PDF(Pubmed)
Abstract：
UNASSIGNED: Locally advanced head and neck cancers treated with radical chemoradiation have unsatisfactory outcomes. Oral metronomic chemotherapy improves outcomes in comparison to maximum tolerated dose chemotherapy in the palliative setting. Limited evidence suggests that it may do so in an adjuvant setting. Hence this randomized study was conducted.
UNASSIGNED: Patients of head and neck (HN) cancer with primary in oropharynx, larynx or hypopharynx, with PS 0-2 post radical chemoradiation with documented complete response were randomized 1:1 to either observation or oral metronomic adjuvant chemotherapy (MAC) for 18 months. MAC consisted of weekly oral methotrexate (15 mg/m2) and celecoxib (200 mg PO BD). The primary endpoint was OS and the overall sample size was 1038. The study had 3 planned interim analyses for efficacy and futility. Trial registration- Clinical Trials Registry- India (CTRI): CTRI/2016/09/007315 [Registered on: 28/09/2016] Trial Registered Prospectively.
UNASSIGNED: 137 patients were recruited and an interim analysis was done. The 3 year PFS was 68.7% (95% CI 55.1-79.0) versus 60.8% (95% CI 47.9-71.4) in the observation and metronomic arm respectively (P value = 0.230). The hazard ratio was 1.42 (95% CI 0.80-2.51; P value = 0.231). The 3 year OS was 79.4% (95% CI 66.3-87.9) versus 62.4% (95% CI 49.5-72.8) in the observation and metronomic arm respectively (P value = 0.047). The hazard ratio was 1.83 (95% CI 1.0-3.36; P value = 0.051).
UNASSIGNED: In this phase 3 randomized study, oral metronomic combinations of weekly methotrexate and daily celecoxib failed to improve the PFS or OS. Hence observation post-complete response post radical chemoradiation remains the standard of care.
UNASSIGNED: ICON funded this study.
UNASSIGNED: Patients of head and neck (HN) cancer with primary in oropharynx, larynx or hypopharynx, with PS 0-2 post radical chemoradiation with documented complete response were randomized 1:1 to either observation or oral metronomic adjuvant chemotherapy (MAC) for 18 months. MAC consisted of weekly oral methotrexate (15 mg/m2) and celecoxib (200 mg PO BD). The primary endpoint was OS and the overall sample size was 1038. The study had 3 planned interim analyses for efficacy and futility. Trial registration- Clinical Trials Registry- India (CTRI): CTRI/2016/09/007315 [Registered on: 28/09/2016] Trial Registered Prospectively.
UNASSIGNED: 137 patients were recruited and an interim analysis was done. The 3 year PFS was 68.7% (95% CI 55.1-79.0) versus 60.8% (95% CI 47.9-71.4) in the observation and metronomic arm respectively (P value = 0.230). The hazard ratio was 1.42 (95% CI 0.80-2.51; P value = 0.231). The 3 year OS was 79.4% (95% CI 66.3-87.9) versus 62.4% (95% CI 49.5-72.8) in the observation and metronomic arm respectively (P value = 0.047). The hazard ratio was 1.83 (95% CI 1.0-3.36; P value = 0.051).
UNASSIGNED: In this phase 3 randomized study, oral metronomic combinations of weekly methotrexate and daily celecoxib failed to improve the PFS or OS. Hence observation post-complete response post radical chemoradiation remains the standard of care.
UNASSIGNED: ICON funded this study.
摘要：
■接受根治性放化疗治疗的局部晚期头颈癌的疗效不理想。与姑息治疗中的最大耐受剂量化疗相比，口服节拍化疗可改善预后。有限的证据表明它可能在佐剂环境中这样做。因此进行了这项随机研究。
■头颈部（HN）癌患者，原发性口咽，喉或下咽,有记录的完全缓解的根治性放化疗后PS0-2患者以1:1的比例随机接受观察或口服节拍辅助化疗(MAC)18个月.MAC由每周口服甲氨蝶呤（15mg/m2）和塞来昔布（200mgPOBD）组成。主要终点为OS，总样本量为1038。该研究对疗效和无效性进行了3次计划的中期分析。试验注册-临床试验注册-印度（CTRI）：CTRI/2016/09/007315[注册时间：28/09/2016]试验注册。
■招募了137名患者，并进行了中期分析。3年PFS分别为68.7%(95%CI55.1-79.0)和60.8%(95%CI47.9-71.4)(P值=0.230)。风险比为1.42（95％CI0.80-2.51；P值=0.231）。3年OS分别为79.4%(95%CI66.3-87.9)和62.4%(95%CI49.5-72.8)(P值=0.047)。风险比为1.83（95％CI1.0-3.36；P值=0.051）。
■在这项第三阶段随机研究中，每周口服甲氨蝶呤和每日服用塞来昔布的节拍法组合未能改善PFS或OS.因此，根治性放化疗后完全反应后的观察仍然是护理标准。
■ICON资助了这项研究。
■头颈部（HN）癌患者，原发性口咽，喉或下咽,有记录的完全缓解的根治性放化疗后PS0-2患者以1:1的比例随机接受观察或口服节拍辅助化疗(MAC)18个月.MAC由每周口服甲氨蝶呤（15mg/m2）和塞来昔布（200mgPOBD）组成。主要终点为OS，总样本量为1038。该研究对疗效和无效性进行了3次计划的中期分析。试验注册-临床试验注册-印度（CTRI）：CTRI/2016/09/007315[注册时间：28/09/2016]试验注册。
■招募了137名患者，并进行了中期分析。3年PFS分别为68.7%(95%CI55.1-79.0)和60.8%(95%CI47.9-71.4)(P值=0.230)。风险比为1.42（95％CI0.80-2.51；P值=0.231）。3年OS分别为79.4%(95%CI66.3-87.9)和62.4%(95%CI49.5-72.8)(P值=0.047)。风险比为1.83（95％CI1.0-3.36；P值=0.051）。
■在这项第三阶段随机研究中，每周口服甲氨蝶呤和每日服用塞来昔布的节拍法组合未能改善PFS或OS.因此，根治性放化疗后完全反应后的观察仍然是护理标准。
■ICON资助了这项研究。
