Bibault Jean-Emmanuel, Dussart Sophie, Pommier Pascal, Morelle Magali, Huguet Marius, Boisselier Pierre, Coche-Dequeant Bernard, Alfonsi Marc, Bardet Etienne, Rives Michel, Calugaru Valentin, Chajon Enrique, Noel Georges, Mecellem Hinda, Servagi Vernat Stephanie, Perrier Lionel, Giraud Philippe
Radiation Oncology Department, Paris Descartes University, Paris Sorbonne Cité, Hôpital Européen Georges Pompidou, Paris, France.
Radiation Oncology Department, Leon Berard Cancer Centre, Lyon, France.
Int J Radiat Oncol Biol Phys. 2017 Nov 15;99(4):929-937. doi: 10.1016/j.ijrobp.2017.06.2456. Epub 2017 Jun 27.
The Advanced Radiotherapy Oto-Rhino-Laryngologie (ART-ORL) study (NCT02024035) was performed to prospectively evaluate the clinical and economic aspects of helical TomoTherapy and volumetric modulated arc therapy (RapidArc, Varian Medical Systems, Palo Alto, CA) for patients with head and neck cancer.
Fourteen centers participated in this prospective comparative study. Randomization was not possible based on the availability of equipment. Patients with epidermoid or undifferentiated nasopharyngeal carcinoma or epidermoid carcinoma of the oropharynx and oral cavity (T1-T4, M0, N0-N3) were included between February 2010 and February 2012. Only the results of the clinical study are presented in this report, as the results of the economic assessment have been published previously. Inverse probability of treatment weighting using the propensity score analysis was undertaken in an effort to adjust for potential bias due to nonrandomization. Locoregional control, cancer-specific survival, and overall survival assessed 18 months after treatment, as well as long-term toxicity and salivary function, were evaluated.
The analysis included 166 patients. The following results are given after inverse probability of treatment weighting adjustment. The locoregional control rate at 18 months was significantly better in the TomoTherapy group: 83.3% (95% confidence interval [CI], 72.5%-90.2%) versus 72.7% (95% CI, 62.1%-80.8%) in the RapidArc group (P=.025). The cancer-specific survival rate was better in the TomoTherapy group: 97.2% (95% CI, 89.3%-99.3%) versus 85.5% (95% CI, 75.8%-91.5%) in the RapidArc group (P=.014). No significant difference was shown in progression-free or overall survival. TomoTherapy induced fewer acute salivary disorders (P=.012). Posttreatment salivary function degradation was worse in the RapidArc group (P=.012).
TomoTherapy provided better locoregional control and cancer-specific survival than RapidArc treatment, with fewer salivary disorders. No significant difference was shown in progression-free and overall survival. These results should be explored in a randomized trial.
开展先进放疗耳鼻喉科(ART-ORL)研究(NCT02024035),以前瞻性评估螺旋断层放疗和容积调强弧形放疗(Varian Medical Systems公司的RapidArc,加利福尼亚州帕洛阿尔托)用于头颈癌患者的临床和经济情况。
14个中心参与了这项前瞻性比较研究。基于设备可用性无法进行随机分组。2010年2月至2012年2月纳入了患有表皮样或未分化鼻咽癌或口咽及口腔表皮样癌(T1-T4,M0,N0-N3)的患者。本报告仅呈现临床研究结果,因为经济评估结果已在之前发表。采用倾向得分分析进行治疗权重的逆概率计算,以努力校正因非随机分组导致的潜在偏倚。评估了治疗后18个月的局部区域控制、癌症特异性生存和总生存情况,以及长期毒性和唾液功能。
分析纳入了166例患者。在进行治疗权重逆概率调整后得出以下结果。螺旋断层放疗组18个月时的局部区域控制率显著更好:83.3%(95%置信区间[CI],72.5%-90.2%),而RapidArc组为72.7%(95%CI,62.1%-80.8%)(P=0.025)。螺旋断层放疗组的癌症特异性生存率更高:97.2%(95%CI,89.3%-99.3%),而RapidArc组为85.5%(95%CI,75.8%-91.5%)(P=0.014)。无进展生存或总生存方面未显示出显著差异。螺旋断层放疗导致的急性唾液紊乱更少(P=0.012)。RapidArc组治疗后唾液功能退化更严重(P=0.012)。
与RapidArc治疗相比,螺旋断层放疗提供了更好地局部区域控制和癌症特异性生存,且唾液紊乱更少。无进展生存和总生存方面未显示出显著差异。这些结果应在随机试验中进一步探究。