METHODS: In this randomized phase 2 trial, we aimed to compare Doc-RT with the standard Cis-RT in postoperative OSCC patients. Eligible patients had AJCC stage III-IV resectable OSCC with high-risk pathologic features. Two hundred twenty-four patients were enrolled and randomly assigned to receive concurrent Doc-RT or Cis-RT. The primary endpoint was 2-year disease-free survival (DFS). Secondary endpoints included overall survival (OS), locoregional-free survival (LRFS), distant metastasis-free survival (DMFS), and adverse events (AEs). Integrin β1 (ITGB1) expression was analyzed as a biomarker for efficacy.
RESULTS: After a median 28.8-month follow-up, 2-year DFS rates were 63.7% for Doc-RT arm and 56.1% for Cis-RT arm (p = 0.55). Meanwhile, Doc-RT demonstrated comparable efficacy to Cis-RT in OS, LRFS, and DMFS. Doc-RT resulted in fewer grade 3 or 4 hematological AEs. Low ITGB1 was associated with improved Doc-RT efficacy versus Cis-RT.
CONCLUSIONS: This randomized trial directly compared Doc-RT with Cis-RT for high-risk postoperative OSCC patients, with comparable efficacy and less toxicity. ITGB1 merits further validation as a predictive biomarker to identify OSCC patients most likely to benefit from Doc-RT. Findings indicate docetaxel may be considered as a concurrent chemoradiation option in this setting.
BACKGROUND: www.
RESULTS: gov . NCT02923258 (date of registration: October 4, 2016).
方法:在这项随机2期试验中,我们旨在比较术后OSCC患者的Doc-RT与标准Cis-RT.符合条件的患者患有AJCCIII-IV期可切除的OSCC,具有高危病理特征。招募了24名患者,并随机分配接受同时的Doc-RT或Cis-RT。主要终点是2年无病生存期(DFS)。次要终点包括总生存期(OS),无局部区域生存(LRFS),无远处转移生存期(DMFS),和不良事件(AE)。分析整合素β1(ITGB1)表达作为生物标志物的功效。
结果:经过中位28.8个月的随访,Doc-RT组的2年DFS率为63.7%,Cis-RT组为56.1%(p=0.55)。同时,Doc-RT在OS中表现出与Cis-RT相当的功效,LRFS,和DMFS。Doc-RT导致较少的3级或4级血液学AE。与Cis-RT相比,低ITGB1与Doc-RT疗效改善相关。
结论:这项随机试验直接比较了术后高危OSCC患者的Doc-RT和Cis-RT,疗效相当,毒性较小。ITGB1值得进一步验证作为预测生物标志物,以识别最有可能从Doc-RT中受益的OSCC患者。研究结果表明,在这种情况下,多西他赛可被视为同步放化疗的选择。
背景:www.
结果:政府。NCT02923258(注册日期:2016年10月4日)。