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.; Porta, C.. - 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
Buti S.;
2018-01-01
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.