Preisler H, Davis R B, Kirshner J, Dupre E, Richards F, Hoagland H C, Kopel S, Levy R N, Carey R, Schulman P
Blood. 1987 May;69(5):1441-9.
Patients with acute nonlymphocytic leukemia were randomized to receive remission induction therapy consisting of seven days of cytosine arabinoside and three days of daunorubicin ("7 + 3") or to receive the same regimen intensified by either the addition of 6-thioguanine or by extension of the administration of cytosine arabinoside to ten days. Additionally, all patients were randomized to receive or not to receive cotrimoxazole antibacterial prophylaxis during the remission induction phase. Neither an increase in intensity of chemotherapy nor the antibacterial prophylaxis increased the remission rate above the 53% for patients treated with the standard "7 + 3" regimen. The second part of this study addressed the issue of the utility of long-term maintenance chemotherapy. To this end, patients were randomized to discontinue all treatment after 8 months of maintenance chemotherapy or to continue maintenance therapy for a total of 3 years. Although there was a transient increase in the relapse rate for patients who discontinued therapy, the proportion of long-term remitters was identical in the two patient groups. Additionally, there is a suggestion of a survival advantage for patients randomized to discontinue all therapy at 8 months.
急性非淋巴细胞白血病患者被随机分为两组，一组接受由7天阿糖胞苷和3天大剂量柔红霉素组成的缓解诱导疗法（“7 + 3”方案），另一组接受通过添加6-硫鸟嘌呤或延长阿糖胞苷给药时间至10天来强化的相同方案。此外，所有患者在缓解诱导期被随机分为接受或不接受复方新诺明抗菌预防治疗。无论是化疗强度的增加还是抗菌预防治疗，都没有使接受标准“7 + 3”方案治疗的患者缓解率高于53%。本研究的第二部分探讨了长期维持化疗的效用问题。为此，患者被随机分为两组，一组在维持化疗8个月后停止所有治疗，另一组继续维持治疗共3年。尽管停止治疗的患者复发率有短暂上升，但两组患者的长期缓解者比例相同。此外，有迹象表明，随机分配在8个月时停止所有治疗的患者有生存优势。
