Leichman C G, Fleming T R, Muggia F M, Tangen C M, Ardalan B, Doroshow J H, Meyers F J, Holcombe R F, Weiss G R, Mangalik A
University of Southern California School of Medicine, Los Angeles, USA.
J Clin Oncol. 1995 Jun;13(6):1303-11. doi: 10.1200/JCO.1995.13.6.1303.
A variety of fluorinated pyrimidine-based regimens for the treatment of disseminated colorectal cancer have been presented in the medical literature. The Southwest Oncology Group designed a screening trial of seven regimens of fluorouracil (5-FU) to assess efficacy and toxicity afforded by biochemical modulation or schedule variations.
Six hundred twenty patients were entered into this trial between August 1989 and January 1993. Eligible patients were classified as having recurrent or disseminated disease that was measurable or nonmeasurable. All eligible patients were evaluated for toxicity and survival; patients with measurable disease were evaluated for response according to standard criteria.
No regimen achieved a higher response rate than single-agent bolus 5-FU. Eighty-four percent of patients have been monitored until death. The median survival time for the entire cohort is 14 months. Survival hazards ratios showed a positive trend in favor of the unmodulated infusion regimens, while high-grade toxicities occurred more frequently in the 5-FU bolus arms. The major high-grade toxicities were granulocytopenia and diarrhea.
In this trial, no regimen provided substantial improvement relative to 5-FU bolus or single-agent therapy for either response or survival in the treatment of disseminated colorectal cancer. The single-agent infusion regimens demonstrated the most encouraging results with a favorable toxicity profile and a 2-month longer survival duration than 5-FU bolus therapy.
医学文献中已介绍了多种用于治疗播散性结直肠癌的基于氟嘧啶的治疗方案。西南肿瘤协作组设计了一项针对七种氟尿嘧啶（5-FU）方案的筛选试验，以评估生化调节或给药方案变化所带来的疗效和毒性。
1989年8月至1993年1月期间，620例患者进入该试验。符合条件的患者被分类为患有可测量或不可测量的复发性或播散性疾病。所有符合条件的患者均评估毒性和生存期；对患有可测量疾病的患者根据标准标准评估缓解情况。
没有一种方案的缓解率高于单药推注5-FU。84%的患者被监测至死亡。整个队列的中位生存期为14个月。生存风险比显示出有利于未调节输注方案的积极趋势，而5-FU推注组中高级别毒性更频繁发生。主要的高级别毒性是粒细胞减少和腹泻。
在该试验中，在治疗播散性结直肠癌时，相对于5-FU推注或单药治疗，没有一种方案在缓解或生存方面有实质性改善。单药输注方案显示出最令人鼓舞的结果，具有良好的毒性特征，生存期比5-FU推注治疗长2个月。
