研究动态
Articles below are published ahead of final publication in an issue. Please cite articles in the following format: authors, (year), title, journal, DOI.

NRG Oncology RTOG 0022 最终报告:一项三维适形放疗和强度调控放疗的一/二期研究。

Final Report of NRG Oncology RTOG 0022: A Phase I/II Study of Conformal and Intensity.

发表日期:2023 Mar 14
作者: Adam S Garden, Jonathan Harris, Avraham Eisbruch, K S Clifford Chao, William H Morrison, Paul M Harari, Todd Allen Swanson, Christopher U Jones, Sue S Yom, Sharon A Spencer, Rufus Scrimger, George Shenouda, Monica Shukla, Harold Y Lau, Michelle Mierzwa, Pedro Torres-Saavedra, Quynh Thu Le
来源: Int J Radiat Oncol

摘要:

XXXX XXXX XXXX XXXX(XXXX)是第一项评估IMRT用于头颈部肿瘤多机构可行性的临床试验。二年局部区域失败和急性口干症状减轻是主要终点,此前已有报道。此报告提供了经过长期随访的次要终点。符合资格的患者为T1-2、N0-1咽喉癌患者。次要终点包括疾病控制和总生存率。局部区域失败率由累计发生率法估计,疾病无瘤生存率和总生存率由Kaplan-Meier法估计。晚期毒性经XXXX/EORTC标准分级,并用描述性统计报告。分析了69名受试者中的67名。其中50名患者(75%)为T2病情,38名(57%)为淋巴结阴性(N0)。中位随访时间为11.9年。估计的10年局部区域失败率、无病生存率和总生存率分别为15%(95%CI为8-25)、50%(95%CI为38-62)和67%(95%CI为55-78)。最高的晚期毒性报告为:5级:0%,4级:9%,3级:13%和2级:63%。3-4级晚期毒性涉及黏膜(7%)、骨头(4%)、食管(4%)、唾液腺(4%)、疼痛(3%)、体重减轻(1%)和出血(1%)。2-3级唾液腺毒性报告比例为70%,但随着时间而改善。41名(74.5%)和17名(42.5%)存活患者在 5年和10年以上进行了毒性评估。基于早期开展的头颈部IMRT治疗的前瞻性数据集,此XXXX/XXXX XXXX的报告提供了早期技术的基准长期结果。在10年内,三分之二的患者仍然健在,且晚期3-4级毒性水平可接受。 版权所有©2023。Elsevier Inc. 发布。
XXXX XXXX XXXX XXXX (XXXX) XXXX was the first clinical trial evaluating multi-institution feasibility of IMRT for head and neck cancer. The primary endpoints of 2-year local-regional failure and reduction in acute xerostomia were reported previously. This report provides secondary endpoints with long-term follow-up.Eligibility included patients diagnosed with T1-2, N0-1 oropharyngeal cancer. Secondary endpoints included disease control and overall survival. Local-regional failure rates were estimated by the cumulative incidence method, and disease-free and overall survival rates were estimated by the Kaplan-Meier method. Late toxicities were graded by XXXX/EORTC criteria and are reported with descriptive statistics.Sixty-seven of 69 enrolled patients were analyzed. Fifty patients (75%) had T2 disease and 38 (57%) were node negative (N0). Median follow-up was 11.9 years. Estimated 10-year local-regional failure, disease-free survival and overall survival rates were 15% (95%CI 8-25), 50% (95%CI 38-62) and 67% (95%CI 55-78), respectively. Highest reported late toxicities were: grade 5: 0%, grade 4: 9%, grade 3: 13%, and grade 2: 63%. Grade 3-4 late toxicities involved mucous membranes (7%), bone (4%), esophagus (4%), salivary gland (4%), pain (3%), weight loss (1%), and hemorrhage (1%). Grade 2-3 salivary gland toxicity was reported in 70% but improved over time. Forty-one (74.5%) and 17 (42.5%) of surviving patients had a toxicity assessment at > 5 years and >10 years, respectively.This report of XXXX/XXXX XXXX, based on an early, prospectively collected dataset of head and neck IMRT treatments, provides benchmark long-term outcomes of this early version of the technology. At 10 years, 2/3 of patients were alive, with an acceptable level of grade 3-4 late toxicities.Copyright © 2023. Published by Elsevier Inc.