First-line therapies of advanced renal cell carcinoma (aRCC), nivolumab (Opdivo®; Bristol-Myers Squibb) in combination with ipilimumab (Yervoy®; Bristol-Myers Squibb) and pembrolizumab (Keytruda®; Merck & Co) in combination with axitinib (Inlyta®; Pfizer), have demonstrated significantly improved clinical outcomes versus the tyrosine kinase inhibitor (TKI) sunitinib (Sutent®; Pfizer).

And both African American (black) and white patients treated with similar first-line therapies for treatment of advanced renal cell carcinoma (aRCC) experienced similar outcomes but different response rates.

This is the conclusion based on a study by researchers for Fox Chase Cancer Center, one of the leading comprehensive cancer centers in the United States. [1]

The outcomes of the study were presented as a poster presentation during the annual meeting for the American Society of Clinical Oncology (ASCO), held June 3 – 7, 2022 in Chicago, Il. [1]

TRP Targeted Radiopharmaceuticals Summit
Port Worthy
American Lung Association
Novasep Top 6 qualities to look for in a CDMO partner for ADCs

“This [study] was a retrospective study looking at potential differences in treatment patterns and outcomes between African American and white metastatic kidney cancer patients,” noted Daniel Geynisman, MD, the study author and chief of the Division of Genitourinary Medical Oncology at Fox Chase.

Advertisement #3

Underrepresented
Geynisman explained that African American (black) patients are grossly underrepresented in all advanced renal cell carcinoma trials and clinical trials in oncology in general. “Little is known about the impact of racial differences in the use of first-line therapies and clinical outcomes in the real- world setting,” he added.

To address this, Geynisman and colleagues conducted a multicenter study examining data on 473 advanced kidney cancer patients with the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC), a prognostic model to predict survival of metastatic kidney cancer patients with intermediate or poor-risk disease.

Daniel M. Geynisman, MD,Chief, Division of Genitourinary Medical Oncology, Associate Professor, Department of Hematology/Oncology and Vice Chair, Quality Improvement Program at Fox Chase Cancer Center in Philadelphia, PA. Photo courtesy: © 2020- 2022 Temple University Health System. Used with permission.

Study design
Use of first-line therapy, treatment discontinuation, and clinical outcomes—including disease response, landmark progression-free survival (PFS), landmark overall survival (OS), and treatment-related adverse event rates (TRAE)—were assessed descriptively by race.The

The likelihood of receiving first-line therapies was based on factors like performance status, which refers to a patient’s ability to perform certain daily activities such as eating, getting dressed, and bathing without help.

Ninety-five (20.1%) of the study patients were African American or black patients and 378 (79.9%) were white. The median follow-up was 10.9 months.

The researchers found that a higher proportion of African American (black) versus white American patients had received first-line TKI monotherapy (21.1% vs. 16.1%). Treatment discontinuation rate was higher in African American (black) patients (49.5% vs. 43.4%), while the treatment related adverse events (TRAE) rate was slightly lower in African American (black) versus white American patients (25.3% vs. 32.5%).

The researchers also noted that more African American (black) patients presented with potentially more aggressive disease (poor risk by IMDC criteria) and worse performance status than white patients.

“The key efficacy findings are that first, African American (black) and white patients are often treated in similar fashions. There were no significant differences in the use of immune-based combination therapies between these groups,” Geynisman said.

“The second finding is that long-term outcomes seem generally similar between the two groups. The response rates, however, were lower in African Americans (black) compared to white Americans (overall response rate [ORR]: 58.8% vs. 74.8%; complete response [CR]: 8.2% vs. 11.4%). [This] is something that needs to be explored further and may have been a spurious finding due to the sample size or the retrospective conduct of the analysis,” he noted.

Next steps
“The next steps for this study would be to extend follow-up and to investigate why the response rates are different. We would need a larger sample size and ideally a prospective registry to really answer those questions, as well as novel genomic biomarkers to help understand any potential differences between African American (black) and white advanced kidney cancer patients.”

Highlights of prescribing information
Nivolumab (Opdivo®; Bristol-Myers Squibb)[Prescribing Information]
Ipilimumab (Yervoy®; Bristol-Myers Squibb)[Prescribing Information]
Pembrolizumab (Keytruda®; Merck & Co)[Prescribing Information]
Axitinib (Inlyta®; Pfizer)[Prescribing Information]
Sunitinib (Sutent®; Pfizer)[Prescribing Information]

Reference
[1] Geynisman DM, Kish JK, Falkenstein A, Huo S, Del Tejo V, Rosenblatt L, Guttenplan S, Balanean A, Feinberg BA. Racial differences in treatment patterns and outcomes of first-line (1L) therapies for advanced renal cell carcinoma (aRCC) in the real-world (RW) setting. J Clin Oncol 40, 2022 (suppl 16; abstr 4548) | DOI 10.1200/JCO.2022.40.16_suppl.4548

Featured image: Human kidney cross section. Photo courtesy: © 2019 – 2022 Fotolia/Adobe. used with permission.

Advertisement #5