Shinchi Hiroyuki, Takao Sonshin, Noma Hidetoshi, Matsuo Yoichiro, Mataki Yuko, Mori Shinichiro, Aikou Takashi
First Department of Surgery, Kagoshima University School of Medicine, 8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan.
Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):146-50. doi: 10.1016/s0360-3016(01)02806-1.
The purpose of this study was to evaluate whether external-beam radiotherapy (EBRT) with concurrent continuous 5-fluorouracil (5-FU) infusion affects the length and quality of survival in patients with locally unresectable pancreatic cancer.
Thirty-one patients with histologically proven locally advanced and unresectable pancreatic cancer without distant metastases were evaluated in this prospective randomized trial. Sixteen patients received EBRT (50.4 Gy/28 fractions) with concurrent continuous infusion of 5-FU (200 mg/m(2)/day), whereas 15 patients received no chemoradiation. The length and quality of survival was analyzed and compared for the two groups.
The median survival of 13.2 months and the 1-year survival rate of 53.3% in the chemoradiation group were significantly better than the respective 6.4 months and 0% in the group without chemoradiotherapy (p = 0.0009). The average monthly Karnofsky score, a quality of life indicator, was 77.1 in the chemoradiation group, which was significantly higher than the 65.5 in the group without chemoradiotherapy (p < 0.0001). The number of hospital days per month of survival was significantly less in the chemoradiation than in the no-therapy group (12.3 vs. 19.0 days, p < 0.05). In the chemoradiation group, 5 patients (31%) had a partial response, and 9 (56%) had radiologically stable disease at a median duration of 6.1 months. The patients who had chemoradiation had a lower rate of liver and peritoneal metastases than patients without chemoradiotherapy (31% vs. 64%). Of 10 patients who experienced pain before chemoradiation, 8 (80%) received pain relief that lasted a median of 5.2 months.
EBRT with concurrent continuous 5-FU infusion increased the length and quality of survival as compared to no chemoradiotherapy and provided a definite palliative benefit for patients with unresectable pancreatic cancer.
本研究旨在评估外照射放疗(EBRT)联合持续静脉输注5-氟尿嘧啶(5-FU)是否会影响局部不可切除胰腺癌患者的生存时长和质量。
在这项前瞻性随机试验中,对31例经组织学证实为局部晚期且不可切除、无远处转移的胰腺癌患者进行了评估。16例患者接受EBRT(50.4 Gy/28次分割)并同时持续输注5-FU(200 mg/m²/天),而15例患者未接受放化疗。分析并比较了两组患者的生存时长和质量。
放化疗组的中位生存期为13.2个月,1年生存率为53.3%,显著优于未接受放化疗组的6.4个月和0%(p = 0.0009)。作为生活质量指标的卡诺夫斯基评分平均每月在放化疗组为77.1,显著高于未接受放化疗组的65.5(p < 0.0001)。放化疗组每月生存的住院天数显著少于未治疗组(12.3天对19.0天,p < 0.05)。在放化疗组中,5例患者(31%)出现部分缓解,9例患者(56%)在中位时长6.1个月时影像学检查显示疾病稳定。接受放化疗的患者发生肝转移和腹膜转移的比率低于未接受放化疗的患者(31%对64%)。在放化疗前有疼痛的10例患者中,8例(80%)疼痛得到缓解,中位持续时间为5.2个月。
与未进行放化疗相比,EBRT联合持续静脉输注5-FU可延长生存时长并提高生存质量,为不可切除胰腺癌患者带来明确的姑息治疗益处。