Table 2. Efficacy parameters in the CORALLEEN and NeoPAL trials.
| Parameters | CORALLEEN trial | NeoPAL trial | |||
|---|---|---|---|---|---|
| Ribociclib arm (n=49) | Chemotherapy arm (n=52) | Palbociclib arm (n=53) | Chemotherapy arm (n=53) |
||
| Clinical-radiological response, n (%) | |||||
| ORR by MRI | 28 (57.1) | 41 (78.8) | – | – | |
| ORR by US | – | – | 25 (47.2) | 24 (45.3) | |
| ORR by physical examination | 31 (63.3) | 28 (53.8) | 38 (71.7) | 38 (71.7) | |
| Breast conserving surgery | 44 (84.6)† | 39 (72.2)† | 36 (69.2)‡ | 35 (68.6)‡ | |
| Pathological response, n (%) | |||||
| pCR (ypT0/Tis ypN0) | 0 (0) | 3 (5.8) | 2 (3.8)‡ | 3 (5.9)‡ | |
| RCB 0–I | 3 (6.1) | 6 (11.8) | 4 (7.7)‡ | 8 (15.7)‡ | |
| Biological response, median % [range] | |||||
| Ki67 level | 3 [1–8] | 10 [3–20] | 3 [1–40] | 9 [2–15] | |
| Molecular response, n (%) | |||||
| Luminal A intrinsic subtype conversion | 43 (87.8) | 43 (82.7) | – | – | |
| Other response measures, n (%) | |||||
| Low-ROR score | 23 (46.9) | 24 (46.2) | – | – | |
| PEPI score 0 | 11 (22.4) | 9 (17.3) | 6 (11.5)§ | 8 (16.0)§ | |
†, in the CORALLEEN trial, 44 out of 52 evaluable patients in ribociclib arm and 39 out of 54 evaluable patients in chemotherapy arm received breast conserving surgery. ‡, in the NeoPAL trial, patients evaluable for breast conserving surgery, pCR and RCB were 52 and 51 in palbociclib arm and chemotherapy arm, respectively; pCR and RCB results were reported as per central review. §, PEPI score for relapse-free survival was tested in 52 patients in palbociclib arm and 50 patients in chemotherapy arm; 9 out of 51 (17.6%) evaluable patients in palbociclib arm and 4 out of 50 (8.0%) evaluable patients in chemotherapy arm reported PEPI score 0 for breast cancer-specific survival. ORR, objective response rate; US, ultrasound; MRI, magnetic resonance imaging; pCR, pathologic complete response; Tis, tumour in situ; RCB, residual cancer burden; ROR, risk of relapse; PEPI, preoperative endocrine prognostic index.