Abstract：
OBJECTIVE: The objective of this study was to compare clinical outcomes of intensity-modulated radiation therapy (IMRT) alone versus IMRT + brachytherapy (BT) in patients with T1-T2N0M0 oropharyngeal squamous cell cancers (OPSCC).
METHODS: 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 50 Gy/25 fractions/5 weeks in phase I followed by randomization (1:1) to further treatment with IMRT (20 Gy/10 fractions/2 weeks) or BT (192Ir high dose rate, 21 Gy/7 fractions/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 posttreatment salivary excretion fraction ratio <45%. Secondary endpoints were local control, disease-free survival, and overall survival.
RESULTS: Between November 2010 and 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 = .008). Physician-rated Radiation Therapy Oncology Group grade ≥2 xerostomia at any time point was observed in 30% of patients (9/30) in the IMRT arm and 6.7% (2/30) in the BT arm (P = .02). At a median follow-up of 42.5 months, the 3-year local control 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 = .24).
CONCLUSIONS: 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.
METHODS: 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 50 Gy/25 fractions/5 weeks in phase I followed by randomization (1:1) to further treatment with IMRT (20 Gy/10 fractions/2 weeks) or BT (192Ir high dose rate, 21 Gy/7 fractions/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 posttreatment salivary excretion fraction ratio <45%. Secondary endpoints were local control, disease-free survival, and overall survival.
RESULTS: Between November 2010 and 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 = .008). Physician-rated Radiation Therapy Oncology Group grade ≥2 xerostomia at any time point was observed in 30% of patients (9/30) in the IMRT arm and 6.7% (2/30) in the BT arm (P = .02). At a median follow-up of 42.5 months, the 3-year local control 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 = .24).
CONCLUSIONS: 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.
摘要：
目的：比较T1-T2N0M0口咽鳞状细胞癌（OPSCC）患者单纯调强放疗（IMRT）与IMRT近距离放疗（BT）的临床疗效。
方法：这项开放标签的随机对照试验在塔塔纪念医院进行，孟买,印度。I期和II期OPSCC患者在I期考虑IMRT，剂量为50Gy/25＃/5周，然后随机分组（1：1）接受IMRT（20Gy/10＃/2周）或BT（192Ir高剂量率-21Gy/7fractions/每天2分）的进一步治疗。该试验的主要终点是使用99mTc唾液闪烁显像评估的6个月时口干症的减少。严重的唾液毒性(口干症)定义为治疗后唾液排泄分数比率<45%。次要终点是局部控制(LC)，无病生存期（DFS）和总生存期（OS）。
结果：在2010年11月至2020年2月之间，90例患者被随机分为单独IMRT（N=46）或IMRT+BT（N=44）。11例患者（8例残留/复发疾病，2失去跟进，IMRT组1例第二原发）和9例患者（8例残留/复发，在主要终点的6个月时，BT组的1次随访失败）无法评估。6个月时,在BT组中，唾液闪烁显像的口干症发生率为14％（5/35：95％CI5％-30％），而在IMRT组中为44％（14/32：95CI26％-62％）（p=0.008）。在任何时间点，IMRT组的30％（9/30）患者和BT组的6.7％（2/30）患者（p=0.02）中观察到医生评定的RTOG等级≥2口干症。中位随访时间为42.5个月，IMRT组的3年LC为56.4%(95%CI-43%-73%),BT组为66.2%(95%CI:53%-82%)(P=0.24)。这强烈支持在合适的情况下将BT添加到IMRT。
方法：这项开放标签的随机对照试验在塔塔纪念医院进行，孟买,印度。I期和II期OPSCC患者在I期考虑IMRT，剂量为50Gy/25＃/5周，然后随机分组（1：1）接受IMRT（20Gy/10＃/2周）或BT（192Ir高剂量率-21Gy/7fractions/每天2分）的进一步治疗。该试验的主要终点是使用99mTc唾液闪烁显像评估的6个月时口干症的减少。严重的唾液毒性(口干症)定义为治疗后唾液排泄分数比率<45%。次要终点是局部控制(LC)，无病生存期（DFS）和总生存期（OS）。
结果：在2010年11月至2020年2月之间，90例患者被随机分为单独IMRT（N=46）或IMRT+BT（N=44）。11例患者（8例残留/复发疾病，2失去跟进，IMRT组1例第二原发）和9例患者（8例残留/复发，在主要终点的6个月时，BT组的1次随访失败）无法评估。6个月时,在BT组中，唾液闪烁显像的口干症发生率为14％（5/35：95％CI5％-30％），而在IMRT组中为44％（14/32：95CI26％-62％）（p=0.008）。在任何时间点，IMRT组的30％（9/30）患者和BT组的6.7％（2/30）患者（p=0.02）中观察到医生评定的RTOG等级≥2口干症。中位随访时间为42.5个月，IMRT组的3年LC为56.4%(95%CI-43%-73%),BT组为66.2%(95%CI:53%-82%)(P=0.24)。这强烈支持在合适的情况下将BT添加到IMRT。
