Nissen-Meyer R, Kjellgren K, Malmio K, Månsson B, Norin T
Cancer. 1978 Jun;41(6):2088-98. doi: 10.1002/1097-0142(197806)41:6<2088::aid-cncr2820410604>3.0.co;2-j.
One single six-day course with cyclophosphamide (total dose 30 mg/kg) was given immediately after mastectomy to 507 breast cancer patients, with 519 randomized controls receiving no adjuvant chemotherapy. The control group now has 234 recurrences and 196 deaths, and the treatment group 175 recurrences and 146 deaths. The differences of 59 recurrences and 50 deaths in favour of the treatment group are significant with p values less than 0.001 and less than 0.01 respectively. The differences in recurrence rates increased gradually, reached 10.71% four years after mastectomy (p less than 0.001), and remained at the same level for another 6 years. The differences in death rates increased until 6 years after mastectomy, and was 10.48% after 10 years. With this pattern, the mechanism is probably not a delay in onset of clinical recurrences, but a definite reduction of recurrence rates due to tumoricidal chemotherapy. Prognostic factors or menstrual state had apparently no influence on the effect of this type of adjuvant chemotherapy. Side effects were of short duration and very moderate. Since there was a good effect in the prognostically most favourable groups of patients, treatment of such cases seems therefore also justified. The same chemotherapy course given 3 weeks after mastectomy seemed without effect.
507例乳腺癌患者在乳房切除术后立即接受了一个为期6天的环磷酰胺疗程（总剂量30mg/kg），519例随机对照患者未接受辅助化疗。对照组目前有234例复发和196例死亡，治疗组有175例复发和146例死亡。治疗组在复发和死亡例数上分别减少了59例和50例，差异具有显著性，p值分别小于0.001和小于0.01。复发率的差异逐渐增加，乳房切除术后4年达到10.71%（p小于0.001），并在随后的6年保持在同一水平。死亡率的差异一直增加到乳房切除术后6年，10年后为10.48%。按照这种模式，其机制可能不是临床复发的延迟出现，而是由于杀肿瘤化疗使复发率明确降低。预后因素或月经状态显然对此类辅助化疗的效果没有影响。副作用持续时间短且非常轻微。由于在预后最有利的患者组中有良好效果，因此对这类病例进行治疗似乎也是合理的。在乳房切除术后3周给予相同的化疗疗程似乎没有效果。
