Aim: We report the outcomes observed with nivolumab in metastatic renal cell carcinoma patients with poor prognostic features enrolled in the Italian expanded access program. Patients & methods: Nivolumab was available for patients who relapsed after at least one prior systemic treatment in the advanced or metastatic setting. Results: Of 389 patients, 32 (8%) had brain metastasis, 129 (33%) had liver and 193 (50%) had bone metastasis. These subpopulations achieved a disease control rate of 53, 45 and 47%, respectively. Fifty-one patients had G4 tumor, and they showed 23% objective response rate. The safety profile of the subgroups was in line with the expanded access program population. No new safety signals were reported. Conclusion: Patients with poor prognostic features may derive relevant benefits from nivolumab.

Negative prognostic factors and resulting clinical outcome in patients with metastatic renal cell carcinoma included in the Italian nivolumab-expanded access program / Bracarda, S., Galli, L., Maruzzo, M., Lo Re, G., Buti, S., Favaretto, A., Di Costanzo, F., Sacco, C., Merlano, M., Mucciarini, C., Zafarana, E., Romito, S., Maestri, A., Giorgio, C.G., Ionta, M.T., Turci, D., De Giorgi, U., Procopio, G., Cortesi, E., Giannarelli, D., et al.. - In: FUTURE ONCOLOGY. - ISSN 1479-6694. - 14:14(2018), pp. 1347-1354. [10.2217/fon-2017-0570]

Negative prognostic factors and resulting clinical outcome in patients with metastatic renal cell carcinoma included in the Italian nivolumab-expanded access program

Cortesi E.;
2018

Abstract

Aim: We report the outcomes observed with nivolumab in metastatic renal cell carcinoma patients with poor prognostic features enrolled in the Italian expanded access program. Patients & methods: Nivolumab was available for patients who relapsed after at least one prior systemic treatment in the advanced or metastatic setting. Results: Of 389 patients, 32 (8%) had brain metastasis, 129 (33%) had liver and 193 (50%) had bone metastasis. These subpopulations achieved a disease control rate of 53, 45 and 47%, respectively. Fifty-one patients had G4 tumor, and they showed 23% objective response rate. The safety profile of the subgroups was in line with the expanded access program population. No new safety signals were reported. Conclusion: Patients with poor prognostic features may derive relevant benefits from nivolumab.
2018
EAP; mRCC; nivolumab; prognostic factors; adult; aged; aged 80 and over; antibodies; monoclonal; antineoplastic agents; bone neoplasms; brain neoplasms; carcinoma; renal cell; disease progression; disease-free survival; female; humans; Italy; Kaplan-Meier estimate; Kidney neoplasms; liver neoplasms; male; middle aged; neoplasm recurrence; local; Nivolumab; patient selection; prognosis; prospective studies; treatment outcome
01 Pubblicazione su rivista::01a Articolo in rivista
Negative prognostic factors and resulting clinical outcome in patients with metastatic renal cell carcinoma included in the Italian nivolumab-expanded access program / Bracarda, S., Galli, L., Maruzzo, M., Lo Re, G., Buti, S., Favaretto, A., Di Costanzo, F., Sacco, C., Merlano, M., Mucciarini, C., Zafarana, E., Romito, S., Maestri, A., Giorgio, C.G., Ionta, M.T., Turci, D., De Giorgi, U., Procopio, G., Cortesi, E., Giannarelli, D., et al.. - In: FUTURE ONCOLOGY. - ISSN 1479-6694. - 14:14(2018), pp. 1347-1354. [10.2217/fon-2017-0570]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1296542
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