Phase III Randomized Trial of Palonosetron and Dexamethasone With or Without Aprepitant to Prevent Nausea and Vomiting Induced by Full-dose Single-day Cisplatin-based Chemotherapy in Lung Cancer

Wu, Fang; Lin, Xiaoping; Yang, Zhanghuan; Sun, Ziyi; Zeng, Fanxu; Heng, Jianfu; Qu, Jingjing; Zeng, Liang; Yang, Nong; Zhang, Yongchang

doi:10.1016/j.cllc.2018.08.006

Cited by 12 publications

(21 citation statements)

References 23 publications

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“…The primary endpoint of the study was overall CR throughout 5 days post-HEC. The CR rate in PAD recipients, used as the reference arm, was comparable to rates in 1,453 patients who were randomized to PAD in seven randomized controlled trials (RCTs) for HEC-induced CINV [14][15][16][17][18][19][20]; CR rates in the RCTs vs. our study were 86.6% vs. 93.7%, 73.4% vs. 79.6%, and 69.5% vs. 79.6% in the acute, delayed, and overall phases, respectively ( Table 5). Mean-while, the overall CR rate (81.8%) with RAD was slightly higher than in our previous phase III study (77.1%) [21], but comparable to that with PAD (79.6%).…”

Section: Discussionmentioning

confidence: 86%

Ramosetron versus Palonosetron in Combination with Aprepitant and Dexamethasone for the Control of Highly-Emetogenic Chemotherapy-Induced Nausea and Vomiting

et al. 2020

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Original ArticlePurpose The purpose of this study was to compare ramosetron (RAM), aprepitant (APR), and dexamethasone (DEX) [RAD] with palonosetron (PAL), APR, and DEX [PAD] in controlling highlyemetogenic chemotherapy (HEC)-induced nausea and vomiting. Materials and MethodsPatients were randomly assigned (1:1) to receive RAD or PAD:RAM (0.3 mg intravenously) or PAL (0.25 mg intravenously) D1, combined with APR (125 mg orally, D1 and 80 mg orally, D2-3) and DEX (12 mg orally or intravenously, D1 and 8 mg orally, D2-4). Patients were stratified by gender, cisplatin-based chemotherapy, and administration schedule. The primary endpoint was overall complete response (CR), defined as no emesis and no rescue regimen during 5 days of HEC. Secondary endpoints were overall complete protection (CP; CR+nausea score < 25 mm) and total control (TC; CR+nausea score < 5 mm). Quality of life was assessed by Functional Living Index Emesis (FLIE) questionnaire on D0 and D6. ResultsA total of 279 patients receiving RAD (n=137) or PAD (n=142) were evaluated. Overall CR rates in RAD and PAD recipients were 81.8% and 79.6% (risk difference [RD], 2.2%; 95% confidence interval [CI], −7.1 to 11.4), respectively. Overall CP and TC rates for RAD and PAD were 56.2% and 58.5% (RD, −2.3%; 95% CI, −13.9 to 9.4) and 47.5% vs. 43.7% (RD, 3.8%; 95% CI, −7.9 to 15.5), respectively. FLIE total score ≥ 108 (no impact on daily life) was comparable between RAD and PAD (73.9% vs. 73.4%, respectively). Adverse events were similar between the two groups. ConclusionIn all aspects of efficacy, safety and quality of life, RAD is non-inferior to PAD for the control of chemotherapy-induced nausea and vomiting in cancer patients receiving HEC.

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Section: Discussionmentioning

confidence: 86%

Ramosetron versus Palonosetron in Combination with Aprepitant and Dexamethasone for the Control of Highly-Emetogenic Chemotherapy-Induced Nausea and Vomiting

et al. 2020

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“…We preliminarily screened 2118 potential qualified studies. Four studies assessing 518 patients (ADH group, 261 patients; DH group, 257 patients) were ultimately included in the analysis (Figure 1) (11)(12)(13)(14). All the studies were RCTs.…”

Section: Search Results and Study Quality Assessmentmentioning

confidence: 99%

“…Several trials have been conducted to examine this issue. In one randomized controlled trial (RCT), Wu reported a better overall complete response (CR) and a lower rate of rescue antiemetic treatment (RAT) in the ADH group, but the no nausea rate (NNR) was similar in the two groups (11). Aksu also reported that ADH led to a better CR and lower Functional Living Index Emesis (FLIE) scores in patients with LC (12).…”

Section: Introductionmentioning

confidence: 99%

Use of dexamethasone and a 5-HT3 receptor antagonist with or without aprepitant to prevent chemotherapy-induced nausea and vomiting among patients with lung cancer who are treated with platinum-based chemotherapy: a systematic review and meta-analysis of randomized controlled trials

Liu

et al. 2021

Ann Palliat Med

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Background: Researchers have not clearly determined whether adding aprepitant (ADH) to dexamethasone and one 5-HT3 receptor antagonist (DH) is clinically effective at preventing chemotherapyinduced nausea and vomiting (CINV) among patients with lung cancer (LC) treated with platinum-based chemotherapy (PBC). Therefore, we conducted a meta-analysis to examine the efficacy and safety of ADH and DH.Methods: We searched the PubMed, ScienceDirect, Cochrane Library, and Scopus databases, among others, for relevant studies. The primary outcomes were the complete response (CR) and the no nausea rate (NNR). The secondary endpoints were the number of patients who needed rescue antiemetic treatment (RAT), adverse events (AEs), and the Functional Living Index Emesis (FLIE) score.Results: We initially screened 2,118 articles; ultimately, four randomized controlled trials (RCTs) with 518 patients were included. The ADH group had a superior overall CR [risk ratio (RR): 1.16 (1.06, 1.27), P=0.002] and a lower number of patients who needed RAT [RR: 0.44 (0.29, 0.65), P<0.0001]. The ADH group also had a better overall NNR [RR: 1.11 (0.97, 1.26), P=0.12] and delayed CR [RR: 1.12 (0.97, 1.31), P=0.13]. No significant differences were observed in acute CR, acute NNR, or delayed NNR. In the subgroup analysis of the overall CR and NNR, ADH was superior in certain clinical characteristics (China, cisplatin-based chemotherapy, 2 nd -generation 5-HT3 receptor antagonist, ADC <50%, and Eastern Cooperative Oncology Group (ECOG) score of 0-2). No significant differences in the AEs characterized as hematological or nonhematological toxicity were observed between the groups.

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“…A terapia antiemética também pode ser realizada com a administração de aprepitanto e palonosetrona, no qual se observou um benefício clínico ao controle das NVIQ (Bubalo et al, 2018;Di Renzo et al, 2020, Ioroi et al, 2018Sugimori et al, 2017;Wu et al, 2018). Estudos recentes mostram que a profilaxia de NVIQ em pacientes pediátricos é feito através de um regime triplo que utiliza um antagonista 5-HT3, dexametasona e um antagonista NK-1, contudo, é difícil determinar os benefícios da adição de corticosteroides no tratamento da NVIQ nesses pacientes devido aos vários estudos heterogêneos existentes (Gupta et al, 2021;Sherani et al, 2019,).…”

Section: Combinação Dos Antagonistas Do Receptor De Serotonina Com Antagonistas Do Receptor De Neurocinina E/ou Dexametasonaunclassified

Farmacoterapia atual das náuseas e vômitos induzidos por antineoplásicos

Santos¹,

Gusmão

Oliveira³

et al. 2021

RSD

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As náuseas e vômitos induzidos por quimioterapia (NVIQ) são reações adversas à medicamentos comuns com o uso de antineoplásicos. Embora existam avanços na terapêutica profilática, o manejo de medicamentos antieméticos na prática clínica ainda tem sido um desafio a ser enfrentado. O objetivo do presente estudo foi buscar na literatura científica as principais terapias farmacológicas utilizadas nesta condição. Uma revisão sistemática foi realizada, no qual buscou-se artigos científicos indexados no PubMed, ScienseDirect e Web of Science, utilizando os seguintes descritores: chemotherapy; nausea; vomiting; drug therapy; serotonin 5-HT3 receptor antagonists, neurokinin-1 receptor antagonista. O grau de emetogenicidade causado pelos agentes antineoplásicos influencia diretamente no tratamento das NVIQ, que incluem os antagonistas dos receptores de serotonina (5-HT3), antagonistas dos receptores de neurocinina (NK-1). Este tratamento pode ser feito de forma individualizada, porém, caso ele não seja responsivo, é possível fazer a associação entre essas duas classes. Em casos mais complicados é indicado uma terapia tripla que é composta pela combinação de antagonistas dos receptores de 5-HT3 com antagonistas dos receptores de NK-1 e dexametasona. Portanto, a eficácia da terapia antiemética é aumentada nessa tríadequando comparados ao tratamento desses medicamentos de forma individualizada. Os antagonistas dos receptores de 5-HT3 de primeira geração são muito eficazes, contudo, a palonosetrona, de segunda geração, é mais eficaz e seguro. Uma formulação de netupitanto e palonosetrona, quando administrado juntamente com a dexametasona, tem sido uma boa opção para o tratamento de NVIQ.

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Phase III Randomized Trial of Palonosetron and Dexamethasone With or Without Aprepitant to Prevent Nausea and Vomiting Induced by Full-dose Single-day Cisplatin-based Chemotherapy in Lung Cancer

Cited by 12 publications

References 23 publications

Ramosetron versus Palonosetron in Combination with Aprepitant and Dexamethasone for the Control of Highly-Emetogenic Chemotherapy-Induced Nausea and Vomiting

Ramosetron versus Palonosetron in Combination with Aprepitant and Dexamethasone for the Control of Highly-Emetogenic Chemotherapy-Induced Nausea and Vomiting

Use of dexamethasone and a 5-HT3 receptor antagonist with or without aprepitant to prevent chemotherapy-induced nausea and vomiting among patients with lung cancer who are treated with platinum-based chemotherapy: a systematic review and meta-analysis of randomized controlled trials

Farmacoterapia atual das náuseas e vômitos induzidos por antineoplásicos

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