1488P - Prevention of chemotherapy-induced nausea and vomiting with a fixed-dose combination of netupitant and palonosetron (NEPA) following highly emetoge...

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Complications of Treatment
Supportive Care
Presenter Paul Hesketh
Citation Annals of Oncology (2014) 25 (suppl_4): iv517-iv541. 10.1093/annonc/mdu356
Authors P. Hesketh1, K. Jordan2, R. Gralla3
  • 1Medical Oncology/hematology, Lahey Hospital & Medical Center, 01805 - Burlington/US
  • 2Dept. Hematology/ Oncology, Martin Luther University of Halle, 06120 - Halle/DE
  • 3Medical Oncology, Albert Einstein College of Medicine, Bronx/US

Abstract

Aim

Female gender and young age are well-established patient-related risk factors increasing the emetogenic potential of chemotherapy. NEPA, a novel fixed-dose combination of the new NK1 receptor antagonist (RA), netupitant (NETU) and the pharmacologically distinct 5-HT3 RA, palonosetron (PALO) was superior to PALO in pivotal studies. The intent of this analysis was to evaluate the effect of gender and age on treatment response.

Methods

Data was combined from 3 pivotal studies in chemotherapy-naïve patients with solid tumors undergoing cisplatin-based HEC. Patients received either NEPA (100/200/300 mg oral NETU+0.50 mg oral PALO) (studies 1 & 2) or 0.50 mg oral PALO (studies 1 & 3). All patients also received dexamethasone (DEX) on days 1-4. Overall (0-120h) complete response (CR: no emesis, no rescue medication) rates were calculated for females and males

Results

In both treatment groups, CR rates were lower in all females (69% PALO, 82% NEPA) and those<55 yrs (70% PALO, 85% NEPA) compared with males (78% PALO, 91% NEPA) and those≥55 yrs (77% PALO, 89% NEPA). However, the beneficial effect of NEPA over PALO was seen in both gender and age groups as evidenced by a similar absolute difference of ∼13%. To evaluate the combined effect of gender+age, patients were divided into 4 emetic risk groups. A clear trend existed across the risk groups with (older) males exhibiting higher rates than (younger) females and NEPA rates higher than PALO in all gender/age risk groups.

PALO NEPA % Difference (95% CI)
Females<55 (high risk) (N=100/100) 69.0% 80.0% 11.0 (-1.0;23.0)
Females≥55 (moderate risk) (N=108/103) 69.4% 84.5% 15.0 (3.9;26.2)
Males<55 (low risk) (N=91/126) 71.4% 89.7% 18.3 (7.6;29.0)
Males≥55 (lowest risk) (N=206/153) 81.1% 92.8% 11.7 (5.0;18.5)

Conclusions

NEPA resulted in a consistent and similar magnitude of benefit for both younger and older patients, both genders, and for all combined gender/age risk groups. Younger women remain the most at risk for emesis, but the NEPA fixed-dose combination+DEX offers a clear advantage over PALO+DEX for this group as well.

Disclosure

P. Hesketh: Non-compensated consultant for Helsinn Healthcare; K. Jordan: Speakers bureau for Merck and Helsinn Healthcare; Advisor for Helsinn Healthcare; R. Gralla: Advisor for Helsinn Healthcare, Merck, and Eisai