1571P - Prevention of delayed nausea (DN): a pooled analysis of 562 women receiving highly emetogenic chemotherapy (HEC) in prospective clinical trials of p...
|Date||01 October 2012|
|Event||ESMO Congress 2012|
|Session||Poster presentation III|
|Topics|| Supportive Care
L. Celio1, F. Longo2, S. Brugnatelli3, G. Mansueto4, E. Bonizzoni5, F.G.M. De Braud6, F. Ricchini6, M.S. Aapro7
Chemotherapy-induced nausea occurs more frequently than vomiting, and women are particularly prone to experience DN instead of delayed vomiting. We conducted a pooled analysis to evaluate the efficacy of three regimens for preventing DN: 1-day regimen (n = 241): Palo plus dexamethasone 8 mg IV (Day 1); 3-day regimen (n = 209): Palo plus dexamethasone 8 mg (Day 1) and dexamethasone 8 mg PO (Days 2 and 3); triple regimen (n = 112): Palo plus dexamethasone 12 mg and aprepitant (Day 1) and dexamethasone 8 mg PO plus aprepitant (Days 2 and 3).Methods
The analysis was based upon outcomes in 562 chemo-naïve women (mean age 52.7 years; PS ECOG 0: 93%; metastatic disease: 11%) with solid tumors (90% breast cancer) enrolled in two Phase III and two Phase II trials of HEC (AC-based: 91%; cisplatin: 9%). The pre-specified primary end point was the proportion of patients with no nausea during the delayed period (Days 2-5) after the first cycle of chemotherapy. The two primary comparisons were 3-day regimen vs. 1-day regimen, and triple regimen vs. 3-day regimen. Penalized multivariable logistic regressions were also performed adopting the Firth's correction in order to adjust estimates for potential over-fitting, skewed data and multi-collinearity. Results were reported as adjusted odds ratios (OR) with two-sided probability values.Results
The 3-day to 1-day regimen comparison was not statistically significant (DN, 46.4% vs. 44.4%, two-sided Fisher's exact test, P = 0.777). The triple regimen to 3-day regimen comparison was significant (DN, 58.9% vs. 46.4%; P < 0.0001). For no nausea end point in the overall phase (Days 1-5) adjusted ORs (95% CI) were: 3-day regimen vs. 1-day regimen: OR 1.19 (0.80 - 1.77), P = 0.398; triple regimen vs. 3-day regimen: OR 2.86 (1.44 - 5.83), P = 0.003.Conclusions
This analysis suggests that Palo plus 1-day or 3-day dexamethasone have similar effects on DN. The addition of aprepitant to 3-day regimen improves the prevention of DN in women receiving HEC. Complete results accounting for risk factors (age and alcohol consumption) will also be presented.Disclosure
All authors have declared no conflicts of interest.