![]() In a way, trials evaluating dual therapy have been using the IMDC risk model as a predictive tool for dual therapy efficacy rather than its originally intended use as a prognostic tool in the TKI era. To understand the utility of dual therapy in IMDC favorable-risk RCC, we must first understand the limitations of the IMDC risk model. OS, PFS, and ORR in intermediate-risk/ poor-risk patientsÄAssessed using the Functional Assessment of Cancer Therapy-Kidney Symptom Index–Disease-Related Symptoms (FKSI-DRS), EORTC Core Quality of Life (QLQ-C30), EuroQol Group-5 Dimensions-3 Levels (EQ-5D-3 L), and Visual Analog Scale (VAS) questionnaires. Here, we address the urgent need to develop strategies to improve patient selection criteria for dual therapy in this subgroup. While we agree with the overall recommendation to improve drug access, we are concerned about the potential risk of overtreatment if dual therapy is used as a straightforward intervention for this patient subgroup. There are no roles for atezolizumab-bevacizumab or nivolumab-ipilimumab in the management of favorable-risk RCC, with the first trial failing to demonstrate an OS benefit across any RCC IMDC risk group and the second enrolling an IMDC favorable-risk group only for exploratory purposes. Nevertheless, dual therapy (in particular pembrolizumab-axitinib, , pembrolizumab-lenvatinib, avelumab-axitinib, and nivolumab-cabozantinib, ) was incorporated in established guidelines as a potential first-line treatment option for IMDC favorable-risk patients. In fact, not even progression-free survival (PFS) or complete response (CR) benefits were reported consistently across dual therapy in the IMDC favorable-risk group ( Table 1), ,, ,, , although none of these trials was powered for subgroup analysis. While the overall survival (OS) benefits of dual therapy over sunitinib monotherapy have undoubtedly been proven for patients with International Metastatic RCC Database Consortium (IMDC) intermediate or poor risk, this benefit has not been demonstrated in the IMDC favorable-risk group, ,,. ![]() ![]() Dual therapy (immune checkpoint inhibitor -ICI, ICI-tyrosine kinase inhibitor ) has changed the treatment landscape for patients with metastatic renal cell carcinoma (mRCC), ,,.
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