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

Keywords

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal/therapeutic use
  • Antineoplastic Agents/therapeutic use
  • Bone Neoplasms/drug therapy
  • Brain Neoplasms/drug therapy
  • Carcinoma, Renal Cell/drug therapy
  • Disease Progression
  • Disease-Free Survival
  • Female
  • Humans
  • Italy
  • Kaplan-Meier Estimate
  • Kidney Neoplasms/drug therapy
  • Liver Neoplasms/drug therapy
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local/drug therapy
  • Nivolumab
  • Patient Selection
  • Prognosis
  • Prospective Studies
  • Treatment Outcome

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  • Cite this

    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., ... 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, 14(14), 1347-1354. https://doi.org/10.2217/fon-2017-0570