Background Nivolumab plus ipilimumab (nivo/ipi) is an approved therapy for patients with metastatic renal cell carcinoma (mRCC) who have intermediate- or poor-risk disease.1 Clinical factors that guide the selection of this regimen for patients with mRCC are urgently needed.
Methods We retrospectively analyzed medical records of patients with mRCC who were hospitalized because of cancer-related symptoms and received their first cycle of nivo/ipi in the inpatient setting. Clinical parameters including demographics, histology, clinical history, response and survival were collected. The 4-month survival probability, progression-free survival (PFS) and overall survival (OS) were calculated using Kaplan-Meier methods.
Results Between November 2017 and June 2020, 21 patients were identified that fit the search: 19 patients (91%) had poor-risk disease based on the International metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk score; 17 patients (81%) had ≥4 risk factors; 9 patients (43%) had sarcomatoid features on histology. Shortness of breath (28%) and abdominal pain (19%) were the two most common reasons for hospitalization. Partial response was achieved in 14% (3/21) of patients. Median PFS for all patients was 1.7 months (95% CI 0 - 3.9); median OS for all patients was 1.7 months (95% CI 0 – 4.2); the 4-month survival probability was 36% (95% CI 25% - 47%) (figure 1).
Conclusions In this retrospective study, patients with mRCC who have intermediate- or poor-risk disease and are hospitalized for cancer-related symptoms derive little clinical benefit from nivo/ipi when started in the inpatient setting. Alternative more effective systemic therapies should be considered for these patients.
Acknowledgements We would like to thank the software developers at the Department of Genitourinary Medical Oncology at MD Anderson Cancer Center and the informatics analysts from the Department of Pharmacy Quality Improvement and Analytics at MD Anderson Cancer Center.
Trial Registration N/A
Ethics Approval This study was approved by the Institutional Review Board of MD Anderson Cancer Center, approval number PA16-0736.
Motzer RJ, Tannir NM, McDermott DF, Aren Frontera O, Melichar B, Choueiri TK, et al. Nivolumab plus Ipilimumab versus sunitinib in advanced renal-cell carcinoma. N Engl J Med. 2018;378:1277–90.
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