879 - Treatment of patients with metastatic kidney cancer during haemodialysis with mTOR inhibitors

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anticancer Agents
Urothelial Cancers
Cancer in Special Situations
Biological Therapy
Presenter Cristina Masini
Authors C. Masini1, M. Milella2, G. Di Lorenzo3, A. Onofri4, M. Santoni5, V. Prati6, M. Nicodemo7, P.F. Conte8, R. Sabbatini9
  • 1Dept. Of Hematology/oncology, Ospedale Policlinico-Modena, 41214 - Modena/IT
  • 2Divisione Di Oncologia Medica A, Istituto Nazionale Tumori Regina Elena, Roma/IT
  • 3Genitourinary Cancer Section And Rare-cancer Center, University Federico II, 80131 - Napoli/IT
  • 4AO Ospedali Riuniti, Università Politecnica delle Marche, Ancona/IT
  • 5Clinica Di Oncologia Medica, AO Ospedali Riuniti, Università Politecnica delle Marche, Ancona/IT
  • 6Oncologia Medica A Direzione Universitaria, Fondazione del Piemonte per l’Oncologia, Istituto per la Ricerca e, Torino/IT
  • 7Divisione Di Oncologia, Ospedale "Sacro Cuore-Don Calabria" Negrar, Verona/IT
  • 8Dept. Of Hematology/oncology, Ospedale Policlinico-Modena, IT-41100 - Modena/IT
  • 9Ospedale Policlinico-Modena, 41214 - Modena/IT



On the basis of a few published data, sunitinib and sorafenib can be administered safely to patients (pts) with metastatic renal cell carcinoma (mRCC) and end-stage renal disease on haemodialysis (HD). Aim of this study was to investigate the safety and efficacy of temsirolimus and everolimus in pts with mRCC on HD.

Patients and methods

between September 2007 and February 2012, 13 pts with mRCC undergoing HD were treated with temsirolimus and everolimus in 6 Italian Institutions. We retrospectively reviewed the medical records of these pts to evaluate the doses of mTOR inihibitors administered, the tolerability and the activity of the treatment.


Gender: 9 males/4 females; median age: 63 years (range 47–79). All pts were undergoing HD, in 7 cases for bilateral nephrectomy; the time interval between the start of HD and the start of mTOR inhibitors treatment was 37 months. Everolimus was administered at 10 mg daily in 5 pts and at 5 mg in one patient; 7 pts received temsirolimus at 25 mg weekly. Everolimus was administered as second-line treatment in 4 pts, as third and fourth-line in two pts; temsirolimus was given as first-line treatment to 4 pts, as second-line to one patient and as third-line to 2 pts. No unexpected adverse event (AE) and no grade 4 haematological or non-haematological toxicity were reported. The most common grade 1–2 non-haematological treatment-related AEs were fatigue (9/13 pts), dyslipidemia (4/13 pts), oral mucositis in 2/13 pts. A grade 3 dyspnea due to interstitial pneumonia led to treatment discontinuation. The most frequent grade 1–2 haematologic toxicity was anemia (10/13 pts). None of the patients had to change the number of dialysis sessions during mTOR inhibitors treatment. None of the pts experienced an objective response while a disease stabilization was observed in 7 pts. At the time of the analysis, 7 pts had died due to disease progression. The estimated median progression-free survival (PFS) of this cohort of pts was 6.1 months.


In this small retrospective series of pts the incidence of AEs was as expected, and a prolonged PFS was observed. The use of temsirolimus and everolimus is not contraindicated in pts with mRCC and severe renal impairment on HD.


All authors have declared no conflicts of interest.