- A 20-year follow-up of high-dose chemotherapy (HDCT) for breast cancer with ≥4 positive lymph nodes shows no OS benefit except for a subgroup with ≥10 nodes.
- No benefit seen with triple-negative breast cancer (TNBC).
- This phase 3 trial compared HDCT+autologous hematopoietic stem cell transplant with conventional-dose chemotherapy (CDCT).
Why this matters
- This is the largest such randomized controlled trial, with the longest follow-up.
- 20-year follow-up of Dutch trial of 885 patients age
- 4 cycles of chemo at same dose as CDCT, but fifth cycle in HDCT group contained cyclophosphamide, 6000 mg/m2; thiotepa, 480 mg/m2; and carboplatin, 1600 mg/m2; followed by hematopoietic stem cell transplant.
- Funding: None disclosed.
- No OS increase with HDCT:
- 41.5% CDCT vs 45.3% HDCT.
- HR: 0.89 (95% CI, 0.75-1.06).
- Subgroup with ≥10 ALN had absolute improvement of 14.6%.
- HR, 0.72 (95% CI, 0.54-0.95).
- Subgroup with TNBC had nonsignificant absolute improvement of 15.4%.
- HR: 0.67 (95% CI, 0.42-1.05).
- No differences between groups in second malignant neoplasm or major cardiovascular event.
- HDCT group had more hypertension, hypercholesterolemia, and dysrhythmias.
- Currently used CDCT differs from version in this trial.