836P - Treatment and outcome(s) of a large cohort of poor risk metastatic renal cell carcinoma (prRCC) patients (pts)

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Renal Cell Cancer
Presenter Alessandra Felici
Citation Annals of Oncology (2014) 25 (suppl_4): iv280-iv304. 10.1093/annonc/mdu337
Authors A. Felici1, D. Santini2, U. De Giorgi3, S. Iacobelli4, G. Facchini5, M. Santoni6, E. Verzoni7, L. Derosa8, G. Di Lorenzo9, R. Ardito10, G. Badalamenti11, P. Marchetti12, E. Cortesi13, R. Cengarle14, S.L. Fedeli15, V. Adamo16, P. Maroto17, F.M. Guida18, I. Sperduti19, M. Milella20
  • 1Medical Oncology, Regina Elena National Cancer Institute, 00144 - Roma/IT
  • 2Medical Oncology, Campus Bio-Medico di Roma, 00128 - Roma/IT
  • 3Medical Oncology, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola, 47014 - Meldola (FC)/IT
  • 4Medical Oncology, Ospedale Clinicizzato SS.Annunziata, Chieti/IT
  • 5Medical Oncology, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli/IT
  • 6Medical Oncology, AOU Ospedali Riuniti Ancona Università Politecnica delle Marche, 60126 - Ancona/IT
  • 7Oncologia Medica, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milano/IT
  • 8Polo Oncologico, Azienda Ospedaliero Universitaria S.Chiara, 56100 - Pisa/IT
  • 9Department Of Oncology, Cattedra di Oncologia Medica, Università degli Studi Federico II, 80131 - Napoli/IT
  • 10Medical Oncology, IRCCS, Rionero in Vulture (PZ)/IT
  • 11Oncologia Medica, Azienda Ospedaliera Universitaria Policlinico 'Paolo Giaccone', palermo/IT
  • 12Oncologia Medica, Azienda Ospedaliera Sant'Andrea - " Sapienza" Facoltà di Medicina e Psicologia, 00189 - Roma/IT
  • 13Department Of Radiology, Oncology And Human Pathology, Sapienza University of Rome, 00161 - Roma/IT
  • 14Medical Oncology, Ospedale Carlo Poma, Mantova/IT
  • 15Medical Oncology, Ospedali Riuniti Marche Nord, Pesaro/IT
  • 16Human Pathology, Unit of Integrated Therapies in Oncology, University Policlinic "G. Martino", 98125 - Messina/IT
  • 17Dept. Of Medical Oncology, Hospital de la Sta. Creu i St. Pau, ES-08025 - Barcelona/ES
  • 18Medical Oncology, university campus bio-medico, 00128 - Roma/IT
  • 19Biostatistics, Regina Elena National Cancer Institute, 00144 - Roma/IT
  • 20Divisione Di Oncologia Medica A, Istituto Nazionale Tumori Regina Elena, Roma/IT



With the exception of the Temsirolimus (Tem) registration trial, prRCC is grossly underrepresented in clinical trials.


We collected information on a large cohort of prRCC (239 pts) from 20 Italian and 2 Spanish centers.


Three prognostic models (MSKCC, modified MSKCC - mMSKCC, International Metastatic RCC Database Consortium - DC) and 8 individual risk factors (RF) were considered: multiple metastatic sites (89%), time from diagnosis to treatment (82%), and anaemia (77%) were the most frequent individual RF. Eighty-nine percent, 63%, and 61% of pts had at least 3 RF according to mMSKCC, MSKCC, and DC, respectively; mMSKCC had the best discriminating power between intermediate and prRCC (median OS: 28 vs 8 mos, respectively; p < 0.0001). Two hundred and thirty three pts received first-line treatment (VEGFR-TKI 70%, Tem 24%, other 4%). Second- and third-line therapy were administered in 43% and 13% of pts, respectively. After first-line treatment, the total number of RF was reduced in 30% of pts (p < 0.0001). Median PFS and OS were 4 (95% CI: 3-5) and 9 (95% CI: 7-11) mos, respectively, for the entire population; overall DCR (PR and SD > 6 mos) was 44% and was significantly higher for pts receiving first-line TKI versus Tem (50% vs 26%, p = 0.002). Age, nephrectomy status, mMSKCC, and total number of RF, but not the type of treatment received (Tem vs VEGFR-TKI), were independently associated with OS at multivariate analysis. Thirty seven percent of prRCC pts survived >12 mos (29% and 40% in pts receiving Tem and VEGFR-TKI, respectively). Basal Hb and calcium levels within normal limits were significantly associated with higher chances of achieving long-term survival upon VEGFR-TKI treatment, while a non-significant trend towards a higher proportion of long-term survivors upon Tem treatment was observed for longer time from diagnosis to treatment and normal LDH levels, in an exploratory analysis of predictive factors.


Despite heterogeneity, prRCC may benefit from systemic treatment across multiple lines of therapy. Further prognostic/predictive stratification within the prRCC group is clearly necessary (see also the abstract by Guida et al. at this Meeting).


All authors have declared no conflicts of interest.