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在晚期癌症患者中进行的 selinexor 1B 期研究中预防恶心、呕吐和厌食的支持性护理:一项探索性研究。

Supportive care for the prevention of nausea, vomiting and anorexia in a phase 1B study of selinexor in advanced cancer patients: an exploratory study.

机构信息

Symptom Control & Palliative Medicine, University of Texas MD Anderson Cancer Center, Houston, USA.

Department of Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center, Houston, USA.

出版信息

Invest New Drugs. 2022 Feb;40(1):124-133. doi: 10.1007/s10637-021-01184-5. Epub 2021 Sep 24.

DOI:10.1007/s10637-021-01184-5
PMID:34559346
Abstract

INTRODUCTION

Clinical observations of cancer patients treated with selinexor have reported high incidence of nausea and anorexia. The study objective was to investigate the adoption of prophylactic olanzapine for the prevention of nausea, vomiting and anorexia in cancer patients receiving selinexor and standard chemotherapy.

METHODS

We retrospectively reviewed supportive care interventions in patients receiving selinexor and recorded frequency of adverse events (NCI-CTAE). Association between categorical variables were analyzed using Fisher's exact tests; repeated measures analysis was performed to assess weight changes over time.

RESULTS

Of 124 evaluable patients, 83 (66.9%) were female, 93 were white (75.0%), and the most common cancer was ovarian (N = 30, 24.2%). One hundred and four patients (83.9%) received olanzapine, of which 93 (89.4%) were prophylactically treated, the majority (86.5%) receiving low 2.5 mg daily dose. Other anti-emetics included ondansetron in 90 patients (72.6%), dexamethasone prescribed in 50 patients (40.3%) and metoclopramide in 49 patients (39.5%), while aprepitant/fosaprepitant (N = 2, 1.6%) were prescribed infrequently. Cancer patients receiving prophylactic olanzapine (N = 93) compared to patients who never received olanzapine (N = 20) had more Grade 1 + anorexia (31.2% vs 20.0%), less nausea (53.8% vs 70.0%), less vomiting (33.3% vs 40.0%), and increased hyperglycemia (29.0% vs 10.0%), but differences were non-statistically significant. In addition, there was minimal weight loss over time in both groups and no statistically significant differences in weight loss between groups.

CONCLUSION

Prophylactic olanzapine decreased nausea, vomiting and maintained weight over 3 months but did not prevent anorexia in patients receiving selinexor and chemotherapy. Low dose olanzapine was well tolerated but associated with hyperglycemia.

摘要

介绍

对接受塞来昔布治疗的癌症患者的临床观察报告称,恶心和厌食的发生率很高。本研究的目的是调查在接受塞来昔布和标准化疗的癌症患者中,预防性使用奥氮平预防恶心、呕吐和厌食的情况。

方法

我们回顾性地审查了接受塞来昔布治疗的患者的支持性护理干预措施,并记录了不良事件的频率(NCI-CTAE)。使用 Fisher 确切检验分析分类变量之间的关联;进行重复测量分析以评估随时间的体重变化。

结果

在 124 例可评估的患者中,83 例(66.9%)为女性,93 例为白人(75.0%),最常见的癌症是卵巢癌(N=30,24.2%)。104 例(83.9%)患者接受了奥氮平治疗,其中 93 例(89.4%)接受了预防性治疗,大多数(86.5%)接受了低剂量 2.5mg 每日剂量。其他止吐药包括奥氮平 90 例(72.6%)、地塞米松 50 例(40.3%)和甲氧氯普胺 49 例(39.5%),阿瑞匹坦/福沙匹坦(N=2,1.6%)的使用频率较低。接受预防性奥氮平治疗的癌症患者(N=93)与从未接受过奥氮平治疗的患者(N=20)相比,更易发生 1+级厌食症(31.2% vs 20.0%)、恶心发生率更低(53.8% vs 70.0%)、呕吐发生率更低(33.3% vs 40.0%),且高血糖发生率更高(29.0% vs 10.0%),但差异无统计学意义。此外,两组患者的体重均有轻微减轻,且两组间的体重减轻无统计学差异。

结论

在接受塞来昔布和化疗的患者中,预防性使用奥氮平可减少恶心、呕吐并维持 3 个月的体重,但不能预防厌食症。低剂量奥氮平耐受性良好,但与高血糖有关。

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