873 - Could the safety profile of everolimus be different in different cancers? Fondazione IRCCS Istituto Nazionale Tumori (INT) experience in renal cell...

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anticancer agents
Complications/Toxicities of Treatment
Biological Therapy
Presenter Elena Verzoni
Authors E. Verzoni1, S. Pusceddu1, G. Procopio2, R. Buzzoni3, I. Testa1, E. Bajetta4, A. Damato1, F.G.M. De Braud1
  • 1Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 - Milano/IT
  • 2Oncologia Medica, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 - Milano/IT
  • 3Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 - Milano/IT
  • 4Medical Oncology, Istituto di Oncologia del Policlinico di Monza, IT-20052 - Monza/IT



Everolimus is an inhibitor of the mammalian target of rapamycin (mTOR), a kinase which plays a key role in cellular processes. The toxicity profile of antiangiogenic therapies lacks disease specificity; while few data on everolimus are available.


We retrospectively analyzed data about safety profile of everolimus in patients (pts) with different cancer treated in our Institution: 21 pts with metastatic renal cell cancer (mRCC), 20 pts with biliary tract cancer, 12 pts with pancreatic neuroendocrine tumors (NETs). All were pre-treated with 1 standard treatment (Tirosine Kinase Inhibitors/chemotherapy/somatostatine analogs +/- chemotherapy, respectively) at least and received everolimus at 10 mg od continuously.


mRCC pts: median age 64 years (53-78), median treatment exposure 6.8 months (3-20); previous treatments (1/2/3:28%/47%/23% respectively) AEs: mucositis (68%, 1 pt G3), hypertriglyceridemia (56%; 20% G3), hypercholesterolemia (43%, 1 pt G3), rash (31% 1 pt G3), pneumonitis (10% all G1), no haematological AEs Biliary tract cancer pts: median age 61 years (48-74), median treatment exposure 4.6 months (2-10), previous treatments (1/2: 85%/15% respectively) AEs: thrombocytopenia (60%, 3 pts G3), fatigue (30%, 2 pts G3), mucositis (25% no G3), 20% rash (no G3) NETs pts: median age 57(38-76), median treatment exposure 8.1 months (3-12); previous treatments (1/2:45%/55% respectively) AEs: 60% fatigue (2 pts G3), neutropenia 35% (1 pt G3), mucositis 25% (no G3), 12% rash (no G3), thrombocytopenia 15% (no G3), hypercholesterolemia 12% (no G3), hypertriglyceridemia 8% (no G3) Dose reductions from 10 mg to 5 mg: 26% in mRCC, 27% in biliary cancers, 25% in NETs Drug interruptions(< 3 day): 8% in RCC, 5% in biliary, 7% in NETs Drug withdrawn due to AE: nobody.


Everolimus is safe and well tolerated. AEs seem to be maintained across the different baseline disease. However the differences in the frequencies of the same AEs observed suggest a potential impact of previous treatment on Everolimus tolerability. May be interesting to study the inter-individual and the oncotype variability of everolimus in terms of different activities of the drug efflux pump P-glycoprotein. Moreover the metabolism of cytochrome P450 and the polymorphism in his gene could be further investigated.


All authors have declared no conflicts of interest.