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 Anti-Cancer Agents & Biologic Therapy
Renal Cell Cancer
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.