Difference between revisions of "Editing test page 2"
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| − | {| class="wikitable sortable" style="width: 100%; text-align:center;" | + | {| class="wikitable sortable" 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]] | ||
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''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 | ||
*[[Dexamethasone (Decadron)]] (dose not specified by reference) the day before, the day of, and day after [[Pemetrexed (Alimta)]] | *[[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)''' | '''21-day cycle for up to 6 cycles (see note)''' | ||
| − | |||
===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] | #'''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. [ | + | ##'''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. [https://annonc.oxfordjournals.org/content/16/6/923.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/15824080 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] | #'''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}}== | ||
{| class="wikitable" style="float:right; margin-left: 5px;" | {| class="wikitable" style="float:right; margin-left: 5px;" | ||
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|- | |- | ||
|} | |} | ||
| − | {| class="wikitable sortable" style="width: 100%; text-align:center;" | + | {| class="wikitable sortable" 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]] | ||
| Line 89: | Line 81: | ||
''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 | ||
*[[Dexamethasone (Decadron)]] (dose not specified by reference) the day before, the day of, and day after [[Pemetrexed (Alimta)]] | *[[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)''' | '''21-day cycle for up to 6 cycles (see note)''' | ||
| − | |||
===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] | #'''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. [ | + | ##'''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. [https://annonc.oxfordjournals.org/content/16/6/923.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/15824080 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] | #'''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] | ||
| − | + | test edit after update (visual) | |
| − | test edit after update ( | ||
[[Category:Null pages]] | [[Category:Null pages]] | ||
Revision as of 13:23, 18 September 2021
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
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