Department of Radiation Medicine, Oregon Health and Science University, Portland, OR, USA.
Department of Surgery, Oregon Health and Science University, Portland, OR, USA.
J Natl Cancer Inst. 2017 Jul 1;109(7). doi: 10.1093/jnci/djw324.
There are no randomized data to guide clinicians treating patients with gallbladder cancer (GBC). Several retrospective studies reported the survival benefits of adjuvant radiotherapy (RT) and chemoradiation (CRT). In this paper, we examine whether these publications have impacted the utilization of adjuvant therapies and whether their survival benefits are evident in a contemporary cohort of patients.
Using the National Cancer Data Base, we identified 5029 patients diagnosed with T1-3N0-1 GBC and treated with surgical resection from 2005 to 2013. We described trends in receipt of adjuvant treatments for three time periods (2005-2007, 2008-2010, 2011-2013) and calculated three-year overall survival (OS) probabilities for 2989 patients treated in 2005-2010. All statistical tests were two-sided.
The percentage of patients who received no adjuvant treatments was unchanged from 2005 to 2013. Adjuvant RT decreased from 4.2% to 1.7% ( P < .001), adjuvant chemotherapy increased from 8.3% to 13.8% ( P < .001), and adjuvant CRT remained stable at 15.9% ( P = .98). Adjuvant treatments were associated with improved three-year OS, with adjusted hazard ratio of 0.47 (95% confidence interval [CI] = 0.39 to 0.58) for CRT, 0.77 (95% CI = 0.61 to 0.97) for chemotherapy, and 0.63 (95% CI = 0.44 to 0.92) for RT. Adjuvant CRT was associated with improved survival in all categories, except T1N0, and in patients with negative and positive margins.
Over the past decade there was no increase in the utilization of adjuvant therapies in the United States for patients with resected GBC. Adjuvant therapy is associated with statistically significantly improved three-year OS. This analysis should form the basis for current clinical recommendations and support future prospective trials.
目前尚无随机数据可用于指导治疗胆囊癌（GBC）患者的临床医生。几项回顾性研究报告了辅助放疗（RT）和放化疗（CRT）的生存获益。本文旨在探讨这些文献是否影响了辅助治疗的应用，以及这些生存获益是否在当代患者群体中得到体现。
我们利用国家癌症数据库，确定了 5029 例 2005 年至 2013 年间接受手术切除治疗的 T1-3N0-1 期 GBC 患者。我们描述了三个时间段（2005-2007 年、2008-2010 年、2011-2013 年）接受辅助治疗的趋势，并计算了 2005-2010 年接受治疗的 2989 例患者的 3 年总生存率（OS）概率。所有统计检验均为双侧检验。
2005 年至 2013 年，未接受辅助治疗的患者比例保持不变。辅助 RT 从 4.2%降至 1.7%（P<.001），辅助化疗从 8.3%增至 13.8%（P<.001），而辅助 CRT 则保持稳定（15.9%，P=0.98）。辅助治疗与改善 3 年 OS 相关，调整后的 CRT（95%置信区间[CI]：0.39 至 0.58）、化疗（0.77，0.61 至 0.97）和 RT（0.63，0.44 至 0.92）的危险比（HR）分别为 0.47、0.77 和 0.63。辅助 CRT 除 T1N0 外，在切缘阴性和阳性的患者中均与生存改善相关。
在过去十年中，美国接受切除 GBC 治疗的患者中，辅助治疗的应用并未增加。辅助治疗与统计学显著改善的 3 年 OS 相关。本分析应作为当前临床建议的基础，并支持未来的前瞻性试验。
