头颈部癌姑息治疗的短疗程加速放疗（SHARON）I-II期研究
Phase I-II Study of Short-course Accelerated Radiotherapy (SHARON) for Palliation in Head and Neck Cancer.
作者信息
Farina Eleonora, Capuccini Jenny, Macchia Gabriella, Caravatta Luciana, Nguyen Nam P, Cammelli Silvia, Farioli Andrea, Zanirato Rambaldi Giuseppe, Cilla Savino, Wondemagegnhu Tigeneh, Uddin A F M Kamal, Sumon Mostafà Aziz, Genovesi Domenico, Buwenge Milly, Cellini Francesco, Valentini Vincenzo, Deodato Francesco, Morganti Alessio G
机构信息
Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine (DIMES), S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.
Radiotherapy Unit, Department of Oncology, Giovanni Paolo II Foundation, Catholic University of Sacred Heart, Campobasso, Italy
出版信息
Anticancer Res. 2018 Apr;38(4):2409-2414. doi: 10.21873/anticanres.12491.
AIM
To determine the maximum tolerated dose (MTD) of a short-course accelerated radiotherapy and its feasibility for symptomatic palliation of advanced head and neck cancer or head and neck metastases from any primary site.
PATIENTS AND METHODS
A phase I trial in four dose-escalation steps was planned: total dose ranged between 14 and 20 Gy in a total of four fractions administered twice a day. The dose-limiting toxicity (DLT) was determined as grade 3 or more toxicity occurring during treatment. The MTD obtained was used to plan a phase II trial.
RESULTS
A total of 48 patients were treated. In the phase I trial, the 20 Gy dose level was determined to be the MTD. In the phase II trial, the palliative response rate was 82.7%, with a median duration of palliation of 3 months.
CONCLUSION
Short-course accelerated radiotherapy was well tolerated and effective for palliation. These findings may help design future prospective randomized studies.
目的
确定短疗程加速放疗的最大耐受剂量（MTD）及其对晚期头颈癌或来自任何原发部位的头颈部转移瘤进行症状性姑息治疗的可行性。
患者与方法
计划进行一项分四个剂量递增步骤的I期试验：总剂量在14至20 Gy之间，共分四次给予，每天两次。剂量限制毒性（DLT）被确定为治疗期间出现的3级或更高级别的毒性。获得的MTD用于计划II期试验。
结果
共治疗48例患者。在I期试验中，20 Gy剂量水平被确定为MTD。在II期试验中，姑息缓解率为82.7%，中位姑息持续时间为3个月。
结论
短疗程加速放疗耐受性良好且姑息治疗有效。这些发现可能有助于设计未来的前瞻性随机研究。
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