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

Sergio Bracarda, Luca Galli, Marco Maruzzo, Giovanni Lo Re, Sebastiano Buti, Adolfo Favaretto, Francesco Di Costanzo, Cosimo Sacco, Marco Merlano, Claudia Mucciarini, Elena Zafarana, Sante Romito, Antonio Maestri, Carmelo G. Giorgio, Maria T. Ionta, Daniele Turci, Ugo De Giorgi, Giuseppe Procopio, Enrico Cortesi, Diana GiannarelliCamillo Porta

Research output: Contribution to journalArticle

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.
Original languageItalian
Pages (from-to)1347-1354
Number of pages8
JournalFuture Oncology
Volume14
Issue number14
DOIs
Publication statusPublished - Jun 1 2018

Cite this

Negative prognostic factors and resulting clinical outcome in patients with metastatic renal cell carcinoma included in the Italian nivolumab-expanded access program. / Bracarda, Sergio; Galli, Luca; Maruzzo, Marco; Lo Re, Giovanni; Buti, Sebastiano; Favaretto, Adolfo; Di Costanzo, Francesco; Sacco, Cosimo; Merlano, Marco; Mucciarini, Claudia; Zafarana, Elena; Romito, Sante; Maestri, Antonio; Giorgio, Carmelo G.; Ionta, Maria T.; Turci, Daniele; De Giorgi, Ugo; Procopio, Giuseppe; Cortesi, Enrico; Giannarelli, Diana; Porta, Camillo.

In: Future Oncology, Vol. 14, No. 14, 01.06.2018, p. 1347-1354.

Research output: Contribution to journalArticle

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, CG, Ionta, MT, Turci, D, De Giorgi, U, Procopio, G, Cortesi, E, Giannarelli, D & Porta, C 2018, 'Negative prognostic factors and resulting clinical outcome in patients with metastatic renal cell carcinoma included in the Italian nivolumab-expanded access program', Future Oncology, vol. 14, no. 14, pp. 1347-1354. https://doi.org/10.2217/fon-2017-0570
Bracarda, Sergio ; Galli, Luca ; Maruzzo, Marco ; Lo Re, Giovanni ; Buti, Sebastiano ; Favaretto, Adolfo ; Di Costanzo, Francesco ; Sacco, Cosimo ; Merlano, Marco ; Mucciarini, Claudia ; Zafarana, Elena ; Romito, Sante ; Maestri, Antonio ; Giorgio, Carmelo G. ; Ionta, Maria T. ; Turci, Daniele ; De Giorgi, Ugo ; Procopio, Giuseppe ; Cortesi, Enrico ; Giannarelli, Diana ; Porta, Camillo. / Negative prognostic factors and resulting clinical outcome in patients with metastatic renal cell carcinoma included in the Italian nivolumab-expanded access program. In: Future Oncology. 2018 ; Vol. 14, No. 14. pp. 1347-1354.
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T1 - Negative prognostic factors and resulting clinical outcome in patients with metastatic renal cell carcinoma included in the Italian nivolumab-expanded access program

AU - Bracarda, Sergio

AU - Galli, Luca

AU - Maruzzo, Marco

AU - Lo Re, Giovanni

AU - Buti, Sebastiano

AU - Favaretto, Adolfo

AU - Di Costanzo, Francesco

AU - Sacco, Cosimo

AU - Merlano, Marco

AU - Mucciarini, Claudia

AU - Zafarana, Elena

AU - Romito, Sante

AU - Maestri, Antonio

AU - Giorgio, Carmelo G.

AU - Ionta, Maria T.

AU - Turci, Daniele

AU - De Giorgi, Ugo

AU - Procopio, Giuseppe

AU - Cortesi, Enrico

AU - Giannarelli, Diana

AU - Porta, Camillo

PY - 2018/6/1

Y1 - 2018/6/1

N2 - 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.

AB - 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.

KW - EAP

KW - mRCC

KW - nivolumab

KW - prognostic factors

U2 - 10.2217/fon-2017-0570

DO - 10.2217/fon-2017-0570

M3 - Articolo

VL - 14

SP - 1347

EP - 1354

JO - Future Oncology

JF - Future Oncology

SN - 1479-6694

IS - 14

ER -