Real-World Treatment with Nivolumab or Cabozantinib for Metastatic Renal Cell Carcinoma (mRCC) in the Veneto Region of Italy: Results of AMOUR Study

Abstract

Background Second-or third-line treatment options for metastatic renal cell carcinoma (mRCC) have dramatically changed in the last few years. There are no criteria for the choice between nivolumab and cabozantinib, which both demonstrated overall survival (OS) gain in pivotal trials. Objective We conducted an analysis of oncological outcomes in patients treated in the Veneto Region (Italy), studying different sequences of TKI-nivolumab-cabozantinib or TKI-cabozantinib-nivolumab in a publicly funded healthcare system. Patients and MethodsWe conducted a retrospective, real-world analysis of all consecutive patients with mRCC treated with nivolumab or cabozantinib in 2017-2018 at 19 Oncology Units in the Veneto Region. Results We identified 170 patients, 73 % males, median age 68.4 years. All patients started second-line treatment, 59 % received a third-line therapy. Patients with NLR > 3 had a shorter OS (p < 0.0001). In the second-line treatment, nivolumab was administered to 108 patients (63 %), cabozantinib to 29 (17 %); in the third-line treatment nivolumab was administered to 42 patients (25 %), cabozantinib to 49 (29 %). Median OS and PFS in second line treatment were 28.4 and 6.6 months for nivolumab, 16.8 and 6.6 months for cabozantinib. Median OS and PFS in third-line treatment were 27 and 5.2 months for nivolumab, 16.6 and 7.5 months for cabozantinib. Median OS for nivolumab>cabozantinib sequence versus cabozantinib > nivolumab was 28.8 versus 19.9 months (p = 0.2); median PFS for both the sequences were similar at 5.7 months. A cost effectiveness per month of survival of the two sequences analysis was performed: the cost per month for the nivolumab > cabozantinib sequence was 1738.60whereas the cost for the other one was €1624.80. Conclusions In our real-world cohort, most patients received nivolumab as second-line treatment. Outcomes of single drugs are superimposable with those in the published literature. Both the sequences of nivolumab and cabozantinib appear to be viable, effective strategies from an OS and cost-effective perspective.

Cabozantinib use in second or subsequent line of treatment in renal cell carcinoma: an analysis of Italian administrative databases

“…Cabozantinib was frequently used as second-line treatment, mostly after front-line sunitinib or pazopanib therapy, or as a third-line treatment, often after nivolumab. This finding is in line with another Italian analysis ( 17 ). When, however, cabozantinib was given as third-line treatment or beyond, a large number of different sequencies were reported and no pattern of therapies use could clearly be identified.…”

“…Similar results emerged in the International Metastatic RCC Database Consortium, involving 413 patients from various countries, where the median times to cabozantinib treatment failure were 8.3 months for first-line, 7.3 months for second-line, 7.0 months for third-line and 8.0 months for fourth-line treatment ( 16 ). A recent, smaller study conducted in northeastern Italy reported a median duration of treatment of 6.6 months for second-line and 7.5 months for third-line cabozantinib use, thus confirming the activity of cabozantinib regardless of its line of use ( 17 ). Our finding of a median treatment persistence of cabozantinib of 8.7 months is, therefore, consistent with previous results from other unselected European and worldwide RCC patient populations.…”

“…the therapeutic class of cabozantinib) more than doubled in Italy between 2014 and 2022 ( 22 ). A number of studies have examined the cost-effectiveness of RCC drugs, including cabozantinib, both at an international level and in the Italian context ( 17 , 23 , 24 ). These studies are useful instruments to evaluate the impact of new treatments, in consideration of the rapidly evolving scenario and of the increasing number of therapeutic options for advanced RCC.…”

Real-World Evidence—Current Developments and Perspectives

“…Given the help of RWE research, the utility and application of cancer therapies can be studied, e.g., in second- or third-line treatment where several equivalent options exist. A recent real-world analysis showed that nivolumab rather than cabozantinib was administered as a second line to metastatic renal cell carcinoma (mRCC) patients, even though there were no criteria of favoring one or the other on the basis of former RCT results, and real-world cost-effectiveness of both treatments seemed to be similar [ 35 ]. In another RWE study in mRCC patients, those with a clear cell histology and good risk features had a significantly longer progression-free survival with cabozantinib—thus, certain subgroups of patients may benefit from cabozantinib rather than from nivolumab [ 36 ].…”