Division of Medical Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou; College of Medicine, Chang Gung University, No. 5, Fushin St., Gueishan District, Taoyuan, 333, Taiwan, ROC.
Department of Radiation Oncology, Chang Gung Memorial Hospital at Linkou and Chang Gung University, Taoyuan, Taiwan, ROC.
J Cancer Res Clin Oncol. 2020 Jan;146(1):33-41. doi: 10.1007/s00432-019-03033-8. Epub 2019 Nov 14.
Concurrent chemoradiotherapy (CCRT) is one of the standard treatments for patients with advanced head and neck squamous cell carcinoma (HNSCC). However, CCRT may lead to decreased quality of life (QoL) and treatment compliance. This study aimed to determine the effects of PG2 (Astragalus polysaccharides) injection on CCRT-associated adverse events (AEs) and patients' compliance with the CCRT course.
In this phase II double-blind randomized placebo-controlled trial, PG2 injection (sterile powder form) or placebo was administrated three times per week in parallel with CCRT to patients with HNSCC. The chemotherapy regimen included 50 mg/m cisplatin every 2 weeks with daily tegafur-uracil (300 mg/m) and leucovorin (60 mg/day).
The study was terminated prematurely due to the successful launch of a newly formulated PG2 injection (lyophilized form). A total of 17 patients were enrolled. The baseline demographics and therapeutic compliance were comparable between the CCRT/PG2 and CCRT/placebo groups. During CCRT, severe treatment-associated AEs were less frequent in the CCRT/PG2 group than in the CCRT/placebo group. Furthermore, less QoL fluctuations from the baseline during CCRT were noted in the CCRT/PG2 group than in the CCRT/placebo group, with a significant difference in the pain, appetite loss, and social eating behavior. The tumor response, disease-specific survival and overall survival did not differ between the two groups.
This preliminary study demonstrated PG2 injection exhibited an excellent safety profile, and has potential in ameliorating the deterioration in QoL and the AEs associated with active anticancer treatment among patients with advanced pharyngeal or laryngeal HNSCC under CCRT. Further research in patients with other cancer types or treatment modalities may widen PG2's application in clinical settings.
同期放化疗（CCRT）是治疗晚期头颈部鳞状细胞癌（HNSCC）患者的标准治疗方法之一。然而，CCRT 可能会导致生活质量（QoL）下降和治疗依从性降低。本研究旨在确定 PG2（黄芪多糖）注射液对 CCRT 相关不良事件（AEs）和患者对 CCRT 疗程依从性的影响。
在这项 II 期双盲随机安慰剂对照试验中，PG2 注射液（无菌粉末形式）或安慰剂与 HNSCC 患者的 CCRT 同时每周给药三次。化疗方案包括每 2 周给予 50mg/m2 顺铂，每日给予替加氟-尿嘧啶（300mg/m2）和亚叶酸（60mg/天）。
由于新配方 PG2 注射液（冻干形式）的成功推出，该研究提前终止。共纳入 17 例患者。CCRT/PG2 和 CCRT/安慰剂组的基线人口统计学和治疗依从性相似。在 CCRT 期间，CCRT/PG2 组严重治疗相关 AEs 的发生率低于 CCRT/安慰剂组。此外，CCRT/PG2 组在 CCRT 期间从基线的 QoL 波动较小，疼痛、食欲减退和社会进食行为方面有显著差异。两组肿瘤反应、疾病特异性生存率和总生存率无差异。
这项初步研究表明，PG2 注射液具有良好的安全性，在改善晚期咽或喉 HNSCC 患者 CCRT 下的生活质量恶化和与积极抗癌治疗相关的不良事件方面具有潜力。在其他癌症类型或治疗方式的患者中进行进一步研究可能会扩大 PG2 在临床环境中的应用。
