Re-examining post-operative chemoradiotherapy in head and neck cancer: an updated long-term combined analysis of RTOG 9501/EORTC 22931.

However, this analysis lacked tests of interaction necessary to identify a predictive biomarker.

然而，这项分析缺乏必要的相互作用测试，以识别预测性生物标志物。

In addition, updated data are now available.

此外，现已更新了相关数据。

patients_and_methods

This study assessed 744 patients enrolled on RTOG 9501 and EORTC 22931, randomized trials that compared CRT with radiation (RT) following surgery.

该研究评估了参与RTOG 9501和EORTC 22931的744名患者，这两项随机试验比较了手术后放化疗（CRT）与单纯放疗（RT）的效果。

Overall survival(OS) was analyzed with Cox regression.

总生存（OS）采用Cox回归分析。

Cancer-specific mortality (CSM), other-cause mortality (OCM), and recurrence outcomes were analyzed with competing risks methodology.

癌症特异性死亡（CSM）、其他原因死亡（OCM）和复发结果采用竞争风险方法进行分析。

Tests of interaction assessed for differential benefits of CRT in various subgroups.

交互作用检验评估了在不同亚组中放化疗（CRT）的差异性益处。

Results

Median follow-up was 6.9 years.

中位随访时间为6.9年。

Among all patients, CRT improved OS [hazard ratio(HR) 0.81, 95% confidence interval(CI) 0.68-0.97, P = 0.026].

在所有患者中，放化疗改善了总生存期[风险比（HR）0.81，95%置信区间（CI）0.68-0.97，P = 0.026]。

Although CRT improved OS in the subgroup with ENE and/or positive margins (HR 0.71, 95% CI 0.57-0.89, P = 0.003) and not in those without these features (HR 0.94, 95% CI 0.68-1.30, P = 0.7), tests of interaction showed no evidence of a differential effect of CRT in these subgroups (P-interaction = 0.17).

尽管在有ENE和/或阳性切缘的亚组中，放化疗改善了总生存期（HR 0.71，95% CI 0.57-0.89，P = 0.003），但在没有这些特征的患者中并未改善（HR 0.94，95% CI 0.68-1.30，P = 0.7），交互作用检验显示没有证据表明放化疗在这两个亚组中有不同的效果（P-交互作用 = 0.17）。

There was also no evidence of interaction when analyzing other outcomes, or when assessing ENE and margin status individually.

在分析其他结果时，或单独评估ENE和边缘状态时，也未发现交互作用的证据。

While CRT significantly reduced CSM (HR 0.68, 95% CI 0.55-0.83, P < 0.001), it also significantly increased OCM (HR 1.51, 95% CI 1.07-2.12, P = 0.018).

尽管放化疗显著降低了癌症特异性死亡率（CSM）（HR 0.68，95%置信区间（CI）0.55-0.83，P < 0.001），但同时也显著增加了其他原因死亡率（OCM）（HR 1.51，95% CI 1.07-2.12，P = 0.018）。

Post-operative CRT improved locoregional recurrence (HR 0.64, 95% CI 0.48-0.85, P = 0.002), but not distant metastasis (HR 0.83, 95% CI 0.64-1.08, P = 0.17).

术后放化疗改善了局部区域复发（HR 0.64，95% 置信区间 0.48-0.85，P = 0.002），但对远处转移无改善（HR 0.83，95% 置信区间 0.64-1.08，P = 0.17）。

Conclusions

Concurrent chemotherapy improved OS in head and neck cancer patients undergoing post-operative radiotherapy in the combined populations of EORTC 22931 and RTOG 9501.

在 EORTC 22931 和 RTOG 9501 的联合人群中，同步化疗改善了接受术后放疗的头颈部癌症患者的总生存期。

ENE and/or positive margins are not predictive biomarkers, and patients without these features may still benefit from CRT.

ENE 和/或阳性切缘不是预测性生物标志物，没有这些特征的患者仍可能从放化疗中受益。

CRT improved CSM, but this was partly offset by higher OCM.

放化疗改善了癌症特异性死亡率（CSM），但这部分被较高的其他原因死亡率（OCM）所抵消。

Refining the population most likely to benefit from post-operative CRT, taking into consideration both oncologic and patient-related factors, needs further exploration.

需要进一步探索的是，考虑到肿瘤学和患者相关因素，精确识别最有可能从术后放化疗中受益的人群。