818P - Progression free survival (PFS) and overall survival (OS) in patients receiving 3 targeted therapies (TTs) for metastatic renal-cell carcinoma (mRCC)

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Cytotoxic agents
Renal Cell Cancer
Biological therapy
Presenter Roberto Iacovelli
Authors R. Iacovelli1, M. Santoni2, G. Di Lorenzo3, L. Cerbone4, M. Aglietta5, C. Masini6, M.O. Giganti7, C. Messina8, C.N. Sternberg9, G. Procopio10
  • 1Dipartimento Di Scienze Radiologiche, Oncologiche Ed Anatomo-patologiche, Sapienza University of Rome, 00161 - Rome/IT
  • 2Medical Oncology, Università Politecnica delle Marche, Ancona/IT
  • 3Department Of Oncology, Cattedra di Oncologia Medica, Università degli Studi Federico II, 80131 - Napoli/IT
  • 4Medical Oncology, San Camillo and Forlanini Hospital, Rome/IT
  • 5Div Oncologia Ed Ematologia, Fondazione Piemontese per la Ricerca sul Cancro Onlus, IT-10060 - Candiolo/IT
  • 6Dept. Of Hematology/oncology, Ospedale Policlinico-Modena, 41214 - Modena/IT
  • 7Medical Oncology, Niguarda Cà Grande Hospital, Milan/IT
  • 8Medical Oncology, Ospedali Riuniti di Bergamo, Bergamo/IT
  • 9Medical Oncology, San Camillo Forlanini Hospital, Rome/IT
  • 10Oncologia Medica, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milano/IT



In recent years, TTs have improved the prognosis of mRCC patients (pts). Despite a not negligible number of pts received 3 TTs in clinical practice, no TTs have been evaluated as 3rd line. Aim of this study is to investigate the clinical outcome in pts who received 3 TTs.

Patients and methods

Pts with clear-cell mRCC who received 3 TTs were included. A questionnaire was sent to main Italian centers involved in the treatment of mRCC. Demographic data, history of RCC, type and length of first, second and third line were collected; MSKCC risk class was calculated before starting the 1st and 3rd lines, Heng class before the 3rd line. Sequences of class and specific TTs were evaluated: TKIàTKIàmTOR and TKIàmTORàTKI or sunitinib (SU)-sorafenib(SO)- everolimus(EV) and SU-EV-SO. Median PFS, OS and Time to Strategy Failure (TTSF: from start of 1st to end of 3rd line) were estimated with the Kaplan-Meyer method with 95% CI and curves were compared with log-rank test. The study had the ethical approval.


1905 pts were screened and 252 pts (13%) were treated with 3 TTs. The median age was 60 yrs (range 52–68), 73% were male, 96% underwent nephrectomy and 38% were metastatic at diagnosis. At 1st line, the Motzer class was good, intermediate, and poor in 48%, 47% and 5% of pts, respectively. PFS for type and line of therapy are reported in the table below. The TTSF was 36.4 (30.5–42.2) vs. 30.6 (26.5–34.6) mos (p = 0.11), and the OS was 52.1 (41.6–62.6) vs. 36.3 (31.2–41.4) mos (p = 0.01), for TKIàTKIàm-TOR and and TKIàm-TORàTKI, respectively. TTSF for SU-SO-EV was 36.5 vs. 30.4 mos for SU-EV-SO (p = 0.011). When stratified by ECOG-PS before 3rd line or baseline MSKCC, TS maintained its independent prognostic role (p = 0.002 and p = 0.004, respectively).


Only few patients received 3 lines of TTs. The sequence sunitinib-sorafenib-everolimus was associated with a better TTSF and OS as compared to the sequence sunitinib-everolimus-sorafenib.

Therapy 1st line 2nd line 3rd line
Sunitinib 60 10.1 31 11.2 8 14.1
Sorafenib 25 13.1 35 7.7 28 5.2
Pazopanib 2 6.4 0 / 0 /
Bevac. + IFN 11 11.3 0 / 1 4.3
Everolimus 0 / 30 4.7 55 6.9
Temsirolimus 2 5.1 3 5.6 5 2.6
Other 0 / 0 / 3 3.2
TOTAL 100 11.6 100 6.8 100 6.2


All authors have declared no conflicts of interest.