Difference between revisions of "Malignant pleural mesothelioma - null regimens"

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. While not clinically relevant, these references provide further insight into the historical development of the treatment landscape. See the [[Mesothelioma|main mesothelioma page]] for current regimens.
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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 [[Malignant pleural mesothelioma|main MPM page]] for regimens that include active anticancer treatment.
  
 
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==Best supportive care==
 
==Best supportive care==
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{| class="wikitable" style="float:right; margin-left: 5px;"
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−
|-
 
−
|[[#top|back to top]]
 
−
|}
 
 
===Regimen===
 
===Regimen===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
−
!style="width: 20%"|Years of enrollment
+
!style="width: 20%"|Dates of enrollment
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|Comparator
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|rowspan=2|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2431123/ Muers et al. 2008 (MS01)]
 
|rowspan=2|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2431123/ Muers et al. 2008 (MS01)]
 
|rowspan=2|2001-2006
 
|rowspan=2|2001-2006
−
|rowspan=2 style="background-color:#1a9851"|Phase III (C)
+
|rowspan=2 style="background-color:#1a9851"|Phase 3 (C)
−
|1. MVP
+
|1. [[#MVP_999|MVP]]
 
|style="background-color:#ffffbf"|Did not meet primary endpoint of OS
 
|style="background-color:#ffffbf"|Did not meet primary endpoint of OS
 
|-
 
|-
−
|2. [[Mesothelioma#Vinorelbine_monotherapy|Vinorelbine]]
+
|2. [[Malignant_pleural_mesothelioma#Vinorelbine_monotherapy|Vinorelbine]]
 
|style="background-color:#fee08b"|Might have inferior OS
 
|style="background-color:#fee08b"|Might have inferior OS
 
|-
 
|-
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===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://www.thelancet.com/journals/lancet/article/PIIS0140-6736(08)60727-8/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2431123/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/18486741 PubMed]
+
# '''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]
  
−
=Maintenance after first line therapy=
+
=Maintenance after first-line therapy=
 
==Best supportive care==
 
==Best supportive care==
−
{| class="wikitable" style="float:right; margin-left: 5px;"
+
 
−
|-
 
−
|[[#top|back to top]]
 
−
|}
 
 
===Regimen===
 
===Regimen===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
−
!style="width: 20%"|Years of enrollment
+
!style="width: 20%"|Dates of enrollment
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(13)70125-6/fulltext Buikhuisen et al. 2013 (NVALT 5)]
+
|[https://doi.org/10.1016/S1470-2045(13)70125-6 Buikhuisen et al. 2013 (NVALT 5)]
 
|2004-2009
 
|2004-2009
−
|style="background-color:#1a9851"|Phase III (C)
+
|style="background-color:#1a9851"|Phase 3 (C)
−
|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
 
|-
 
|-
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''No antineoplastic treatment after first-line therapy.''
 
''No antineoplastic treatment after first-line therapy.''
 
====Preceding treatment====
 
====Preceding treatment====
−
*[[Regimen_classes#Pemetrexed-containing_regimen|Pemetrexed-containing chemotherapy]] x 4
+
*First-line [[Regimen_classes#Pemetrexed-containing_regimen|pemetrexed-containing chemotherapy]] x 4
 
===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://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(13)70125-6/fulltext link to original article] [https://pubmed.ncbi.nlm.nih.gov/23583604 PubMed]
+
# '''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
  
 
=Advanced or metastatic disease, subsequent lines of therapy=
 
=Advanced or metastatic disease, subsequent lines of therapy=
 
==Best supportive care==
 
==Best supportive care==
−
{| class="wikitable" style="float:right; margin-left: 5px;"
+
 
−
|-
 
−
|[[#top|back to top]]
 
−
|}
 
 
===Regimen===
 
===Regimen===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
−
!style="width: 20%"|Years of enrollment
+
!style="width: 20%"|Dates of enrollment
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[http://jco.ascopubs.org/content/26/10/1698.long Jassem et al. 2008]
+
|[https://doi.org/10.1200/jco.2006.09.9887 Jassem et al. 2008 (JMEW)]
 
|2001-2004
 
|2001-2004
−
|style="background-color:#1a9851"|Phase III (C)
+
|style="background-color:#1a9851"|Phase 3 (C)
−
|[[Mesothelioma#Pemetrexed_monotherapy_2|Pemetrexed]]
+
|[[Malignant_pleural_mesothelioma#Pemetrexed_monotherapy_2|Pemetrexed]]
 
|style="background-color:#fc8d59"|Seems to have inferior PFS
 
|style="background-color:#fc8d59"|Seems to have inferior PFS
 
|-
 
|-
−
|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30446-1/fulltext Maio et al. 2017 (DETERMINE)]
+
|[https://doi.org/10.1016/S1470-2045(17)30446-1 Maio et al. 2017 (DETERMINE)]
 
|2013-2014
 
|2013-2014
−
|style="background-color:#1a9851"|Randomized Phase IIb (C)
+
|style="background-color:#1a9851"|Randomized Phase 2b (C)
−
|Tremelimumab
+
|[[#Tremelimumab_monotherapy_999|Tremelimumab]]
 
|style="background-color:#ffffbf"|Did not meet primary endpoint of OS
 
|style="background-color:#ffffbf"|Did not meet primary endpoint of OS
 
|-
 
|-
Line 91: Line 86:
  
 
===References===
 
===References===
−
# 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. [http://jco.ascopubs.org/content/26/10/1698.long link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/18375898 PubMed]
+
# '''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]
−
# '''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. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30446-1/fulltext link to original article] [https://pubmed.ncbi.nlm.nih.gov/28729154 PubMed]
+
# '''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. [https://doi.org/10.1016/S1470-2045(17)30446-1 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28729154/ PubMed] [https://clinicaltrials.gov/study/NCT01843374 NCT01843374]
  
 
==Placebo==
 
==Placebo==
−
{| class="wikitable" style="float:right; margin-left: 5px;"
+
 
−
|-
 
−
|[[#top|back to top]]
 
−
|}
 
 
===Regimen===
 
===Regimen===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
−
!style="width: 20%"|Years of enrollment
+
!style="width: 20%"|Dates of enrollment
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)70056-2/fulltext Krug et al. 2015 (VANTAGE-014)]
+
|[https://doi.org/10.1016/S1470-2045(15)70056-2 Krug et al. 2015 (VANTAGE-014)]
 
|2005-2011
 
|2005-2011
−
|style="background-color:#1a9851"|Phase III (C)
+
|style="background-color:#1a9851"|Phase 3 (C)
−
|Vorinostat
+
|[[#Vorinostat_monotherapy_999|Vorinostat]]
 
|style="background-color:#ffffbf"|Did not meet primary endpoint of OS
 
|style="background-color:#ffffbf"|Did not meet primary endpoint of OS
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8560642/ Fennell et al. 2021 (CONFIRM<sub>meso</sub>)]
 +
|2017-2020
 +
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[Malignant_pleural_mesothelioma#Nivolumab_monotherapy|Nivolumab]]
 +
| style="background-color:#d73027" |Inferior OS
 
|-
 
|-
 
|}
 
|}
−
''No active antineoplastic treatment.''
+
''No active antineoplastic treatment. Note that CONFIRM should not be confused with the trial by the same name in breast cancer.''
  
 
===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://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)70056-2/fulltext link to original article] [https://pubmed.ncbi.nlm.nih.gov/25800891 PubMed]
+
# '''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]
 +
# '''CONFIRM<sub>meso</sub>:''' 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. [https://doi.org/10.1016/s1470-2045(21)00471-x link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8560642/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34656227/ PubMed] [https://clinicaltrials.gov/study/NCT03063450 NCT03063450]
  
 
[[Category:Mesothelioma regimens]]
 
[[Category:Mesothelioma regimens]]

Latest revision as of 13:20, 8 April 2024

Back to Top

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

  1. 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

No antineoplastic treatment after first-line therapy.

Preceding treatment

References

  1. 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

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

  1. 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
  2. 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 CONFIRM should not be confused with the trial by the same name in breast cancer.

References

  1. 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
  2. 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
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