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25-06-2022 | Renal cell carcinoma | Adis Journal Club | Article

Targeted Oncology

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


Authors: Marco Maruzzo, Francesco Pierantoni, Alberto Bortolami, Dario Palleschi, Andrea Zivi, Maurizio Nicodemo, Donata Sartori, Rocco De Vivo, Fable Zustovich, Davide Bimbatti, Davide Pastorelli, Giuseppe Dione Vultaggio, Mariella Soraru’, Melissa Ballestrin, Caterina Modonesi, Paola Randisi, Carmen Barile, Gino Perri, Umberto Basso & Vittorina Zagonel



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.


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 Methods

We 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.


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 1738.60 whereas the cost for the other one was €1624.80.


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.

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 Key Points

In a large retrospective cohort of patients, nivolumab and cabozantinib in second- or third-line treatments have an observed median survival that is comparable to published data

The NLR ratio in the second and the third line treatments confirmed its prognostic power, establishing that the cut-off value of 3 is prognostic even in this setting

From a cost-effectiveness point of view, the NC sequence was slightly more expensive than the CN sequence, but overall sequence costs per month of OS gain were comparable between NC and CN.