Glimelius B, Graf W, Hoffman K, Påhlman L, Sjödén P O, Wennberg A
Department of Oncology, Akademiska sjukhuset, University of Uppsala, Sweden.
Acta Oncol. 1992;31(6):645-51. doi: 10.3109/02841869209083847.
A Nordic multicenter study in asymptomatic patients with advanced colorectal cancer compared initial chemotherapy with sequential methotrexate-5-FU with leucovorin rescue (MFL) for 6 months versus primary expectancy with chemotherapy only after the appearance of symptoms. The study (183 patients randomized between January 1985 and February 1990) showed that symptom-free survival, progression-free survival and survival respectively were about 6 months longer in the group of patients randomized to initial MFL. Whether these prolongations could be achieved without an impaired 'quality of life' was studied in an associated study. Between January 1985 and March 1987, 43 patients were randomized at one of the hospitals, 36 of which were interviewed with a questionnaire at randomization. Even if all these patients were considered, by the physician, to be 'free of symptoms from their disease', 16/36 (44%) had symptoms that could be referred to the disease. In spite of this, the patients were in a good general condition, and considerably better off than patients considered to have 'symptoms from the disease' who were interviewed with the same questionnaire when randomized in a parallel study of symptomatic patients. Patients randomized to initial chemotherapy and interviewed longitudinally maintained their good condition throughout treatment. Toxicity was mild, although the patients expressed more adverse effects than the physicians recorded. Since symptom-free survival, progression-free survival and survival were statistically significantly longer in the group of patients randomized to MFL also in this associated study, it is concluded that initial chemotherapy can prolong symptom-free survival and survival without reduced 'quality of life' during the treatment period.
一项北欧多中心研究，对无症状的晚期结直肠癌患者进行了比较，一组采用初始化疗，即连续6个月使用甲氨蝶呤-5-氟尿嘧啶并联合亚叶酸钙解救（MFL）方案，另一组则仅在出现症状后才进行化疗，采取观察等待策略。该研究（1985年1月至1990年2月期间对183例患者进行随机分组）表明，随机接受初始MFL方案治疗的患者组，其无症状生存期、无进展生存期和总生存期分别延长了约6个月。在一项相关研究中，探讨了在不降低“生活质量”的情况下是否能够实现这些生存期的延长。1985年1月至1987年3月期间，在其中一家医院对43例患者进行了随机分组，其中36例患者在随机分组时接受了问卷调查。即使所有这些患者被医生认为“疾病无症状”，但其中16/36（44%）的患者仍有可归因于该疾病的症状。尽管如此，这些患者的总体状况良好，并且比在一项有症状患者的平行研究中随机分组时接受相同问卷访谈的、被认为“有疾病症状”的患者状况要好得多。随机接受初始化疗并接受纵向访谈的患者在整个治疗过程中保持了良好的状态。毒性反应较轻，尽管患者报告的不良反应比医生记录的更多。由于在这项相关研究中，随机接受MFL方案治疗的患者组的无症状生存期、无进展生存期和总生存期在统计学上也显著更长，因此得出结论，初始化疗可以延长无症状生存期和总生存期，且在治疗期间不会降低“生活质量”。
