Table 2.
Comparison of aromatase inhibitors and fulvestrant
Study | Duration (months) | Dose (mg/day) | No. of patients | Study outcomes | Assessment |
---|---|---|---|---|---|
Z1031 trial. Ellis et al. 2011 and 2017 [53, 54] | 4 | Exemestane 25 or letrozole 2.5 or anastrozole 1 | 377 |
1. pCR: 1.6% (AI 16 weeks); 5.7% (switched to chemotherapy at 2 weeks) 2. ORR (clinical palpation): 62.9% exemestane; 74.8% letrozole; 69.1% anastrozole. 3. BCS: 51% (patients mastectomy at baseline); 83% (patients marginal for BCS) |
Monthly physical examination, toxicity assessment, and tumor assessment. |
CARMINA 02 Lerebours et al. 2016 [28] | 4 or 6 | Anastrozole 1 or fulvestrant 500 mg/month | 116 |
1. pCR: NR. 2. ORR (clinical palpation): 52.6% anastrozole; 36.8% fulvestrant. 3. BCS: 57.6% anastrozole; 50% fulvestrant (p = 0.5) |
Clinical assessment, ultrasound, and MRI at baseline, 1 month, and 4 months. |
Grassadonia et al. 2014 [65] | Mean 5.7 | Anastrozole 1 or exemestane 25 or letrozole 2.5 | 144 |
1. pCR: 1.4% 2. ORR (clinical palpation): 86.6% (9.6% CR and 77% PR) 3. BCS: 84% (ineligible for BCS at baseline) |
Caliper measurement at baseline, monthly, and before surgery. |
FIRST Robertson et al. 2009 [66] | Until progression | Anastrozole 1 or fulvestrant 500 mg/month | 205 |
1. pCR: NR. 2. ORR (clinical palpation): 35.5% anastrozole; 36% fulvestrant (p = 0.947) 3. BCS: NR. |
Clinical and radiological tumor assessment every 12 ± 2 weeks until progression. |
BCS breast-conserving surgery, pCR pathological complete response, ORR objective response rate, CR complete response, PR partial response, NR not reported. See Additional file 1, Table S2 for definitions