1490P - Aprepitant, granisetron and dexamethasone versus palonosetron and dexamethasone for cisplatin-induced nausea and vomiting in patients with upper ga...

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Complications of Treatment
Supportive Care
Gastrointestinal Cancers
Presenter Kenji Ishido
Citation Annals of Oncology (2014) 25 (suppl_4): iv517-iv541. 10.1093/annonc/mdu356
Authors K. Ishido, K. Higuchi, M. Azuma, T. Sasaki, S. Tanabe, C. Katada, W. Koizumi
  • Department Of Gastroenterology, Kitasato University School of Medicine, 252-0380 - Sagamihara/JP

Abstract

Aim

Large-scale clinical studies on chemotherapy-induced nausea and vomiting (CINV) induced by highly emetogenic chemotherapy (HEC) showed that antiemetic therapy with a 3-drug combination of aprepitant, granisetron and dexamethasone (AGD) or a 2-drug combination of palonosetron and dexamethasone (PD) were superior to conventional antiemetic therapy a 5HT3 receptor antagonist and dexamethasone. But the AGD and PD regimens have not been compared. We performed a randomized crossover trial to compare the efficacy of AGD and PD in HEC.

Methods

The subjects were patients with esophageal or gastric cancer who underwent HEC including ≥60 mg/m2 cisplatin as first-line treatment. Patients were randomly assigned into groups treated with AGD (oral aprepitant 125 mg on day 1, 80 mg on days 2–3; intravenous granisetron 3 mg on day 1; intravenous dexamethasone (D) 6.6 mg on day 1 and oral D 4 mg on days 2-3) or PD (intravenous palonosetron 0.75 mg on day 1; intravenous D 13.2 mg on day 1 and oral D 8 mg on days 2-3). The antiemetic therapies were crossed-over in the second course. The primary endpoint was a complete response (CR: defined as no emetic episodes and no requirement for rescue medication) in the overall phase (0-120 h) during the first course. The planned sample size of 80 patients provided 80% power to detect a 30% improvement in CR with a two-sided alpha of 0.05.

Results

Eighty-fifth patients were enrolled in the study and 84 were evaluable. Baseline factors were well-balanced between the two groups. The CR rate did not differ significantly between the two groups, but the frequency of no vomiting was significantly higher in the AGD group (Table 1). Regarding patient's preference after the second course, 41.0% of patients preferred AGD, 19.7% preferred PD, and 39.3% indicated no preference. Based on a QOL survey, the frequency of no or minimal impact on daily life in the vomiting domain was significantly higher in the AGD group (79.1% vs. 53.7%; p = 0.014).

Persentages of patients reaching efficacy endpoints

AGD, N=43 PD, N=41 p value
Complete response 67.4% 58.5% 0.399
No vomiting 81.4% 58.5% 0.025
No nausea 39.5% 39.0% 0.962
No rescue 674% 75.6% 0.409

Conclusions

The primary endpoint of CR was not achieved, but AGD combination therapy seems to more effective than PD therapy for prevention of HEC-induced CINV.

Disclosure

All authors have declared no conflicts of interest.