First-line immunotherapy benefits patients of all races with NSCLC equally
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Key takeaways
- Black, Hispanic and white patients with NSCLC had similar survival rates with first-line immunotherapy.
- Patients with higher BMI had longer PFS and quicker time to discontinuation than those with lower BMI.
Survival rates for patients with non-small cell lung cancer treated with first-line immunotherapy did not differ based on race or other socioeconomic determinants, according to a study in Journal of the National Comprehensive Cancer Network.
However, patients with high BMI had longer PFS and concluded their treatments quicker than patients with low BMI, and patients who had difficultly caring for themselves had poorer results.
“Our real-world data from a diverse patient pool mirrors what we’ve seen in more controlled clinical trials when it comes to how well immunotherapy works for diverse groups of patients in terms of survival,” Matthew Lee, MD, MPH, assistant professor of oncology at Montefiore Einstein Comprehensive Cancer Center, and Haiying Cheng, MD, PhD, associate professor of oncology at Montefiore, told Healio. “This highlights a crucial need for a stronger effort to include more patients from underrepresented backgrounds in clinical trials. By doing this, we can be more confident in our treatments and make sure everyone gets the best care possible.”
Background and methods
The American Cancer Society estimated lung and bronchial cancer caused more than twice as many deaths (127,070) than the next leading cancer in the United States, per its 2023 report.
Use of immunotherapy has improved survival rates during the last decade, but clinical trials consisted mainly of white patients. Black and Hispanic patients made up only 1% to 10% of the population, according to background data from the study.
“Previous pivotal immunotherapy trials didn't include enough patients from these underrepresented minority groups,” Lee and Cheng said. “At Montefiore Einstein Comprehensive Cancer Center, we care for a diverse population of patients, and we wanted to dig into how well immunotherapy works for them.”
Researchers did a retrospective cohort study of patients diagnosed with lung cancer between Jan. 1, 2013, and June 1, 2022, at Montefiore to determine whether first-line immunotherapy had different impacts on patients based on their race, income and insurance.
To be included in the study, patients had to be diagnosed with metastatic NSCLC, completed at least two clinical visits, aged 18 years or older, had at least one first-line immunotherapy treatment, a follow-up at least 2 weeks after the final immunotherapy, and no known driver alterations in EGFR, ALK or ROS1.
A total of 248 patients met the criteria from a cohort of 5,920.
Results, what’s next
Black patients (39.1% of the cohort), Hispanic patients (30.2%) and white patients (30.7%) had similar OS rates (26.3 months vs. 23.5 vs. 16.8) and time to discontinuation (4.5 months vs. 4.9 vs. 4.9) at a median follow up of 1 year.
Patients with a higher BMI (more than 25 kg/m2) had longer median PFS (P = .01) and treatment finish (P = .02). Patients on Medicare had longer PFS than patients on commercial insurance or Medicaid (P = .008).
Patients with a PD-L1 tumor proportion score 1% or 50% had longer PFS (P = .01 and P = .03).
Patients with a lower ECOG Performance Status had worse OS, PFS and time to discontinuation (P < .0001).
“This study underscores the significance of tailoring treatments in real-world practice, such as potential adjustments with a poor ECOG performance status, weight/BMI, and PD-L1 status,” Lee and Cheng said. “This insight might guide healthcare providers to rethink treatment intensity and regimen. It’s crucial for future studies to include more diverse patient groups to validate these findings, ensuring our clinical decisions are better informed and more inclusive.”
Lee and Cheng said the use of national datasets can unveil more information on how socioeconomic determinants impact results.
“Our study suggested potential progression-free survival differences based on these factors, but there's much more to uncover,” they said.
References:
- American Cancer Society, Key statistics for lung cancer. Available at https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Published Jan. 12, 2023. Accessed Dec. 19, 2023.
- Lee M, et al. J. Natl Compr Canc Netw. 2023;doi:10.6004/jnccn.2023.7064
For more information:
Matthew Lee, MD, MPH, can be reached at mlee7@montefiore.org. Haiying Cheng, MD, PhD, can be reached at hcheng@montefiore.org.
Perspective
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Michael E. Menefee, MD
Randomized controlled trials are the gold standard for demonstrating efficacy and achieving regulatory approval for novel cancer therapeutics. However, most studies that lead to approval have substantial underrepresentation of ethnic minority populations. Retrospective analyses and observational studies can provide real-world data that may answer questions that were inadequately addressed during pivotal trials.This study demonstrated that underrepresented minority populations derive similar benefit with immunotherapy in the first-line setting to those who received it in pivotal studies. Further, the investigators also identified determinants that may help predict benefit based on BMI, insurance and income — factors not traditionally captured in prospective trials.
Despite well-intentioned efforts by various stakeholders in drug development such as government agencies, sponsors and investigators, adequate participation of Black and Latino patients remains elusive due to multiple factors, including implicit bias, access to health care and other socioeconomic challenges. Further, even if equitable representation were achieved in a randomized controlled trial, the absolute number of minority patients studied would still be relatively small, and generalizing those results may be less reliable. Therefore, studies evaluating real-world data will continue to be important and necessary to characterize the efficacy and safety of drugs more accurately, and with greater precision, particularly for any group that has low participation in a pivotal study.
I commend the authors for performing this important analysis, which contributes further to the growing body of real-world data evaluating novel therapeutics in underrepresented patients with advanced lung cancer. Real-world data can fill gaps in knowledge, and it is needed to complement the data generated in randomized studies. Nevertheless, despite the apparent similar efficacy among racial ethnic groups in this and other studies, it is imperative that we continue, and intensify, efforts to achieve participation in clinical trials that is reflective of our diverse population.
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Lee M, et al. J. Natl Compr Canc Netw. 2023;doi:10.6004/jnccn.2023.7064
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