Phase III Clinical Trials in First-Line Follicular Lymphoma: A Review of Their Design and Interpretation.
Follicular lymphoma
Obinutuzumab
Rituximab
Journal
Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
received:
15
01
2021
accepted:
07
04
2021
pubmed:
28
5
2021
medline:
6
8
2021
entrez:
27
5
2021
Statut:
ppublish
Résumé
Follicular lymphoma (FL) is one of the most common subtypes of non-Hodgkin lymphoma worldwide. Improved survival outcomes with rituximab-based therapy in clinical trials led to the establishment of rituximab-based immunochemotherapy as standard of care for first-line (1L) treatment of FL. In the GALLIUM trial, obinutuzumab-based immunochemotherapy demonstrated improved progression-free survival (PFS), prolonged time-to-next antilymphoma treatment (TTNT) and comparable overall survival (OS) compared with rituximab-based immunochemotherapy as 1L treatment for FL. Using GALLIUM as an example, this article aims to explain how improved outcomes in 1L treatment of FL have changed the landscape for the design and interpretation of future trials. As approved therapies for 1L FL already achieve good responses, it is becoming more difficult to design trials that demonstrate further treatment benefits with the currently accepted primary endpoints. New endpoints are needed to reflect the long remission times, low relapse rates, and impact of subsequent therapies in FL. PFS is used as a primary efficacy endpoint in registrational clinical trials for indolent malignancies like FL, where improvement in OS is not always observed due to the large number of patients and long study duration required to demonstrate a clear survival benefit. However, there are limitations to using PFS as the primary endpoint. Other potential endpoints, including TTNT, progression of disease within 2 years, response rate, and minimal residual disease status are explored.
Identifiants
pubmed: 34041708
doi: 10.1007/s12325-021-01738-2
pii: 10.1007/s12325-021-01738-2
pmc: PMC8280048
doi:
Substances chimiques
Rituximab
4F4X42SYQ6
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Review
Langues
eng
Pagination
3489-3505Informations de copyright
© 2021. The Author(s).
Références
Ann Oncol. 2014 Feb;25(2):442-7
pubmed: 24412823
Lancet Oncol. 2015 Sep;16(9):1111-1122
pubmed: 26256760
J Clin Oncol. 2018 Aug 10;36(23):2363-2365
pubmed: 29856695
Blood. 2016 Jan 21;127(3):279-86
pubmed: 26576865
J Clin Oncol. 2019 Nov 1;37(31):2815-2824
pubmed: 31339826
Eur J Cancer. 2017 May;76:216-225
pubmed: 28336303
Haematologica. 2019 Jun;104(6):1202-1208
pubmed: 30573503
J Clin Oncol. 2005 Nov 20;23(33):8447-52
pubmed: 16230674
Blood Adv. 2021 Mar 23;5(6):1729-1732
pubmed: 33729455
JAMA Intern Med. 2013 Apr 22;173(8):611-2
pubmed: 23529157
J Natl Cancer Inst. 2007 May 2;99(9):706-14
pubmed: 17470738
Biosci Rep. 2018 Oct 5;38(5):
pubmed: 30054431
Blood. 2005 Dec 1;106(12):3725-32
pubmed: 16123223
Bone Marrow Transplant. 2016 Dec;51(12):1565-1568
pubmed: 27595280
Blood. 2018 Jul 5;132(1):49-58
pubmed: 29666118
Adv Ther. 2017 Feb;34(2):324-356
pubmed: 28004361
Leukemia. 2020 Feb;34(2):522-532
pubmed: 31462735
J Clin Oncol. 2018 Sep 1;36(25):2593-2602
pubmed: 29975624
Breast Cancer Res Treat. 2019 Aug;176(3):495-506
pubmed: 31065873
J Mol Diagn. 2018 Jul;20(4):389-397
pubmed: 29689379
J Natl Cancer Inst. 2009 Dec 2;101(23):1642-9
pubmed: 19903805
Lancet Oncol. 2018 Nov;19(11):1530-1542
pubmed: 30309758
J Clin Oncol. 2009 Sep 20;27(27):4555-62
pubmed: 19652063
Cancer Med. 2017 Dec;6(12):2766-2774
pubmed: 29076254
Haematologica. 2013 Jul;98(7):1107-14
pubmed: 23645690
N Engl J Med. 2018 Sep 6;379(10):934-947
pubmed: 30184451
Blood. 2021 May 13;137(19):2704-2707
pubmed: 33512481
J Clin Oncol. 2014 Sep 20;32(27):3059-68
pubmed: 25113753
J Clin Oncol. 2013 Apr 20;31(12):1506-13
pubmed: 23530110
J Clin Oncol. 2009 Apr 1;27(10):1607-14
pubmed: 19255334
J Clin Oncol. 2005 Aug 1;23(22):5019-26
pubmed: 15983392
JAMA. 2014 Jan 22-29;311(4):405-11
pubmed: 24449319
Blood. 2008 Dec 15;112(13):4824-31
pubmed: 18799723
Blood. 1997 Jun 1;89(11):3909-18
pubmed: 9166827
Lancet. 2011 Jan 1;377(9759):42-51
pubmed: 21176949
Ther Adv Hematol. 2013 Jun;4(3):189-98
pubmed: 23730496
Blood Adv. 2020 Dec 8;4(23):5951-5957
pubmed: 33275769
J Clin Oncol. 2012 Dec 10;30(35):4317-22
pubmed: 23109699
AAPS J. 2017 May;19(3):669-681
pubmed: 28224402
J Clin Oncol. 2007 Feb 10;25(5):579-86
pubmed: 17242396
J Clin Oncol. 2008 Oct 1;26(28):4579-86
pubmed: 18662969
Onco Targets Ther. 2015 Apr 22;8:921-8
pubmed: 25960663
J Clin Oncol. 2018 Aug 10;36(23):2395-2404
pubmed: 29856692
J Biopharm Stat. 2016;26(1):71-98
pubmed: 26366479
Mediterr J Hematol Infect Dis. 2017 Apr 15;9(1):e2017029
pubmed: 28512558
J Clin Oncol. 2011 Aug 10;29(23):3194-200
pubmed: 21747087
N Engl J Med. 2017 Oct 5;377(14):1331-1344
pubmed: 28976863
Am J Hematol. 2020 Dec;95(12):1503-1510
pubmed: 32815559
Lancet. 2013 Apr 6;381(9873):1203-10
pubmed: 23433739
J Clin Oncol. 2007 May 20;25(15):1986-92
pubmed: 17420513
J Am Coll Cardiol. 2015 Dec 8;66(22):2536-49
pubmed: 26653629
Lancet Oncol. 2018 Apr;19(4):549-561
pubmed: 29475724
Blood. 2013 Nov 14;122(20):3482-91
pubmed: 24106207
Clin Adv Hematol Oncol. 2020 Jun;18 Suppl 10(6):1-20
pubmed: 33843867
J Clin Oncol. 2017 Jan 10;35(2):253-254
pubmed: 28056207
J Clin Oncol. 2018 Oct 1;36(28):2845-2853
pubmed: 30125215
J Clin Oncol. 2020 Feb 10;38(5):522
pubmed: 31804862
J Clin Oncol. 2017 Feb 10;35(5):552-560
pubmed: 28029309