Introduction
Methods
Study design and patients
Treatment
Outcomes
Statistical analysis
Results
Patient population
PAL + LET (n = 84) | LET (n = 81) | |
---|---|---|
Age, median (range), y | 63 (41–89) | 64 (38–84) |
Age distribution, years, n (%) | ||
18‒44 | 2 (2) | 4 (5) |
45‒64 | 45 (54) | 38 (47) |
≥ 65 | 37 (44) | 39 (48) |
Race, n (%) | ||
White | 76 (90) | 72 (89) |
Black | 1 (1) | 1 (1) |
Asian/other | 7 (8) | 8 (10) |
ECOG performance status, n (%) | ||
0 | 46 (55) | 45 (56) |
1 | 38 (45) | 36 (44) |
Disease stage, n (%) | ||
Stage III | 3 (4) | 1 (1) |
Stage IV | 81 (96) | 80 (99) |
Disease site, n (%) | ||
Visceral | 38 (45) | 43 (53) |
Bone only | 16 (19) | 12 (15) |
Other (nonvisceral) | 30 (36) | 26 (32) |
Disease-free interval, n (%) | ||
> 12 months from adjuvant to recurrence | 25 (30) | 30 (37) |
≤ 12 months from adjuvant to recurrence or de novo advanced disease | 59 (70) | 51 (63) |
De novo advanced disease | 44 (52) | 37 (46) |
Prior systemic treatment, n (%) | ||
None | 44 (52) | 37 (46) |
Chemotherapy | 34 (40) | 37 (46) |
Antihormonal | 27 (32) | 29 (36) |
Tamoxifen | 24 (29) | 25 (31) |
Anastrozole | 8 (10) | 12 (15) |
Letrozole | 2 (2) | 1 (1) |
Exemestane | 4 (5) | 2 (2) |
Treatment exposure
Efficacy
Subsequent treatments
PAL + LET (n = 80) | LET (n = 79) | |
---|---|---|
Any systemic therapy, n (%) | 66 (83) | 70 (89) |
Systemic therapy agents, n (%) | ||
Antihormonal therapy | 50 (63) | 58 (73) |
Nonsteroidal AI | 14 (18) | 20 (25) |
Steroidal AI | 21 (26) | 28 (35) |
Fulvestrant | 27 (34) | 34 (43) |
Tamoxifen | 11 (14) | 17 (22) |
Chemotherapy | 47 (59) | 51 (65) |
Anthracyclines | 15 (19) | 22 (28) |
Capecitabine | 27 (34) | 33 (42) |
Gemcitabine | 4 (5) | 8 (10) |
Taxanes | 34 (43) | 31 (39) |
Vinorelbine | 12 (15) | 6 (8) |
Other | 19 (24) | 19 (24) |
mTOR inhibitor | 12 (15) | 13 (17) |
Blinded therapy (clinical trial) | 2 (3) | 5 (6) |
Palbociclib | 1 (1) | 2 (3) |
Safety
PAL + LET (n = 83) | LET (n = 77) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
All Grades (%) | Grade 1 (%) | Grade 2 (%) | Grade 3 (%) | Grade 4 (%) | All Grades (%) | Grade 1 (%) | Grade 2 (%) | Grade 3 (%) | Grade 4 (%) | |
Neutropenia | 75 | 1 | 15 | 53 | 6 | 5 | 1 | 3 | 1 | 0 |
Leukopenia | 43 | 5 | 21 | 18 | 0 | 4 | 1 | 3 | 0 | 0 |
Fatigue | 41 | 16 | 18 | 5 | 2 | 23 | 14 | 8 | 1 | 0 |
Anemia | 35 | 6 | 23 | 5 | 1 | 5 | 1 | 3 | 1 | 0 |
Nausea | 30 | 21 | 7 | 2 | 0 | 14 | 8 | 5 | 1 | 0 |
Arthralgia | 27 | 10 | 15 | 2 | 0 | 18 | 7 | 9 | 3 | 0 |
Hot flush | 23 | 21 | 2 | 0 | 0 | 14 | 12 | 3 | 0 | 0 |
Alopecia | 22 | 21 | 1 | N/A | N/A | 3 | 3 | 0 | N/A | N/A |
Diarrhea | 22 | 8 | 10 | 4 | 0 | 12 | 8 | 4 | 0 | 0 |
Back pain | 21 | 11 | 7 | 1 | 1 | 16 | 9 | 7 | 0 | 0 |
Decreased appetite | 21 | 17 | 2 | 1 | 0 | 7 | 5 | 1 | 0 | 0 |
Thrombocytopenia | 19 | 12 | 4 | 4 | 0 | 3 | 1 | 0 | 1 | 0 |
Dyspnea | 18 | 10 | 5 | 4 | 0 | 8 | 4 | 3 | 1 | 0 |
Vomiting | 18 | 13 | 5 | 0 | 0 | 4 | 3 | 0 | 1 | 0 |
Constipation | 16 | 8 | 6 | 1 | 0 | 9 | 3 | 7 | 0 | 0 |