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 Anti-Cancer Agents & Biologic Therapy
Renal Cell Cancer
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.