Comparing rate of immunotherapy treatment change due to toxicity by gender.

Authors

null

Kevin Joseph Chua

Section of Urologic Oncology, Rutgers Cancer Institute of New Jersey and Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ

Kevin Joseph Chua , Joshua Sterling , Sai Krishnaraya Doppalapudi , Alain Kaldany , Shane Kronstedt , Arnav Srivastava , Hao Liu , Eric A. Singer

Organizations

Section of Urologic Oncology, Rutgers Cancer Institute of New Jersey and Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, Biostatistics Shared Resource, Rutgers Cancer Institute of New Jersey, and Department of Biostatistics and Epidemiology, Rutgers School of Public Health, New Brunswick, NJ, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ

Research Funding

U.S. National Institutes of Health

Background: Immunotherapy (IO) is associated with a variety of treatment related toxicities. However, the impact of toxicity on the treatment discontinuation rate between males and females is unknown. We hypothesized that immune related adverse events would lead to more frequent treatment changes in females since autoimmune diseases occur more frequently in females Methods: The Oncology Research Information Exchange Network (ORIEN) Avatar Database collects clinical data from ten different United States cancer centers, where patients receive IO. Of 1,035 patients receiving IO, 447 patients were analyzed, excluding those (N = 573) who did not have documentation noting if a patient changed treatment. 15 additional patients with an unknown or gender-specific cancer were excluded. All cancer types and stages were included. Primary endpoint was documented treatment change due to toxicity. Significance was calculated with logistic regression, linear regression, chi-squared test for categorical variables and Mann-Whitney U test for continuous nonparametric variables. Results: 447 patients (281 males and 166 females) received IO treatment for cancer. The most common cancers treated were kidney, skin, and lung for 99, 84, and 54 patients, respectively. Females had a shorter IO course compared to males on Mann-Whitney U test (median 3.7 vs 5.1 months, respectively, p=0.02) and multivariable linear regression (Beta -3.87, 95% CI -6.591, -1.149, p=0.005). 54 patients changed IO treatment due to toxicity. There was no significant difference in the rate of treatment change due to toxicity between females and males on chi-square test (11.4% vs. 12.5%, respectively, p = 0.75) and logistic regression (Table). Pembrolizumab, Nivolumab, Ipilimumab/Nivolumab, Ipilimumab, Durvalumab, Avelumab, and Atezolizumab were given to 16, 14, 9, 9, 3, 2 and 1 patients who changed treatment due to toxicity, respectively. The median length of time for IO treatment prior to change for toxicity was 3 months (IQR 1.4 – 5.9 months). Significantly more patients with COPD changed treatment due to toxicity (Table). Conclusions: Females received a shorter course of IO than males. However, there was no significant difference in the treatment discontinuation rate due to toxicity between males and females receiving IO. Toxicity related treatment change was associated with COPD. Studies with larger sample sizes with more granular data (i.e., type of adverse effects) are needed to truly characterize if a difference between genders and IO toxicity exists.

Analysis of risk factors associated with changing IO due to toxicity.


Univariable
Multivariable

OR
95% CI
p-value
OR
95% CI
p-value
Female
0.908
0.501-1.647
0.752
0.924
0.453-1.885
0.827
Age ≥ 60
1.241
0.688-2.240
0.473
1.409
0.699-2.842
0.338
BMI ≥ 25
0.838
0.426-1.648
0.608
0.760
0.374-1.544
0.448
COPD
2.335
1.045-5.220
0.039
2.491
1.025-6.054
0.044
Combo IO
1.719
0.853-3.466
0.130
2.122
0.951-4.738
0.066

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Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Developmental Therapeutics—Immunotherapy

Track

Developmental Therapeutics—Immunotherapy

Sub Track

Other IO-Related Topics

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 2656)

DOI

10.1200/JCO.2022.40.16_suppl.2656

Abstract #

2656

Poster Bd #

310

Abstract Disclosures