Table 1. Summary of the letrozole P024, IMPACT and PROACT trials.
Letrozole P024 | IMPACT | PROACT | |
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Postmenopausal women with HR+ breast cancer
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337 randomised | 330 randomised | 451 randomised | |
Patient characteristics at baseline | None were BCS candidates at baseline; 14% deemed inoperable | Pretreatment surgical assessment available for 220 patients – 96 eligible for BCS | 386 of the patients either required a mastectomy or were deemed inoperable at baseline |
Definition of HR positivity | ER/PgR staining >10% | ER staining >1% | ‘ER+/PgR+’ |
Neoadjuvant endocrine therapy | L for 4 months T for 4 months | A for 12 weeks A+T for 12 weeks T for 12 weeks | A for 3 months T for 3 months |
Concomitant chemotherapy? | No | — | Yes |
Primary end point | Clinical response by palpation | Overall response by caliper measurements | Overall response by ultrasound measurements |
Response (per primary end point) | 55% (L) vs 36% (T); P<0.001 | 37% (A) vs 39% (A+T) vs 36% (T) | 39.5% (A) vs 35.4% (T) |
Rate of down staging to BCS | 45% (L) vs 35% (T); P=0.022 | 44%(A) vs 24% (A+T) vs 31% (T) | 43.0% (A) vs 30.8% (T) in improved feasible surgery in hormone therapy-only group (n=314) |
Abbreviations: A=anastrozole 1 mg daily; BCS=breast conserving surgery; ER=oestrogen receptor; HR=hormone receptor; IMPACT=Immediate Preoperative Anastrozole, Tamoxifen or Combined with Tamoxifen; L=letrozole 2.5 mg daily; PROACT=Preoperative ‘Arimidex’ Compared to Tamoxifen; PgR=progesterone receptor; T=tamoxifen 20 mg daily.