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
Presenter Luigi Celio
Authors L. Celio1, F. Longo2, S. Brugnatelli3, G. Mansueto4, E. Bonizzoni5, F.G.M. De Braud6, F. Ricchini6, M.S. Aapro7
  • 1Oncologia, Fondazione IRCCS "Istituto Nazionale Tumori", 20133 - Milan/IT
  • 2Medical Oncology, Policlinico Umberto Primo, Rome/IT
  • 3Medical Oncology, Policlinico San Matteo, Pavia/IT
  • 4U.o.c. Oncologia Medica, Ospedale Fabrizio Spaziani, 03100 - Frosinone/IT
  • 5Section Of Medical Statistics And Biometry, Faculty of Medicine, University of Milan, Milan/IT
  • 6Medical Oncology, Fondazione IRCCS "Istituto Nazionale Tumori", 20133 - Milan/IT
  • 7Institut Multidisciplinaire D’oncologie, Clinique de Genolier, 1272 - Genolier/CH

Abstract

Purpose

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.