mRCC: immediate nephrectomy shows no additional benefit in SURTIME

  • Bex A & al.
  • JAMA Oncol
  • 13.12.2018

  • von Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • In patients with clear cell metastatic renal cell carcinoma (mRCC), sunitinib followed by cytoreductive nephrectomy (CN) yields progression-free rate (PFR) and survival similar to immediate CN.
  • The deferred approach improved OS in the intent-to-treat (ITT) but not the per protocol (PP) population.

Why this matters

  • Sunitinib treatment before planned surgery may identify patients with inherent resistance to systemic therapy.

Study design

  • In the open-label SURTIME trial, 99 treatment-naive patients (vs 458 planned) with clear cell mRCC were randomly assigned to immediate CN followed by sunitinib (n=50) or sunitinib followed by CN (deferred group; n=49).
  • Revised endpoint: 28-week PFR.
  • Funding: Pfizer.

Key results

  • Median follow-up, 3.3 years.
  • 48 patients received presurgical sunitinib in the deferred group, whereas 40 received postoperative sunitinib in the immediate CN group.
  • ITT population: in the deferred CN vs the immediate CN groups:
    • 28-week PFR was 43% vs 42% (P=.61).
    • PFS was not statistically different (HR, 0.88; P=.57).
    • Median OS was significantly higher (32.4 vs 15.0 months; HR, 0.57; P=.03).
    • Grade ≥3 adverse event rate was 58% vs 52%.
  • In the PP population (n=73), OS was similar between both groups (HR, 0.71; P=.23).

Limitations

  • Early termination resulting from poor accrual.