Immunotherapy versus standard of care in metastatic renal cell carcinoma. A systematic review and meta-analysis

Roberto Iacovelli, Chiara Ciccarese, Emilio Bria, Davide Bimbatti, Emanuela Fantinel, Claudia Mosillo, Iolanda Bisogno, Matteo Brunelli, Giampaolo Tortora, Camillo Porta

Research output: Contribution to journalReview articlepeer-review


BACKGROUND: Recently, immune checkpoint inhibitors against PD-1/PD-L1 or CTLA4 have emerged as new treatments for metastatic renal cell carcinoma (mRCC), despite discrepancy between their effects on OS and PFS. We performed a meta-analysis of randomized trials comparing immunotherapy to standard of care (SOC) in mRCC.

METHODS: Searching the MEDLINE/PubMed, Cochrane Library and ASCO Meeting abstracts prospective studies were identified. Data extraction was conducted according to the PRISMA statement. The measured outcomes were OS, PFS, and ORR.

RESULTS: A total of 2832 patients were available for evaluation of OS, and 3033 for PFS and ORR. Compared to SOC, immunotherapy improved OS (HR = 0.75; 95%CI 0.66-0.85; p < 0.001), and PFS (HR = 0.88; 95%CI 0.80-0.97; p = 0.009). The PFS benefit was not confirmed when considering patients treated in first-line only (p = 0.10). Conversely, significant ORR improvement was found in patients treated in first-line only (HR = 1.14; 95%CI 1.02-1.28; p = 0.03) but not in the overall population.

CONCLUSIONS: Immunotherapy improved OS compared to SOC in mRCC, irrespective of treatment line. In first-line, immunotherapy also increased the ORR compared to sunitinib. A lack of correlation between OS and PFS was confirmed, the latter to be used cautiously for the design and interpretation of trials involving immunotherapy in mRCC.

Original languageEnglish
Pages (from-to)112-117
Number of pages6
JournalCancer Treatment Reviews
Publication statusPublished - Nov 2018


  • Antineoplastic Agents/therapeutic use
  • Carcinoma, Renal Cell/drug therapy
  • Humans
  • Immunotherapy
  • Kidney Neoplasms/drug therapy
  • Prognosis
  • Standard of Care


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