奥氮平治疗局部晚期或转移性胃癌、肝胆胰和肺癌患者化疗相关厌食的随机双盲安慰剂对照研究。

Randomized Double-Blind Placebo-Controlled Study of Olanzapine for Chemotherapy-Related Anorexia in Patients With Locally Advanced or Metastatic Gastric, Hepatopancreaticobiliary, and Lung Cancer.

机构信息

Department of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.

Department of Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.

出版信息

J Clin Oncol. 2023 May 10;41(14):2617-2627. doi: 10.1200/JCO.22.01997. Epub 2023 Mar 28.

DOI:10.1200/JCO.22.01997

PMID:36977285

Abstract

PURPOSE

Anorexia occurs in 30%-80% of patients with advanced malignancies, which may be worsened with chemotherapy. This trial assessed the efficacy of olanzapine in stimulating appetite and improving weight gain in patients receiving chemotherapy.

METHODS

Adults (≥18 years) with untreated, locally advanced, or metastatic gastric, hepatopancreaticobiliary (HPB), and lung cancers were randomly assigned (double-blind) to receive olanzapine (2.5 mg once a day for 12 weeks) or placebo along with chemotherapy. Both groups received standard nutritional assessment and dietary advice. The primary outcomes were the proportion of patients with weight gain > 5% and the improvement in appetite (assessed by the visual analog scale [VAS] and the Functional Assessment of Chronic Illness Therapy system of Quality-of-Life questionnaires Anorexia Cachexia subscale [FAACT ACS]). Secondary end points were change in nutritional status, quality of life (QOL), and chemotherapy toxicity.

RESULTS

We enrolled 124 patients (olanzapine, 63 and placebo, 61) with a median age of 55 years (18-78 years), of whom 112 (olanzapine, 58 and placebo, 54) were analyzable. The majority (n = 99, 80%) had metastatic cancer (gastric [n = 68, 55%] > lung [n = 43, 35%] > HPB [n = 13, 10%]). The olanzapine arm had a greater proportion of patients with a weight gain of > 5% (35 of 58 [60%] 5 of 54 [9%], < .001) and improvement in appetite by VAS (25 of 58 [43%] 7 of 54 [13%], < .001) and by FAACT ACS (scores ≥37:13 of 58 [22%] 2 of 54 [4%], = .004). Patients on olanzapine had better QOL, nutritional status, and lesser chemotoxicity. Side effects attributable to olanzapine were minimal.

CONCLUSION

Low-dose, daily olanzapine is a simple, inexpensive, well-tolerated intervention that significantly improves appetite and weight gain in newly diagnosed patients on chemotherapy.

摘要

目的

厌食症发生于 30%-80%的晚期恶性肿瘤患者中，化疗可能会使其加重。本试验评估了奥氮平对接受化疗的患者刺激食欲和增加体重的疗效。

方法

未经治疗的局部晚期或转移性胃、肝胰胆（HPB）和肺癌的成年患者（≥18 岁）被随机（双盲）分配接受奥氮平（每天 2.5mg，持续 12 周）或安慰剂加化疗。两组均接受标准营养评估和饮食建议。主要结局是体重增加≥5%的患者比例和食欲改善（通过视觉模拟量表[VAS]和慢性疾病治疗的功能评估系统生活质量问卷的厌食-恶病质亚量表[FAACT ACS]评估）。次要终点是营养状况、生活质量（QOL）和化疗毒性的变化。

结果

我们纳入了 124 名患者（奥氮平 63 例，安慰剂 61 例），中位年龄为 55 岁（18-78 岁），其中 112 名（奥氮平 58 例，安慰剂 54 例）可进行分析。大多数患者（n=99，80%）患有转移性癌症（胃癌[n=68，55%]＞肺癌[n=43，35%]＞HPB[n=13，10%]）。奥氮平组体重增加≥5%的患者比例更大（58 例中有 35 例[60%]，54 例中有 5 例[9%]，<.001），VAS 食欲改善的患者比例也更高（58 例中有 25 例[43%]，54 例中有 7 例[13%]，<.001）和 FAACT ACS 评分≥37 的患者比例（58 例中有 13 例[22%]，54 例中有 2 例[4%]，=.004）。接受奥氮平治疗的患者 QOL、营养状况更好，化疗毒性更小。奥氮平相关的副作用很少。