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EORTC 30974

Needs review

A randomized phase III study comparing standard dose BEP with sequential high-dose cisplatin, etoposide, and ifosfamide (VIP) plus stem-cell support in males with poor-prognosis germ-cell cancer. An intergroup study of EORTC, GTCSG, and Grupo Germinal (EORTC 30974)

Phase 3N = 137NCT00003941

Population
Males with poor-prognosis germ-cell cancer; 131 analysed (66 BEP, 65 high-dose chemotherapy, per the open-access full text)
Design
Randomised phase III intergroup study: four cycles of BEP versus one cycle of standard-dose VIP plus three cycles of high-dose VIP with stem-cell infusion. Aimed to detect a 15% improvement in 1-year failure-free survival with 222 patients; closed early with 137 because of slow accrual. 131 patients analysed.
Arms
  • BEP (control, n = 66): Four cycles of standard-dose cisplatin, etoposide and bleomycin
  • High-dose VIP (experimental, n = 65): One cycle of standard-dose cisplatin, etoposide and ifosfamide (VIP) followed by three cycles of high-dose VIP with stem-cell infusion
People
Daugaard G, senior author Schmoll HJ, EORTC, GTCSG and Grupo Germinal
Δ Complete response rate+11.3 pointsΔ 24-month FFS+13.4 points
Show the numbers
Results reported for EORTC 30974
EndpointAnalysisHigh-dose VIPBEPEffect
Complete response rateIntention to treatprimaryDaugaard 201144.6%33.3%P=0.18Reported as 44.6% versus 33.3% for the HD-CT and BEP arms in that order (intention to treat, as in the abstract). The summarised PMC full text suggests Table 5 gives different percentages (43.1% and 30.3%); not independently confirmed.
FFSAnalysed patients (131)primaryDaugaard 201158.2% at 2 y (48.0–71.9%)44.8% at 2 y (32.5–56.4%)P=0.060The abstract gives the two values 'respectively' without naming the arms; the PMC Results sentence assigns 44.8% (95% CI 32.5-56.4) to BEP and 58.2% (95% CI 48.0-71.9) to high-dose chemotherapy. The reported difference of 16.3% (SD 7.5%, P = 0.060) is not the difference between those two rates, and the Discussion quotes 61.1% for high-dose chemotherapy; the abstract and Results values are used. Overall log-rank P = 0.057.
Results reported for EORTC 30974
EndpointAnalysisHigh-dose VIPBEPEffect
Complete response rateIntention to treatprimaryDaugaard 201144.6%33.3%P=0.18Reported as 44.6% versus 33.3% for the HD-CT and BEP arms in that order (intention to treat, as in the abstract). The summarised PMC full text suggests Table 5 gives different percentages (43.1% and 30.3%); not independently confirmed.
FFSAnalysed patients (131)primaryDaugaard 201158.2% at 2 y (48.0–71.9%)44.8% at 2 y (32.5–56.4%)P=0.060The abstract gives the two values 'respectively' without naming the arms; the PMC Results sentence assigns 44.8% (95% CI 32.5-56.4) to BEP and 58.2% (95% CI 48.0-71.9) to high-dose chemotherapy. The reported difference of 16.3% (SD 7.5%, P = 0.060) is not the difference between those two rates, and the Discussion quotes 61.1% for high-dose chemotherapy; the abstract and Results values are used. Overall log-rank P = 0.057.
Primary publication: Daugaard G, Skoneczna I, Aass N, De Wit R, De Santis M, Dumez H, et al. A randomized phase III study comparing standard dose BEP with sequential high-dose cisplatin, etoposide, and ifosfamide (VIP) plus stem-cell support in males with poor-prognosis germ-cell cancer. An intergroup study of EORTC, GTCSG, and Grupo Germinal (EORTC 30974). Ann Oncol. 2011;22(5):1054-1061. PubMedDOI

Appears in

Sources

  1. Daugaard G, Skoneczna I, Aass N, De Wit R, De Santis M, Dumez H, et al. A randomized phase III study comparing standard dose BEP with sequential high-dose cisplatin, etoposide, and ifosfamide (VIP) plus stem-cell support in males with poor-prognosis germ-cell cancer. An intergroup study of EORTC, GTCSG, and Grupo Germinal (EORTC 30974). Ann Oncol. 2011;22(5):1054-1061.

    PubMedDOI