Weh H J, Wilke H J, Dierlamm J, Klaassen U, Siegmund R, Illiger H J, Schalhorn A, Kreuser E D, Hilgenfeld U, Steinke B
Department of Oncology and Hematology, Medical University Clinic, Hamburg, Germany.
Ann Oncol. 1994 Mar;5(3):233-7. doi: 10.1093/oxfordjournals.annonc.a058799.
No effective salvage therapy is known for patients with metastatic colorectal carcinoma progressive after chemotherapy with 5-fluorouracil (5-FU)/folinic acid (FA) or 5-FU/alpha interferon (IFN) combinations. The aim of the study was to test whether weekly FA/high-dose 5-FU is an effective therapy in pretreated patients with progressive metastatic colorectal carcinoma.
Between January and December 1992, 57 patients with metastatic colorectal carcinoma were treated with weekly infusions of high-dose 5-fluorouracil (5-FU) (2600 mg/m2 as 24-hour infusion) and folinic acid (FA) (500 mg/m2 as 1-hour infusion prior to 5-FU). All patients were pretreated with chemotherapy, most of them with regimens containing 5-FU i.v. bolus/FA or 5-FU/alfa interferon (IFN), and all had documented progressive disease at the time of entering the study. In patients with partial remission (PR) or stable disease (SD) with improvement of their clinical condition, therapy was continued until progressive disease (PD) was documented. In all other patients therapy was stopped after one course (6 infusions).
5/57 patients (9%) achieved PR, 32/57 (56%) SD, in 19/57 (33%) disease was progressive and one toxic death occurred. 26/32 patients (81%) with SD or PR after the first chemotherapy again obtained SD or PR on high-dose 5-FU/FA but only 8/18 (44%) of those with PD after first chemotherapy did so. The median duration of SD/PR was 3 months and the median survival for all patients 8 months (range 3-17+). Apart from one toxic death, toxicity consisting for the most part of mucositis (n = 24), nausea (n = 23), diarrhoea (n = 18) and hand-foot syndrome (n = 12) was moderate.
Pretreated patients with metastatic colorectal carcinoma, notably those with a primary PR or SD, can probably benefit from weekly high-dose 5-FU/FA.
对于接受5-氟尿嘧啶（5-FU）/亚叶酸（FA）或5-FU/α干扰素（IFN）联合化疗后病情进展的转移性结直肠癌患者，尚无有效的挽救治疗方法。本研究的目的是测试每周一次的FA/高剂量5-FU对预处理的病情进展的转移性结直肠癌患者是否为有效治疗方法。
1992年1月至12月期间，57例转移性结直肠癌患者接受每周一次的高剂量5-氟尿嘧啶（5-FU）（2600mg/m²，24小时输注）和亚叶酸（FA）（500mg/m²，在5-FU之前1小时输注）静脉输注治疗。所有患者均接受过化疗预处理，大多数患者采用含5-FU静脉推注/FA或5-FU/α干扰素（IFN）的方案，并且在进入研究时均有记录的病情进展。对于部分缓解（PR）或病情稳定（SD）且临床状况改善的患者，继续治疗直至记录到病情进展（PD）。在所有其他患者中，一个疗程（6次输注）后停止治疗。
57例患者中有5例（9%）达到PR，32例（56%）为SD，19例（33%）病情进展，发生1例毒性死亡。首次化疗后达到SD或PR的32例患者中有26例（81%）在高剂量5-FU/FA治疗后再次获得SD或PR，但首次化疗后病情进展的患者中只有8例（44%）如此。SD/PR的中位持续时间为3个月，所有患者的中位生存期为8个月（范围3-17+）。除1例毒性死亡外，主要由粘膜炎（n=24）、恶心（n=23）、腹泻（n=18）和手足综合征（n=12）组成的毒性为中度。
预处理的转移性结直肠癌患者，尤其是那些初次达到PR或SD的患者，可能会从每周一次的高剂量5-FU/FA治疗中获益。
