Older sufferers with early-stage breast most cancers who obtain immune checkpoint inhibitors might expertise a better danger of extreme immune-related unwanted side effects.
Older sufferers who beforehand acquired immune checkpoint inhibitors for early-stage breast most cancers might have an elevated danger of creating high-grade immune-related unwanted side effects, in accordance with findings from a multi-institutional research offered on the 2024 San Antonio Breast Most cancers Symposium (SABCS).
Particularly, the prevalence of any- and high-grade immune-related unwanted side effects have been 72.6% and 18.9%, respectively, in sufferers with early-stage breast most cancers who acquired immune checkpoint inhibitors. Among the many affected person inhabitants, Dr. Alexis LeVee and colleagues demonstrated the distribution of any- and high-grade immune-related unwanted side effects. Concerning any-grade immune-related unwanted side effects, none have been noticed in 27% of sufferers, one was noticed in 43%, two was noticed in 23%, three was noticed in 5.7%, 4 was noticed in 1.2% and 5 was noticed in 0.2%. Of notice, no high-grade immune-related unwanted side effects occurred in 81% of sufferers, one was noticed in 17% and two have been noticed in 1.7%. There have been no high-grade immune-related unwanted side effects reported after two.
“The speed of [immune-related side effects] could also be greater in our research in contrast [with] that noticed in KEYNOTE-522 resulting from variations in affected person populations, with our research consisting of older sufferers who might have had extra comorbidities,” LeVee and colleagues wrote within the poster presentation.
LeVee is chief fellow, Hematology and Medical Oncology at Metropolis of Hope in Los Angeles, California.
Glossary:
Immune checkpoint inhibitors: a kind of immunotherapy that blocks checkpoint proteins, that are accountable for inflicting most cancers development.
KEYNOTE-522 was a part 3 trial that evaluated beforehand untreated sufferers with stage 2 or 3 triple-negative breast most cancers, a research that was revealed in The New England Journal of Medication. Sufferers on the trial have been both handled with neoadjuvant (presurgical) remedy with Keytruda (pembrolizumab) plus paclitaxel and carboplatin (chemotherapy) or placebo (inactive drug) plus paclitaxel and carboplatin. The incidence of treatment-related unwanted side effects of grade 3 (extreme) or larger was 78.0% within the Keytruda group versus 73.0% within the placebo group.
The multi-institutional research included sufferers with levels 1 to three breast most cancers who acquired immune checkpoint inhibitors at 4 tutorial establishments between 2014 and 2024.
Concerning affected person demographics, any-grade immune-related unwanted side effects occurred in 307 sufferers and didn’t happen in 116. Median age was 51.0 and 50.5 in sufferers from the any-grade immune-related unwanted side effects cohort who did and didn’t have any-grade immune-related unwanted side effects, respectively. Concerning menopausal standing, 155 sufferers (50.5%) and 61 sufferers (52.6%) have been premenopausal amongst those that skilled any-grade immune-related unwanted side effects and people who didn’t, respectively. Postmenopausal standing was reported in 148 (48.2%) and 52 (44.8%) sufferers, and unknown menopausal standing was reported in 4 (1.3%) and three (2.6%) sufferers. Physique mass index (BMI) was 27.0 and 27.3. Amongst sufferers who did and didn’t expertise any-grade immune-related unwanted side effects, respectively, 199 (64.8%) and 56 (48.3%) of sufferers have been White, 25 (8.1%) and 27 (23.3%) have been Hispanic, 26 (8.5%) and 10 (8.6%) have been Black, 30 (9.8%) and 12 (10.3%) have been Asian or Pacific Islander, 1 (0.3%) and a couple of (1.7%) have been American Indian, and 26 (8.5%) and 9 (7.8%) have been unknown.
Smoking standing and comorbidities have been additionally noticed amongst sufferers within the research. In sufferers from the any-grade immune-related unwanted side effects cohort who did and didn’t expertise any-grade immune-related unwanted side effects, respectively, 12 (3.9%) and 4 (3.4%) sufferers have been present people who smoke, 101 (32.9%) and 32 (27.6%) have been former people who smoke, 193 (62.9%) and 80 (69.0%) have been by no means people who smoke, and 26 (8.5%) and 9 (7.8%) have been unknown. Autoimmune illness was reported in 30 (9.8%) and 5 (4.3%), diabetes mellitus in 35 (11.4%) and 12 (10.3%), hypertension in 85 (27.7%) and 34 (29.3%), hyperlipidemia in 51 (16.6%) and 15 (12.9%), CKD in 12 (3.9%) and 1 (0.9%), preexisting lung illness 102 (33.2%) and 35 (30.2%), and coronary artery illness in 12 (3.9%) and a couple of (1.7%).
Affected person demographics for the high-grade immune-related unwanted side effects cohort included 80 sufferers who skilled high-grade immune-related unwanted side effects and 343 who didn’t expertise high-grade immune-related unwanted side effects. Median age was 53.5 and 50.0 in sufferers from the high-grade immune-related unwanted side effects cohort who did and didn’t expertise high-grade immune-related unwanted side effects, respectively. Concerning menopausal standing, 34 sufferers (42.5%) and 182 sufferers (53.1%) have been premenopausal amongst those that skilled high-grade immune-related unwanted side effects and people who didn’t, respectively. Postmenopausal standing was reported in 45 (56.2%) and 155 (45.2%) sufferers, and unknown menopausal standing was reported in 1 (1.3%) and 6 (1.7%) sufferers. BMI was 26.1 and 27.4. Amongst sufferers who did and didn’t expertise high-grade immune-related unwanted side effects, respectively, 54 (67.5%) and 201 (58.6%) of sufferers have been White, 5 (6.3%) and 47 (13.7%) have been Hispanic, 3 (3.8%) and 33 (9.6%) have been Black, 11 (13.8%) and 31 (9.0%) have been Asian or Pacific Islander, 1 (1.3%) and a couple of (0.6%) have been American Indian, and 6 (7.5%) and 29 (8.5%) have been unknown.
Smoking standing and comorbidities have been additionally noticed amongst sufferers within the research. In sufferers from the high-grade immune-related unwanted side effects cohort who did and didn’t expertise high-grade immune-related unwanted side effects, respectively, 3 (3.8%) and 13 (3.8%) sufferers have been present people who smoke, 18 (22.5%) and 115 (33.5%) have been former people who smoke, 58 (72.5%) and 215 (62.7%) have been by no means people who smoke, and 1 (1.3%) and 0 (0%) have been unknown. Autoimmune illness was reported in 8 (10.0%) and 27 (7.9%), diabetes mellitus in 12 (15.0%) and 35 (10.2%), hypertension in 22 (27.7%) and 97 (28.3%), hyperlipidemia in 10 (12.5%) and 56 (16.3%), CKD in 7 (8.8%) and 6 (1.7%), preexisting lung illness 32 (40.0%) and 105 (30.6%) and coronary artery illness in 5 (6.3%) and 9 (2.6%).
Immune-Associated Aspect Results Skilled By Sufferers
“Univariate evaluation confirmed that sufferers [who are White] … have been at greater danger of any-grade [immune-related side effects], whereas older sufferers, by no means people who smoke, and people with persistent kidney illness have been at greater danger of high-grade [immune-related side effects],” LeVee and colleagues wrote on the poster.
The most typical varieties of any-grade immune-related unwanted side effects included thyroiditis (infected thyroid gland; 112 sufferers), rash (106 sufferers), colitis (infected massive gut; 67 sufferers), hepatitis (infected liver; 49 sufferers), adrenal insufficiency/hypophysitis (infected pituitary glad; 35 sufferers), arthralgia (joint ache; 25 sufferers), pneumonitis (infected lungs; 11 sufferers) and diabetes mellitus (eight sufferers). Nearly all of these immune-related unwanted side effects have been grades 1 or 2 (delicate or critical).
“Additional analysis is critical to determine danger elements and biomarkers of immune-related aspect effectin sufferers with early breast most cancers to assist stop immune-related aspect effectand mitigate long-term issues,” LeVee and colleagues concluded.
References:
“Incidence and Threat Components of Immune-Associated Hostile Occasions in Early-Stage Breast Most cancers Sufferers: Findings from a Multi-Institutional Research” by Dr. Alexis LeVee, et al. Introduced at: 2024 San Antonio Breast Most cancers Symposium; December 10-13, 2024; San Antonio, TX. Summary PS5-03.
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