PDF(Pubmed)
Abstract：
BACKGROUND: Oral squamous cell carcinoma (OSCC) causes significant mortality and morbidity worldwide. Surgical resection with adjuvant radiotherapy remains the standard treatment for locally advanced resectable OSCC. Results from landmark trials have established postoperative concurrent cisplatin-radiotherapy (Cis-RT) as the standard treatment for OSCC patients with high-risk pathologic features. However, cisplatin-related toxicity limits usage in clinical practice. Given the need for effective but less toxic alternatives, we previously conducted a single-arm trial showing favorable safety profiles and promising efficacy of concurrent docetaxel-radiotherapy (Doc-RT).
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).
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).
摘要：
背景：口腔鳞状细胞癌（OSCC）在全球范围内引起显著的死亡率和发病率。辅助放疗的手术切除仍然是局部晚期可切除OSCC的标准治疗方法。具有里程碑意义的试验结果已将术后同步顺铂放疗（Cis-RT）确定为具有高风险病理特征的OSCC患者的标准治疗方法。然而,顺铂相关毒性限制了临床实践的使用。鉴于需要有效但毒性较小的替代品，我们之前进行了一项单臂试验,该试验显示了多西他赛同步放疗(Doc-RT)的良好安全性和有希望的疗效.
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）。
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）。
