Table 1.
Studies included and study arm characteristics.
| Study | Treatment arms | Total patients n per arm | Patient age, median (range) | Patient enrolment dates | HR + patients with VM status | HR + non-VM n (% per arm) | HR + VM n (% per arm) | HR + VLM n (% per arm) | HR + VnLM n, (% per arm) |
|---|---|---|---|---|---|---|---|---|---|
| First line | |||||||||
| EORTC35 | Tamoxifen | 189 | 62 (37–87) | Oct 1996–Dec 2002 | 178 | 95 (53.4) | 83 (46.6) | NA | NA |
| Exemestane | 182 | 63 (37–86) | 168 | 88 (52.4) | 80 (47.6) | NA | NA | ||
| Study 002536 | Tamoxifen | 274 | 66 (43–92) | Nov 1998–Jun 2000 | 209 | 135 (64.6) | 74 (35.4) | 23 (11.0) | 51 (24.4) |
| Study 0027a 37 | Tamoxifen | 328 | 66 (41–92) | Aug 1995–Jul 1998 | 144 | 71 (49.3) | 73 (50.7) | 15 (10.4) | 58 (40.3) |
| Anastrozole | 340 | 67 (34–91) | 153 | 98 (64.1) | 55 (35.9) | 24 (15.7) | 31 (20.3) | ||
| Study 003038 | Tamoxifen | 182 | 67 (40–92) | Feb 1996–Jul 1998 | 160 | 80 (50.0) | 80 (50.0) | 26 (16.3)) | 54 (33.8) |
| Anastrozole | 171 | 68 (30–88) | 150 | 73 (48.7) | 77 (51.3) | 13 (8.7) | 64 (42.7) | ||
| FIRST8 | Anastrozole | 103 | 68 (48–87) | Feb 2006–Jan 2008 | 102 | 45 (44.1) | 57 (55.9) | 13 (12.7) | 44 (43.1) |
| Fulvestrant 500 mg | 102 | 66 (40–89) | 100 | 54 (54.0) | 46 (46.0) | 14 (14.0) | 32 (32.0) | ||
| FALCON9 | Anastrozole | 232 | 62 (36–90) | Oct 2012–Jul 2014 | 232 | 113 (48.7) | 119 (51.3) | NA | NA |
| Fulvestrant 500 mg | 230 | 64 (38–87) | 230 | 95 (41.3) | 135 (58.7) | NA | NA | ||
| CONFIRMb 39–41 | Fulvestrant 500 mg | 162 | 61 (not reported) | Feb 2005–Aug 2007 | 162 | 72 (44.4) | 90 (55.6) | 47 (29.0) | 43 (26.5) |
| Totalc | 2495 | 1988 | 1019 (51.3) | 969 (48.7) | |||||
| SERM | 691 (34·8) | ||||||||
| AI | 805 (40·5) | ||||||||
| SERD 500 mg | 492 (24·7) | ||||||||
| Second line | |||||||||
| Study 0020a 44 | Anastrozole | 230 | 64 (33–89) | May 1997–Sep 1999 | 183 | 109 (59.6) | 74 (40.4) | 42 (23.0) | 32 (17.5) |
| Fulvestrant 250 mg | 219 | 63 (35–86) | 160 | 93 (58.1) | 67 (41.9) | 39 (24.4) | 28 (17.5) | ||
| Study 0021a 45 | Anastrozole | 193 | 62 (36–94) | May 1997–Sep 1999 | 168 | 93 (55.4) | 75 (44.6) | 38 (22.6) | 37 (22.0) |
| Fulvestrant 250 mg | 204 | 63 (33–89) | 177 | 88 (49.7) | 89 (50.3) | 44 (24.9) | 45 (25.4) | ||
| EFECT46 | Exemestane | 340 | 63 (32–91) | Aug 2003–Nov 2005 | 336 | 142 (42.3) | 194 (57.7) | 106 (31.5) | 88 (26.2) |
| Fulvestrant 250 mg | 351 | 63 (38–88) | 345 | 150 (43.5) | 195 (56.5) | 109 (31.6) | 86 (24.9) | ||
| SoFEAd 47 | Exemestane | 249 | 66 (59–75) | Mar 2004–Aug 2010 | 249 | 104 (41.8) | 145 (58.2) | 72 (28.9) | 73 (29.3) |
| Fulvestrant 250 mg | 231 | 63 (57–74) | 231 | 88 (38.1) | 143 (61.9) | 72 (31.2) | 71 (30.7) | ||
| FINDER148 | Fulvestrant 250 mg | 45 | 61 (50–77) | Mar 2006–Mar 2008 | 43 | 19 (44.2) | 24 (55.8) | 9 (20.9) | 15 (34.9) |
| Fulvestrant 500 mg | 47 | 61 (45–83) | 45 | 19 (42.2) | 26 (57.8) | 9 (20.0) | 17 (37.8) | ||
| FINDER249 | Fulvestrant 250 mg | 47 | 63 (42–88) | May 2006–Jun 2008 | 46 | 13 (28.3) | 33 (71.7) | 19 (41.3) | 14 (30.4) |
| Fulvestrant 500 mg | 46 | 67 (49–85) | 45 | 9 (20.0) | 36 (80.0) | 19 (42.2) | 17 (37.8) | ||
| CONFIRM39–41 | Fulvestrant 250 mg | 152 | 61 (not reported) | Feb 2005–Aug 2007 | 152 | 71 (46.7) | 81 (53.3) | 41 (27.0) | 40 (26.3) |
| Fulvestrant 500 mg | 144 | 61 (not reported) | 144 | 55 (38.2) | 89 (61.8) | 36 (25.0) | 53 (36.8) | ||
| Totalc | 2498 | 2324 | 1053 (45.3) | 1271 (54.7) | 655 (28.2) | 616 (26.5) | |||
| AI | 936 (40·3) | ||||||||
| SERD 250 mg | 1154 (59·7) | ||||||||
| SERD 500 mg | 234 (10·1) | ||||||||
Superscript numerals indicate cited study references and superscript letters indicate footnotes.
AI aromatase inhibitor, BC breast cancer, EORTC European Organisation for Research and Treatment of Cancer, HR+ hormone receptor-positive, non-VM non-visceral metastases, SERD selective estrogen receptor degrader, SERM selective estrogen receptor modulator, VM visceral metastases.
aPatient age data are mean and range.
bPatients from CONFIRM were treated in both the first- and second-line settings.
cTotal number of patients with HR+ BC and VM status equals the number of HR+ patients with non-VM plus the number of patients with VM. Percentage of HR+ patients with non-VM, VM, VLM, VnLM equals number of HR+ patients with each status divided by total HR+ patients with known VM status per trial arm.
dPatient age data are median and interquartile range.