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Войти в исследования Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
Reduced/No Dexamethasone With Netupitant/Palonosetron and Olanzapine for Chemotherapy‑Induced Nausea/Vomiting in Highly Emetogenic Chemotherapy: Phase III Noninferiority Trial.
СтатьяКлиническое исследование III фазыEquivalence TrialМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Meng Yanchun, Liu Yingying, Lin Mingxi, Wang Lili, Mu Yuxin, Yang Ling, Du Yiqun, Liu Xiaojun, Chen Yong, Tian Shaodong, Zhou Qin, Zhuang Xiaojie, Li Zikang, Liu Jinsong, Fang Shencun, Fan Weifei, Mao Yu, Zhang Ling, Wu Hao, Yan Fei, Weng Jie, Zhao Jianhua, Long Xiangyu, Liu Lianfang, Zhou Jianbo, Zhang Jian
Аннотация
PURPOSE: Guideline-recommended 4-day dexamethasone (DEX) for highly emetogenic chemotherapy (HEC) raises toxicity and immunotherapy interference concerns. We tested whether DEX reduction or omission with netupitant/palonosetron (NEPA) plus olanzapine (OLZ) is noninferior to standard DEX.
PATIENTS AND METHODS: In this open-label, randomized phase III noninferiority trial across 28 Chinese centers, adults receiving HEC received NEPA (day 1) plus OLZ (days 1-4) and were randomly assigned to standard DEX (12 mg day 1, 8 mg days 2-4), DEX-sparing (6 mg day 1 only), or DEX-free (no DEX). The primary end point was complete response (CR; no emesis/no rescue medication) from 0 to 120 h. Noninferiority margin was -12% (one-sided α = .025).
RESULTS: Of 644 randomly assigned patients (median age 54.9 years; 66.0% female), stratified analysis showed overall CR rates of 72.4% for standard, 72.2% for DEX-sparing (stratified risk difference [RD], -0.2% [95% CI, -8.7 to 8.5]; Pnoninferiority = .005), and 70.1% for DEX-free (stratified RD, -2.2% [95% CI, -10.7 to 6.4]; Pnoninferiority = .014). Both met noninferiority, confirmed in per-protocol analysis. Steroid-related toxicities were significantly lower with DEX-sparing and DEX-free regimens versus standard.
CONCLUSION: NEPA plus OLZ with reduced (6 mg day 1 only) or no DEX is noninferior to standard 4-day DEX for chemotherapy-induced nausea and vomiting prevention in HEC, supporting steroid-sparing strategies particularly relevant in the chemo-immunotherapy era.
PATIENTS AND METHODS: In this open-label, randomized phase III noninferiority trial across 28 Chinese centers, adults receiving HEC received NEPA (day 1) plus OLZ (days 1-4) and were randomly assigned to standard DEX (12 mg day 1, 8 mg days 2-4), DEX-sparing (6 mg day 1 only), or DEX-free (no DEX). The primary end point was complete response (CR; no emesis/no rescue medication) from 0 to 120 h. Noninferiority margin was -12% (one-sided α = .025).
RESULTS: Of 644 randomly assigned patients (median age 54.9 years; 66.0% female), stratified analysis showed overall CR rates of 72.4% for standard, 72.2% for DEX-sparing (stratified risk difference [RD], -0.2% [95% CI, -8.7 to 8.5]; Pnoninferiority = .005), and 70.1% for DEX-free (stratified RD, -2.2% [95% CI, -10.7 to 6.4]; Pnoninferiority = .014). Both met noninferiority, confirmed in per-protocol analysis. Steroid-related toxicities were significantly lower with DEX-sparing and DEX-free regimens versus standard.
CONCLUSION: NEPA plus OLZ with reduced (6 mg day 1 only) or no DEX is noninferior to standard 4-day DEX for chemotherapy-induced nausea and vomiting prevention in HEC, supporting steroid-sparing strategies particularly relevant in the chemo-immunotherapy era.