Introduction
Patients and methods
Study design
Patients
Treatment
Assessments
Statistics
Ethics
Results
PLD N = 105 | Capecitabine N = 105 | |
---|---|---|
N (%) |
N (%) | |
Median age of patient, years (range) | 62 (36–82) | 63 (22–85) |
ECOG performance status | ||
Missing | 5 (4) | 1 (1) |
0 | 51 (49) | 53 (50) |
1 | 43 (41) | 45 (43) |
2 | 6 (6) | 5 (5) |
3 | 0 | 1 (1) |
Prior anthracyclines | ||
Yes | 39 (37) | 38 (36) |
No | 66 (63) | 67 (64) |
Menopausal status | ||
Premenopausal | 5 (5) | 5 (5) |
Postmenopausal | 85 (83) | 87 (85) |
Not known/examined | 15 (14) | 13 (12) |
Efficacy
PLD N = 98 | Capecitabine N = 102 | |||
---|---|---|---|---|
Prior anthracycline | ||||
No | Yes | No | Yes | |
Number of patients | 61 | 37 | 64 | 38 |
Number of events | 34 | 27 | 38 | 30 |
Median TTP (months) | 7.1 | 5.8 | 8.3 | 4.8 |
Log-rank P value | 0.64 | 0.04 | ||
Proportion without progression (%) | ||||
At 6 months | 54 | 47 | 56 | 42 |
At 12 months | 21 | 18 | 36 | 13 |
Safety
Adverse Event | PLD N = 98 | Capecitabine N = 102 |
P
a
| ||
---|---|---|---|---|---|
All grades No. (%) | Grade 3–4 No. (%) | All grades No. (%) | Grade 3–4 No. (%) | ||
Hematologic Toxicity | |||||
Leukopenia | 37 (38) | 4 (4) | 17 (17) | 1 (1) | .002 |
Anemia | 25 (26) | 1 (1) | 21 (20) | 5 (5) | .10 |
Neutropenia | 18 (18) | 3 (3) | 10 (10) | 2 (2) | .19 |
Thrombocytopenia | 6 (6) | 1 (1) | 6 (6) | 1 (1) | 1.0 |
Non-hematologic toxicity occurring in ≥20 % of patients in either arm | |||||
Hand-foot syndrome | 65 (66) | 38 (39) | 69 (67) | 27 (26) | .08 |
Stomatitis | 39 (40) | 6 (6) | 18 (17) | 0 | .0007 |
Fatigue | 53 (54) | 4 (4) | 55 (54) | 7 (7) | .71 |
Ear, nose, throat abnormality | 42 (43) | 6 (6) | 17 (17) | 0 | <.0001 |
Nausea | 41 (42) | 0 | 42 (41) | 2 (2) | .59 |
Alopecia | 27 (28) | – | 10 (10) | – | .002 |
Constipation | 25 (26) | 0 | 10 (10) | 0 | .005 |
Vomiting | 18 (18) | 0 | 30 (30) | 2 (2) | .09 |
Peripheral sensory neuropathy | 17 (17) | 1 (1) | 25 (24) | 0 | .19 |
Diarrhea | 16 (16) | 0 | 44 (43) | 13 (13) | <.0001 |
Dyspnea | 14 (14) | 3 (3) | 24 (24) | 7 (7) | .23 |
Cardiac events | |||||
Total events | 9 (9) | 1 (1) | 13 (13) | 0 | .50 |
Without anthracycline pretreatment | |||||
Total no. of patients | 61 | 64 | |||
Patients with cardiac events, no. (%) | 6 (10) | 1 (2) | 6 (9) | 0 (0) | 1.0b
|
With anthracycline pretreatment | |||||
Total no. of patients | 37 | 38 | |||
Patients with cardiac events, no. (%) | 3 (8) | 0 | 7 (18) | 0 | 0.31b
|
Quality of life
Domain | Parameter | Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | EOT/EOS | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
PLD | CAPE | PLD | CAPE | PLD | CAPE | PLD | CAPE | PLD | CAPE | ||
Physical functioning | No. patients |
n = 19 |
n = 10 |
n = 52 |
n = 36 |
n = 48 |
n = 28 |
n = 30 |
n = 23 |
n = 5 |
n = 5 |
Score changea
| 0 | 0 | −1.0 | −13.0 | −2.8 | −10.7 | −0.7 | −15.9 | −10.7 | −24.0 | |
P
c
| .86 | .01 | .06 | .006 | .31 | ||||||
Role functioning | No. patients |
n = 19 |
n = 10 |
n = 51 |
n = 36 |
n = 48 |
n = 28 |
n = 30 |
n = 24 |
n = 5 |
n = 5 |
Score changea
| 2.6 | −3.3 | −5.2 | −15.3 | −6.6 | −14.3 | −4.4 | −22.2 | −16.7 | −23.3 | |
P
c
| .33 | .24 | .25 | .02 | .67 | ||||||
Cognitive functioning | No. patients |
n = 19 |
n = 10 |
n = 52 |
n = 36 |
n = 47 |
n = 28 |
n = 30 |
n = 26 |
n = 5 |
n = 5 |
Score changea
| 4.4 | −13.3 | −1.0 | −0.9 | 2.8 | 1.8 | −0.6 | 2.6 | 0 | −23.3 | |
P
c
| .04 | .73 | .98 | .26 | .18 | ||||||
Global health status | No. patients |
n = 16 |
n = 9 |
n = 45 |
n = 31 |
n = 43 |
n = 21 |
n = 27 |
n = 20 |
n = 5 |
n = 4 |
Score changea
| 8.3 | −6.5 | 6.5 | −4.0 | 4.4 | −2.0 | 0 | −16.2 | −13.3 | 2.1 | |
P
c
| .25 | .29 | .63 | .04 | .99 | ||||||
Fatigue | No. patients |
n = 19 |
n = 10 |
n = 52 |
n = 36 |
n = 48 |
n = 29 |
n = 30 |
n = 25 |
n = 5 |
n = 5 |
Score changeb
| −3.2 | 2.2 | 4.6 | 11.4 | 3.7 | 8.4 | 1.8 | 19.1 | 11.1 | 24.4 | |
P
c
| .41 | .49 | .29 | .02 | .54 | ||||||
Constipation | No. patients |
n = 19 |
n = 8 |
n = 52 |
n = 35 |
n = 47 |
n = 27 |
n = 30 |
n = 23 |
n = 5 |
n = 5 |
Score changeb
| −3.5 | 0 | 10.9 | −2.8 | 10.6 | −4.9 | 17.8 | −13.0 | 0 | −6.7 | |
P
c
| .44 | .07 | .22 | .004 | .48 | ||||||
Dermatology/skin | No. patients |
n = 15 |
n = 9 |
n = 42 |
n = 28 |
n = 40 |
n = 20 |
n = 22 |
n = 19 |
n = 5 |
n = 3 |
Score changb
| 6.1 | −5.6 | 9.1 | 1.2 | 33.3 | 12.1 | 37.1 | 22.8 | 18.3 | 44.4 | |
P
c
| .08 | .20 | .04 | .26 | .70 |
Domain | PLD | Capecitabine |
---|---|---|
No. responses across all cycles | 522 | 708 |
Physical condition (%) | ||
Same | 56.8 | 56.2 |
Better | 14.8 | 19.8 |
Emotional condition (%) | ||
Same | 58.8 | 57.3 |
Better | 13.8 | 19.5 |
Social life enjoyment (%) | ||
Same | 63.6 | 62.4 |
Better | 13.2 | 16.5 |
Overall quality of life (%) | ||
Same | 55.5 | 55.7 |
Better | 14.3 | 18.2 |