821P - Everolimus in patients with metastatic renal cell carcinoma who progress after initial vascular endothelial growth factor receptor-tyrosine kinase i...

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Cytotoxic agents
Renal Cell Cancer
Biological therapy
Presenter Simon Chowdhury
Authors S. Chowdhury1, J. Larkin2
  • 1Department Of Medical Oncology, Guy's and St. Thomas' Hospital NHS Trust, SE1 9RT - London/UK
  • 2Department Of Medicine, Royal Marsden Hospital, SW3 6JJ - London/UK



The phase III RECORD-1 trial demonstrated clinical benefit of everolimus in patients with metastatic renal cell carcinoma (mRCC) who had failed initial VEGFr-TKI therapy. REACT (RAD001 Expanded Access Clinical Trial in RCC) was designed to address an unmet medical need by providing everolimus to patients with mRCC prior to regulatory approval. UK results from the REACT trial are reported here.


REACT was an open-label, international, expanded-access program. Eligible patients had measurable or nonmeasurable mRCC of any histology, and had progressed on, or were intolerant of, VEGFr-TKI therapy. Patients received a once-daily oral 10 mg dose of everolimus. The primary objective of REACT was to evaluate long-term safety of everolimus. Tumour response was also assessed according to RECIST.


A total of 120 patients were enrolled in the UK, 9% of worldwide enrolment. Prior sunitinib was received by 76% of patients; only 5.8% of patients received more than one VEGFr-TKI. Everolimus was received for a median duration of 21.8 weeks (range, 2.0–59.0), numerically longer than reported overall for REACT (14.0 weeks; range, 0.1–83.7). Safety findings and tumour responses were consistent with those observed in the global patient population. The most commonly reported grade 3/4 AEs were anaemia (20.8%), hyperglycaemia (10%), and lower respiratory tract infection (7.5%). Stomatitis and pneumonitis occurred in 13.3% and 10% of patients, respectively (all grades); grade 3 events were reported in 6.7% and 3.3% of patients (no grade 4 events). Investigator-assessed best overall responses were stable disease in 67 (55.8%) patients and a partial response in 1 patient (0.8%), comparable with the overall population. No complete responses were documented in this trial.


The REACT trial provided everolimus in advance of regulatory approval and commercial availability to mRCC patients in the UK who failed initial VEGFr-TKI therapy. Everolimus was well tolerated, and safety findings were consistent with those reported for global REACT.


S. Chowdhury: Consultant or Advisory: Novartis, Pfizer, GSK, Sanofi-Aventis, Janssen-Cilag, Dendreon.

All other authors have declared no conflicts of interest.