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Abstract：
BACKGROUND: The National Comprehensive Cancer Network (NCCN) guideline recommends consideration of weekly cisplatin as an alternative option for patients with head and neck cancer undergoing definitive chemoradiation. However, in a recent phase III trial (ConCERT), 20% of patients treated with weekly cisplatin could not receive a total of 200 mg/m2, and the association of low adherence to weekly cisplatin and cancer control outcomes remains unclear. To fill this knowledge gap, we performed an observational cohort study of patients with head and neck cancer undergoing definitive chemoradiation with weekly cisplatin.
METHODS: Our institutional database was queried for patients with non-metastatic head and neck cancer who underwent definitive chemoradiation with weekly cisplatin (40 mg/m2) between November 2007 and April 2023. Adherence to weekly cisplatin was defined as receiving at least 5 cycles with a total cumulative dose of 200 mg/m2. Survival outcomes were evaluated using Kaplan-Meier method, log-rank tests, Cox proportional hazard multivariable (MVA) analyses. Logistic MVA was performed to identify variables associated with low adherence to weekly cisplatin. Fine-Gray MVA was performed to analyze failure outcomes with death as a competing event.
RESULTS: Among 119 patients who met our criteria, 51 patients (42.9%) had low adherence to weekly cisplatin. Median follow up was 19.8 months (interquartile range 8.8-65.6). Low adherence to weekly cisplatin was associated with worse overall survival (adjusted hazards ratio [aHR] 2.94, 95% confidence interval [CI] 1.58-5.47, p < 0.001) and progression-free survival (aHR 2.32, 95% CI 1.29-4.17, p = 0.005). It was also associated with worse distant failure (aHR 4.55, 95% CI 1.19-17.3, p = 0.03), but not locoregional failure (aHR 1.61, 95% CI 0.46-5.58, p = 0.46). KPS < 90 was the only variable associated with low adherence to weekly cisplatin (adjusted odds ratio [aOR] 2.67, 95% CI 1.10-6.65, p = 0.03).
CONCLUSIONS: Our study suggested that over 40% of patients underwent fewer than 5 weekly cisplatin cycles and that low adherence to weekly cisplatin was an independent, adverse prognostic factor for worse survival and distant failure outcomes. Those with reduced adherence to weekly cisplatin were more likely to have poor performance status. Further studies are warranted to improve the adherence to chemotherapy and outcomes.
METHODS: Our institutional database was queried for patients with non-metastatic head and neck cancer who underwent definitive chemoradiation with weekly cisplatin (40 mg/m2) between November 2007 and April 2023. Adherence to weekly cisplatin was defined as receiving at least 5 cycles with a total cumulative dose of 200 mg/m2. Survival outcomes were evaluated using Kaplan-Meier method, log-rank tests, Cox proportional hazard multivariable (MVA) analyses. Logistic MVA was performed to identify variables associated with low adherence to weekly cisplatin. Fine-Gray MVA was performed to analyze failure outcomes with death as a competing event.
RESULTS: Among 119 patients who met our criteria, 51 patients (42.9%) had low adherence to weekly cisplatin. Median follow up was 19.8 months (interquartile range 8.8-65.6). Low adherence to weekly cisplatin was associated with worse overall survival (adjusted hazards ratio [aHR] 2.94, 95% confidence interval [CI] 1.58-5.47, p < 0.001) and progression-free survival (aHR 2.32, 95% CI 1.29-4.17, p = 0.005). It was also associated with worse distant failure (aHR 4.55, 95% CI 1.19-17.3, p = 0.03), but not locoregional failure (aHR 1.61, 95% CI 0.46-5.58, p = 0.46). KPS < 90 was the only variable associated with low adherence to weekly cisplatin (adjusted odds ratio [aOR] 2.67, 95% CI 1.10-6.65, p = 0.03).
CONCLUSIONS: Our study suggested that over 40% of patients underwent fewer than 5 weekly cisplatin cycles and that low adherence to weekly cisplatin was an independent, adverse prognostic factor for worse survival and distant failure outcomes. Those with reduced adherence to weekly cisplatin were more likely to have poor performance status. Further studies are warranted to improve the adherence to chemotherapy and outcomes.
摘要：
背景：国家综合癌症网络（NCCN）指南建议考虑将每周一次的顺铂作为头颈部癌症患者接受确定性放化疗的替代选择。然而,在最近的III期试验（ConCERT）中，20％的患者每周顺铂治疗不能总共接受200mg/m2，低依从性与每周顺铂和癌症控制结果的关系仍不清楚。为了填补这一知识空白，我们对接受每周一次顺铂确定性放化疗的头颈部癌患者进行了一项观察性队列研究.
方法：我们的机构数据库查询了2007年11月至2023年4月期间接受每周顺铂（40mg/m2）确定性放化疗的非转移性头颈癌患者。坚持每周顺铂定义为接受至少5个周期，总累积剂量为200mg/m2。使用Kaplan-Meier方法评估生存结果，对数秩测试，Cox比例风险多变量(MVA)分析。进行LogisticMVA以确定与每周顺铂依从性低相关的变量。进行Fine-GrayMVA分析以死亡为竞争性事件的失败结果。
结果：在符合我们标准的119名患者中，51例患者（42.9%）每周顺铂依从性低。中位随访时间为19.8个月（四分位距8.8-65.6）。对每周顺铂的低依从性与较差的总生存期（校正风险比[aHR]2.94，95%置信区间[CI]1.58-5.47，p<0.001）和无进展生存期（aHR2.32，95%CI1.29-4.17，p=0.005）相关。它还与更严重的远处衰竭相关(aHR4.55，95%CI1.19-17.3，p=0.03)，但不是局部失败(aHR1.61，95%CI0.46-5.58，p=0.46)。KPS<90是与每周顺铂依从性低相关的唯一变量(调整后比值比[aOR]2.67,95%CI1.10-6.65,p=0.03)。
结论：我们的研究表明，超过40％的患者接受少于5个每周顺铂周期，并且每周顺铂依从性低是独立的，不良预后因素生存和远处失败的结果。那些每周顺铂依从性降低的人更有可能表现不佳。需要进一步的研究来提高对化疗的依从性和预后。
方法：我们的机构数据库查询了2007年11月至2023年4月期间接受每周顺铂（40mg/m2）确定性放化疗的非转移性头颈癌患者。坚持每周顺铂定义为接受至少5个周期，总累积剂量为200mg/m2。使用Kaplan-Meier方法评估生存结果，对数秩测试，Cox比例风险多变量(MVA)分析。进行LogisticMVA以确定与每周顺铂依从性低相关的变量。进行Fine-GrayMVA分析以死亡为竞争性事件的失败结果。
结果：在符合我们标准的119名患者中，51例患者（42.9%）每周顺铂依从性低。中位随访时间为19.8个月（四分位距8.8-65.6）。对每周顺铂的低依从性与较差的总生存期（校正风险比[aHR]2.94，95%置信区间[CI]1.58-5.47，p<0.001）和无进展生存期（aHR2.32，95%CI1.29-4.17，p=0.005）相关。它还与更严重的远处衰竭相关(aHR4.55，95%CI1.19-17.3，p=0.03)，但不是局部失败(aHR1.61，95%CI0.46-5.58，p=0.46)。KPS<90是与每周顺铂依从性低相关的唯一变量(调整后比值比[aOR]2.67,95%CI1.10-6.65,p=0.03)。
结论：我们的研究表明，超过40％的患者接受少于5个每周顺铂周期，并且每周顺铂依从性低是独立的，不良预后因素生存和远处失败的结果。那些每周顺铂依从性降低的人更有可能表现不佳。需要进一步的研究来提高对化疗的依从性和预后。
