Premier Inc., 2320 Cascade Pointe Blvd., Charlotte, NC, USA.
J Med Econ. 2011;14(3):341-9. doi: 10.3111/13696998.2011.582908. Epub 2011 May 4.
This study evaluated the rate of uncontrolled chemotherapy-induced nausea and vomiting (CINV) after initiating antiemetic prophylaxis with palonosetron versus other 5-HT₃ receptor antagonists (RAs) in patients diagnosed with hematologic malignancies (lymphoma and leukemia) and receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) in a hospital outpatient setting.
Patients aged ≥ 18 years and diagnosed with hematologic malignancies initiating HEC or MEC and antiemetic prophylaxis with palonosetron (Group 1) and other 5-HT₃ RAs (Group 2) for the first time in a hospital outpatient setting between 4/1/2007 and 3/31/2009 were identified from the Premier Perspective Database. Within each cycle, CINV events were identified (in the hospital outpatient, inpatient, and emergency room settings) through ICD-9 codes for nausea, vomiting, and/or volume depletion (from each CT administration day 1 until the end of the CT cycle), or use of rescue medications (day 2 until the end of the CT cycle). Negative binomial distribution generalized linear multivariate regression model estimating the CINV event rate on CT, specific CT cycles, and cancer diagnosis (leukemia/lymphoma)-matched groups in the follow-up period (first of 8 cycles or 6 months) was developed.
Of 971 identified patients, 211 initiated palonosetron (Group 1). Group 1 patients comprised of more females [50.2 vs. 41.4%; p = 0.0226], Whites [74.4 vs. 70.4%, and Hispanics [7.6 vs. 6.3%; all races p = 0.0105], received more HEC treatments [89.6 vs. 84.2%; all CT types p = 0.0129], and had more lymphoma diagnosed patients [89.6 vs. 76.3%; all cancer types p = 0.0033] at baseline. After controlling for differences in several demographic and clinical variables, the regression model predicted a 20.4% decrease in CINV event rate per CT cycle for Group 1 versus Group 2 patients. Study limitations include potential lack of generalizability, absence of data on certain confounders including alcohol consumption and prior history of motion sickness, potential underestimation of incidence of uncontrolled CINV, and inability to draw conclusions pertaining to cause and effect relationship.
In this retrospective hospital study, patients with hematologic malignancies treated with HEC or MEC and initiated on antiemetic prophylaxis with palonosetron in the hospital outpatient setting were more likely to experience significantly lower CINV event rates (in the hospital outpatient, inpatient, and emergency room settings) versus patients initiated on other 5-HT₃ RAs.
本研究评估了在医院门诊环境中，接受高致吐性化疗（HEC）或中度致吐性化疗（MEC）治疗的血液恶性肿瘤（淋巴瘤和白血病）患者，在开始接受帕洛诺司琼与其他 5-HT₃ 受体拮抗剂（RAs）预防止吐治疗后，无控制的化疗引起的恶心和呕吐（CINV）的发生率，与其他 5-HT₃ RAs 相比。
从 Premier 透视数据库中确定了 2007 年 4 月 1 日至 2009 年 3 月 31 日期间首次在医院门诊环境中接受 HEC 或 MEC 治疗且首次接受帕洛诺司琼（第 1 组）和其他 5-HT₃ RAs（第 2 组）预防止吐治疗的年龄≥18 岁且诊断为血液恶性肿瘤的患者。在每个周期内，通过 ICD-9 代码识别 CINV 事件（在医院门诊、住院和急诊室环境中），用于恶心、呕吐和/或容量不足（从每个 CT 给药日 1 到 CT 周期结束），或使用救援药物（第 2 天到 CT 周期结束）。在随访期间（第 1 个 8 个周期或 6 个月），开发了一种负二项式分布广义线性多元回归模型，以估计 CT 上、特定 CT 周期和癌症诊断（白血病/淋巴瘤）匹配组的 CINV 事件发生率。
在 971 名患者中，有 211 名患者接受了帕洛诺司琼（第 1 组）治疗。第 1 组患者中，女性患者更多[50.2% vs. 41.4%；p=0.0226]，白人患者更多[74.4% vs. 70.4%，和西班牙裔患者更多[7.6% vs. 6.3%；所有种族 p=0.0105]，接受的 HEC 治疗更多[89.6% vs. 84.2%；所有 CT 类型 p=0.0129]，诊断为淋巴瘤的患者更多[89.6% vs. 76.3%；所有癌症类型 p=0.0033]。在控制了几个人口统计学和临床变量的差异后，回归模型预测第 1 组与第 2 组患者的 CINV 事件率每 CT 周期降低 20.4%。研究局限性包括潜在的普遍性不足、缺乏某些混杂因素（包括饮酒和晕动病史）的数据、无法控制的 CINV 发生率的潜在低估以及无法得出关于因果关系的结论。
在这项回顾性医院研究中，在医院门诊环境中接受 HEC 或 MEC 治疗且接受帕洛诺司琼预防止吐治疗的血液恶性肿瘤患者，与接受其他 5-HT₃ RAs 治疗的患者相比，更有可能显著降低 CINV 事件发生率（在医院门诊、住院和急诊室环境中）。
