Use of Low Dose Olanzapine for the Control of Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy in a Rural Medical College in Etawah District, Uttar Pradesh, India

Kailash Mittal, Parveen Mendiratta, N. Bala
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Abstract

BACKGROUND Chemotherapy-induced nausea and vomiting (CINV) is a frequent and feared adverse effect of cancer chemotherapy. International guidelines recommend combinations of 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists, dexamethasone, and/or neurokinin-1 (NK1) receptor antagonists for the control of CINV in patients receiving highly emetogenic chemotherapy (HEC) as a part of their treatment. Even though, nausea in delayed period is less controlled and poses a major concern for these patients. METHODS This open label, prospective study was conducted in a rural medical college in Etawah District in Uttar Pradesh, India from November 2017 to November 2018 over a period of 1 year to observe the efficacy of low dose (5 mg OD) olanzapine in combination with standard anti-emetic regimen for the prevention of CINV. Olanzapine is a food and drug administration (FDA) approved antipsychotic drug that has anti-emetic activity and has shown to improve CINV. Low dose olanzapine along with a standard combination of ondansetron, dexamethasone and aprepitant was given to patients receiving highly emetogenic chemotherapy (Cisplatin >70 mg/m2 or doxorubicin-cyclophosphamide combination). CINV was assessed using common toxicity criteria of adverse events (CTCAE) version 5.0. RESULTS Complete response to nausea was observed in 90.90 %, 60.60 % and 54.54 % in acute, delayed and overall period respectively. Complete response to vomiting was observed in 96.96 %, 69.69 % and 66.66 % in acute, delayed and overall period respectively. Complete response to Grade-2 (or above) nausea was observed in 96.96 %, 93.93 % and 90.90 % in acute, delayed and overall period, respectively. Daytime Grade -3 somnolence which was seen in 2/33 patients (6.06 %) was attributable to olanzapine. Patients receiving olanzapine were more likely to have complete response of nausea and emesis in the early, late, and overall assessment periods especially of higher grade (G2 and G3). CONCLUSIONS The authors concluded that low dose olanzapine 5 mg OD combined with an NK1- receptor antagonist, a 5-HT3–receptor antagonist, and dexamethasone is safe and efficacious in the prevention of CINV in patients receiving HEC. KEYWORDS Olanzapine, Low Dose, CINV, HEC
在印度北方邦Etawah地区的一所农村医学院,使用低剂量奥氮平控制接受高致吐性化疗患者的恶心和呕吐
化疗引起的恶心和呕吐(CINV)是癌症化疗中常见且令人恐惧的不良反应。国际指南推荐将5-羟色胺3型(5-HT3)受体拮抗剂、地塞米松和/或神经激肽1 (NK1)受体拮抗剂联合应用于接受高度致呕吐性化疗(HEC)的患者,作为其治疗的一部分来控制CINV。尽管如此,延迟期的恶心较难控制,是这些患者的主要关注点。方法于2017年11月至2018年11月在印度北方邦Etawah区的一所农村医学院进行了一项为期1年的开放标签前瞻性研究,观察低剂量(5mg OD)奥氮平联合标准止吐方案预防CINV的疗效。奥氮平是美国食品和药物管理局(FDA)批准的抗精神病药物,具有止吐活性,并已证明可改善CINV。对于接受高致吐性化疗(顺铂> 70mg /m2或阿霉素-环磷酰胺联合)的患者,给予低剂量奥氮平联合昂丹西琼、地塞米松和阿瑞吡坦的标准组合。CINV采用不良事件通用毒性标准(CTCAE) 5.0版进行评估。结果急性期、延迟期和总期恶心完全缓解率分别为90.90%、60.60%和54.54%。急性期、延迟期和总期呕吐完全缓解率分别为96.96%、69.69%和66.66%。急性期、延迟期和总期2级(或以上)恶心完全缓解率分别为96.96%、93.93%和90.90%。2/33例患者(6.06%)的白天3级嗜睡可归因于奥氮平。接受奥氮平治疗的患者在早期、晚期和总体评估期的恶心和呕吐完全缓解的可能性更大,特别是高分级(G2和G3)。结论:低剂量奥氮平5mg OD联合NK1受体拮抗剂、5- ht3受体拮抗剂和地塞米松预防HEC患者CINV安全有效。关键词:奥氮平,低剂量,CINV, HEC
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