncbi.nlm.nih.gov/31103412 PubMed] |
==Cisplatin & Pemetrexed -- proposed version {{#subobject:c2805d|Regimen=1}}== | ==Cisplatin & Pemetrexed -- proposed version {{#subobject:c2805d|Regimen=1}}== | ||
| Line 59: | Line 62: | ||
{| class="wikitable" style="color:white; background-color:#404040" | {| class="wikitable" style="color:white; background-color:#404040" | ||
|<small>'''FDA-recommended dose'''</small> | |<small>'''FDA-recommended dose'''</small> | ||
| − | |style="background-color:#1a9851"|<small>'''NCCN Category 1'''</small> | + | | style="background-color:#1a9851" |<small>'''NCCN Category 1'''</small> |
|- | |- | ||
|} | |} | ||
{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
| − | !style="width: 25%"|Study | + | ! style="width: 25%" |Study |
| − | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]] |
| − | !style="width: 25%"|Comparator | + | ! style="width: 25%" |Comparator |
| − | !style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] |
|- | |- | ||
|[http://jco.ascopubs.org/content/21/14/2636.long Vogelzang et al. 2003 (JMCH)] | |[http://jco.ascopubs.org/content/21/14/2636.long Vogelzang et al. 2003 (JMCH)] | ||
| − | |style="background-color:#1a9851"|Phase III (E-RT) | + | | style="background-color:#1a9851" |Phase III (E-RT) |
|[[#Cisplatin_monotherapy|Cisplatin]] | |[[#Cisplatin_monotherapy|Cisplatin]] | ||
| − | |style="background-color:#91cf60"|Seems to have superior OS | + | | style="background-color:#91cf60" |Seems to have superior OS |
|- | |- | ||
|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01238-6/abstract Zalcman et al. 2016 (MAPS)] | |[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01238-6/abstract Zalcman et al. 2016 (MAPS)] | ||
| − | |style="background-color:#1a9851"|Phase III (C) | + | | style="background-color:#1a9851" |Phase III (C) |
|[[#Cisplatin.2C_Pemetrexed.2C_Bevacizumab|PCB]] | |[[#Cisplatin.2C_Pemetrexed.2C_Bevacizumab|PCB]] | ||
| − | |style="background-color:#fc8d59"|Seems to have inferior OS | + | | style="background-color:#fc8d59" |Seems to have inferior OS |
|- | |- | ||
|[https://doi.org/10.1200/JCO.2017.72.9012 Grosso et al. 2017 (LUME-Meso)] | |[https://doi.org/10.1200/JCO.2017.72.9012 Grosso et al. 2017 (LUME-Meso)] | ||
| − | |style="background-color:#1a9851"|Phase II/III (C) | + | | style="background-color:#1a9851" |Phase II/III (C) |
|Cisplatin, Nintedanib, Pemetrexed | |Cisplatin, Nintedanib, Pemetrexed | ||
| style="background-color:#ffffbf" |Seems not superior (*) | | style="background-color:#ffffbf" |Seems not superior (*) | ||
| Line 86: | Line 89: | ||
''Note: JMCH did not specify the total number of cycles and some patients did receive more than 6 cycles. Reported efficacy for LUME-Meso is based on the 2019 update.'' | ''Note: JMCH did not specify the total number of cycles and some patients did receive more than 6 cycles. Reported efficacy for LUME-Meso is based on the 2019 update.'' | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
| + | |||
*[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV over 2 hours once on day 1, '''given second, 30 minutes after pemetrexed''' | *[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV over 2 hours once on day 1, '''given second, 30 minutes after pemetrexed''' | ||
*[[Pemetrexed (Alimta)]] 500 mg/m<sup>2</sup> IV over 10 minutes once on day 1, '''given first''' | *[[Pemetrexed (Alimta)]] 500 mg/m<sup>2</sup> IV over 10 minutes once on day 1, '''given first''' | ||
====Supportive medications==== | ====Supportive medications==== | ||
| + | |||
*Folic acid 350 to 1000 mcg PO once per day, starting 1 to 3 weeks before [[Pemetrexed (Alimta)]], to continue throughout therapy | *Folic acid 350 to 1000 mcg PO once per day, starting 1 to 3 weeks before [[Pemetrexed (Alimta)]], to continue throughout therapy | ||
*[[Cyanocobalamin (Vitamin B12)]] 1000 mcg IM once 1 to 3 weeks before [[Pemetrexed (Alimta)]], then 1000 mcg IM once every 9 weeks | *[[Cyanocobalamin (Vitamin B12)]] 1000 mcg IM once 1 to 3 weeks before [[Pemetrexed (Alimta)]], then 1000 mcg IM once every 9 weeks | ||
| Line 97: | Line 102: | ||
===References=== | ===References=== | ||
| − | # '''JMCH:''' Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. [http://jco.ascopubs.org/content/21/14/2636.long link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/12860938 PubMed] | + | |
| − | ## '''Update:''' Manegold C, Symanowski J, Gatzemeier U, Reck M, von Pawel J, Kortsik C, Nackaerts K, Lianes P, Vogelzang NJ. Second-line (post-study) chemotherapy received by patients treated in the phase III trial of pemetrexed plus cisplatin versus cisplatin alone in malignant pleural mesothelioma. Ann Oncol. 2005 Jun;16(6):923-7. Epub 2005 Apr 11. [http://annonc.oxfordjournals.org/content/16/6/923.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/15824080 PubMed] | + | #'''JMCH:''' Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. [http://jco.ascopubs.org/content/21/14/2636.long link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/12860938 PubMed] |
| + | ##'''Update:''' Manegold C, Symanowski J, Gatzemeier U, Reck M, von Pawel J, Kortsik C, Nackaerts K, Lianes P, Vogelzang NJ. Second-line (post-study) chemotherapy received by patients treated in the phase III trial of pemetrexed plus cisplatin versus cisplatin alone in malignant pleural mesothelioma. Ann Oncol. 2005 Jun;16(6):923-7. Epub 2005 Apr 11. [http://annonc.oxfordjournals.org/content/16/6/923.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/15824080 PubMed] | ||
<!-- # '''Abstract:''' Gerard Zalcman, Julien Mazières, Jacques Margery, Laurent Greillier, Clarisse Audigier-Valette, Denis Moro-Sibilot, Oliver Molinier, Romain Corre, Isabelle Monnet, Valérie Gounant, Henri Janicot, Radj Gervais, Chrystele Locher, Bernard Milleron, Quan Tran, Marie Paule Lebitasy, Franck Morin, Christian Creveuil, Jean-Jacques Parienti, Arnaud Scherpereel, French Cooperative Thoracic Intergroup (IFCT). Bevacizumab 15mg/kg plus cisplatin-pemetrexed (CP) triplet versus CP doublet in Malignant Pleural Mesothelioma (MPM): Results of the IFCT-GFPC-0701 MAPS randomized phase 3 trial. J Clin Oncol 33, 2015 (suppl; abstr 7500) [http://meetinglibrary.asco.org/content/150191-156 link to abstract] --> | <!-- # '''Abstract:''' Gerard Zalcman, Julien Mazières, Jacques Margery, Laurent Greillier, Clarisse Audigier-Valette, Denis Moro-Sibilot, Oliver Molinier, Romain Corre, Isabelle Monnet, Valérie Gounant, Henri Janicot, Radj Gervais, Chrystele Locher, Bernard Milleron, Quan Tran, Marie Paule Lebitasy, Franck Morin, Christian Creveuil, Jean-Jacques Parienti, Arnaud Scherpereel, French Cooperative Thoracic Intergroup (IFCT). Bevacizumab 15mg/kg plus cisplatin-pemetrexed (CP) triplet versus CP doublet in Malignant Pleural Mesothelioma (MPM): Results of the IFCT-GFPC-0701 MAPS randomized phase 3 trial. J Clin Oncol 33, 2015 (suppl; abstr 7500) [http://meetinglibrary.asco.org/content/150191-156 link to abstract] --> | ||
| − | # '''MAPS:''' Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Rivière F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-14. Epub 2015 Dec 21. Erratum in: Lancet. 2016 Apr 2;387(10026):e24. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01238-6/abstract link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/26719230 PubMed] | + | #'''MAPS:''' Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Rivière F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-14. Epub 2015 Dec 21. Erratum in: Lancet. 2016 Apr 2;387(10026):e24. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01238-6/abstract link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/26719230 PubMed] |
| − | # '''LUME-Meso:''' Grosso F, Steele N, Novello S, Nowak AK, Popat S, Greillier L, John T, Leighl NB, Reck M, Taylor P, Planchard D, Sørensen JB, Socinski MA, von Wangenheim U, Loembé AB, Barrueco J, Morsli N, Scagliotti G. Nintedanib plus pemetrexed/cisplatin in patients with malignant pleural mesothelioma: Phase II results from the randomized, placebo-controlled LUME-Meso trial. J Clin Oncol. 2017 Nov 1;35(31):3591-3600. Epub 2017 Sep 11. [https://doi.org/10.1200/JCO.2017.72.9012 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/28892431 PubMed] | + | #'''LUME-Meso:''' Grosso F, Steele N, Novello S, Nowak AK, Popat S, Greillier L, John T, Leighl NB, Reck M, Taylor P, Planchard D, Sørensen JB, Socinski MA, von Wangenheim U, Loembé AB, Barrueco J, Morsli N, Scagliotti G. Nintedanib plus pemetrexed/cisplatin in patients with malignant pleural mesothelioma: Phase II results from the randomized, placebo-controlled LUME-Meso trial. J Clin Oncol. 2017 Nov 1;35(31):3591-3600. Epub 2017 Sep 11. [https://doi.org/10.1200/JCO.2017.72.9012 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/28892431 PubMed] |
| − | ## '''Update:''' Scagliotti GV, Gaafar R, Nowak AK, Nakano T, van Meerbeeck J, Popat S, Vogelzang NJ, Grosso F, Aboelhassan R, Jakopovic M, Ceresoli GL, Taylor P, Orlandi F, Fennell DA, Novello S, Scherpereel A, Kuribayashi K, Cedres S, Sørensen JB, Pavlakis N, Reck M, Velema D, von Wangenheim U, Kim M, Barrueco J, Tsao AS. Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2019 Jul;7(7):569-580. Epub 2019 May 15. [https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(19)30139-0/fulltext link to original article] [https://pubmed.ncbi.nlm.nih.gov/31103412 PubMed] | + | ##'''Update:''' Scagliotti GV, Gaafar R, Nowak AK, Nakano T, van Meerbeeck J, Popat S, Vogelzang NJ, Grosso F, Aboelhassan R, Jakopovic M, Ceresoli GL, Taylor P, Orlandi F, Fennell DA, Novello S, Scherpereel A, Kuribayashi K, Cedres S, Sørensen JB, Pavlakis N, Reck M, Velema D, von Wangenheim U, Kim M, Barrueco J, Tsao AS. Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2019 Jul;7(7):569-580. Epub 2019 May 15. [https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(19)30139-0/fulltext link to original article] [https://pubmed.ncbi.nlm.nih.gov/31103412 PubMed] |
| − | Version 1.31. | + | Version 1.31.6 test edit |
[[Category:Null pages]] | [[Category:Null pages]] | ||
Revision as of 19:10, 7 March 2020
Cisplatin & Pemetrexed -- current version
| back to top |
Regimen
| FDA-recommended dose |
| Study | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|
| Vogelzang et al. 2003 (JMCH) | Phase III (E-RT) | Cisplatin | Seems to have superior OS |
| Zalcman et al. 2016 (MAPS) | Phase III (C) | PCB | Seems to have inferior OS |
| Grosso et al. 2017 (LUME-Meso) | Phase II/III (C) | Cisplatin, Nintedanib, Pemetrexed | Seems not superior (*) |
Note: JMCH did not specify the total number of cycles and some patients did receive more than 6 cycles. Reported efficacy for LUME-Meso is based on the 2019 update.
Chemotherapy
- Cisplatin (Platinol) 75 mg/m2 IV over 2 hours once on day 1, given second, 30 minutes after pemetrexed
- Pemetrexed (Alimta) 500 mg/m2 IV over 10 minutes once on day 1, given first
Supportive medications
- Folic acid 350 to 1000 mcg PO once per day, starting 1 to 3 weeks before Pemetrexed (Alimta), to continue throughout therapy
- Cyanocobalamin (Vitamin B12) 1000 mcg IM once 1 to 3 weeks before Pemetrexed (Alimta), then 1000 mcg IM once every 9 weeks
- Dexamethasone (Decadron) (dose not specified by reference) the day before, the day of, and day after Pemetrexed (Alimta)
21-day cycle for up to 6 cycles (see note)
References
- JMCH: Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. link to original article contains verified protocol PubMed
- Update: Manegold C, Symanowski J, Gatzemeier U, Reck M, von Pawel J, Kortsik C, Nackaerts K, Lianes P, Vogelzang NJ. Second-line (post-study) chemotherapy received by patients treated in the phase III trial of pemetrexed plus cisplatin versus cisplatin alone in malignant pleural mesothelioma. Ann Oncol. 2005 Jun;16(6):923-7. Epub 2005 Apr 11. link to original article PubMed
- MAPS: Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Rivière F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-14. Epub 2015 Dec 21. Erratum in: Lancet. 2016 Apr 2;387(10026):e24. link to original article contains protocol PubMed
- LUME-Meso: Grosso F, Steele N, Novello S, Nowak AK, Popat S, Greillier L, John T, Leighl NB, Reck M, Taylor P, Planchard D, Sørensen JB, Socinski MA, von Wangenheim U, Loembé AB, Barrueco J, Morsli N, Scagliotti G. Nintedanib plus pemetrexed/cisplatin in patients with malignant pleural mesothelioma: Phase II results from the randomized, placebo-controlled LUME-Meso trial. J Clin Oncol. 2017 Nov 1;35(31):3591-3600. Epub 2017 Sep 11. link to original article contains verified protocol PubMed
- Update: Scagliotti GV, Gaafar R, Nowak AK, Nakano T, van Meerbeeck J, Popat S, Vogelzang NJ, Grosso F, Aboelhassan R, Jakopovic M, Ceresoli GL, Taylor P, Orlandi F, Fennell DA, Novello S, Scherpereel A, Kuribayashi K, Cedres S, Sørensen JB, Pavlakis N, Reck M, Velema D, von Wangenheim U, Kim M, Barrueco J, Tsao AS. Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2019 Jul;7(7):569-580. Epub 2019 May 15. link to original article PubMed
Cisplatin & Pemetrexed -- proposed version
| back to top |
Regimen
| FDA-recommended dose | NCCN Category 1 |
| Study | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|
| Vogelzang et al. 2003 (JMCH) | Phase III (E-RT) | Cisplatin | Seems to have superior OS |
| Zalcman et al. 2016 (MAPS) | Phase III (C) | PCB | Seems to have inferior OS |
| Grosso et al. 2017 (LUME-Meso) | Phase II/III (C) | Cisplatin, Nintedanib, Pemetrexed | Seems not superior (*) |
Note: JMCH did not specify the total number of cycles and some patients did receive more than 6 cycles. Reported efficacy for LUME-Meso is based on the 2019 update.
Chemotherapy
- Cisplatin (Platinol) 75 mg/m2 IV over 2 hours once on day 1, given second, 30 minutes after pemetrexed
- Pemetrexed (Alimta) 500 mg/m2 IV over 10 minutes once on day 1, given first
Supportive medications
- Folic acid 350 to 1000 mcg PO once per day, starting 1 to 3 weeks before Pemetrexed (Alimta), to continue throughout therapy
- Cyanocobalamin (Vitamin B12) 1000 mcg IM once 1 to 3 weeks before Pemetrexed (Alimta), then 1000 mcg IM once every 9 weeks
- Dexamethasone (Decadron) (dose not specified by reference) the day before, the day of, and day after Pemetrexed (Alimta)
21-day cycle for up to 6 cycles (see note)
References
- JMCH: Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. link to original article contains verified protocol PubMed
- Update: Manegold C, Symanowski J, Gatzemeier U, Reck M, von Pawel J, Kortsik C, Nackaerts K, Lianes P, Vogelzang NJ. Second-line (post-study) chemotherapy received by patients treated in the phase III trial of pemetrexed plus cisplatin versus cisplatin alone in malignant pleural mesothelioma. Ann Oncol. 2005 Jun;16(6):923-7. Epub 2005 Apr 11. link to original article PubMed
- MAPS: Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Rivière F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-14. Epub 2015 Dec 21. Erratum in: Lancet. 2016 Apr 2;387(10026):e24. link to original article contains protocol PubMed
- LUME-Meso: Grosso F, Steele N, Novello S, Nowak AK, Popat S, Greillier L, John T, Leighl NB, Reck M, Taylor P, Planchard D, Sørensen JB, Socinski MA, von Wangenheim U, Loembé AB, Barrueco J, Morsli N, Scagliotti G. Nintedanib plus pemetrexed/cisplatin in patients with malignant pleural mesothelioma: Phase II results from the randomized, placebo-controlled LUME-Meso trial. J Clin Oncol. 2017 Nov 1;35(31):3591-3600. Epub 2017 Sep 11. link to original article contains verified protocol PubMed
- Update: Scagliotti GV, Gaafar R, Nowak AK, Nakano T, van Meerbeeck J, Popat S, Vogelzang NJ, Grosso F, Aboelhassan R, Jakopovic M, Ceresoli GL, Taylor P, Orlandi F, Fennell DA, Novello S, Scherpereel A, Kuribayashi K, Cedres S, Sørensen JB, Pavlakis N, Reck M, Velema D, von Wangenheim U, Kim M, Barrueco J, Tsao AS. Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2019 Jul;7(7):569-580. Epub 2019 May 15. link to original article PubMed
Version 1.31.6 test edit