Table 1.
Main randomized clinical trials of endocrine therapies as first-line treatment in advanced breast cancer.
| Study/arms | n | ORR (%) | CBR (%) | Median TTP or PFS (months) | Median OS (months) |
|---|---|---|---|---|---|
| Anz versus Tam [Nabholtz et al. 2000] | 353 | 2117 | 5946 | 115.6 * | 3332 |
| Let versus Tam [Mouridsen et al. 2001] | 907 | 3221 * | 5038 * | 9.46.0 * | 3432 |
| Exem versus Tam [Paridaens et al. 2008] | 391 | 46 | – | 9.95.8 * | 3743 |
| Fulv 250 mg versus Tam [Howell et al. 2004] | 578 | 31.633.9 | 54.362 | 6.88.3 | 36.938.7 |
| Fulv 250 mg versus Anz [Osborne et al. 2003] | 400 | 17.5 | 42.2 | 5.4 | – |
| 17.5 | 36.1 | 3.4 | |||
| FACT trial Fulv LD + Anz versus Anz [Bergh et al. 2012] | 514 | 31.833.6 | 55.055.1 | 10.810.2 | 37.838.2 |
| SWOG trial Fulv LD + Anz versus Anz [Mehta et al. 2012] | 707 | – | – | 1513.5 * | 47.741.3* |
| FIRST trial** Fulv HD versus Anz [Robertson et al. 2009, 2014b] | 205 | 3635.5 | 72.567 | 23.413.1* | 54.148.4* |
| PALOMA-01** Let + palbociclib versus Let [Finn et al. 2015] | 165 | 4333 | 8147* | 20.210.2* | -– |
*
Statistically significant difference.
**
Randomized phase II.
Anz, anastrozole; CBR, clinical benefit rate; Exem, exemestane; Fulv, fulvestrant; Let, letrozole; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; Tam, tamoxifen; TTP, time-to-progression.