Abstract 2190
Background
Current antiemetic guidelines recommend antiemetic triplet regimen for cisplatin-based chemotherapy. Although several prior studies have identified risk factors for chemotherapy-induced nausea and vomiting (CINV), only a few have evaluated antiemetic triplet regimen, particularly with palonosetron. Therefore, the purpose of the present study was to confirm and compare the risk factors for CINV when using palonosetron or granisetron.
Methods
A total of 825 patients in the phase III clinical trial on cisplatin regimen were evaluated. The primary endpoint was complete response (CR) rate in the overall period (0–120 h). All patients were evaluated for CINV risk factors. Using a post-hoc analysis, the impact of antiemetic treatment on CR was assessed, and odds ratio (OR) with 95% confidence intervals (CIs) for antiemetic treatment failure were evaluated by using multivariate logistic regression models. CINV risk factors were also evaluated separately in each treatment group.
Results
The multivariate analysis revealed that female (OR: 2.572; 95% CI: 1.855–3.566), less than 60 years old (OR: 1.717; 95% CI: 1.252–2.355), the cisplatin dosage (OR: 1.017; 95% CI: 1.001–1.033), and granisetron use (OR: 1.357; 95% CI: 1.013–1.817) were all significantly associated with antiemetic treatment failure in the entire study group. Similarly, female and age were also identified as the risk factors associated with treatment failure in both groups (P < 0.0001). Kaplan–Meier plots of time to event classified each treatment group and revealed no significant difference between the groups for patients with zero risk factors (P = 0.353). For patients with one or more risk factors, those treated with palonosetron experienced significantly higher CR rates than those treated with granisetron (P = 0.049).
Conclusions
This analysis revealed risk factors of CINV when using triplet antiemetic regimen Including palonosetron or granisetron for cisplatin. Palonosetron might be preferred for patients with one or more risk factors.
Clinical trial identification
Clinical trial information: UMIN 000004863 *UMIN: University Medical Information Network
Legal entity responsible for the study
Pharma Valley Center, Shizuoka Organization for Creation of Industries
Funding
Pharma Valley Center, Shizuoka Organization for Creation of Industries
Disclosure
T. Yamanaka: Reserch Funding: Taiho. K. Goto: Taiho, Chugai, Ono. N. Yamamoto: Consulting or Advisory Role: Chugai Pharmaceutical Co, Ltd, Ono Pharmaceutical Co. Ltd, Research Funding: Ono Pharmaceutical Co., Ltd, Taiho Pharmaceutical Co., Ltd. All other authors have declared no conflicts of interest.