Takeaway
- The 15-year results of the phase 3 Italian Mammella InterGruppo (MIG)-1 trial show that most survival outcomes remained numerically but not statistically superior with dose-dense (DD) adjuvant chemotherapy (every-2-week cycles) vs every-3-week cycles for high-risk early breast cancer.
Why this matters
- Findings reveal long-term benefit of DD chemotherapy, primarily based on numerical superiority.
Study design
- Italian phase 3 randomized controlled trial (RCT), 1214 patients with high-risk early breast cancer.
- High risk was defined by lymph node-positive or lymph node-negative disease with ≥1 of 5 other factors, including tumor size >2 cm.
- Patients given 5-fluoruracil, epirubicin, and cyclophosphamide (FEC) every 2 weeks (FEC14, the DD group) or FEC every 3 weeks (FEC21, the regular frequency group) for 6 total cycles.
- Funding: Italian Ministry of Health; other.
Key results
- Median follow-up, 15.8 years.
- DD vs the regular frequency group had numerically but not statistically superior:
- OS:
- 71% vs 68%.
- HR, 0.89 (P=.25).
- Event-free survival:
- 47% vs 43%.
- HR, 0.87 (P=.18).
- OS:
- DD subgroup with hormone-receptor-negative tumors vs regular-frequency group had:
- Numerically superior OS:
- 70% vs 65%.
- HR, 0.73 (95% CI, 0.51-1.06).
- Statistically superior event-free survival:
- 58% vs 43%.
- HR, 0.70 (95% CI, 0.51-0.96).
- Numerically superior OS:
Limitations
- Underpowered because planned accrual not reached.
Only healthcare professionals with a Univadis account have access to this article.
You have reached your limit of complementary articles
Free Sign Up Available exclusively to healthcare professionals