Li Rongrong, Dou Shengjin, Ruan Min, Zhang Chenping, Zhu Guopei
Department of Oral and Maxillofacial-Head Neck Oncology, Ninth People's Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, P.R. China.
Medicine (Baltimore). 2018 Apr;97(17):e0564. doi: 10.1097/MD.0000000000010564.
This prospective study was conducted to evaluate the feasibility and safety of customized chemotherapy regimens based on the gene characteristics of salivary gland tumors.
Patients were enrolled with histologically confirmed intermediate or high grade, stage T3-4, N1-3 disease, and T1-2, N0 patients with a close (≤1 mm) or microscopically positive surgical margin were also enrolled in the study. All patients received radical surgery and postoperative concurrent chemoradiotherapy. To evaluate the responsiveness of therapies, the chemotherapy regimen was based on gene targets, β-tubulin III, ABCB1, STMN1, and CYP1B1 (for docetaxel) and TYMS (for pemetrexed). The primary endpoints were treatment compliance and acute toxicities.
A total of 20 patients were enrolled between September 2013 and January 2016. The median age was 46 years (range: 23-70 years). Genetic testing showed that 8 patients may have been sensitive to docetaxel, 5 patients may have been sensitive to pemetrexed, and 7 patients sensitive to either docetaxel or pemetrexed. All patients received the full dose of radiation. A total of 19 patients (95%) completed 2 cycles of concurrent chemotherapy (CCT). One patient treated concurrently with pemetrexed experienced grade 3 neutropenia. Three patients experienced grade 3 oral mucositis, and 2 patients experienced grade 3 dermatitis.
Our study demonstrated that a CCT selecting method based on the gene targets associated with drug sensitivity was clinically feasible and safe. Further studies enrolled more patients with longer follow-up times are needed to confirm the clinical efficacy of this CCT selecting method.
本前瞻性研究旨在评估基于涎腺肿瘤基因特征的定制化疗方案的可行性和安全性。
纳入组织学确诊为中或高级别、T3 - 4期、N1 - 3期疾病的患者，以及手术切缘接近（≤1毫米）或显微镜下阳性的T1 - 2期、N0期患者。所有患者均接受根治性手术及术后同步放化疗。为评估治疗反应性，化疗方案基于基因靶点，β-微管蛋白III、ABCB1、STMN1和CYP1B1（用于多西他赛）以及TYMS（用于培美曲塞）。主要终点为治疗依从性和急性毒性。
2013年9月至2016年1月共纳入20例患者。中位年龄为46岁（范围：23 - 70岁）。基因检测显示，8例患者可能对多西他赛敏感，5例患者可能对培美曲塞敏感，7例患者对多西他赛或培美曲塞敏感。所有患者均接受了全剂量放疗。共有19例患者（95%）完成了2周期同步化疗（CCT）。1例接受培美曲塞同步治疗的患者出现3级中性粒细胞减少。3例患者出现3级口腔黏膜炎，2例患者出现3级皮炎。
我们的研究表明，基于与药物敏感性相关基因靶点的CCT选择方法在临床上是可行且安全的。需要进一步纳入更多患者并进行更长时间随访的研究来证实这种CCT选择方法的临床疗效。
