875 - Everolimus in the sequence after failure of VEGFR-directed therapy in MRCC - a retrospective analysis

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anticancer agents
Renal Cell Cancer
Biological therapy
Presenter Lothar Bergmann
Authors L. Bergmann1, V. Grünwald2, U. Kube3, S. Weikert4, C. Kahl5, T.C. Gauler6, L. Maute7
  • 1Medical Clinic Iii, Universitätsklinikum Frankfurt(Johannes-Wolfgang Goethe Institute), 60590 - Frankfurt am Main/DE
  • 2Clinic For Hematology, Hemostasis, Oncology, Medical School Hannover, DE-30625 - Hannover/DE
  • 3Urology, Bethanien Hospital, Chemnitz/DE
  • 4Urology, Charite, Berlin/DE
  • 5Hematology/ Oncology, Klinikum Magdeburg, DE-39130 - Magdeburg/DE
  • 6Dept. Of Medicine (cancer Research), University Hospital EssenWestdeutsches Tumorzentrum, DE-45122 - Essen/DE
  • 7Department For Internal Medicine Ii, J.W.Goethe University Hospital, 60590 - Frankfurt/DE


In a retrospective NIS, 81 patients receiving everolimus after failure of VEGFR directed therapy have been analyzed in regard to response, duration of treatment and subsequent therapies. In total, the data of 81 patients (57 m, 24 f) with 93% ccRCC and 6% ncRCC (1% undefined) have been analyzed. The median age was 58 years (23–78 y). 36% had synchronous and 63% metachronous metastases. According to the MSKCC score at initial diagnosis, 24% have been “favorable”, 26% “intermediate”, 7% “poor prognosis” and in 43% there was no initial prognostic score defined by the treating physicians. The major locations of metastases have been lung (56.8%), lymph nodes (34.6%), skeleton system (17.3%), 36 44% of the patients had multiple locations. As 1st line therapy, 24% had cytokine or immunotherapy based therapies, 52% sunitinib and 17% sorafenib. The duration of 1st line therapy was 7.0 months in median for all patients (including cytokines) and 7.8 and 13.7 months for those treated with sunitinib or sorafenib, respectively. 50 patients achieved a second line therapy prior to everolimus, 22 patients were treated with sorafenib and 26 patients with sunitinib dependent on the 1st line therapy. Most patients treated with everolimus in 2nd or 3rd line therapy had an ECOG of 1 (49.4%) followed by ECOG 0 (39.5%) and ECOG 2 (9.9%). The median duration of treatment with everolimus was 4.5 months (0.6–22.5), 36% of the patients were more than 6 months on treatment with everolimus. Best response was CR in 2.5%, PR in 12% and SD in 47% of the patients (CBR 61%). Reasons for discontinuation were PD (72%), intolerance (16%), patients request (6%) and others (6%). 77/81 patients (95%) received a further therapy after discontinuation of everolimus. The agents administered beyond everolimus were sunitinib (29%), sorafenib (29%) and 36% received other therapies as temsirolimus, pazopanib or dovitinib. Best reported responses have been CR (1%), PR (9%), SD (48%) of the reported patients. 27 patients received an additional sequence of therapy (4th to 5th line). In summary, these data confirm the results of the RECORD-1 trial in clinical practice and demonstrate a clinical benefit of therapies beyond everolimus. 58% of the patients were still alive at time of evaluation.


L. Bergmann: The retrospective analysis was supported by a grant of Novartis Pharma. The presenter has been an advisor for Novartis Pharma.

V. Grünwald: Advisory board Novartis.

S. Weikert: Advisory board Novartis.

T.C. Gauler: Advisary board Novartis.

All other authors have declared no conflicts of interest.