Outcomes of patients with intermediate‐risk or poor‐risk metastatic renal cell carcinoma who received their first cycle of nivolumab and ipilimumab in the hospital because of symptomatic disease: The MD Anderson Cancer Center experience

Abstract

Nivolumab plus ipilimumab (nivo/ipi) is an approved therapy for patients with intermediate-risk or poor-risk metastatic renal cell carcinoma (mRCC). Clinical factors that guide the selection of this regimen for patients with mRCC are urgently needed. We retrospectively analyzed medical records of patients with mRCC who were hospitalized at MD Anderson Cancer Center 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. Between November 2017 and 21 June 2020 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; and 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); and the 4-month survival probability was 36% (95% CI 25%-47%). In this retrospective study, patients with intermediate-risk or poor-risk mRCC who are hospitalized at a large tertiary referral center for cancer-related symptoms derive limited clinical benefit from nivo/ipi when started in the inpatient setting. Alternative, more effective systemic therapies should be considered for these patients.

Novel standards and emerging therapies for systemically treatment-naïve clear cell renal cell carcinoma - a rapidly changing landscape

“…At a median follow-up of approximately 18 months, combination therapy had an ORR of 55.7%, with 8% of patients achieving a complete response. Further, superior OS (HR = 0.6) was found regardless of PD-L1 expression and across all IMDC risk groups, and emerging data also confirms that this clinical benefit is extended for patients with sarcomatoid RCC [28] . Based on the data from these pivotal studies, both axitinib/pembrolizumab and cabozantinib/nivolumab have received FDA approval and remain standard options in the first-line setting for all eligible advanced ccRCC patients.…”

Compassionate Use Program of Ipilimumab and Nivolumab in Intermediate or Poor Risk Metastatic Renal Cell Carcinoma: A Large Multicenter Italian Study

“…Patients who interrupted the IPI-NIVO induction phase early achieved a shorter PFS (1.8 months) and OS (32.9% at 12 months) compared to those who completed the four cycles. A very low 4-month OS probability (36%) was recently reported in a real-world cohort of intermediate or poor IMDC risk patients starting IPI-NIVO after hospitalization for mRCC-related symptoms, as a demonstration that patients with more advanced and symptomatic disease derive less benefit from the IPI-NIVO combination [17]. Therefore, a longer follow-up of our cohort will be of paramount importance to evaluate the rate and clinical characteristics of long-term responders-the group of patients deriving the greatest benefit from IPI-NIVO synergistic activation of the immune response.…”

Evolution of Surgical Treatment of Metastatic Spine Tumors.

“…68,69 Patients with RCC spinal metastases have wide range in reported survival that re ects patient Tokuhashi scores, from 5-32.9 months, according to one recent review. 70 Currently, nivolumab (PD-1 inhibitor) with or without ipilimumab (CTLA-4 targeted therapy) is the most commonly studied treatment regimen, [71][72][73] with vascular endothelial growth factor receptor (VEGFR) TKIs and mammalian target of rapamycin (mTOR) inhibitors for additional targeted therapy. 69,74 Future studies are needed to determine the optimal combination of drugs and their timing in order to minimize side effects.…”