Table 1.
Characteristics of patients and treatments in the olanzapine and control groups.
| Characteristic | Control Group (n = 105) |
Olanzapine Group (n = 113) |
|---|---|---|
| Mean age (range) | 52 (23–88) | 50 (23–74) |
| Mean weight in kg (range) | 77 (36–138) | 78 (39–127) |
| Breast cancer Stage | ||
| I | 7.7% | 8.0% |
| II | 57.7% | 54.0% |
| III | 34.6% | 36.3% |
| Concomitant medical conditionsa | 96.1% | 98.2% |
| History of motion sickness | 42.9% | 41.4% |
| History of morning sickness (if applicable) | 63.8% | 58.4% |
| History of alcohol intake | ||
| Less than 1 drink/day | 41.9% | 47.8% |
| More than 1 drink/day | 16.2% | 15.0% |
| None | 41.9% | 37.2% |
| Planned chemotherapy | ||
| AC x 4 | 51.4% | 53.1% |
| FEC x 3 | 39.0% | 37.2% |
| TCH x 6 | 9.5% | 9.7% |
| Median number of cycles (range) | 3 (1–6) | 3 (1–6) |
| Acute CINV risk score at enrollment (range)b | 8 (5–12) | 8 (5–12) |
| Delayed CINV risk score enrollment (range)c | 20 (11–37) | 20 (10–50) |
| Number of delivered cycles of chemotherapy | ||
| One | 12.4% | 6.2% |
| Two | 4.8% | 2.6% |
| Three | 38.1% | 41.6% |
| Four | 38.1% | 44.2% |
| ≥ Five | 6.7% | 5.3% |
| Total cycles delivered | 346 | 383 |
| Completed studyd | 76.2% | 82.3% |
Abbreviations: A = doxorubicin, C = cyclophosphamide, F = 5-fluorouracil, E = epirubicin, H = trastuzumab, T = docetaxel, CINV = chemotherapy induced nausea and vomiting.
a
Cardiovarcular disease, diabetes, gastrointestinal, musculoskeletal, thyroid, other.
b
From the acute risk model developed by Dranitaris et al. (2009). Patients with a risk score of 8 had an acute N&V risk of approximately 24%.
c
From the delayed risk model developed by Petrella et al. (2009). Patients with a risk score of 20 had an acute N&V risk of approximately 40%.
d
13 and 4 patients in the placebo and olanzapine groups quit the study because of poor nausea control.