Introduction
Patients and methods
Patients and treatment
Assessments
Statistical analysis
Results
Characteristic by cohort | Palo plus 1-day Dex | Palo plus 3-day Dex |
P valuea
| ||
---|---|---|---|---|---|
N
| % |
N
| % | ||
MEC, evaluable patients | 125 | 100 | 112 | 100 | |
Age (years) | |||||
Median (min–max) | 59 (31–77) | 60 (35–80) | |||
<50 years | 27 | 21.6 | 24 | 21.4 | 1.0 |
Gender | 0.515 | ||||
Male | 63 | 50.4 | 51 | 45.5 | |
Female | 62 | 49.6 | 61 | 54.5 | |
Early stage disease | 61 | 48.8 | 65 | 58.0 | 0.192 |
Primary tumor | 0.792 | ||||
Breast | 28 | 22.4 | 31 | 27.7 | |
Colorectal | 66 | 52.8 | 53 | 47.3 | |
Lung | 15 | 12.0 | 13 | 11.6 | |
Other | 16 | 12.8 | 15 | 13.4 | |
Chemotherapy regimen | 0.840 | ||||
Oxaliplatin-based | 63 | 50.4 | 52 | 46.4 | |
Carboplatin-based | 20 | 16.0 | 16 | 14.3 | |
Irinotecan-based | 14 | 11.2 | 15 | 13.4 | |
Otherb
| 28 | 22.4 | 29 | 25.9 | |
Alcohol consumption | 0.604 | ||||
Never | 67 | 53.6 | 56 | 50.0 | |
Everyday | 58 | 46.4 | 56 | 50.0 | |
Risk group | 0.841 | ||||
Lowc
| 111 | 88.8 | 98 | 87.5 | |
Highd
| 14 | 11.2 | 14 | 12.5 | |
AC, evaluable patients | 186 | 100 | 194 | 100 | |
Age (years) | |||||
Median (min–max) | 51 (28–77) | 50 (26–78) | |||
<50 years | 81 | 43.5 | 93 | 47.9 | 0.411 |
Early-stage breast cancer | 186 | 100 | 194 | 100 | |
Alcohol consumption | 0.559 | ||||
Never/Occasionallye
| 174 | 93.5 | 178 | 91.7 | |
Everyday | 12 | 6.5 | 16 | 8.3 | |
Risk group | 0.257 | ||||
Lowc
| 138 | 74.2 | 133 | 68.6 | |
Highd
| 48 | 25.8 | 61 | 31.4 |
Protection against delayed vomiting and nausea
Daily protection against delayed symptoms
Duration and severity of delayed symptoms
End point | Risk groupa
| Palo plus 1-day Dex, n/N (%) | Palo plus 3-day Dex, n/N (%) |
P valueb
|
---|---|---|---|---|
Duration of delayed vomitingc
| High | 1.0 | ||
1 day | 3/5 (60) | 1/2 (50) | ||
≥2 days | 2/5 (40) | 1/2 (50) | ||
Duration of delayed nauseac
| High | 0.303 | ||
1 day | 3/9 (33.3) | 1/10 (10) | ||
≥2 days | 6/9 (66.7) | 9/10 (90) | ||
Severity of delayed nausea | High | 1.0 | ||
Mild | 5/9 (55.6) | 6/10 (60) | ||
Moderate-to-severe | 4/9 (44.4) | 4/10 (40) | ||
Duration of delayed vomitingc
| Low | 0.615 | ||
1 day | 8/12 (66.7) | 5/6 (83.3) | ||
≥2 days | 4/12 (33.3) | 1/6 (16.7) | ||
Duration of delayed nauseac
| Low | 0.328 | ||
1 day | 15/38 (39.5) | 16/30 (53.3) | ||
≥2 days | 23/38 (60.5) | 14/30 (46.7) | ||
Severity of delayed nausea | Low | 0.539 | ||
Mild | 32/38 (84.2) | 23/30 (76.7) | ||
Moderate-to-severe | 6/38 (15.8) | 7/30 (23.3) |
End point | Risk groupa
| Palo plus 1-day Dex, n/N (%) | Palo plus 3-day Dex,n/N (%) |
P valueb
|
---|---|---|---|---|
Duration of delayed vomitingc
| High | 1.0 | ||
1 day | 14/22 (63.6) | 12/20 (60) | ||
≥2 days | 8/22 (36.4) | 8/20 (40) | ||
Duration of delayed nauseac
| High | 0.798 | ||
1 day | 10/45 (22.2) | 9/48 (18.8) | ||
≥2 days | 35/45 (77.8) | 39/48 (81.2) | ||
Severity of delayed nausea | High | 0.111 | ||
Mild | 9/45 (20) | 17/48 (35.4) | ||
Moderate-to-severe | 36/45 (80) | 31/48 (64.6) | ||
Duration of delayed vomitingc
| Low | 1.0 | ||
1 day | 11/17 (64.7) | 6/8 (75) | ||
≥2 days | 6/17 (35.3) | 2/8 (25) | ||
Duration of delayed nauseac
| Low | 0.058 | ||
1 day | 28/70 (40) | 13/55 (23.6) | ||
≥2 days | 42/70 (60) | 42/55 (76.4) | ||
Severity of delayed nausea | Low | 0.039 | ||
Mild | 39/70 (55.7) | 41/55 (74.5) | ||
Moderate-to-severe | 31/70 (44.3) | 14/55 (25.5) |
Prediction of delayed CINV
Variable | Odds ratioa (95 % CI) |
P value |
---|---|---|
Delayed vomiting | ||
Anti-emetic prophylaxis (1-day vs. 3-day regimen)b
| 1.89 (0.76–4.71) | 0.172 |
Age (<50 vs. ≥50 years) | 0.62 (0.18–2.14) | 0.452 |
Gender (female vs. male) | 0.69 (0.27–1.77) | 0.435 |
Alcohol consumption (never vs. regularly) | 1.27 (0.49–3.27) | 0.626 |
Acute vomiting (yes vs. no) | 5.40 (1.04–28.1) | 0.045 |
Acute moderate-to-severe nausea (yes vs. no) | 2.04 (0.56–7.39) | 0.277 |
Delayed nausea (moderate-to-severe or mild) | ||
Anti-emetic prophylaxis (1-day vs. 3-day regimen)b
| 1.19 (0.68–2.07) | 0.546 |
Age (<50 vs. ≥50 years) | 1.12 (0.55–2.25) | 0.756 |
Gender (female vs. male) | 1.46 (0.81–2.64) | 0.204 |
Alcohol consumption (never vs. regularly) | 0.93 (0.52–1.67) | 0.804 |
Acute vomiting (yes vs. no) | 0.76 (0.17–3.45) | 0.727 |
Acute moderate-to-severe nausea (yes vs. no) | 5.98 (2.11–16.9) | 0.0007 |
Variable | Odds ratioa (95 % CI) |
P value |
---|---|---|
Delayed vomiting | ||
Anti-emetic prophylaxis (1-day vs. 3-day regimen)b
| 3.28 (1.43–7.52) | 0.005 |
Age (<50 vs. ≥50 years) | 1.23 (0.50–3.03) | 0.653 |
Interaction (anti-emetic prophylaxis) (age) | 0.32 (0.09–1.06) | 0.062 |
Alcohol consumption (never vs. regularly) | 0.42 (0.15–1.13) | 0.085 |
Acute vomiting (yes vs. no) | 3.48 (1.65–7.33) | 0.001 |
Acute moderate-to-severe nausea (yes vs. no) | 3.41 (1.66–7.00) | 0.0009 |
Delayed nausea (moderate-to-severe or mild) | ||
Anti-emetic prophylaxis (1-day vs. 3-day regimen)b
| 1.56 (1.00–2.43) | 0.050 |
Age (<50 vs. ≥50 years) | 1.29 (0.82–2.02) | 0.271 |
Alcohol consumption (never vs. regularly) | 0.76 (0.33–1.75) | 0.521 |
Acute vomiting (yes vs. no) | 1.07 (0.50–2.33) | 0.853 |
Acute moderate-to-severe nausea (yes vs. no) | 11.6 (4.94–27.2) | <0.0001 |