Kobayashi S, Tomokuni A, Gotoh K, Takahashi H, Akita H, Marubashi S, Yamada T, Teshima T, Fukui K, Fujiwara Y, Sakon M
Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
Eur J Surg Oncol. 2017 Apr;43(4):763-771. doi: 10.1016/j.ejso.2016.12.008. Epub 2017 Jan 11.
This study aims to evaluate survival and the objective response to neoadjuvant combination therapy with gemcitabine and radiation therapy in patients with biliary tract cancer.
The chemoradiation therapy regimen consisted of 3 cycles of full-dose gemcitabine (1000 mg/m at days 1, 8, and 15, every 4 weeks) with 50-60 Gy radiation. We compared 27 patients who received neoadjuvant chemoradiation therapy and 79 patients who were treated without neoadjuvant therapy. Hemi-hepatectomy or pancreatoduodenectomy was planned for all of the patients in the study population. CT-based staging was used to adjust for the pre-treatment characteristics of the patients.
After confirming the reproducibility of CT-based staging, we analyzed the survival of the patients. The multivariate analysis showed that the absence of arterial invasion on CT, the absence of lymph node swelling, and neoadjuvant therapy were independent prognostic factors. The three-year recurrence-free survival (RFS) rates in patients treated with and without neoadjuvant therapy were 78% and 58%, respectively (P = 0.0263). The adjusted overall survival (OS) (determined by the inverse probability of treatment weighting method using the inverse propensity score) was improved by neoadjuvant therapy (P = 0.00187); the hazard ratio was 0.3505.
Neoadjuvant chemoradiation therapy might have the potential to improve RFS and OS.
UMIN-CTR UMIN000015450.
本研究旨在评估吉西他滨与放射治疗联合新辅助治疗对胆道癌患者的生存率及客观反应。
放化疗方案包括3个周期的全剂量吉西他滨(每4周,第1、8和15天,1000mg/m)联合50 - 60Gy放射治疗。我们比较了27例接受新辅助放化疗的患者和79例未接受新辅助治疗的患者。研究人群中的所有患者均计划进行半肝切除术或胰十二指肠切除术。基于CT的分期用于调整患者的治疗前特征。
在确认基于CT分期的可重复性后,我们分析了患者的生存率。多因素分析显示,CT上无动脉侵犯、无淋巴结肿大和新辅助治疗是独立的预后因素。接受和未接受新辅助治疗的患者三年无复发生存率(RFS)分别为78%和58%(P = 0.0263)。新辅助治疗改善了调整后的总生存率(OS)(通过使用逆倾向评分的治疗加权逆概率方法确定)(P = 0.00187);风险比为0.3505。
新辅助放化疗可能具有改善RFS和OS的潜力。
UMIN - CTR UMIN000015450