Deodato Francesco, Clemente Gennaro, Mattiucci Gian Carlo, Macchia Gabriella, Costamagna Guido, Giuliante Felice, Smaniotto Daniela, Luzi Stefano, Valentini Vincenzo, Mutignani Massimiliano, Nuzzo Gennaro, Cellini Numa, Morganti Alessio G
Department of Radiation Therapy, Centro di Ricerca e Formazione ad Alta Tecnologia nelle Scienze Biomediche, Università Cattolica del Sacro Cuore, Campobasso, Italy.
Int J Radiat Oncol Biol Phys. 2006 Feb 1;64(2):483-8. doi: 10.1016/j.ijrobp.2005.07.977. Epub 2005 Oct 19.
To evaluate long-term effects of chemoradiation and intraluminal brachytherapy in terms of local control, disease-free survival, overall survival, and symptom relief in patients with unresectable or residual extrahepatic biliary carcinoma.
Twenty-two patients with unresectable (17 patients) or residual (5 patients) nonmetastatic extrahepatic bile tumors received external beam radiation therapy (39.6-50.4 Gy) between 1991 and 1997. In 21 patients, 5-fluorouracil (96-h continuous infusion, Days 1-4, 1,000 mg/m2/day) was administered. Twelve patients received a boost of intraluminal brachytherapy with 192Ir wires (30-50 Gy) 1 cm from the source axis.
During external beam radiotherapy, 10 patients (45.4%) developed Grade 1 to 2 gastrointestinal toxicity. In patients with unresectable tumor who could be evaluated, the clinical response was 28.6% (4 of 14). Two patients showed complete response. In all 22 patients, median durations of local control, disease-free survival, and overall survival were 44.5 months, 16.3 months, and 23.0 months, respectively. Two patients who received external beam radiation therapy and intraluminal brachytherapy developed late duodenal ulceration. In patients with unresectable tumors, median survival was 13.0 months and 22.0 months in those treated with and without brachytherapy, with 16.7% and no 5-year survival, respectively (p=0.607). Overall 5-year survival was 18.0%: 40% and 11.7% in patients treated with partial resection and in those with unresectable tumor, respectively (p=0.135).
This study confirmed the role of concurrent chemoradiation in advanced biliary carcinoma; the role of intraluminal brachytherapy boost remains to be further analyzed in larger clinical trials.
评估放化疗及腔内近距离放射治疗对无法切除或残留的肝外胆管癌患者局部控制、无病生存期、总生存期及症状缓解方面的长期影响。
1991年至1997年间,22例无法切除(17例)或残留(5例)的非转移性肝外胆管肿瘤患者接受了外照射放疗(39.6 - 50.4 Gy)。21例患者接受了5-氟尿嘧啶治疗(第1 - 4天,1000 mg/m²/天,持续96小时静脉输注)。12例患者接受了距源轴1 cm处的192Ir线腔内近距离放射治疗增强剂量(30 - 50 Gy)。
在外照射放疗期间,10例患者(45.4%)出现1至2级胃肠道毒性。在可评估的无法切除肿瘤患者中,临床缓解率为28.6%(14例中的4例)。2例患者显示完全缓解。在所有22例患者中,局部控制、无病生存期及总生存期的中位持续时间分别为44.5个月、16.3个月和23.0个月。2例接受外照射放疗及腔内近距离放射治疗的患者发生了晚期十二指肠溃疡。在无法切除肿瘤的患者中,接受和未接受近距离放射治疗的患者中位生存期分别为13.0个月和22.0个月,5年生存率分别为16.7%和0%(p = 0.607)。总体5年生存率为18.0%:部分切除患者和无法切除肿瘤患者分别为40%和11.7%(p = 0.135)。
本研究证实了同步放化疗在晚期胆管癌中的作用;腔内近距离放射治疗增强剂量的作用仍有待在更大规模的临床试验中进一步分析。