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Bladder and Urothelial Cancer Treatments / Renal Cell Carcinoma Treatment · Journal article
Asian Journal of Oncology · September 5, 2026
Early or partial results. Treat as a signal, not a conclusion.
This prospective observational study of 31 patients with metastatic renal cell carcinoma treated with PD-1/PD-L1 inhibitors in a public-sector Indian cancer center reports an objective response rate of 51.6% at 3 months, with immune-related adverse events (subclinical hypothyroidism, colitis, pneumonitis) occurring in approximately 10–13% of patients each and no treatment-related deaths. The findings suggest feasibility of checkpoint inhibitor use in low- and middle-income country settings but represent a single center with enriched poor-risk disease and cannot establish superiority or define optimal patient selection without larger multicenter confirmation.
Single-center, prospective, observational study. Adults ≥18 years with histologically confirmed metastatic renal cell carcinoma, measurable disease, and ECOG performance status 0–3, treated at a government cancer center in India. Most had clear-cell histology and intermediate- or poor-risk disease by IMDC criteria.. Intervention: PD-1/PD-L1–based immunotherapy: nivolumab (27 patients, 87.1%, mostly monotherapy) or pembrolizumab (4 patients, 12.9%, 3 in combination with VEGFR TKIs: cabozantinib, lenvatinib, or axitinib). Used as first-line (61.3%), second-line (32.3…. n = 31. Single government cancer center, India.
Objective response rate at 3 months was 51.6% (2 complete responses, 14 partial responses out of 31 patients) Most common adverse events were asthenia (19.4%) and fatigue (12.9%) Immune-related adverse events: subclinical hypothyroidism 12.9%, colitis 12.9%, pneumonitis 9.7%
Most common adverse events were asthenia (19.4%) and fatigue (12.9%) Immune-related adverse events: subclinical hypothyroidism 12.9%, colitis 12.9%, pneumonitis 9.7%
This single-center study provides preliminary evidence that PD-1/PD-L1 checkpoint inhibitors can be feasibly deployed in public-sector LMIC settings with response rates and toxicity profiles comparable to high-income country trials. However, the small sample size, lack of a control group, and short follow-up (3-month primary endpoint) limit direct clinical guidance; larger prospective registries are needed to refine patient selection, optimize toxicity management, and establish sustainability of this approach in resource-limited settings.
Single-center prospective observational study with modest sample size (n=31) and surrogate endpoint (ORR at 3 months); demonstrates feasibility in a LMIC setting but lacks a comparator and control group, and requires confirmation in larger studies.
As stated by the source record.
Quoted from the source exactly as published.
This single-center study provides preliminary evidence that PD-1/PD-L1 checkpoint inhibitors can be feasibly deployed in public-sector LMIC settings with response rates and toxicity profiles comparable to high-income country trials. However, the small sample size, lack of a control group, and short follow-up (3-month primary endpoint) limit direct clinical guidance; larger prospective registries are needed to refine patient selection, optimize toxicity management, and establish sustainability of this approach in resource-limited settings.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Objectives: Immune checkpoint inhibitors (ICIs) targeting the PD-1/PD-L1 axis have changed the management of metastatic renal cell carcinoma (mRCC). Most pivotal trials come from high-income settings and include highly selected patients. Prospective real-world data from low- and middle- income countries (LMICs), especially from public hospitals in India, are scarce. Material and Methods: This was a single-center, prospective, observational study of adults with histologically confirmed mRCC treated with PD-1/ PD-L1-based regimens at a government cancer center. Eligible patients were ≥18 years, had measurable metastatic disease, and Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0–3. Treatment with nivolumab or pembrolizumab, with or without vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs), and line of therapy were chosen by the treating oncologist. Radiological response was assessed every 3 months using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; toxicities were graded using Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with a focus on immune-related adverse events (irAEs). The primary endpoint was objective response rate (ORR) at 3 months; secondary endpoints included toxicity profile and descriptive 12-month outcomes. Results: Thirty-one patients were enrolled. Most had clear-cell histology and intermediate- or poor-risk disease by IMDC criteria. ECOG PS was 0–1 in 19 patients (61%), 2 in 8 (26%), and 3 in 4 (13%). Nineteen patients (61.3%) received PD-1-based therapy as first line, 10 (32.3%) as second line, and 2 (6.5%) as third line. Nivolumab was used in 27 patients (87.1%), mostly as monotherapy; 4 patients (12.9%) received pembrolizumab, including 3 in combination with TKIs (cabozantinib, lenvatinib, or axitinib). At 3 months, 2 patients achieved complete response (CR) and 14 partial responses (PR), yielding an ORR of 51.6%. Only 1 patient had definite progressive disease (PD) at first assessment; the remainder had stable disease or were not fully evaluable. The most common were asthenia (19.4%) and fatigue (12.9%). Immune-related adverse events (AEs) included subclinical hypothyroidism (12.9%), colitis (12.9%), and pneumonitis (9.7%). Treatment discontinuation due to toxicity occurred in 2 patients (severe colitis and pneumonitis). No treatment-related deaths were recorded. Conclusion: In this prospective real-world cohort from an Indian government cancer center—enriched for intermediate- and poor-risk disease and ECOG PS ≥2—PD-1/PD-L1-based therapy produced ORR comparable to pivotal trials, with a manageable toxicity profile. These findings support the feasibility of ICIs in the public-sector LMIC setting and highlight the need for larger multicenter registries to refine patient selection, toxicity management, and access strategies.
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