Table 2.
Clinical studies of Palbociclib in breast cancer
| Study
|
|||||
|---|---|---|---|---|---|
| DeMichele et al42 | Slamon et al43 | Finn et al46 | |||
| Meeting | ASCO 2013 Annual Meeting (updated presentation) | ASCO 2010 Annual Meeting | AACR Annual Meeting 2014* | ||
| Phase | II | Ib | II | ||
| N | 37 | 12 | 165 | ||
| Primary endpoint | Safety and efficacy (response rate and PFS) | Safety and tolerability | PFS | ||
| Therapy | Palbociclib | Palbociclib + letrozole | Palbociclib + letrozole | Versus letrozole | |
| Breast cancer subtype | ER+ HER2− | 29/37 | |||
| ER+ HER2+ TNBC | 2/37 6/37 |
ER+ HER2− | ER+ HER2− | ||
| Palbociclib + letrozole*** | Letrozole*** | ||||
| Prior chemotherapy for advanced disease | 34/37 (92%) | 8 (67%) | 34 (40%) | 37 (46%) | |
| Response rate | 2/36 (1%) PR 18/36 (50%) SD** |
3/12 (25%) PR 9/12 (75%) SD |
NR | NR | |
| PFS | ER+TNBC | 3.8 months 1.9 months |
NR | 20.2 months | 10.2 months |
Notes:
This study was also presented at IMPAKT 201244 and SABCS 2012,45 as discussed in the text. For simplicity, data presented in the table represent the updated presentation at AACR 2014;46
one patient (1/6) with TNBC had stable disease, (5/6) had progression of disease;
demographic data obtained from SABCS 201245 presentation; however, the updated report at AACR represents the same patient population. Palbociclib (Pfizer, Inc., New York, NY, USA).
Abbreviations: AACR, American Association for Cancer Research; ASCO, American Society of Clinical Oncology; ER, estrogen receptor; NR, not reported in abstract; PFS, progression-free survival; PR, partial response; SABCS, San Antonio Breast Cancer Symposium; SD, stable disease; TNBC, triple-negative breast cancer.