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大剂量亚叶酸(FA)和氟尿嘧啶(FU)联合或不联合胸腺刺激素(TS)治疗转移性结直肠癌:一项随机多中心临床试验的结果

High-dose folinic acid (FA) and fluorouracil (FU) plus or minus thymostimulin (TS) for treatment of metastatic colorectal cancer: results of a randomized multicenter clinical trial.

作者信息

Mustacchi G, Pavesi L, Milani S, Iaffaioli V, Caraco A, Comella G, Contu A, Farris A, Attado-Parinello G, Narcisi M

机构信息

Centro Oncologico, Universita di Trieste, Italy.

出版信息

Anticancer Res. 1994 Mar-Apr;14(2B):617-9.

PMID:8010718
Abstract

The purpose of this study was to ascertain the possible protective effect of thymostimulin (TS) on chemotherapy-induced leukopenia and related febrile episodes, beside the potential of improving therapeutic efficacy and tolerability of high-dose folinic acid (FA) plus fluorouracil (FU) in metastatic colorectal cancer. In 211 evaluable patients the objective responses were 19/105 (18%) in the FA-FU arm versus 32/106 (30%) obtained with the same regimen plus TS. The difference was statistically significant (p = 0.02). No difference was observed in terms of hematological toxicity, while the TS treated patients experienced a significantly lower incidence of mucositis and diarrhoea (p = 0.03). No significant differences were recorded in the incidence of febrile episodes and other treatment-related toxicities. The possibility of improving response to chemotherapy in advanced colorectal cancer without increasing systemic toxicity is particularly interesting and deserves further attention.

摘要

本研究的目的是确定胸腺刺激素(TS)对化疗引起的白细胞减少症及相关发热性发作可能具有的保护作用,以及其在转移性结直肠癌中提高大剂量亚叶酸钙(FA)加氟尿嘧啶(FU)治疗效果和耐受性的潜力。在211例可评估患者中,FA - FU组的客观缓解率为19/105(18%),而相同方案加用TS组的客观缓解率为32/106(30%)。差异具有统计学意义(p = 0.02)。在血液学毒性方面未观察到差异,而接受TS治疗的患者黏膜炎和腹泻的发生率显著较低(p = 0.03)。在发热性发作及其他与治疗相关的毒性发生率方面未记录到显著差异。在不增加全身毒性的情况下提高晚期结直肠癌对化疗反应的可能性尤其令人关注,值得进一步研究。

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