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Genitourinary tumours, non-prostate

1272 - Phase III randomized, sequential, open-label study to evaluate the efficacy and safety of Sorafenib-Pazopanib versus Pazopanib-Sorafenib in the treatment of metastatic renal cell carcinoma (SWITCH-II)

Date

09 Sep 2017

Session

Genitourinary tumours, non-prostate

Topics

Cytotoxic Therapy;  Renal Cell Cancer

Presenters

Margitta Retz

Citation

Annals of Oncology (2017) 28 (suppl_5): v295-v329. 10.1093/annonc/mdx371

Authors

M. Retz1, J. Bedke2, E. Herrmann3, M. Grimm4, U. Zimmermann5, L. Müller6, C. Leiber7, D. Teber8, M. Wirth9, C. Bolenz10, R. van Alphen11, M. De Santis12, A. Beeker13, M. Frank14, J.E. Gschwend1

Author affiliations

  • 1 Dept. Of Urology, Technical University of Munich, Klinikum rechts der Isar, 81675 - Munich/DE
  • 2 Dept. Of Urology, Universitätsklinikum Tübingen, 72076 - Tübingen/DE
  • 3 Dept. Of Urology, Universitätsklinikum Münster, 48149 - Münster/DE
  • 4 Dept. Of Urology, Universitätsklinikum Jena, 07743 - Jena/DE
  • 5 Dept. Of Urology, Universitätsmedizin Greifswald, 17475 - Greifswald/DE
  • 6 Medical Oncology, Onkologie Leer–Emden–Papenburg, 26789 - Leer/DE
  • 7 Dept. Of Urology, Universitätsklinikum Freiburg, 79106 - Freiburg/DE
  • 8 Dept. Of Urology, Universitätsklinikum Heidelberg, 69120 - Heidelberg/DE
  • 9 Dept. Of Urology, Universitätsklinikum Dresden, 01307 - Dresden/DE
  • 10 Dept. Of Urology, Universitätsklinikum Ulm, 89075 - Ulm/DE
  • 11 Dept. Of Oncology, TweeSteden Ziekenhuis, 5042 AD - Tilburg/NL
  • 12 Dept. Of Oncology, Kaiser-Franz-Josef-Spital, 1100 - Vienna/AT
  • 13 Dept. Of Oncology, Spaarne Ziekenhuis, 2134 TM - Hoofddorp/NL
  • 14 Biostatistics, iOMEDICO AG, 79110 - Freiburg/DE
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Abstract 1272

Background

The previous SWITCH-I study explored the two possible sequences of Sunitinib and Sorafenib for the treatment of advanced/metastatic renal cell carcinoma (mRCC) and showed similar total progression-free-survival (tPFS) and overall survival (OS) times. This trial compared the sequential therapy with the multikinase inhibitors Sorafenib (So) followed by Pazopanib (Pa) or vice versa in mRCC patients (pts).

Methods

This multicentre, randomised phase 3 study assessed the sequential use of So-Pa versus Pa-So in pts with mRCC without prior systemic therapy. Pts were randomised to So 400 mg twice daily followed by Pa 800 mg once daily (So-Pa) in case of progression or intolerable toxicity or vice versa (Pa-So). The primary endpoint was non-inferiority of tPFS with So−Pa compared to Pa−So, assessed from randomisation to progression or death during second-line therapy defined as hazard ratio (HR)

Results

377 pts were randomised (So-Pa, n = 189; Pa-So, n = 188). Median tPFS was 8.6 mo (95% CI 7.7-10.2) for So-Pa and 12.9 mo (95% CI 10.8-15.2) for Pa-So with a HR of 1.36 (upper limit of one-sided 95% CI 1.68). Therefore, non-inferiority of So-Pa in regard to tPFS was not met. However, marked statistical differences were noted in favour of Pa-So in total TTP, 1st-line PFS and DCR but not for OS and 2nd-line PFS. In the So-Pa arm 106/189 (56%) received Pa as 2nd line and for the Pa-So arm 87/188 (46%) received So as 2nd line. The most frequent any-grade treatment-emergent first-line adverse events for So were diarrhoea (56%), fatigue (37%) and hand-foot skin reaction (35%) and for Pa diarrhoea (60%), hypertension (48%) and fatigue (45%).

Conclusions

Non-inferiority of the sequence So-Pa compared to Pa–So in terms of the primary endpoint tPFS was not met. However, superiority of the sequence Pa-So over So-Pa for tPFS was not proven either, since the study design was computed with a HR of 

Clinical trial identification

NCT01613846, first received May 4, 2012

Legal entity responsible for the study

Technische Universität München

Funding

Bayer Vital GmbH and in part GSK/Novartis

Disclosure

M. Retz: Honoraria Advisory boards and lectures: Bristol-Myers Squib, Janssen-Cilag, Roche, MSD, Ipsen, Merck-Pfizer, Novartis, Bayer. J. Bedke: Consultancies, honoraria or study participation from Bayer, Bristol-Myers Squib, GSK, Immatics, Nektar, Novartis, Pfizer and Roche. M-O. Grimm: Consultancy fees: AstraZeneca, Amgen, Bayer Health Care, Bristol-Myers Squib, GSK, Novartis, Pfizer, Sanofi; grants: Novartis, Bristol-Myers Squib; payment for lectures: Bayer Health Care, Bristol-Myers Squib, GSK, Hexal, Janssen Cilag, JenaPharm, Novartis, Pfizer, Pierre Fabre. M. De Santis: Study Grants: Pierre Fabre; Honoraria: Amgen, Astellas, AstraZeneca, Bayer, Bristol-Myers Squib, Celgene, Dendreon, Eisai, ESSA, Ferring, GSK, Ipsen, Janssen, Merck, MSD, Novartis, Pfizer, Pierre Fabre, Roche, Sanofi, SeaGen, Shionogi, Synthon, Takeda, TevaOncoGenex. J.E. Gschwend: Honoraria Advisory boards and lectures: Amgen, Astellas, Bayer, Eisai, Janssen, Novartis, Pierre-Fabre, Roche. All other authors have declared no conflicts of interest.

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