Initial systemic therapy for metastatic clear cell renal cell carcinoma

Patients with advanced or metastatic clear cell RCC are typically treated with systemic therapy as initial treatment.

The decision to start systemic therapy and the selection of agent(s) depend on disease-related symptoms, patient comorbidities, and tumor risk stratification. Listed treatments are preferred options, although alternative agents that are not listed may also be effective. Clinical trials are encouraged if available.
There is a potential risk of early disease progression in those who are treated with a regimen that only contains immunotherapy, regardless of risk stratification. All patients who are treated with immunotherapy-only regimens should be closely assessed for treatment response, and subsequent-line therapy should be promptly administered in those with early disease progression.
For further details on evidence, refer to UpToDate content on systemic therapy for advanced clear cell RCC and targeted therapy for RCC.

Select patients may be candidates for cytoreductive nephrectomy prior to initiation of immunotherapy. Refer to UpToDate content on surgical management of RCC.

IMDC: International Metastatic Renal Cell Carcinoma Database Consortium; KPS: Karnofsky performance status; LLN: lower limit of normal; RCC: renal cell carcinoma; ULN: upper limit of normal; VEGFR: vascular endothelial growth factor receptor.

* Limited disease burden is defined as a small number of low-volume metastatic lesions confined to one or two organs such as the lungs or the bones. Patients with limited disease burden on imaging are usually asymptomatic. However, the decision to treat must take into account multiple factors, including the rate of growth, location of tumor (eg, proximity to vital organs with potential for damage), and symptoms.

¶ For patients with limited burden, favorable-risk disease who desire a more aggressive management approach, alternative options include antiangiogenic therapy (sunitinib or pazopanib), pembrolizumab, nivolumab, or a combination immunotherapy-based regimen used for those with substantial burden, favorable-risk disease.

Δ For patients who are ineligible for or decline initial treatment with immunotherapy combinations, we offer antiangiogenic therapy that incorporates a VEGFR inhibitor. For patients with substantial burden, favorable risk disease, options include lenvatinib plus everolimus, sunitinib, and pazopanib. For those with intermediate or poor-risk disease, options include lenvatinib plus everolimus or cabozantinib.

◊ Nivolumab plus ipilimumab offers the opportunity for curative intent therapy through durable responses, preserving overall survival benefit, and improving treatment-free survival. By indirect comparison of randomized trials, nivolumab plus ipilimumab confers these treatment benefits to a greater degree than combination immunotherapy plus antiangiogenic therapy, despite having a relatively lower objective response rate.

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Initial systemic therapy for metastatic clear cell renal cell carcinoma