There are few data available on gender-related clinical outcomes and safety of treatment of with immune check point inhibitors (CPI) in patients with renal cell carcinoma (RCC). Giuseppe Procopio, MD, and colleagues in Milan, Italy, conducted an analysis designed to examine the effect of gender on overall survival and adverse events (AEs) in that patient population.
The analysis utilized Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 in an expanded access program of nivolumab at a dose of 3 g/kg once every two weeks in second-line and beyond in patients with metastatic RCC. Patients assuming at least one dose of nivolumab were included in the analysis. Analysis results were reported in an abstract published in conjunction with the ASCO 2019 Annual Meeting.
A total of 389 patients were included in the analysis. Of those, 25.2% were women. At baseline, there were no differences between women and men in age (average, 64 years); overweight/obesity (45% vs 49%); lactate dehydrogenase level (mean U/L 392 vs 32 [sic] units per liter); and neutrophils/lymphocytes ratio >3 (62% vs 63%).
While disease presentation was similar between men and women, women tended to present less lung and bone metastases (66% vs 76%; P=.06 and 42% vs 53%; P=.07, respectively). There were no differences by sex in the International Metastatic RCC Database Consortium (IDMC) prognostic model.
There were no differences between women and men in drug-related AEs (38% vs 30%), grade 3-4 (6% vs 6%), and median number of drug does (53% vs 50%). Following adjustment for known prognostic variables, in multivariable analyses, overall survival was similar in women and men (hazard ratio, 0.81; 95% confidence interval, 0.56-1.17).
In conclusion, the researchers said, “Women demonstrate similar overall survival [compared with] men in metastatic RCC treated with second-line and beyond nivolumab, with no difference observed in serious AEs and dose administered.”
Source: Procopio G, Di Cosimo S, De Giorgi U, et al. Effect of gender on the outcome of patients receiving nivolumab for metastatic renal cancer: Results from a large study population. Abstract published in conjunction with the American Society of Clinical Oncology 2019 Annual Meeting, May 31-June 4, Chicago, Illinois.