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Stereotactic Radiosurgery for Gynecologic Cancer
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Phase 3 Trial of Stereotactic Body Radiotherapy in Localized Prostate Cancer.

Nicholas van As1, Clare Griffin1, Alison Tree1

  • 1From the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).

The New England Journal of Medicine
|October 16, 2024
PubMed
Summary
This summary is machine-generated.

Stereotactic body radiotherapy (SBRT) is noninferior to conventional radiotherapy for treating localized prostate cancer. This study found SBRT to be an effective treatment option with similar outcomes regarding disease control.

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Area of Science:

  • Oncology
  • Radiation Oncology
  • Clinical Trials

Background:

  • The efficacy of stereotactic body radiotherapy (SBRT) compared to conventionally or moderately hypofractionated regimens for localized prostate cancer remains unclear.
  • This study addresses the question of whether SBRT is noninferior to other fractionation schedules in preventing biochemical or clinical failure.

Purpose of the Study:

  • To compare the noninferiority of SBRT versus conventional radiotherapy in patients with localized prostate cancer.
  • To evaluate biochemical or clinical failure rates and toxicity profiles between the two treatment arms.

Main Methods:

  • A phase 3, international, randomized controlled trial involving 874 patients with T1-T2 prostate cancer.
  • Patients were assigned to either SBRT (36.25 Gy in 5 fractions) or control radiotherapy (78 Gy in 39 or 62 Gy in 20 fractions).
  • The primary endpoint was freedom from biochemical or clinical failure, with a noninferiority margin set at a hazard ratio of 1.45.

Main Results:

  • At a median follow-up of 74 months, the 5-year freedom from failure rate was 95.8% for SBRT and 94.6% for control radiotherapy, confirming noninferiority (HR 0.73, P=0.004).
  • Late genitourinary toxicity (Grade ≥2) was higher with SBRT (26.9%) compared to control radiotherapy (18.3%) (P<0.001).
  • Late gastrointestinal toxicity (Grade ≥2) was similar between SBRT (10.7%) and control radiotherapy (10.2%) (P=0.94).

Conclusions:

  • Five-fraction SBRT is noninferior to control radiotherapy for biochemical or clinical failure in low-to-intermediate-risk localized prostate cancer.
  • SBRT represents a potentially efficacious treatment option for this patient population.
  • While effective, SBRT was associated with increased genitourinary toxicity compared to conventional radiotherapy.