Efficacy and safety of granulocyte macrophage-colony stimulating factor (GM-CSF) on the frequency and severity of radiation mucositis in patients with head and neck carcinoma
Efficacy and safety of granulocyte macrophage-colony stimulating factor (GM-CSF) on the frequency and severity of radiation mucositis in patients with head and neck carcinoma
复制标题
DOI：
10.1016/s0360-3016(97)00105-3
复制
发表时间：
1997-03-15
影响因子：
7
通讯作者：
Shenoy, AM
中科院分区：
文献类型：
--
作者：
Kannan, V;Bapsy, PP;Shenoy, AM
目的：基于粘膜保护的临床证据，GM-CSF细胞毒化疗期间，进行了一项试点研究，以确定接受GM-CSF的患者，而接受确定性的常规分割放疗在头颈部cancer.Methods和材料的安全性和粘膜反应：患者被认为是合格的，如果颊粘膜和口咽部被列入在teleradiation领域。10名患有头颈部鳞状细胞癌的成年患者（颊粘膜-8和舌后1/3-2）进入试验。放射治疗采用远钴机，常规2戈伊，5次/周。辐射入口由两个平行相对的横向场组成。在20戈伊后，以1 μ g/kg体重的剂量每天皮下给予GM-CSF，直至放射治疗完成。每天对患者的粘膜反应、疼痛和功能损伤进行评估。结果：中位辐射剂量为66戈伊。8例患者接受了大于或等于60戈伊的治疗。对GM-CSF的耐受性良好。所有10例患者均完成了计划的GM-CSF每日剂量，未中断。4例患者的粘液毒性为I级，直至完成放疗（剂量范围50-66戈伊）。6例患者在放疗期间发生II级反应，最大尺寸为1.0-1.5 cm的糜烂性粘膜病变。无患者发生III级粘膜炎。GM-CSF治疗期间最大粘膜疼痛为I级。在两名患者开始GM-CSF后，疼痛强度降低。轻度至中度功能障碍。所有患者在治疗期间均能够保持足够的口服摄入。结论：GM-CSF联合常规分割放疗是可行的，无明显毒副作用。放疗的急性副作用，即粘膜炎，疼痛和功能障碍是零至最小。结果提示GM-CSF在放射治疗期间具有粘膜保护作用，值得在随机双盲试验中进一步研究。(C)1997年爱思唯尔科学公司
Purpose: Based on the clinical evidence of mucosal protection by GM-CSF during cytotoxic chemotherapy, a pilot study was undertaken to determine the safety and mucosal reaction of patients receiving GM-CSF while undergoing definitive conventional fractionated radiotherapy in head and neck carcinoma.Methods and Materials: Patients were considered eligible if buccal mucosa and oropharynx were included in the teleradiation field. Ten adult patients with squamous cell carcinoma of head and neck (buccal mucosa-8 and posterior 1/3 tongue-2) were entered into the trial. Radiation therapy was delivered with telecobalt machine at conventional 2 Gy fraction and 5 fractions/week. The radiation portals consisted of two parallel opposing lateral fields. GM-CSF was given subcutaneously at a dose of 1 mu g/kg body weight, daily, after 20 Gy until the completion of radiation therapy. Patients were evaluated daily for mucosal reaction, pain, and functional impairment.Results: The median radiation dose was 66 Gy. Eight patients received greater than or equal to 60 Gy. The tolerance to GM-CSF was good. All 10 patients completed the planned daily dose of GM-CSF without interruption. Mucosal toxicity was Grade I in four patients till the completion of radiotherapy (dose range 50-66 Gy). Six patients developed Grade II reaction, fibrinous mucosal lesions of maximum size 1.0-1.5 cm, during radiotherapy. None developed Grade III mucositis. The maximum mucosal pain was Grade I during GM-CSF therapy. In two patients after starting GM-CSF the pain reduced in intensity. Functional impairment was mild to moderate. All patients were able to maintain adequate oral intake during the treatment period. Total regression of mucosal reaction occured within 8 days following completion of radiotherapy.Conclusions: GM-CSF administration concurrently with conventional fractionated radiotherapy was feasible without significant toxicity. The acute side effects of radiotherapy namely mucositis, pain, and functional impairment were nil to minimal. The results are suggestive of mucosal protection by GM-CSF during radiotherapy and warrants further study in randomized double blind trial. (C) 1997 Elsevier Science Inc.