Hejna M, Kornek G V, Raderer M, Depisch D, Brodowicz T, Fiebiger W C, Scheithauer W
Department of Internal Medicine I, University Medical School, Vienna, Austria.
Br J Cancer. 1998 Sep;78(6):760-4. doi: 10.1038/bjc.1998.574.
The aim of the study was to investigate the therapeutic value of reinduction therapy with the same cytostatic treatment that had been used for induction treatment in patients with metastatic colorectal cancer. A total of 71 patients, all of whom had responded or achieved stable disease lasting > or = 12 weeks after six monthly courses of first-line treatment with 5-fluorouracil + racemic leucovorin (5-FU/LV; n = 35) or 5-FU plus the l-isomer of LV (LLV; n = 34) were entered in this study. At the time of relapse, the same treatment was used for initial therapy: racemic LV or LLV was administered at 100 mg m(-2) day(-1) by i.v. bolus injection, immediately followed by 5-FU 400 mg m(-2) day(-1) given as a 2-h infusion. Chemotherapeutic drugs were given on 5 consecutive days at 4-week intervals x 6 or until there was evidence of tumour progression. Among 49 evaluable patients, reinduction therapy that was initiated after a median treatment-free interval of 5.4 months (range 3-14.5) resulted in nine partial response (PR) (18%) and 26 stable disease (SD) (53%), yielding an overall tumour control rate of 69% (95% confidence interval, 54.6-81.7%). The median time to treatment failure from reinduction was 6.4 months, and the median survival duration from reinduction was 8.9 months (20.1 months as judged from the beginning of induction therapy). The toxicity associated with retreatment was generally mild to moderate; compared with initial treatment, there was no significant difference in terms of the overall rate (P = 0.33) or severity (P = 0.19) of adverse reactions. Our data suggest that in patients with advanced colorectal cancer an interrupted treatment strategy, i.e. retreatment with the same regimen in case of relapse > or = 3 months after discontinuation of 6 months of successful treatment with 5-FU/LV or 5-FU/LLV is an acceptable therapeutic concept.
本研究的目的是探讨采用与诱导治疗相同的细胞毒性治疗方案进行再诱导治疗对转移性结直肠癌患者的治疗价值。共有71例患者纳入本研究，所有患者在接受6个周期的一线治疗（5-氟尿嘧啶+消旋亚叶酸钙（5-FU/LV；n = 35）或5-FU加左旋亚叶酸钙（LLV；n = 34））后均有反应或疾病稳定持续≥12周。复发时，采用相同的治疗方案进行初始治疗：消旋亚叶酸钙或LLV以100 mg m(-2) 天(-1) 的剂量静脉推注，随后立即给予5-FU 400 mg m(-2) 天(-1) 持续2小时静脉输注。化疗药物连续5天给药，每4周重复一次，共6次，或直至有肿瘤进展的证据。在49例可评估患者中，在中位无治疗间隔5.4个月（范围3 - 14.5个月）后开始的再诱导治疗导致9例部分缓解（PR）（18%）和26例疾病稳定（SD）（53%），总肿瘤控制率为69%（95%置信区间，54.6 - 81.7%）。再诱导治疗至治疗失败的中位时间为6.4个月，再诱导治疗后的中位生存时间为8.9个月（从诱导治疗开始计算为20.1个月）。与再次治疗相关的毒性一般为轻至中度；与初始治疗相比，不良反应的总发生率（P = 0.33）或严重程度（P = 0.19）无显著差异。我们的数据表明，对于晚期结直肠癌患者，一种间断治疗策略，即在停止使用5-FU/LV或5-FU/LLV成功治疗6个月后复发≥3个月时采用相同方案再次治疗，是一种可接受的治疗理念。
