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. 2022 Jul;17(4):467-474.
doi: 10.1007/s11523-022-00892-z. Epub 2022 Jun 25.

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

Marco Maruzzo  1 , Francesco Pierantoni  2 , Alberto Bortolami  3 , Dario Palleschi  4 , Andrea Zivi  5 , Maurizio Nicodemo  6 , Donata Sartori  7 , Rocco De Vivo  8 , Fable Zustovich  9 , Davide Bimbatti  10 , Davide Pastorelli  11 , Giuseppe Dione Vultaggio  2 , Mariella Soraru'  12 , Melissa Ballestrin  2 , Caterina Modonesi  13 , Paola Randisi  13 , Carmen Barile  14 , Gino Perri  15 , Umberto Basso  10 , Vittorina Zagonel  10
Affiliations

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

Marco Maruzzo et al. Target Oncol. 2022 Jul.

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 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.

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.

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Conflict of interest statement

MM received consulting or advisory board fees from Bristol Myers Squibb, Janssen Cilag, Astellas, IPSEN, Merck Serono, MSD, and Pfizer. VZ received consulting or advisory board fees from Bristol Myers Squibb, Janssen Cilag, Astellas, IPSEN, Roche, MSD, Lilly, and AstraZeneca. The other authors FP, AB, DP, AZ, MN, DS, RDV, FZ, DB, DP, GDV, MS, MB, CM, PR, CB, GP, and UB have disclosed no conflicts of interest that are relevant to the contest of this manuscript.

Figures

Fig. 1
Fig. 1
a OS according to NLR in patients treated in the second line. b OS according to NLR in patients treated in the third line
Fig. 2
Fig. 2
OS according to the different treatment sequences
See this image and copyright information in PMC

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