Gough M H, Durrant K R, Giraud-Saunders A M, Paine C H, McPherson K, Vessey M P
Br J Surg. 1985 Mar;72(3):182-5. doi: 10.1002/bjs.1800720308.
A randomized controlled trial of the value of oral adjuvant cytotoxic chemotherapy in the treatment of potentially curable breast cancer has been in progress in the Oxford Region since 1977. Eighty-seven patients were allocated to treatment with melphalan 0.2 mg/kg for 5 consecutive days every 6 weeks for 2 years; 98 patients were allocated to treatment with oral combination therapy consisting of melphalan 10 mg daily for 5 consecutive days, plus methotrexate 15 mg and 5-fluorouracil 250 mg on the first day, courses being repeated every 6 weeks for 2 years; and 88 patients were allocated to a control group which received no adjuvant chemotherapy. So far, 125 patients have suffered a recurrence of breast cancer and 85 have died. No statistically significant differences in outcome are apparent between the three treatment groups, although there is some indication of a beneficial effect of chemotherapy on disease-free interval in pre-menopausal women. Toxic effects of treatment, notably nausea, vomiting and bone marrow depression, have been moderately severe. In our view, the beneficial effects of current adjuvant cytotoxic chemotherapy, if any, are too modest to justify the suffering which such treatment can cause at a time when a woman with breast cancer might otherwise expect to feel physically well.
自1977年以来，牛津地区一直在进行一项关于口服辅助细胞毒性化疗在治疗潜在可治愈乳腺癌中的价值的随机对照试验。87名患者被分配接受苯丁酸氮芥治疗，剂量为0.2mg/kg，每6周连续5天，共2年；98名患者被分配接受口服联合治疗，即每天口服苯丁酸氮芥10mg，连续5天，加用甲氨蝶呤15mg和氟尿嘧啶250mg，第1天使用，疗程每6周重复一次，共2年；88名患者被分配到对照组，不接受辅助化疗。到目前为止，已有125名患者出现乳腺癌复发，85名患者死亡。尽管有迹象表明化疗对绝经前女性的无病生存期有有益影响，但三个治疗组之间在结果上没有明显的统计学差异。治疗的毒性作用，尤其是恶心、呕吐和骨髓抑制，程度中等严重。我们认为，目前辅助细胞毒性化疗的有益效果（如果有的话）过于微小，不足以证明在乳腺癌女性原本可能感觉身体良好的时候，这种治疗所带来的痛苦是合理的。
