Introduction
Patients and methods
Study design
Eligibility criteria
Treatment plan and random assignment
Study endpoints and assessments
Statistical analysis
Results
Patient characteristics
Variable | Palo plus 1-day Dexa (n = 166) | Palo plus 3-day Dex (n = 166) |
---|---|---|
Age categories (n (%)) | ||
<65 years | 114 (68.7) | 111 (66.9) |
≥65 years | 52 (31.3) | 55 (33.1) |
Mean (±SD) | 56.9 (±11.8) | 57.2 (±11.3) |
Body weight (kg) | ||
Mean (±SD) | 68.8 (±14.7) | 66.6 (±12.6) |
Height (cm) | ||
Mean (±SD) | 163.7 (±8.9) | 163.1 (±7.8) |
Gender (n (%)) | ||
Female | 103 (62) | 113 (68.1) |
Male | 63 (38) | 53 (31.9) |
ECOG scoreb (n (%)) | ||
0 | 152 (91.6) | 152 (91.6) |
1 | 14 (8.4) | 13 (7.8) |
2 | 0 | 1 (0.6) |
Tumor type (n (%)) | ||
Breast | 65 (39.2) | 78 (47) |
Colorectal | 65 (39.2) | 56 (33.7) |
Lung | 15 (9.0) | 13 (7.8) |
Other | 21 (12.6) | 19 (11.5) |
Alcohol consumption (n (%)) | ||
No | 101 (60.8) | 99 (59.6) |
Everydayc
| 65 (39.2) | 67 (40.4) |
Tumor stage (n (%)) | ||
Early | 98 (59) | 115 (69.3) |
Metastatic | 68 (41) | 51 (30.7) |
Chemotherapy (n (%)) | ||
AC-basedd
| 54 (32.5) | 63 (38) |
Oxaliplatin-based | 64 (38.6) | 55 (33.1) |
Carboplatin-based | 21 (12.7) | 16 (9.6) |
Irinotecan-based | 14 (8.4) | 15 (9.1) |
Other | 13 (7.8) | 17 (10.2) |
Efficacy
Complete responses | ||||
---|---|---|---|---|
Palo plus 1-day Dexa (n (%)) | Palo plus 3-day Dex (n (%)) | Difference between groupsb (95% CI), % |
P
c
| |
ITT cohortd, n = 332 |
n = 166 |
n = 166 | ||
Acute phase (0–24 h) | 147 (88.6) | 140 (84.3) | 4.2 (−3.1 to 11.6) | 0.262 |
95% CI | 82.7 to 92.9 | 77.9 to 89.5 | ||
Delayed phase (24–120 h) | 114 (68.7) | 129 (77.7) | −9.0 (−18.5 to 0.4) | 0.116 |
95% CI | 61.0 to 75.6 | 70.6 to 83.8 | ||
Overall phasee (0–120 h) | 112 (67.5) | 118 (71.1) | −3.6 (−13.5 to 6.3) | ND |
95% CI | 59.8 to 74.5 | 63.6 to 77.9 | ||
PP cohortf, n = 324 | (n = 163) | (n = 161) | ||
Acute phase (0–24 h) | 144 (88.3) | 135 (83.9) | 4.5 (−3 to 12) | 0.242 |
95% CI | 82.4 to 92.8 | 77.2 to 89.2 | ||
Delayed phase (24–120 h) | 112 (68.7) | 124 (77.0) | −8.3 (−17.9 to 1.3) | 0.093 |
95% CI | 60.9 to 75.7 | 69.7 to 83.3 | ||
Overall phasee (0–120 h) | 109 (66.9) | 113 (70.2) | −3.3 (−13.4 to 6.8) | ND |
95% CI | 59.1 to 74.0 | 62.5 to 77.1 |
Variable | Palo plus 1-day Dexa (n = 163), n (%) | Palo plus 3-day Dex (n = 161), n (%) | Differenceb, 95% CI (%) |
---|---|---|---|
Complete controlc
| |||
Acute phase (0–24 h) | 142 (87.1) | 132 (82.0) | 5.1 (−2.7 to 13) |
Delayed phase (24–120 h) | 108 (66.3) | 122 (75.8) | −9.5 (−19.3 to 0.3) |
Overall phase (0–120 h) | 105 (64.4) | 109 (67.7) | −3.3 (−13.6 to 7) |
No emetic episodes | |||
Acute phase (0–24 h) | 153 (93.9) | 148 (91.9) | 1.9 (−3.7 to 7.5) |
Delayed phase (24–120 h) | 140 (85.9) | 145 (90.1) | −4.2 (−11.2 to 2.9) |
Overall phase (0–120 h) | 134 (82.2) | 135 (83.9) | −1.6 (−9.8 to 6.5) |
No nausea | |||
Acute phase (0–24 h) | 128 (78.5) | 117 (72.7) | 5.9 (−3.5 to 15.2) |
Delayed phase (24–120 h) | 93 (57.1) | 100 (62.1) | −5.1 (−15.7 to 5.6) |
Overall phase (0–120 h) | 85 (52.1) | 91 (56.5) | −4.4 (−15.2 to 6.5) |
No use of rescue medication | |||
Acute phase (0–24 h) | 148 (90.8) | 144 (89.4) | 1.4 (−5.1 to 7.9) |
Delayed phase (24–120 h) | 119 (73.0) | 134 (83.2)* | −10.2 (−19.2 to −1.3) |
Overall phase (0–120 h) | 116 (71.2) | 129 (80.1) | −9 (−18.3 to 0.3) |
Complete responses | |||
---|---|---|---|
Palo plus 1-day Dexa (n (%)) | Palo plus 3-day Dex (n (%)) |
bDifference, 95% CI (%) | |
Acute phase (0–24 h) Gender | |||
Women | 88/101 (87.1) | 85/109 (78) | 9.1 (−1 to 19.3) |
Men | 54/62 (87.1) | 47/52 (90.4) | −3.3 (−14.9 to 8.3) |
Chemotherapy | |||
AC-basedc
| 44/52 (84.6) | 45/61 (73.8) | 10.8 (−3.9 to 25.6) |
Non-AC-based | 98/111 (88.3) | 87/100 (87.0) | 1.3 (−7.6 to 10.2) |
Delayed phase (24–120 h) Gender | |||
Women | 62/101 (61.4) | 81/109 (74.3)* | −12.9 (−25.5 to −0.4) |
Men | 46/62 (74.2) | 41/52 (78.8) | −4.7 (−20.2 to 10.9) |
Chemotherapy | |||
AC-basedc
| 29/52 (55.8) | 46/61 (75.4)** | −19.6 (−36.9 to −2.3) |
Non-AC-based | 79/111 (71.2) | 76/100 (76.0) | −4.8 (−16.7 to 7) |