Randomized trial of carboplatin versus radiotherapy for stage I seminoma

Journal of Clinical Oncology, 02/08/2011

Oliver RTD et al. – These updated results confirm the noninferiority of single dose carboplatin (at 7 × AUC dose) versus RT in terms of RFR and establish a statistically significant reduction in the medium term of risk of second GCT produced by this treatment.

Methods

  • Random assignment was between RT and 1 infusion of carboplatin dosed at 7 × (glomerular filtration rate + 25) on basis of EDTA (n = 357) and 90% of this dose if determined on basis of creatinine clearance (n = 202)
  • Trial powered to exclude doubling in RFRs assuming a 96-97% 2-year RFR after radiotherapy (HR, approximately 2.0)

Results

  • 1,447 patients were randomly assigned in a 3-to-5 ratio (carboplatin, n = 573; RT, n = 904)
  • RFRs at 5 years 94.7% for carboplatin and 96.0% for RT (RT-C 90% CI, 0.7% to 3.5%; HR, 1.25; 90% CI, 0.83 to 1.89)
  • One death as result of seminoma (in RT arm) occurred
  • Patients receiving at least 99% of the 7 × AUC dose had 5-year RFR of 96.1% (95% CI, 93.4% to 97.7%) compared with 92.6% (95% CI, 88.0% to 95.5%) in those who received lower doses (HR, 0.51; 95% CI, 0.24 to 1.07; P = .08)
  • Clear reduction in rate of contralateral GCTs (carboplatin, n = 2; RT, n = 15; HR, 0.22; 95% CI, 0.05 to 0.95; P = .03), and elevated pretreatment FSH levels (> 12 IU/L) was strong predictor (HR, 8.57; 95% CI, 1.82 to 40.38)

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