835P - Updated OS analysis, multivariate and QTWIST analysis of a randomized sequential open-label study (SWITCH) to evaluate efficacy and safety of soraf...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Renal Cell Cancer
Therapy
Biological Therapy
Presenter Christian Eichelberg
Citation Annals of Oncology (2014) 25 (suppl_4): iv280-iv304. 10.1093/annonc/mdu337
Authors C. Eichelberg1, P.J. Goebell2, W. Vervenne3, M. De Santis4, L. Fischer von Weikersthal5, C. Lerchenmüller6, U. Zimmermann7, M.M.E.M. Bos8, W. Freier9, S. Schirrmacher-Memmel10, M. Staehler11, S. Pahernik12, M. Los13, M. Schenck14, A. Floercken15, C. van Arkel16, K. Hauswald17, M. Indorf17, D. Gottstein18, M. Michel19
  • 1Klinik Für Urologie, Caritas Krankenhaus St.Josef, 93053 - Regensburg/DE
  • 2Urologische Klinik, AURONTE, Erlangen/DE
  • 3Oncology, Deventer Ziekenhuis, Deventer/NL
  • 4Medical Oncology, LBI-ACR-VIEnna and KFJ Spital, Vienna/AT
  • 5Medical Oncology, Gesundheitszentrum Klinikum Amberg, Amberg/DE
  • 6Onkologie, Onkologisches Zentrum Münster, Münster/DE
  • 7Klinik Für Urologie, Universitätsklinikum Greifswald, Greifswald/DE
  • 8Oncology, Reinier de Graaf Gasthuis, Delft/NL
  • 9Onkologische Praxis Hildesheim, Onkologische Praxis Hildesheim, 31135 - Hildesheim/DE
  • 10Department Of Hematology And Oncology, Klinikum Fulda gAG, Fulda/DE
  • 11Dept. Of Urology, University of Munich, Munchen/DE
  • 12Klinik Füe Urologie, Universitätsklinikum Heidelberg, Heidelberg/DE
  • 13Oncology, St. Antonius Ziekenhuis, Nieuwegein/NL
  • 14Klinik Für Urologie, Universitätsklinikum Essen, Essen/DE
  • 15Hematology, Oncology, And Tumorimmunology, Charité, Campus Virchow Klinikum, Berlin/DE
  • 16Medical Oncology, Slingeland Ziekenhuis, Doetinchem/NL
  • 17Medicine, IOMEDICO, Freiburg/DE
  • 18Biostatistics, ICRC-Weyer GmbH, Berlin/DE
  • 19Klinik Für Urologie, Universitätsmedizin Mannheim, Mannheim/DE

Abstract

Aim

Results of the sequential randomized phase III SWITCH study comparing SO/SU and SU/SO have been reported previously (ASCO GU 2014, abstract 393) showing no significant difference in the primary endpoint total PFS (T-PFS, Hazard Ratio [HR] 1.01) nor the secondary endpoints overall survival (OS, HR 1.0) and 1st-line PFS (HR 1.19). We report here the results of an updated overall survival (OS) analysis, a multivariate analysis and QTWIST analysis (all post-hoc). NCT00732914.

Methods

Pts with mRCC unsuitable for cytokines without prior systemic therapy, ECOG PS 0/1, MSKCC score low or intermediate, and ≥1 measurable lesion were randomized to receive open-label SO/SU (arm A) or SU/SO (arm B) in standard dosage. The updated OS analysis was performed with data cut-off 14 JAN 2014 (database closure) using 150 events. A multivariate logistic regression analysis was performed to identify patient factors to reach a second-line therapy. QTWIST analysed the number of days without certain grade 3/4 according to CTCAE v 3.0 (HFSR; fatigue, diarrhea, nausea, rash) from randomisation to disease progression or death.

Results

The updated OS analyses revealed a median OS for SO/SU of 30 months (95%CI 23.3-34.7) and for SU/SO of 27.4 mos (22.3-35.9), HR 0.985 (one-sided 95%CI <1.267, p = 0.46). In the multivariate analysis slow progression speed and the randomization into group SO/SU were identified as factors making it significantly more likely to reach 2nd-line treatment. All other factors analysed did not significantly influence the likelihood to reach 2nd-line. In group SO/SU the QTWIST analysis revealed a median time without AEs of 4.5 mos (95%CI 3.6-5.3) and in group SU/SO of 6.8 mos (4.1-9.1), HR 1.28 (one-sided 95%CI <1.60), p = 0.97).

Conclusions

In this updated OS analysis there was no significant difference between the two sequential treatments concerning OS. In addition, the time without specific AEs of grade 3/4 (QTWIST) was not significantly different. A multivariate analysis showed that slowly progressing pts and those who started on sorafenib were more likely to reach 2nd line on study treatment.

Disclosure

C. Eichelberg: Consultancy or advisory role: Bayer, Pfizer, Novartis, GSK Honoraria: Bayer, Pfizer, Novartis, GSK Research Funding: Bayer, Pfizer, Novartis, GSK, Wilex, Immatics; M. De Santis: Consultancy and Advisory Role: Bayer, Pfizer, Novartis; M. Staehler: Consultancy or Advisory Role: Bayer; A. Floercken: Honoraria: Pfizer, Bayer, GSK; M. Michel: Consultancy and Research Funding: Bayer. All other authors have declared no conflicts of interest.