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. 2023 May 4;2023(5):CD013798. doi: 10.1002/14651858.CD013798.pub2

NCT01613846.

Study characteristics
Methods Study name: SWITCH II
Study design: a two‐arm, RCT, phase III
Blinding: none, open‐label
Study dates: June 14th, 2012 ‐ November 14th, 2016
Date of data cut‐off: not reported
Location: 3 countries (Austria, Germany, the Netherlands), types of centres: cancer centres/clinics, hospitals, university hospitals (72 study locations)
Cross‐over study or cross over permitted: yes, cross‐over study*
*For cross‐over trials, we extracted data on period 1 only.
Participants Inclusion criteria:

  • all sexes

  • age ≥ 18 and ≤ 85 years

  • participants with metastatic / advanced RCC (all histologies), who are not suitable for cytokine therapy and for whom study medication constitutes first‐line treatment

  • non‐clear cell histology RCC

  • intermediate risk according to MSKCC score

  • ECOG ≥ 1 and> 1 organ metastasis + < 24 months between diagnosis and establishing indication for interleukin‐2‐therapy

  • ECOG ≥ 1 and "unable to carry on normal activity or do active work" (Karnofsky Index 70%)

  • Karnofsky Index ≥ 70%

  • MSKCC prognostic score (2004), low or intermediate


Exclusion criteria:

  • major surgery within 4 weeks of start of study

  • prior exposure to study drugs

  • investigational drug therapy within 4 weeks of study entry

  • radiotherapy within 3 weeks of start of study drug and planned radiotherapy during the study

  • concomitant medication: Any condition at the discretion of the investigator that precludes compliance with concomitant therapy restrictions described below


Sample size: N = 377
Age, median (years (range)): experimental arm: 68 (31‐84), control arm: 68 (26‐86)
Sex (m/f, %): experimental arm: 136/53 (72/28), control arm: 137/51 (73/27)
Prognostic factors:

  • KPS, n(%)

    • 100

      • experimental arm: 96 (51), control arm: 85 (45)

    • 90

      • experimental arm: 32 (17), control arm: 46 (25)

    • 80

      • experimental arm: 52 (27), control arm: 44 (23)

    • 70

      • experimental arm: 9 (5), control arm: 12 (6)

    • Missing

      • experimental arm: 0 (0), control arm: 1 (1)

  • MSKCC risk score, n(%)

    • Low

      • experimental arm: 95 (50), control arm: 91 (48)

    • Intermediate

      • experimental arm: 90 (48), control arm: 89 (47)

    • High

      • experimental arm: 4 (2), control arm: 5 (3)

    • Missing/Unknown

      • experimental arm: 0 (0), control arm: 3 (2)

  • Nephrectomy n(%)

    • Total

      • experimental arm: 167 (88), control arm: 161 (86)

    • Partial

      • experimental arm: 19 (10), control arm: 24 (13)
Interventions Experimental arm (n = 189): sorafenib (400 mg, oral, twice/day)
Control arm (n = 188): pazopanib (800 mg, oral, once/day)
Outcomes Primary outcome(s)
‐
Secondary outcome(s)

  • PFS in first‐line, descriptively

    • Time frame: 4 years

  • OS, descriptively (data cut‐off same as for primary endpoint)

    • Time frame: 4 years

  • Health‐related QoL (FACIT‐F, FKSI‐10)

    • Time frame: 4 years

  • Safety and tolerability (AEs, SAEs)

    • Time frame: 4 years

  • Number of participants who discontinued treatment due to an AE


Relevant to this review but not reported: TFST
Other outcomes (not relevant to this review): PFS in second‐line treatment, DCR (CR,PR,SD, RECIST), biomarker programme, time to treatment failure, TTP
Notes Funding sources: Quote: "The SWITCH II trial was sponsored by the Technical University of Munich, Germany with financial grants from Bayer HealthCare GmbH and Novartis GmbH. Bayer HealthCare GmbH and Novartis GmbH were not involved in the trial concept and design. The Association for Urologic Oncology (AUO) of the German Cancer Society supported this study (AN 33/11) as well as the main Association of Austrian Social Security Institutions. The specific role of the sponsors was in the design and conduct of the study."
Declaration of Interest: Quote:"It is certified that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (e.g. employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or
patents filed, received, or pending), are the following:" Margitta Retz, Janssen‐Cilag, Martin Bögemann, Marc‐Oliver Grimm, Maria De Santis, Christian Bolenz, Carsten Bokemeyer, Jürgen E. Geschwend. No conflicts of Interest declare: Uwe Zimmermann, Lothar Müller, Christian Leiber, Dogu Teber, Manfred Wirth, Aart Becker, Jan Lehmann, Robbert van Alphen, Martin Indorf, Melanie Frank.
Clinical study report available: no
Study protocol available: no
Statistical analysis plan available: no