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Bending the Curve Trial by Trial
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Philadelphia BMT Group

Conventional-dose chemotherapy compared with high-dose chemotherapy plus autologous hematopoietic stem-cell transplantation for metastatic breast cancer

Phase 3N = 199

Population
Women aged 18 to 60 years with metastatic breast cancer who had a complete or partial response to induction chemotherapy
Design
Randomised trial in women aged 18 to 60 years with metastatic breast cancer. 553 women enrolled and received four to six cycles of induction chemotherapy; of those with a complete (58) or partial (252) response, 199 were randomised to a single course of high-dose carboplatin, thiotepa and cyclophosphamide with autologous stem-cell transplantation, or to up to 24 cycles of conventional-dose cyclophosphamide, methotrexate and fluorouracil. Primary endpoint survival.
Primary endpoint
OS
Arms
  • High-dose chemotherapy plus transplantation (experimental, n = 110): High-dose carboplatin, thiotepa and cyclophosphamide with autologous hematopoietic stem-cell transplantation
  • Conventional-dose chemotherapy (control, n = 89): Up to 24 cycles of conventional-dose cyclophosphamide, methotrexate and fluorouracil
People
Stadtmauer EA, senior author Glick JH, Philadelphia Bone Marrow Transplant Group
Δ 36-month OS−6 pointsΔ median TTP+0.6 months
Show the numbers
Results reported for Philadelphia BMT Group
EndpointAnalysisHigh-dose chemotherapy plus transplantationConventional-dose chemotherapyEffect
OSITT among patients randomised after response to induction chemotherapyprimarymedian follow-up 37 monthsStadtmauer 200032% at 3 y38% at 3 yNo significant difference in survival between the groups; the abstract gives no P value or hazard ratio.
TTPITT among patients randomised after response to induction chemotherapyprimarymedian follow-up 37 monthsStadtmauer 2000median 9.6 monthsmedian 9 monthsNo significant difference in median time to progression; the abstract gives no P value.
Results reported for Philadelphia BMT Group
EndpointAnalysisHigh-dose chemotherapy plus transplantationConventional-dose chemotherapyEffect
OSITT among patients randomised after response to induction chemotherapyprimarymedian follow-up 37 monthsStadtmauer 200032% at 3 y38% at 3 yNo significant difference in survival between the groups; the abstract gives no P value or hazard ratio.
TTPITT among patients randomised after response to induction chemotherapyprimarymedian follow-up 37 monthsStadtmauer 2000median 9.6 monthsmedian 9 monthsNo significant difference in median time to progression; the abstract gives no P value.
Illustrative — modelled from reported values, not trial data. TTP, primary.
0%25%50%75%100%05101520Months (modelled)
  • High-dose chemotherapy plus transplantation (experimental)
  • Conventional-dose chemotherapy (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsHigh-dose chemotherapy plus transplantationConventional-dose chemotherapy
0100.0%100.0%
664.8%63.0%
1242.0%39.7%
1827.3%25.0%
2417.7%15.7%
Primary publication: Stadtmauer EA, O'Neill A, Goldstein LJ, Crilley PA, Mangan KF, Ingle JN, et al. Conventional-dose chemotherapy compared with high-dose chemotherapy plus autologous hematopoietic stem-cell transplantation for metastatic breast cancer. Philadelphia Bone Marrow Transplant Group. N Engl J Med. 2000;342(15):1069-76. PubMedDOI

Appears in

Sources

  1. Stadtmauer EA, O'Neill A, Goldstein LJ, Crilley PA, Mangan KF, Ingle JN, et al. Conventional-dose chemotherapy compared with high-dose chemotherapy plus autologous hematopoietic stem-cell transplantation for metastatic breast cancer. Philadelphia Bone Marrow Transplant Group. N Engl J Med. 2000;342(15):1069-76.

    PubMedDOI