Three vs 6 Cycles of Chemotherapy for High-Risk Retinoblastoma

医学 卡铂 剜除术 外科 视网膜母细胞瘤 依托泊苷 长春新碱 化疗 化疗方案 养生 临床终点 随机对照试验 内科学 顺铂 环磷酰胺 基因 生物化学 化学
作者
Huijing Ye,Kang Xue,Ping Zhang,Rongxin Chen,Xiaowen Zhai,Li Ling,Wei Ma,Lijuan Tang,Hongsheng Wang,Yuxiang Mao,Siming Ai,Yingwen Bi,Qing Liu,Yusha Zou,Qian Jiang,Huasheng Yang
出处
期刊:JAMA [American Medical Association]
标识
DOI:10.1001/jama.2024.19981
摘要

Importance Adjuvant therapy is an important and effective treatment for retinoblastoma. However, there is a lack of head-to-head clinical trials comparing 3 vs 6 cycles of CEV chemotherapy (carboplatin, etoposide, and vincristine) for enucleated unilateral retinoblastoma with high-risk pathological features. Objective To assess whether 3 cycles of CEV chemotherapy is noninferior to 6 cycles for enucleated unilateral retinoblastoma with high-risk pathological features. Design, Setting, and Participants This double-center, randomized, open-label, noninferiority trial was conducted at 2 premier eye centers in China and included 187 patients who had undergone enucleation for unilateral retinoblastoma with high-risk pathological features (massive choroidal infiltration, retrolaminar optic nerve invasion, or scleral infiltration) between August 2013 and March 2024. The final date of follow-up was March 21, 2024. Interventions Patients were randomly assigned to receive either 3 (n = 94) or 6 (n = 93) cycles of CEV chemotherapy regimen after enucleation. Main Outcomes and Measures The primary end point was disease-free survival, with a noninferiority margin of 12%. Secondary end points encompassed overall survival, safety, economic burden, and the quality of life of children. Results All 187 patients (median [IQR] age, 25.0 [20.0-37.0] months; 83 [44.4%] female) completed the trial. Median (IQR) follow-up was 79.0 (65.5-102.5) months. Five-year disease-free survival was 90.4% for the 3-cycle group vs 89.2% for the 6-cycle group (difference, 1.2% [95% CI, −7.5% to 9.8%]), which met the noninferiority criterion ( P = .003 for noninferiority). The 6-cycle group experienced a higher frequency of adverse events, greater reduction in quality of life scores, and increased costs compared with the 3-cycle group. Conclusions and Relevance Among patients with unilateral pathologic high-risk retinoblastoma, 3 cycles of CEV chemotherapy resulted in 5-year disease-free survival that was noninferior to 6 cycles of CEV chemotherapy. Trial Registration ClinicalTrials.gov Identifier: NCT01906814
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
大幅提高文件上传限制,最高150M (2024-4-1)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
刚刚
刚刚
krkr完成签到,获得积分10
刚刚
Iris完成签到 ,获得积分10
1秒前
1秒前
2秒前
陈如完成签到,获得积分10
2秒前
英姑应助krkr采纳,获得10
3秒前
无花果应助krkr采纳,获得10
3秒前
巴达天使完成签到,获得积分10
3秒前
DaYongDan完成签到 ,获得积分10
4秒前
Frieren完成签到 ,获得积分10
4秒前
5秒前
科研狗发布了新的文献求助10
5秒前
7秒前
达da完成签到,获得积分10
7秒前
clearwind完成签到,获得积分10
7秒前
7秒前
一叶知秋完成签到,获得积分10
7秒前
Christina完成签到,获得积分10
7秒前
123发布了新的文献求助10
7秒前
梦~发布了新的文献求助10
8秒前
8秒前
书生也要读书完成签到,获得积分10
8秒前
赖向珊发布了新的文献求助10
9秒前
jam完成签到,获得积分10
10秒前
12秒前
酷酷行天完成签到,获得积分20
12秒前
昵称有敏感词完成签到,获得积分10
13秒前
甜甜妙梦发布了新的文献求助10
13秒前
哈哈哈发布了新的文献求助10
14秒前
eee丶peng完成签到,获得积分20
15秒前
LF发布了新的文献求助10
15秒前
张豪杰完成签到 ,获得积分10
15秒前
jam发布了新的文献求助10
15秒前
15秒前
CipherSage应助whl采纳,获得10
15秒前
wu完成签到 ,获得积分10
16秒前
shaguodoufutang关注了科研通微信公众号
17秒前
情怀应助高lucky采纳,获得10
17秒前
高分求助中
Sustainability in Tides Chemistry 1500
TM 5-855-1(Fundamentals of protective design for conventional weapons) 1000
Threaded Harmony: A Sustainable Approach to Fashion 799
Livre et militantisme : La Cité éditeur 1958-1967 500
Retention of title in secured transactions law from a creditor's perspective: A comparative analysis of selected (non-)functional approaches 500
"Sixth plenary session of the Eighth Central Committee of the Communist Party of China" 400
Introduction to Modern Controls, with illustrations in MATLAB and Python 310
热门求助领域 (近24小时)
化学 医学 生物 材料科学 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 基因 遗传学 催化作用 物理化学 免疫学 量子力学 细胞生物学
热门帖子
关注 科研通微信公众号,转发送积分 3056892
求助须知:如何正确求助?哪些是违规求助? 2713451
关于积分的说明 7435856
捐赠科研通 2358580
什么是DOI,文献DOI怎么找? 1249424
科研通“疑难数据库(出版商)”最低求助积分说明 607055
版权声明 596283