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首页> 外文期刊>Brachytherapy >Phase I-II trial of perioperative high-dose-rate brachytherapy in oral cavity and oropharyngeal cancer.
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Phase I-II trial of perioperative high-dose-rate brachytherapy in oral cavity and oropharyngeal cancer.

机译：口腔和口咽癌围手术期高剂量近距离放射治疗的I-II期试验。

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BACKGROUND: To determine the feasibility of combined perioperative high-dose-rate brachytherapy (PHDRB) and intermediate-dose external beam radiation therapy (EBRT) as an alternative to full-dose adjuvant EBRT in patients with unirradiated squamous cell cancer (SCC) of the oral cavity and oropharynx. METHODS AND MATERIALS: Forty patients were treated with surgical resection and PHDRB. PHDRB dose was 4Gy b.i.d.x4 (16Gy) for R0 resections and 4Gy b.i.d.x6 (24Gy) for R1 resections, respectively. External beam radiotherapy (45Gy in 25 fractions) was added postoperatively. Patients with Stage III, IVa tumors, and some recurrent cases received concomitant cisplatin-paclitaxel chemotherapy during EBRT. RESULTS: The rate of protocol compliance was 97.5%. Eleven patients (27.5%) developed RTOG Grade 3 or greater toxicity. Four patients (10%) presented complications requiring a major surgical procedure (RTOG 4), and one patient died of bleeding (RTOG 5). Three complications (7.5%) occurred in the perioperative period, and 8 (20.0%) occurred more than 3 months after the completion of the treatment program. Severe complications were more frequent in posteriorly located implants than in anterior implants (p=0.035). After a median follow-up of 50 months for living patients (range, 2.5-86.1+), the 7-year actuarial rates of local and locoregional control were 86% and 82%, respectively; and the 7-year disease-free survival and overall survival rates were 50.4% and 52.3%, respectively. CONCLUSIONS: PHDRB can be integrated into the management of patients with resected cancer of the oral cavity who are candidates to receive postoperative radiation or chemoradiation. The local control and toxicity rates were similar to those expected after standard chemoradiation. PHDRB was associated with high toxicity in posterior locations, and the scheduled PHDRB dose was shifted to the closest lower level.
机译：背景：为了确定围手术期高剂量率近距离放射治疗（PHDRB）和中剂量外束放射治疗（EBRT）替代全剂量辅助EBRT在未照射的鳞状细胞癌（SCC）患者中的可行性口腔和口咽。方法和材料：40例患者接受了手术切除和PHDRB治疗。 R0切除的PHDRB剂量分别为4Gy b.i.d.x4（16Gy）和R1切除的4Gy b.i.d.x6（24Gy）。术后加外照射（45Gy分25步）。患有III期，IVa期肿瘤的患者以及一些复发病例在EBRT期间接受了顺铂-紫杉醇化疗。结果：协议遵守率为97.5％。 11名患者（27.5％）出现RTOG 3级或更高毒性。 4例患者（10％）出现需要大手术的并发症（RTOG 4），1例患者死于出血（RTOG 5）。围手术期发生3例并发症（7.5％），超过3个疗程的3个月（20.0％）发生。后置植入物的严重并发症比前置植入物的更为严重（p = 0.035）。对存活患者进行中位随访50个月（范围为2.5-86.1 +）后，局部和局部控制的7年精算率分别为86％和82％。 7年无病生存率和总生存率分别为50.4％和52.3％。结论：PHDRB可被纳入口腔癌切除患者的管理，这些患者适合接受术后放射或化学放射治疗。局部控制和毒性发生率与标准化学放疗后预期的相似。 PHDRB与在后方的高毒性相关，计划的PHDRB剂量已转移至最接近的较低水平。

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