Beguin Y, Sautois B, Forget P, Bury J, Fillet G
Department of Medicine, University of Liège, Belgium.
Cancer. 1997 Apr 1;79(7):1351-4. doi: 10.1002/(sici)1097-0142(19970401)79:7<1351::aid-cncr12>3.0.co;2-z.
In 1985, the authors published a study of acute myelogenous leukemia (AML) patients treated with a chemotherapeutic regimen that was then considered intensive. Ten years later, the authors reanalyzed the same cohort to determine whether the very promising actuarial results observed at 5 years held after longer follow-up.
Between 1977 and 1982, 61 patients with AML were treated with a protocol consisting of daunorubicin, vincristine, and cytosine arabinoside induction followed by consolidation and maintenance for a total of 2 years. The complete remission (CR) rate was 66%, 84% in males versus 47% in females (P < 0.005). At the time of the first analysis in 1984, the overall survival (OS) was 17%, the projected 5-year continuous CR rate (CCR) 32%, and the disease free survival (DFS) rate 29%, with the best results observed for males and for patients ages 40-60 years (P < 0.05).
When the data were reanalyzed 11 years later in 1995, the results were 14% OS, 23% CCR, and 16% DFS at 5 years. However, these figures dropped to 8%, 18%, and 11% at 10 years and to 8%, 12%, and 7% at 15 years, respectively. Among the 40 CR patients, 31 relapsed (up to 13 years after CR), and all died within 1.6 years after relapse. Nine patients were in CCR: 4 died of unrelated causes (suicide, alcoholic cirrhosis, acute peritonitis, or bladder carcinoma), 1 was lost to follow-up after 11 years, 2 were alive and well at 17 years at last follow-up, and 2 were transplanted in first CR and were doing well at 13 and 14 years at last follow-up. The survival advantage for males over females persisted (P = 0.0197), but the advantage for patients age 40-60 years did not hold.
These long term data indicate that actuarial analysis at 5 years may overestimate the cure rate of AML patients because a number of late relapses do occur. However, the picture is blurred by the incidence of death not related to leukemia or its treatment; and when these patients were censored at the time of death, 17% of CR patients were still projected to be alive and free of leukemia after 17 years.
1985年,作者发表了一项关于急性髓性白血病(AML)患者的研究,这些患者接受了当时被认为是强化的化疗方案治疗。十年后,作者对同一队列进行了重新分析,以确定在更长时间的随访后,5年时观察到的非常有前景的精算结果是否仍然成立。
1977年至1982年期间,61例AML患者接受了一项方案治疗,该方案包括柔红霉素、长春新碱和阿糖胞苷诱导治疗,随后进行巩固和维持治疗,共2年。完全缓解(CR)率为66%,男性为84%,女性为47%(P<0.005)。在1984年首次分析时,总生存率(OS)为17%,预计5年持续完全缓解(CCR)率为32%,无病生存率(DFS)率为29%,男性和40 - 60岁患者的结果最佳(P<0.05)。
1995年在11年后重新分析数据时,5年时的结果为OS 14%,CCR 23%,DFS 16%。然而,这些数字在10年时分别降至8%、18%和11%,在15年时分别降至8%、12%和7%。在40例CR患者中,31例复发(CR后长达13年),且所有患者在复发后1.6年内死亡。9例患者处于CCR状态:4例死于无关原因(自杀、酒精性肝硬化、急性腹膜炎或膀胱癌),1例在11年后失访,2例在最后一次随访时17岁时存活且状况良好,2例在首次CR时接受了移植,在最后一次随访时13岁和14岁时情况良好。男性相对于女性的生存优势仍然存在(P = 0.0197),但40 - 60岁患者的优势不再成立。
这些长期数据表明,5年时的精算分析可能高估了AML患者的治愈率,因为确实发生了一些晚期复发。然而,与白血病或其治疗无关的死亡发生率使情况变得模糊;当这些患者在死亡时被截尾时,17%的CR患者预计在17年后仍存活且无白血病。