Difference between revisions of "Editing test page 2"

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==Cisplatin & Pemetrexed -- current version {{#subobject:c2805d|Regimen=1}}==
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==Carboplatin & Paclitaxel (CP) {{#subobject:3a6h8q|Regimen=1}}==
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{| class="wikitable" style="float:right; margin-left: 5px;"
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CP: '''<u>C</u>'''arboplatin & '''<u>P</u>'''aclitaxel
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|-
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<div class="toccolours" style="background-color:#eeeeee">
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|[[#top|back to top]]
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===Regimen {{#subobject:1yg1q7|Variant=1}}===
−
|}
 
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===Regimen {{#subobject:3b6a3e|Variant=1}}===
 
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{| class="wikitable" style="color:white; background-color:#404040"
 
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|<small>'''FDA-recommended dose'''</small>
 
−
|-
 
−
|}
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
! style="width: 25%" |Study
 
−
! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
−
! style="width: 25%" |Comparator
 
−
! style="width: 25%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[http://jco.ascopubs.org/content/21/14/2636.long Vogelzang et al. 2003 (JMCH)]
 
−
| style="background-color:#1a9851" |Phase III (E-RT)
 
−
|[[#Cisplatin_monotherapy|Cisplatin]]
 
−
| 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)]
 
−
| style="background-color:#1a9851" |Phase III (C)
 
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|[[#Cisplatin.2C_Pemetrexed.2C_Bevacizumab|PCB]]
 
−
| style="background-color:#fc8d59" |Seems to have inferior OS
 
−
|-
 
−
|[https://doi.org/10.1200/JCO.2017.72.9012 Grosso et al. 2017 (LUME-Meso)]
 
−
| style="background-color:#1a9851" |Phase II/III (C)
 
−
|Cisplatin, Nintedanib, Pemetrexed
 
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| style="background-color:#ffffbf" |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/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'''
 
−
====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. [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. [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]
 
−
#'''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]
 
−
==Cisplatin & Pemetrexed -- proposed version {{#subobject:c2805d|Regimen=1}}==
 
−
{| class="wikitable" style="float:right; margin-left: 5px;"
 
−
|-
 
−
|[[#top|back to top]]
 
−
|}
 
−
===Regimen {{#subobject:3b6a3e|Variant=1}}===
 
−
{| class="wikitable" style="color:white; background-color:#404040"
 
−
|<small>'''FDA-recommended dose'''</small>
 
−
| style="background-color:#1a9851" |<small>'''NCCN Category 1'''</small>
 
−
|-
 
−
|}
 
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"
−
! style="width: 25%" |Study
+
!style="width: 20%"|Study
−
! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 20%"|Dates of enrollment
−
! style="width: 25%" |Comparator
+
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
! style="width: 25%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
+
!style="width: 20%"|Comparator
−
|-
+
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
−
|[http://jco.ascopubs.org/content/21/14/2636.long Vogelzang et al. 2003 (JMCH)]
 
−
| style="background-color:#1a9851" |Phase III (E-RT)
 
−
|[[#Cisplatin_monotherapy|Cisplatin]]
 
−
| 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)]
 
−
| style="background-color:#1a9851" |Phase III (C)
 
−
|[[#Cisplatin.2C_Pemetrexed.2C_Bevacizumab|PCB]]
 
−
| 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/10.1056/nejmoa2202170 Forde et al. 2022 (CheckMate 816)]
−
| style="background-color:#1a9851" |Phase II/III (C)
+
|2017-2019
−
|Cisplatin, Nintedanib, Pemetrexed
+
| style="background-color:#1a9851" |Phase 3 (C)
−
| style="background-color:#ffffbf" |Seems not superior (*)
+
|1a. [[#Carboplatin_.26_Paclitaxel_.28CP.29_.26_Nivolumab|CP & Nivolumab]]<br>1b. [[#Cisplatin_.26_Vinorelbine_.28CVb.29_.26_Nivolumab|CVb & Nivolumab]]<br>1c. [[#Cisplatin_.26_Docetaxel_.28DC.29_.26_Nivolumab|DC & Nivolumab]]
 +
| style="background-color:#d73027" |Inferior EFS
 
|-
 
|-
 
|}
 
|}
−
''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: there were additional comparator options depending on histology; see the respective histology-specific pages for more details. This study was conducted in the United States. The reason for the study was that an unanswered question at the time was whether adding an immune checkpoint inhibitor would improve outcomes.''
 +
<div class="toccolours" style="background-color:#fdcdac">
 +
====Biomarker eligibility criteria====
 +
*CheckMate 816: No sensitizing EGFR or ALK mutations
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
−
*[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV over 2 hours once on day 1, '''given second, 30 minutes after pemetrexed'''
+
*[[Carboplatin (Paraplatin)]] AUC 5 or 6 IV once on day 1
−
*[[Pemetrexed (Alimta)]] 500 mg/m<sup>2</sup> IV over 10 minutes once on day 1, '''given first'''
+
*[[Paclitaxel (Taxol)]] 175 or 200 mg/m<sup>2</sup> IV once on day 1
−
====Supportive medications====
+
'''21-day cycle for 3 cycles'''
−
*Folic acid 350 to 1000 mcg PO once per day, starting 1 to 3 weeks before [[Pemetrexed (Alimta)]], to continue throughout therapy
+
</div>
−
*[[Cyanocobalamin (Vitamin B12)]] 1000 mcg IM once 1 to 3 weeks before [[Pemetrexed (Alimta)]], then 1000 mcg IM once every 9 weeks
+
<div class="toccolours" style="background-color:#cbd5e7">
−
*[[Dexamethasone (Decadron)]] (dose not specified by reference) the day before, the day of, and day after [[Pemetrexed (Alimta)]]
+
====Subsequent treatment====
−
'''21-day cycle for up to 6 cycles (see note)'''
+
*[[Surgery#Surgical_resection|Complete resection]]
 +
</div></div>
 
===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]
+
#'''CheckMate 816:''' Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. Epub 2022 Apr 11. [https://doi.org/10.1056/nejmoa2202170 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35403841/ PubMed] [https://clinicaltrials.gov/study/NCT02998528 NCT02998528]
−
##'''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]
+
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#'''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]
+
 
−
##'''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]
+
 
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test edit after update (visual)
+
 
−
[[Category:Null pages]]
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Latest revision as of 14:51, 29 October 2023

Carboplatin & Paclitaxel (CP)

CP: Carboplatin & Paclitaxel

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Forde et al. 2022 (CheckMate 816) 2017-2019 Phase 3 (C) 1a. CP & Nivolumab
1b. CVb & Nivolumab
1c. DC & Nivolumab 		Inferior EFS

Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details. This study was conducted in the United States. The reason for the study was that an unanswered question at the time was whether adding an immune checkpoint inhibitor would improve outcomes.

Biomarker eligibility criteria

  • CheckMate 816: No sensitizing EGFR or ALK mutations

Chemotherapy

21-day cycle for 3 cycles

Subsequent treatment

References

  1. CheckMate 816: Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. Epub 2022 Apr 11. link to original article contains dosing details in manuscript PubMed NCT02998528

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