Yankey Hilario, Ruth Karen J, Dotan Efrat, Reddy Sanjay, Meyer Joshua E
Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.
Department of Biostatistics, Fox Chase Cancer Center, Philadelphia, Pennsylvania.
Adv Radiat Oncol. 2023 Dec 2;9(4):101412. doi: 10.1016/j.adro.2023.101412. eCollection 2024 Apr.
PURPOSE: Conventional chemoradiation (CCRT) is inadequately effective for the treatment of unresectable or inoperable biliary tract cancers (UIBC). Ablative radiation therapy (AR), typically defined as a biologically effective dose (BED) ≥80.5 Gy, has shown some promise in terms of local control and survival in these patients. We compare the efficacy and toxicity of AR to non-AR in UIBC patients. METHODS AND MATERIALS: Patients with UIBC treated with stereotactic body radiation therapy (SBRT; n = 18) or CCRT (n = 28) between 2006 and 2021 were retrospectively analyzed. The associations of treatment, BED groups, selected characteristics with overall survival (OS), progression-free survival (PFS), and local control were estimated separately using Cox proportional hazards regression. Toxicity was scored using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. RESULTS: Median dose fractionation was 60 Gy in 5 fractions (median BED, 127 Gy) for SBRT and 50 Gy in 25 fractions (median BED, 64 Gy) for CCRT. The median follow-up of the entire cohort was 11.5 months. The 1-year OS rate was 62% for BED <80.5 versus 66% for BED ≥80.5 ( = .069). The 1-year PFS rate was 24% for BED <80.5 and 29% for BED ≥80.5 ( = .050). The 1-year local control rate was 20% for BED <80.5 and 41% for BED ≥80.5 ( = .097). BED as a continuous variable ( = .013), BED ≥100 Gy ( = .044), and race (white versus nonwhite) ( = .037) were associated with improved overall mortality. BED ≥80.5 Gy ( = .046), smaller tumor size (<5 cm; = .038) and N0 disease ( <.0001) were associated with improved disease progression rates. Local control was improved in patients with N0 disease compared with N1 disease ( <.0001). Both treatments were well tolerated; there was no difference in acute and late toxicity between AR and non-AR. CONCLUSIONS: In this review, there was improved PFS with BED ≥80.5 Gy with a trend toward OS benefit. BED ≥80.5 Gy was achieved mostly through SBRT and was well tolerated. AR could be considered a more effective treatment modality than CCRT in patients with UIBC.
目的：传统放化疗（CCRT）对不可切除或无法手术的胆管癌（UIBC）治疗效果欠佳。消融性放射治疗（AR），通常定义为生物等效剂量（BED）≥80.5 Gy，在这些患者的局部控制和生存方面已显示出一定前景。我们比较AR与非AR在UIBC患者中的疗效和毒性。 方法与材料：回顾性分析2006年至2021年间接受立体定向体部放射治疗（SBRT；n = 18）或CCRT（n = 28）的UIBC患者。分别使用Cox比例风险回归估计治疗、BED分组、所选特征与总生存期（OS）、无进展生存期（PFS）和局部控制之间的关联。使用不良事件通用术语标准（CTCAE）第5.0版对毒性进行评分。 结果：SBRT的中位剂量分割为60 Gy分5次（中位BED，127 Gy），CCRT为50 Gy分25次（中位BED，64 Gy）。整个队列的中位随访时间为11.5个月。BED <80.5时1年总生存率为62%，BED≥80.5时为66%（P = 0.069）。BED <80.5时1年无进展生存率为24%，BED≥80.5时为29%（P = 0.050）。BED <80.5时1年局部控制率为20%，BED≥80.5时为41%（P = 0.097）。BED作为连续变量（P = 0.013）、BED≥100 Gy（P = 0.044）以及种族（白种人与非白种人）（P = 0.037）与总体死亡率改善相关。BED≥80.5 Gy（P = 0.046）、较小肿瘤大小（<5 cm；P = 0.038）和N0期疾病（P <0.0001）与疾病进展率改善相关。与N1期疾病患者相比，N0期疾病患者的局部控制得到改善（P <0.0001）。两种治疗耐受性均良好；AR与非AR在急性和晚期毒性方面无差异。 结论：在本综述中，BED≥80.5 Gy可改善PFS，且有OS获益趋势。BED≥80.5 Gy大多通过SBRT实现，且耐受性良好。对于UIBC患者，AR可被认为是比CCRT更有效的治疗方式。
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