为了比较仅采用强度调控放射治疗（IMRT）和采用IMRT+近距离放射治疗（BT）对T1-T2N0M0咽峡部鳞状细胞癌（OPSCC）患者的临床结果。该开放标签的随机对照试验在印度孟买的Tata Memorial医院进行。对于I期和II期OPSCC患者，将首先进行IMRT治疗，剂量为50Gy/25#/5周，在第I期后随机分组（1:1）进一步接受IMRT（20Gy/10#/2周）或BT（192Ir高剂量率 - 21Gy/7次/每天2次）。试验的主要终点是使用99mTc唾液腺显像评估6个月内的口干症减轻情况。严重的唾液腺毒性（口干症）定义为治疗后唾液排泄分数比率<45%。次要终点包括局部控制（LC）、无病生存（DFS）和总生存（OS）。从2010年11月到2020年2月，共有90名患者随机分配到IMRT组（N=46）或IMRT+BT组（N=44）。IMRT组有11名患者（8例残留/复发疾病，2例失访，1例出现第二原发病）和BT组有9名患者（8例残留/复发，1例失访）在6个月时无法评估主要终点。在6个月时，通过唾液腺显像检测，BT组的口干症发生率为14%（5/35：95% CI 5%-30%），而IMRT组为44%（14/32：95%CI 26%-62%）（p=0.008）。医生评定的RTOG 2级或更高级别口干症在任何时间点上的发生率为IMRT组30%（9/30）和BT组6.7%（2/30）（p=0.02）。在中位随访42.5个月时，IMRT组的3年LC为56.4%（95% CI-43%-73%），而BT组为66.2%（95% CI: 53%-82%）（P=0.24）。结论：对于T1-T2N0M0 OPSCC患者，将BT与IMRT联合应用可以显著减轻口干症。这强烈支持在适当的病例中添加BT与IMRT联合治疗。版权所有 © 2023 Elsevier Inc.。保留所有权利。

To compare clinical outcomes of intensity modulated radiation therapy (IMRT) alone vs IMRT+ brachytherapy (BT) in patients with T1-T2N0M0 oropharyngeal squamous cell cancers (OPSCC).This open-label randomized controlled trial was conducted at Tata Memorial Hospital, Mumbai, India. Patients with stage I and II OPSCC were considered for IMRT to a dose of 50Gy/25#/5 weeks in phase I followed by randomization (1:1) to further treatment with IMRT (20Gy/10#/2 weeks) or BT (192Ir high dose rate - 21Gy/7fractions/2 fractions per day). The primary endpoint of the trial was the reduction in xerostomia at 6 months evaluated using 99mTc salivary scintigraphy. Severe salivary toxicity (xerostomia) was defined as post-treatment salivary excretion fraction ratio <45%. Secondary endpoints were local control (LC), disease free survival (DFS) and overall survival (OS).Between November 2010 to February 2020, 90 patients were randomized to IMRT(N=46) alone or IMRT+BT(N=44). Eleven patients (8 residual/recurrent disease, 2 lost to follow up, 1 second primary) in the IMRT arm and 9 patients (8 residual/recurrence, 1 lost to follow up) in the BT arm were not evaluable at 6 months for the primary endpoint. At 6 months, xerostomia rates using salivary scintigraphy were 14% (5/35: 95% CI 5%-30%) in the BT arm while it was seen in 44% (14/32: 95%CI 26%-62%) in the IMRT arm (p=0.008). Physician rated RTOG grade ≥2 xerostomia at any time point was observed in 30% (9/30) patients in the IMRT arm and 6.7% (2/30) in the BT arm (p=0.02). At a median follow-up of 42.5 months, the 3-year LC in the IMRT arm was 56.4% (95% CI-43%-73%) while it was 66.2% (95% CI: 53%-82%) in the BT arm (P=0.24) CONCLUSION: The addition of BT to IMRT for T1-T2N0M0 OPSCC results in a significant reduction in xerostomia. This strongly supports the addition of BT to IMRT in suitable cases.Copyright © 2023 Elsevier Inc. All rights reserved.