Difference between revisions of "Carboplatin, Pemetrexed, Pembrolizumab in advanced or metastatic non-small cell lung cancer"

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!Study
 
!Study
 
![[Levels_of_Evidence#Evidence|Evidence]]
 
![[Levels_of_Evidence#Evidence|Evidence]]
|'''[[Overall response rate|ORR]]'''
 
 
!Comparator
 
!Comparator
 
![[Levels_of_Evidence#Efficacy|Efficacy]]
 
![[Levels_of_Evidence#Efficacy|Efficacy]]
 
|-
 
|-
 
|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30498-3/fulltext Langer et al. 2016 (KEYNOTE-021)]
 
|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30498-3/fulltext Langer et al. 2016 (KEYNOTE-021)]
|style="background-color:#1a9851"|Randomized Phase II
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|style="background-color:#1a9851"|Randomized Phase II (E)
|71%
 
 
|[[#Carboplatin_.26_Pemetrexed|Carboplatin & Pemetrexed]] +/- [[#Pemetrexed_monotherapy_2|pemetrexed maintenance]]
 
|[[#Carboplatin_.26_Pemetrexed|Carboplatin & Pemetrexed]] +/- [[#Pemetrexed_monotherapy_2|pemetrexed maintenance]]
 
|style="background-color:#1a9850"|Superior ORR
 
|style="background-color:#1a9850"|Superior ORR
 +
|-
 +
|[https://www.nejm.org/doi/full/10.1056/NEJMoa1801005 Gandhi et al. 2018 (KEYNOTE-189)]
 +
|style="background-color:#1a9851"|Phase III
 +
|[[Complex_multipart_regimens#KEYNOTE-189|See link]]
 +
|style="background-color:#1a9850"|[[Complex_multipart_regimens#KEYNOTE-189|See link]]
 
|-
 
|-
 
|}
 
|}
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''Note: selection of platinum agent in KEYNOTE-189 was per investigator choice.''
 
====Chemoimmunotherapy====
 
====Chemoimmunotherapy====
 
*[[Carboplatin (Paraplatin)]] AUC 5 IV over 15 to 60 minutes once on day 1 '''given last'''
 
*[[Carboplatin (Paraplatin)]] AUC 5 IV over 15 to 60 minutes once on day 1 '''given last'''
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*"Premedication with [[Folic acid (Folate)|folic acid]], [[Cyanocobalamin (Vitamin B12)|vitamin B12]], and [[:Category:Steroids|corticosteroids]] was administered according to local guidelines."
 
*"Premedication with [[Folic acid (Folate)|folic acid]], [[Cyanocobalamin (Vitamin B12)|vitamin B12]], and [[:Category:Steroids|corticosteroids]] was administered according to local guidelines."
  
'''21-day cycle for 4 cycles.''' Followed by [[Pembrolizumab & Pemetrexed maintenance therapy for advanced or metastatic non-small cell lung cancer|pembolizumab +/- pemetrexed maintenance therapy]]
+
'''21-day cycle for 4 cycles'''  
 +
====Subsequent treatment====
 +
*KEYNOTE-021: [[Pembrolizumab & Pemetrexed maintenance therapy for advanced or metastatic non-small cell lung cancer|Pembrolizumab +/- Pemetrexed maintenance]]
 +
*KEYNOTE-189: [[Pembrolizumab & Pemetrexed maintenance therapy for advanced or metastatic non-small cell lung cancer|Pemetrexed & Pembrolizumab maintenance]]
  
 
===References===
 
===References===
# Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Ge Y, Raftopoulos H, Gandhi L; KEYNOTE-021 investigators. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016 Nov;17(11):1497-1508 [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30498-3/fulltext link to original article] '''contains verified protocol''' [http://thelancet.com/cms/attachment/2074509559/2069027402/mmc1.pdf supplementary appendix]; [https://www.ncbi.nlm.nih.gov/pubmed/27745820 PubMed]
+
# '''KEYNOTE-021:''' Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Ge Y, Raftopoulos H, Gandhi L; KEYNOTE-021 investigators. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016 Nov;17(11):1497-1508 [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30498-3/fulltext link to original article] '''contains verified protocol''' [http://thelancet.com/cms/attachment/2074509559/2069027402/mmc1.pdf supplementary appendix]; [https://www.ncbi.nlm.nih.gov/pubmed/27745820 PubMed]
 +
# '''KEYNOTE-189:''' Gandhi L, Rodríguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, Garassino MC; KEYNOTE-189 Investigators. Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer. N Engl J Med. 2018 May 31;378(22):2078-2092. Epub 2018 Apr 16. [https://www.nejm.org/doi/full/10.1056/NEJMoa1801005 link to original article] [https://www.nejm.org/doi/suppl/10.1056/NEJMoa1801005/suppl_file/nejmoa1801005_protocol.pdf link to protocol] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/29658856 PubMed]

Revision as of 15:35, 9 June 2018



Regimen in use at


Regimen

Study Evidence Comparator Efficacy
Langer et al. 2016 (KEYNOTE-021) Randomized Phase II (E) Carboplatin & Pemetrexed +/- pemetrexed maintenance Superior ORR
Gandhi et al. 2018 (KEYNOTE-189) Phase III See link See link

Note: selection of platinum agent in KEYNOTE-189 was per investigator choice.

Chemoimmunotherapy

Supportive medications

21-day cycle for 4 cycles

Subsequent treatment

References

  1. KEYNOTE-021: Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Ge Y, Raftopoulos H, Gandhi L; KEYNOTE-021 investigators. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016 Nov;17(11):1497-1508 link to original article contains verified protocol supplementary appendix; PubMed
  2. KEYNOTE-189: Gandhi L, Rodríguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, Garassino MC; KEYNOTE-189 Investigators. Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer. N Engl J Med. 2018 May 31;378(22):2078-2092. Epub 2018 Apr 16. link to original article link to protocol contains verified protocol PubMed