Real-world comparative effectiveness of second-line ipilimumab for metastatic melanoma: a population-based cohort study in Ontario, Canada.
Comparative effectiveness
Immunotherapy
Metastatic melanoma
Real-world
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
15 Apr 2020
15 Apr 2020
Historique:
received:
17
01
2020
accepted:
27
03
2020
entrez:
16
4
2020
pubmed:
16
4
2020
medline:
19
12
2020
Statut:
epublish
Résumé
For novel cancer treatments, effectiveness in clinical practice is not always aligned with clinical efficacy results. As such it is important to understand a treatment's real-world effectiveness. We examined real-world population-based comparative effectiveness of second-line ipilimumab versus non-ipilimumab treatments (chemotherapy or targeted treatments). We used a cohort of melanoma patients receiving systemic treatment for advanced disease since April 2005 from Ontario, Canada. Patients were identified from provincial drug databases and the Ontario Cancer Registry who received second-line ipilimumab from 2012 to 2015 (treated) or second-line non-ipilimumab treatment prior to 2012 (historical controls). Historical controls were chosen, to permit the most direct comparison to pivotal trial findings. The cohort was linked to administrative databases to identify baseline characteristics and outcomes. Kaplan-Meier curves and multivariable Cox regression models were used to assess overall survival (OS). Observed potential confounders were adjusted for using inverse probability of treatment weighting (IPTW). We identified 329 patients with metastatic melanoma (MM) who had received second-line treatments (189 treated; 140 controls). Patients receiving second-line ipilimumab were older (61.7 years vs 55.2 years) compared to historical controls. Median OS were 6.9 (95% CI: 5.4-8.3) and 4.95 (4.3-6.0) months for ipilimumab and controls, respectively. The crude 1-year, 2-year, and 3-year OS probabilities were 34.3% (27-41%), 20.6% (15-27%), and 15.2% (9.6-21%) for ipilimumab and 17.1% (11-23%), 7.1% (2.9-11%), and 4.7% (1.2-8.2%) for controls. Ipilimumab was associated with improved OS (IPTW HR = 0.62; 95% CI: 0.49-0.78; p < 0.0001). This real-world analysis suggests second-line ipilimumab is associated with an improvement in OS for MM patients in routine practice.
Sections du résumé
BACKGROUND
BACKGROUND
For novel cancer treatments, effectiveness in clinical practice is not always aligned with clinical efficacy results. As such it is important to understand a treatment's real-world effectiveness. We examined real-world population-based comparative effectiveness of second-line ipilimumab versus non-ipilimumab treatments (chemotherapy or targeted treatments).
METHODS
METHODS
We used a cohort of melanoma patients receiving systemic treatment for advanced disease since April 2005 from Ontario, Canada. Patients were identified from provincial drug databases and the Ontario Cancer Registry who received second-line ipilimumab from 2012 to 2015 (treated) or second-line non-ipilimumab treatment prior to 2012 (historical controls). Historical controls were chosen, to permit the most direct comparison to pivotal trial findings. The cohort was linked to administrative databases to identify baseline characteristics and outcomes. Kaplan-Meier curves and multivariable Cox regression models were used to assess overall survival (OS). Observed potential confounders were adjusted for using inverse probability of treatment weighting (IPTW).
RESULTS
RESULTS
We identified 329 patients with metastatic melanoma (MM) who had received second-line treatments (189 treated; 140 controls). Patients receiving second-line ipilimumab were older (61.7 years vs 55.2 years) compared to historical controls. Median OS were 6.9 (95% CI: 5.4-8.3) and 4.95 (4.3-6.0) months for ipilimumab and controls, respectively. The crude 1-year, 2-year, and 3-year OS probabilities were 34.3% (27-41%), 20.6% (15-27%), and 15.2% (9.6-21%) for ipilimumab and 17.1% (11-23%), 7.1% (2.9-11%), and 4.7% (1.2-8.2%) for controls. Ipilimumab was associated with improved OS (IPTW HR = 0.62; 95% CI: 0.49-0.78; p < 0.0001).
CONCLUSIONS
CONCLUSIONS
This real-world analysis suggests second-line ipilimumab is associated with an improvement in OS for MM patients in routine practice.
Identifiants
pubmed: 32293341
doi: 10.1186/s12885-020-06798-1
pii: 10.1186/s12885-020-06798-1
pmc: PMC7158109
doi:
Substances chimiques
Antineoplastic Agents
0
Ipilimumab
0
Types de publication
Clinical Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
304Subventions
Organisme : Canadian Institute of Health Research
ID : FRN151290
Organisme : Ontario Institute for Cancer Research
ID : IA-035
Organisme : Canadian Cancer Society
ID : #2015-703549
Références
Cancer Med. 2016 Jul;5(7):1436-43
pubmed: 27118102
Anticancer Res. 2015 Nov;35(11):6303-10
pubmed: 26504067
N Engl J Med. 2010 Aug 19;363(8):711-23
pubmed: 20525992
J Clin Oncol. 2008 Feb 1;26(4):527-34
pubmed: 18235113
N Engl J Med. 2015 Jan 22;372(4):320-30
pubmed: 25399552
Lancet Oncol. 2016 Nov;17(11):1558-1568
pubmed: 27622997
J Chemother. 2017 Aug;29(4):245-251
pubmed: 28398170
Lancet Oncol. 2015 Aug;16(8):908-18
pubmed: 26115796
Med Care. 2011 Oct;49(10):940-7
pubmed: 21921849
Oncol Lett. 2016 Feb;11(2):1581-1585
pubmed: 26893783
Ann Oncol. 2013 Oct;24(10):2694-8
pubmed: 23942774
Multivariate Behav Res. 2011 May;46(3):399-424
pubmed: 21818162
J Cancer Res Clin Oncol. 2017 Oct;143(10):2087-2094
pubmed: 28608286
Anticancer Drugs. 2018 Jul;29(6):572-578
pubmed: 29659371
Melanoma Res. 2019 Dec;29(6):635-642
pubmed: 30789386
N Engl J Med. 2015 Jun 25;372(26):2521-32
pubmed: 25891173
J Clin Epidemiol. 2004 Dec;57(12):1288-94
pubmed: 15617955
Value Health. 2017 Jul - Aug;20(7):866-875
pubmed: 28712615