肝癌疼痛患者的姑息放疗与最佳支持治疗(CCTG HE1):一项多中心、开放标签、随机对照的三期研究。

IF 41.6 1区 医学 Q1 ONCOLOGY Lancet Oncology Pub Date : 2024-10-01 Epub Date: 2024-09-05 DOI:10.1016/S1470-2045(24)00438-8
Laura A Dawson, Jolie Ringash, Alysa Fairchild, Paul Stos, Kristopher Dennis, Aamer Mahmud, Teri Lynn Stuckless, Francois Vincent, David Roberge, Matthew Follwell, Raimond K W Wong, Derek J Jonker, Jennifer J Knox, Camilla Zimmermann, Philip Wong, Aisling S Barry, Marc Gaudet, Rebecca K S Wong, Thomas G Purdie, Dongsheng Tu, Christopher J O'Callaghan
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引用次数: 0

摘要

背景:肝癌疼痛的姑息治疗方案可能会受到限制,因为患者最终会对标准治疗产生耐药性。本研究旨在确定放疗是否能改善肝癌引起的疼痛:在加拿大9个癌症中心进行的这项开放标签、随机对照、3期试验(CCTG HE1)中,我们纳入了18岁或18岁以上的肝细胞癌或肝转移患者,这些患者对标准治疗难治,东部合作肿瘤学组(Eastern Cooperative Oncology Group)表现为0-3级,预期寿命超过3个月,过去24小时内最严重的疼痛或不适在简短疼痛量表(BPI)中至少达到4级(满分10分),且在随机分配前7天内疼痛或不适情况稳定。按照中心和癌症类型(肝细胞癌与肝转移瘤)分层后,通过最小化方法将患者随机分配(1:1)至单次肝脏放疗(8 Gy),并在放疗前1-2小时口服8毫克昂丹司琼(或同等药物)和4毫克地塞米松,外加最佳支持治疗(包括非阿片类镇痛药或阿片类镇痛药,或地塞米松,或上述药物的组合),或仅进行最佳支持治疗。主要终点是在随机分配后1个月,患者报告的肝癌疼痛或不适在BPI最严重疼痛强度上至少改善2分。所有接受基线和1个月评估的患者均纳入主要终点分析。对所有随机分配接受治疗的患者进行了安全性评估。该试验已在ClinicalTrials.gov(NCT02511522)上注册,并已完成:2015年7月25日至2022年6月2日期间,66名患者接受了筛查,并随机分配到放疗加最佳支持治疗(33人)或最佳支持治疗(33人)。中位年龄为65岁(IQR为57-72),66名患者中有37名(56%)为男性,29名(44%)为女性,43名(65%)有肝转移,23名(35%)有肝细胞癌(未收集种族和民族数据)。截至数据截止日(2022 年 9 月 8 日),中位随访时间为 3-2 个月(95% CI 3-0-3-4)。放疗加最佳支持治疗组的33人中有24人(73%)完成了基线和1个月评估,仅最佳支持治疗组的33人中有18人(55%)完成了基线和1个月评估。放疗加最佳支持治疗组的24名患者中,有16名(67%)在1个月时BPI最严重疼痛强度改善了至少2分,而最佳支持治疗组的18名患者中,有4名(22%)在1个月时BPI最严重疼痛强度改善了至少2分(P=0-0042)。随机化后1个月内最常见的3-4级不良反应是腹痛(放疗组33例中有3例[9%],最佳支持治疗组33例中有1例[3%])和腹水(2例[6%],1例[3%])。未观察到严重不良事件或与治疗相关的死亡:单剂量放疗加最佳支持治疗与单纯最佳支持治疗相比可改善肝癌患者的疼痛,可被视为一种标准的姑息治疗方法:加拿大癌症协会
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Palliative radiotherapy versus best supportive care in patients with painful hepatic cancer (CCTG HE1): a multicentre, open-label, randomised, controlled, phase 3 study.

Background: Palliative treatment options for painful hepatic cancer can be restricted due to patients eventually becoming refractory to standard treatment. The aim of this study was to determine whether radiotherapy improves hepatic pain from cancer.

Methods: In this open-label, randomised, controlled, phase 3 trial (CCTG HE1) done in nine cancer centres across Canada, we included patients aged 18 years or older with hepatocellular carcinoma or liver metastases, who were refractory to standard treatment, with an Eastern Cooperative Oncology Group performance status of 0-3, with life expectancy of more than 3 months, and pain or discomfort at its worst in the past 24 hours on the Brief Pain Inventory (BPI) of at least 4 out of 10, which was stable for up to 7 days before randomisation. Patients were randomly assigned (1:1), via a minimisation method after stratification by centre and type of cancer (hepatocellular carcinoma vs liver metastases), to single-fraction radiotherapy (8 Gy) to the liver with 8 mg ondansetron (or equivalent) orally and 4 mg dexamethasone orally given 1-2 h before radiotherapy plus best supportive care (including non-opioid or opioid analgesia, or dexamethasone, or a combination of these) or best supportive care alone. The primary endpoint was improvement in patient-reported liver cancer pain or discomfort of at least 2 points on worst pain intensity on the BPI at 1 month after randomisation. All patients with both baseline and 1-month assessments were included in the primary endpoint analysis. Safety was assessed in all patients randomly assigned to treatment. This trial is registered with ClinicalTrials.gov, NCT02511522, and is complete.

Findings: Between July 25, 2015, and June 2, 2022, 66 patients were screened and randomly assigned to radiotherapy plus best supportive care (n=33) or best supportive care (n=33). Median age was 65 years (IQR 57-72), 37 (56%) of 66 patients were male, 29 (44%) were female, 43 (65%) had liver metastases, and 23 (35%) had hepatocellular carcinoma (data on race and ethnicity were not collected). As of data cutoff (Sept 8, 2022), median follow-up was 3·2 months (95% CI 3·0-3·4). 24 (73%) of 33 in the radiotherapy plus best supportive care group and 18 (55%) of 33 in the best supportive care only group completed baseline and 1-month assessments. An improvement in hepatic pain of at least 2 points in worst pain intensity on the BPI at 1 month was seen in 16 (67%) of 24 patients in the radiotherapy plus best supportive care group versus four (22%) of 18 patients in the best supportive care group (p=0·0042). The most common grade 3-4 adverse events within 1 month after randomisation were abdominal pain (three [9%] of 33 in the radiotherapy group vs one [3%] of 33 in best supportive care group) and ascites (two [6%] vs one [3%]). No serious adverse events or treatment-related deaths were observed.

Interpretation: Single-fraction radiotherapy plus best supportive care improved pain compared with best supportive care alone in patients with liver cancer, and could be considered a standard palliative treatment.

Funding: Canadian Cancer Society.

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来源期刊
Lancet Oncology
Lancet Oncology 医学-肿瘤学
CiteScore
62.10
自引率
1.00%
发文量
913
审稿时长
3-8 weeks
期刊介绍: The Lancet Oncology is a trusted international journal that addresses various topics in clinical practice, health policy, and global oncology. It covers a wide range of cancer types, including breast, endocrine system, gastrointestinal, genitourinary, gynaecological, haematological, head and neck, neurooncology, paediatric, thoracic, sarcoma, and skin cancers. Additionally, it includes articles on epidemiology, cancer prevention and control, supportive care, imaging, and health-care systems. The journal has an Impact Factor of 51.1, making it the leading clinical oncology research journal worldwide. It publishes different types of articles, such as Articles, Reviews, Policy Reviews, Personal Views, Clinical Pictures, Comments, Correspondence, News, and Perspectives. The Lancet Oncology also collaborates with societies, governments, NGOs, and academic centers to publish Series and Commissions that aim to drive positive changes in clinical practice and health policy in areas of global oncology that require attention.
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