The ORCHIDEE study: Gathering new evidence on the use of everolimus in clinical practice

Mimma Rizzo, Giacomo Cartenì, Giovanni Pappagallo, Lital Hollander, Irene Floriani

Research output: Contribution to journalArticlepeer-review


Randomized clinical trials are the gold standard to test the efficacy of an intervention within a specified patient population. However, the results of the trials may not be generalizable to routine clinical practice. Observational cohort studies may provide information that complements trial results. Targeted therapies are characterized by tolerability profiles that may differ from those of 'traditional' chemotherapy. Therefore, the post-approval evaluation of these drugs by large, well-designed observational cohort studies in real life populations is warranted. Everolimus is an orally-administered inhibitor of the mammalian target of rapamycin. A number of observational cohort studies have been conducted to characterize the effectiveness and safety of everolimus in clinical practice. In particular, the ORCHIDEE study was designed to identify factors predictive of favorable outcome in patients treated with everolimus such as secondline treatment for metastatic renal cell carcinoma after failure of a first-line treatment with a VEGF TKI. ORCHIDEE is a multicenter, single-arm, phase IV study. The study will enroll approximately 200 metastatic renal cell carcinoma metastatic renal cell carcinoma patients from 20 Italian centers over a 24-month period.

Original languageEnglish
Pages (from-to)e290-e292
Issue number6
Publication statusPublished - Nov 1 2014


  • Everolimus
  • Metastatic renal cell carcinoma
  • Observational studies
  • Randomized trials
  • Second-line therapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)


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