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Netherlands high-risk adjuvant HDC trial

High-dose chemotherapy with hematopoietic stem-cell rescue for high-risk breast cancer

Phase 3N = 885

Population
Patients younger than 56 years with breast cancer, no distant metastases, and at least four tumor-positive axillary lymph nodes
Design
Randomised trial after breast surgery. Both groups received fluorouracil-epirubicin-cyclophosphamide (FEC) every 3 weeks for five courses, followed by radiotherapy and tamoxifen; in the high-dose group, high-dose cyclophosphamide, thiotepa and carboplatin with autologous peripheral-blood progenitor-cell transplantation replaced the fifth FEC course.
Arms
  • High-dose chemotherapy (experimental, n = 442): Four FEC courses, then high-dose cyclophosphamide, thiotepa and carboplatin with progenitor-cell transplantation
  • Conventional-dose chemotherapy (control, n = 443): Five courses of FEC
People
Rodenhuis S, Netherlands Working Party on Autologous Transplantation in Solid Tumors
RFSHR 0.83 (95% CI 0.66–1.03)Δ 60-month RFS+6 pointsRFSHR 0.71 (95% CI 0.5–1.0)Δ 60-month RFS+10 points
Show the numbers
Results reported for Netherlands high-risk adjuvant HDC trial
EndpointAnalysisHigh-dose chemotherapyConventional-dose chemotherapyEffect
RFSprimarymedian follow-up 57 monthsRodenhuis 200365% at 5 y59% at 5 yHR 0.83 (95% CI 0.66–1.03)P=0.09Actuarial 5-year relapse-free survival; hazard ratio for relapse in the high-dose group. The abstract does not state which endpoint was prespecified as primary; this is the report's principal comparison.
RFSSubgroup with 10 or more positive axillary nodesexploratorymedian follow-up 57 monthsRodenhuis 200361% at 5 y51% at 5 yHR 0.71 (95% CI 0.5–1.0)P=0.05Subgroup analysis; P value by the log-rank test.
Results reported for Netherlands high-risk adjuvant HDC trial
EndpointAnalysisHigh-dose chemotherapyConventional-dose chemotherapyEffect
RFSprimarymedian follow-up 57 monthsRodenhuis 200365% at 5 y59% at 5 yHR 0.83 (95% CI 0.66–1.03)P=0.09Actuarial 5-year relapse-free survival; hazard ratio for relapse in the high-dose group. The abstract does not state which endpoint was prespecified as primary; this is the report's principal comparison.
RFSSubgroup with 10 or more positive axillary nodesexploratorymedian follow-up 57 monthsRodenhuis 200361% at 5 y51% at 5 yHR 0.71 (95% CI 0.5–1.0)P=0.05Subgroup analysis; P value by the log-rank test.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
RFSRFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
RFS0.830.66–1.03
RFS0.710.5–1
Primary publication: Rodenhuis S, Bontenbal M, Beex LV, Wagstaff J, Richel DJ, Nooij MA, et al. High-dose chemotherapy with hematopoietic stem-cell rescue for high-risk breast cancer. N Engl J Med. 2003;349(1):7-16. PubMedDOI

Appears in

Sources

  1. Rodenhuis S, Bontenbal M, Beex LV, Wagstaff J, Richel DJ, Nooij MA, et al. High-dose chemotherapy with hematopoietic stem-cell rescue for high-risk breast cancer. N Engl J Med. 2003;349(1):7-16.

    PubMedDOI