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局部晚期胰腺癌同步放化疗:吉西他滨与5-氟尿嘧啶对比的随机对照研究

Concurrent chemoradiotherapy treatment of locally advanced pancreatic cancer: gemcitabine versus 5-fluorouracil, a randomized controlled study.

作者信息

Li Chung-Pin, Chao Yee, Chi Kwan-Hwa, Chan Wing-Kai, Teng Ho-Chung, Lee Rheun-Chuan, Chang Full-Young, Lee Shou-Dong, Yen Sang-Hue

机构信息

Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital and Institute of Clinical Medicine, National Yang-Ming University School of Medicine, Taipei, Taiwan.

出版信息

Int J Radiat Oncol Biol Phys. 2003 Sep 1;57(1):98-104. doi: 10.1016/s0360-3016(03)00435-8.

DOI:10.1016/s0360-3016(03)00435-8
PMID:12909221
Abstract

PURPOSE

To determine the efficacy and tolerability of gemcitabine (GEM)-concurrent chemoradiotherapy (CCRT) vs. 5-fluorouracil (5-FU) CCRT for locally advanced pancreatic cancer.

METHODS AND MATERIALS

Thirty-four patients with locally advanced pancreatic cancer were studied. Eighteen patients were randomized to receive GEM CCRT (600 mg/m(2)/wk for 6 weeks) and 16 patients to receive bolus 5-FU CCRT (500 mg/m(2)/d for 3 days repeated every 2 weeks for 6 weeks). All patients were to receive 3D-CRT 50.4-61.2 Gy at 1.8-Gy/d fractions and GEM (1000 mg/m(2) weekly for 3 weeks repeated every 4 weeks) after RT.

RESULTS

The median survival and median time to progression were 14.5 months and 7.1 months for the GEM CCRT group and 6.7 months and 2.7 months for the 5-FU CCRT group (p = 0.027 and p = 0.019, respectively). The quality-adjusted life month survival time was 11.2 +/- 0.5 months for GEM CCRT and 6.0 +/- 0.3 months for 5-FU CCRT patients (p <0.001). The response rate was 50% (four complete responses and five partial responses) for GEM CCRT and 13% (two partial responses) for 5-FU CCRT (p = 0.005). Pain control was 39% for GEM CCRT and 6% for 5-FU CCRT (p = 0.043). Grade 3-4 neutropenia (34% vs. 19%), thrombocytopenia (0% vs. 7%), nausea (33% vs. 31%), vomiting (17% vs. 19%), hospitalization days per month of survival (7.4 +/- 1.7 days vs. 8.0 +/- 1.3 days), and full dose of RT received (78% vs. 75%) were not significantly different between the GEM CCRT and 5-FU CCRT patients.

CONCLUSION

GEM CCRT appears more effective than 5-FU CCRT for locally advanced pancreatic cancer and has comparable tolerability.

摘要

目的

确定吉西他滨(GEM)同步放化疗(CCRT)与5-氟尿嘧啶(5-FU)CCRT治疗局部晚期胰腺癌的疗效和耐受性。

方法和材料

对34例局部晚期胰腺癌患者进行研究。18例患者随机接受GEM CCRT(600mg/m²/周,共6周),16例患者接受大剂量5-FU CCRT(500mg/m²/天,共3天,每2周重复一次,共6周)。所有患者均接受三维适形放疗(3D-CRT),剂量为50.4-61.2Gy,每天1.8Gy分次照射,放疗后接受GEM(1000mg/m²,每周一次,共3周,每4周重复一次)。

结果

GEM CCRT组的中位生存期和中位疾病进展时间分别为14.5个月和7.1个月,5-FU CCRT组分别为6.7个月和2.7个月(p分别为0.027和0.019)。GEM CCRT患者的质量调整生命月生存时间为11.2±0.5个月,5-FU CCRT患者为6.0±0.3个月(p<0.001)。GEM CCRT的缓解率为50%(4例完全缓解和5例部分缓解),5-FU CCRT为13%(2例部分缓解)(p=0.005)。GEM CCRT的疼痛控制率为39%,5-FU CCRT为6%(p=0.043)。GEM CCRT组和5-FU CCRT组患者3-4级中性粒细胞减少(34%对19%)、血小板减少(0%对7%)、恶心(33%对31%)、呕吐(17%对19%)、每月生存住院天数(7.4±1.7天对8.0±1.3天)以及接受的全量放疗比例(78%对75%)差异均无统计学意义。

结论

对于局部晚期胰腺癌,GEM CCRT似乎比5-FU CCRT更有效,且耐受性相当。

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