同期顺铂联合低分割放疗治疗局部晚期头颈部鳞状细胞癌的可行性。
Feasibility of concomitant cisplatin with hypofractionated radiotherapy for locally advanced head and neck squamous cell carcinoma.
机构信息
Department of Radiation Oncology, Barretos Cancer Hospital, Rua Antenor Duarte Villela, 1331, Barretos, SP, 14.784-400, Brazil.
Department of Medical Oncology, Barretos Cancer Hospital, Rua Antenor Duarte Villela, 1331, Barretos, SP, 14.784-400, Brazil.
出版信息
BMC Cancer. 2018 Oct 23;18(1):1026. doi: 10.1186/s12885-018-4893-5.
BACKGROUND
The evolution of radiotherapy over recent decades has reintroduced the hypofractionation for many tumor sites with similar outcomes to those of conventional fractionated radiotherapy. The use of hypofractionation in locally advanced head and neck cancer (LAHNC) has been already used, however, its use has been restricted to only a few countries. The aim of this trial was to evaluate the safety and feasibility of moderate hypofractionated radiotherapy (HYP-RT) with concomitant cisplatin (CDDP).
METHODS
This single-arm trial was designed to evaluate the safety and feasibility of HYP-RT with concomitant CDDP in LAHNC. Stage III and IV patients withnonmetastatic disease were enrolled. Patients were submitted to intensity modulatedradiation therapy, which comprised 55 Gy/20 fractions to the gross tumor and44-48 Gy/20 fractions to the areas of subclinical disease. Concomitant CDDPconsisted of 4 weekly cycles of 35 mg/m2. The primary endpoints were the treatment completion rate and acute toxicity.
RESULTS
Twenty patients were enrolled from January 2015 to September 2016, and 12 (60%) were classified as unresectable. All patients completed the total dose of radiotherapy, and 19 patients (95%) received at least 3 of 4 cycles of chemotherapy. The median overall treatment time was 29 days (27-34). Grade 4 toxicity was reported twice (1 fatigue and 1 lymphopenia). The rates of grade 3 dermatitis and mucositis were 30% and 40%, respectively, with spontaneous resolution. Nasogastric tubes were offered to 15 patients (75%) during treatment; 4 patients (20%) needed feeding tubes after 2 months, and only 1 patient needed a feeding tube after 12 months.
CONCLUSION
HYP-RT with concomitant CDDP was considered feasible for LAHNC, and the rate of acute toxicity was comparable to that of standard concomitant chemoradiation. A feeding tube was necessary for most patients during treatment. Further investigation of this strategy is warranted.
TRIAL REGISTRATION
ClinicalTrials, NCT03194061 . Registered 21 Jun 2017 - Retrospectively registered.
背景
近几十年来，放射治疗的发展已经为许多肿瘤部位重新引入了低分割放疗，其治疗效果与常规分割放疗相似。局部晚期头颈部癌（LAHNC）已经开始使用低分割放疗，但仅在少数国家使用。本试验旨在评估中分割放疗（HYP-RT）联合顺铂（CDDP）治疗 LAHNC 的安全性和可行性。
方法
本单臂试验旨在评估 LAHNC 中 HYP-RT 联合 CDDP 的安全性和可行性。招募非转移性疾病的 III 期和 IV 期患者。患者接受调强放疗，总肿瘤剂量为 55Gy/20 次，亚临床疾病区域为 44-48Gy/20 次。同期 CDDP 包括 4 个每周周期的 35mg/m2。主要终点是治疗完成率和急性毒性。
结果
2015 年 1 月至 2016 年 9 月期间共招募 20 例患者，其中 12 例（60%）为不可切除。所有患者均完成了全剂量放疗，19 例（95%）患者至少接受了 4 个周期化疗中的 3 个周期。中位总治疗时间为 29 天（27-34 天）。报告了 2 例（1 例乏力，1 例淋巴细胞减少）四级毒性。分别有 30%和 40%的患者出现 3 级皮肤炎和黏膜炎，均自行缓解。治疗期间为 15 例（75%）患者提供了鼻胃管；4 例（20%）患者在 2 个月后需要喂食管，只有 1 例患者在 12 个月后需要喂食管。
结论
HYP-RT 联合 CDDP 治疗 LAHNC 是可行的，急性毒性发生率与标准同期放化疗相当。大多数患者在治疗期间需要喂食管。需要进一步研究这种策略。
试验注册
ClinicalTrials，NCT03194061。注册于 2017 年 6 月 21 日-回顾性注册。
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