Role Of Clinical and Demographic Factors in Urinary Bladder and Renal Cell Cancer Patients Treated with Immune-Oncological Drugs.

Abstract

Background: Urinary bladder (UB) and Renal Cell Carcinoma (RCC) are more common in men than women with poor outcomes. Novel immunotherapy (IT) drugs like Immune Check Point Inhibitors (ICIs) are effective but expensive. However, a cost-effective and reliable biomarker to predict response and clinical outcomes is lacking.

Objective: To study the association of histopathological type, grades, number of immunotherapy cycles, and demographic factors (age and gender) with Progression Free Survival (PFS) and Overall Survival (OS) in urinary bladder and renal cell carcinoma patients treated with immune checkpoint inhibitors.

Method: It is a retrospective analysis. We included 89 patients with Urinary bladder and Renal Cell Carcinoma treated with immune checkpoint inhibitors and those registered at Tata Memorial Cente from Jan 2008 to Dec 2019. Clinical evaluation and demographic data were performed as a part of the standard protocol.

Results: When demographic parameters like age and gender were analyzed, there was no significant association with progression-free survival and overall survival of the disease. Also, the progression-free survival and overall survival of the disease were not sustantial in histopathology type (Urinary bladder and Renal Cell Carcinoma) and tumour grade (low and high). Amongst 89 patients, the median immunotherapy cycles were 9 (IQR 5-14) with 61% cases receiving >6 cycles of immunotherapy and 39% cases of <= 6 cycles of immunotherapy. In the cohort, mPFS in<=6 number of immunotherapy cycles was 3.71 months (95% C.I. 2.10- 5.32), and in >6 number of immunotherapy cycles mPFS is 18.37months (95% C.I. 14.32- 22.42) showed significant difference with p value 0.001. Similarly, median OS was 5.62months (95% CI 3.47- 7.76) and 25.27 months (95% CI 21.15-29.38) respectively with p-value 0.001 at<=6 and >6 cycles, with   Hazard ratio (HR) for >6 immunotherapy cycles was 0.39(95% CI 0.23 – 0.68) p-value 0.001 and for PFS 0.42 (95% CI 0.25-0.69) p-value of 0.001 which shows a significant decrease in hazards in >6 immunotherapy cycles group. Thus, the patients who received >= 6 cycles of immunotherapy showed higher median PFS and OS than <6 cycles of immunotherapy.

Conclusion: Among the demographic and clinical factors studied, the number of immunotherapy cycles was significantly associated with progression-free survival and overall survival of the disease.