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 journalArticle

1 Citation (Scopus)

Abstract

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
JournalTumori
Volume100
Issue number6
DOIs
Publication statusPublished - Nov 1 2014

Fingerprint

Renal Cell Carcinoma
Observational Studies
Cohort Studies
Drug Approval
Drug Evaluation
Sirolimus
Vascular Endothelial Growth Factor A
Population
Therapeutics
Randomized Controlled Trials
Safety
Drug Therapy
Everolimus

Keywords

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

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Rizzo, M., Cartenì, G., Pappagallo, G., Hollander, L., & Floriani, I. (2014). The ORCHIDEE study: Gathering new evidence on the use of everolimus in clinical practice. Tumori, 100(6), e290-e292. https://doi.org/10.1700/1778.19300

The ORCHIDEE study : Gathering new evidence on the use of everolimus in clinical practice. / Rizzo, Mimma; Cartenì, Giacomo; Pappagallo, Giovanni; Hollander, Lital; Floriani, Irene.

In: Tumori, Vol. 100, No. 6, 01.11.2014, p. e290-e292.

Research output: Contribution to journalArticle

Rizzo, M, Cartenì, G, Pappagallo, G, Hollander, L & Floriani, I 2014, 'The ORCHIDEE study: Gathering new evidence on the use of everolimus in clinical practice', Tumori, vol. 100, no. 6, pp. e290-e292. https://doi.org/10.1700/1778.19300
Rizzo M, Cartenì G, Pappagallo G, Hollander L, Floriani I. The ORCHIDEE study: Gathering new evidence on the use of everolimus in clinical practice. Tumori. 2014 Nov 1;100(6):e290-e292. https://doi.org/10.1700/1778.19300
Rizzo, Mimma ; Cartenì, Giacomo ; Pappagallo, Giovanni ; Hollander, Lital ; Floriani, Irene. / The ORCHIDEE study : Gathering new evidence on the use of everolimus in clinical practice. In: Tumori. 2014 ; Vol. 100, No. 6. pp. e290-e292.
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