Mix Michael, Ramnath Nithya, Gomez Jorge, de Groot Charles, Rajan Saju, Dibaj Shiva, Tan Wei, Rustum Youcef, Jameson Michael B, Singh Anurag K
Michael Mix, Jorge Gomez, Saju Rajan, Anurag K Singh, Department of Radiation Medicine, Roswell Park Cancer Institute, Buffalo, NY 14263, United States.
World J Clin Oncol. 2015 Oct 10;6(5):156-65. doi: 10.5306/wjco.v6.i5.156.
To prospectively determine the safety and tolerability of oral L-selenomethionine (SLM) with concurrent chemoradiation (CCRT) for Stage III non-small cell lung cancer (NSCLC) and estimate if the incidence and/or severity of adverse events could be reduced by its use.
Sixteen patients with stage III NSCLC were accrued to this single arm, phase II study. CCRT consisted of radiation given at 2 Gy per fraction for 30-33 fractions, 5 d per week with concurrent weekly IV paclitaxel 50 mg/m(2) followed by carboplatin dosed at an area under the time-concentration curve of 2. SLM was dosed in a loading phase at 4800 μg twice daily for one week prior to CCRT followed by once daily dosing during treatment.
No selenium-related toxicity was observed. Analysis revealed grade 3 or higher esophagitis in 3 of 16 patients (19%), pneumonitis in 0, leukopenia in 2 (12.5%), and anemia in 1 (6%); the latter two were significantly reduced when compared to the protocol-stated expected rate of 35% (P = 0.045 for leukopenia, and P < 0.01 for anemia). Median overall survival was 14.9 mo and median failure-free survival was 9 mo (95%CI: 3.3-21.5).
There may be some protective benefit of selenium in the setting of CCRT for inoperable NSCLC. The data suggests decreased rates of myelosuppression when compared to similarly-treated historical and contemporary controls. Further evaluation of selenium in this setting may be warranted.
前瞻性地确定口服L-硒代蛋氨酸(SLM)联合同步放化疗(CCRT)治疗Ⅲ期非小细胞肺癌(NSCLC)的安全性和耐受性,并评估使用SLM是否可降低不良事件的发生率和/或严重程度。
16例Ⅲ期NSCLC患者纳入该单臂Ⅱ期研究。CCRT包括每次2 Gy,共30 - 33次分割,每周5天放疗,同时每周静脉注射紫杉醇50 mg/m²,随后给予卡铂,其时间-浓度曲线下面积为2。在CCRT前一周,SLM在负荷期每日两次给药,剂量为4800 μg,共一周,治疗期间改为每日一次给药。
未观察到与硒相关的毒性。分析显示,16例患者中有3例(19%)发生3级或更高级别的食管炎,0例发生肺炎,2例(12.5%)发生白细胞减少,1例(6%)发生贫血;与方案规定的预期发生率35%相比,后两者显著降低(白细胞减少P = 0.045,贫血P < 0.01)。中位总生存期为14.9个月,中位无进展生存期为9个月(95%CI:3.3 - 21.5)。
在不可切除的NSCLC同步放化疗中,硒可能具有一定的保护作用。数据表明,与接受类似治疗的历史和当代对照相比,骨髓抑制发生率降低。在这种情况下,可能有必要对硒进行进一步评估。