Efficacy benefit of an NK1 receptor antagonist (NK1RA) in patients receiving carboplatin: supportive evidence with NEPA (a fixed combination of the NK1 RA, netupitant, and palonosetron) and aprepitant regimens

被引:16
|
作者
Jordan, Karin [1 ]
Gralla, Richard [2 ]
Rizzi, Giada [3 ]
Kashef, Kimia [4 ]
机构
[1] Univ Halle Wittenberg, Dept Hematol Oncol, Ernst Grube Str 40, D-06120 Halle, Germany
[2] Albert Einstein Coll Med, Bronx, NY 10467 USA
[3] Helsinn Healthcare, Lugano, Switzerland
[4] Eisai Inc, Woodcliff Lake, NJ USA
关键词
Netupitant; Palonosetron; NEPA; Aprepitant; CINV; Carboplatin; CHEMOTHERAPY-INDUCED NAUSEA; MODERATELY EMETOGENIC CHEMOTHERAPY; ADVANCED OVARIAN-CANCER; RANDOMIZED PHASE-III; PLACEBO-CONTROLLED TRIAL; HIGH-DOSE CISPLATIN; DOUBLE-BLIND; ANTIEMETIC THERAPY; NG108-15; CELLS; VOMITING CINV;
D O I
10.1007/s00520-016-3304-1
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Antiemetic guideline recommendations are inconsistent as to whether a neurokinin-1 receptor antagonist (NK1 RA) should be administered with a 5-hydroxytryptamine-3 (5HT(3)) RA + dexamethasone (DEX) in patients receiving carboplatin. Patients receiving cisplatin routinely receive an NK1 RA-containing regimen with a resulting 14-22 % benefit in no emesis rates over a 5-HT3 RA/DEX control. Recent studies suggest a similar benefit in patients receiving carboplatin. NEPA is the first fixed antiemetic combination agent and comprises the highly selective NK1 RA, netupitant, and pharmacologically distinct 5-HT3 RA, palonosetron (PALO). This paper presents the efficacy of NEPA in the subset of patients receiving carboplatin in a phase 3 trial (NCT01376297), in the context of aprepitant (APR) data in the carboplatin setting. One hundred ninety-six patients (47 % of all study patients: n = 145 NEPA + DEX; n = 51 APR + PALO + DEX) received carboplatin in a multinational, double-blind, randomized phase 3 study. Complete response (CR: no emesis/rescue) and no significant nausea (NSN: score aecurrency sign25 on 100 mm visual analog scale) rates were calculated. Cycle 1-4 overall (0-120 h) CR rates were similar for NEPA (80, 91, 92, and 93 %) and APR (82, 88, 88, and 90 %). Overall NSN rates were also similar (NEPA 84-96 %; APR 82-90 %). Response rates for NEPA and APR regimens were similar and consistent with prior studies evaluating the contribution of adding NK1 RAs in patients receiving carboplatin. Considering such evidence, guideline groups/practitioners should consider giving a NK1 RA antiemetic triplet in patients receiving carboplatin.
引用
收藏
页码:4617 / 4625
页数:9
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