Table 1 Shorter duration trials—results
From: PERSEPHONE: are we ready to de-escalate adjuvant trastuzumab for HER2-positive breast cancer?
Trial | Duration of triala | Timing of randomization | Patient characteristics | Chemotherapy with anthracyclines and taxanes | Concomitant trastuzumab with chemotherapy | Patients (n) | Efficacy (short arm versus long arm)b | Notable Subgroup analysis favouring 1 year | Cardiac events (short arm vs long arm) |
|---|---|---|---|---|---|---|---|---|---|
6 months vs 12 months | |||||||||
8 years | Within first 6 months | N−: 59% ER+: 69% | 48% | 47% | 4089 | 11.6% vs 11.2% 4-year DFS events HR 1.07 (0.93–1.24) | Taxane-only, concurrent chemotherapy and trend in ER- | 9% vs 12% | |
PHARE4 | 6 years | At 6 months | N−: 55% ER+: 60% | 74% | 56% | 3380 | 8.9% vs 6.2% 3.5-year DFS events: HR 1.28 (1.05–1.56) | Tumour size >2 cm and sequential chemotherapy-trastuzumab | 1.9% vs 5.7% |
HORG5 | 8 years | Previously to treatment | N−: 17% ER+: 69% | 100% | 100% | 481 | 6.7% vs 4.3% 3-year DFS events: HR 1.57 (0.86–2.10) | No significant findings | 0 vs 2 cases |
9 weeks vs 12 months | |||||||||
SOLD6 | 9 years | Previously to treatment | N−: 60% ER+: 66% | 100% | 100% | 2,176 | 12.0% vs 9.5% 5-year DFS events: HR 1.39 (1.12–1.72) | lower docetaxel dose, trend in ER- and LN1–3 of benefit in 1-year arm | 2.0 vs 3.9% |
SHORT-HER7 | 9 years | Previously to treatment | N−: 51% ER+: 67% | 100% | 100% | 1,253 | 14.6% vs 12.5% 5-year DFS events: HR 1.15 (0.91–1.46) | Stage III and N2/N3 significantly benefit from 1 year | 5.1% vs 14.4% |
