Clinical Research Division and Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA 98109-1024, USA.
J Clin Oncol. 2010 Apr 1;28(10):1766-71. doi: 10.1200/JCO.2009.25.1066. Epub 2010 Feb 16.
It is known that complete remission (CR) prolongs survival in acute myeloid leukemia (AML). In 2003, less stringent response categories were introduced, most notably CR with incomplete platelet recovery (CRp). Although the significance of CRp for survival remains unclear, reports of AML trials frequently combine CR with CRp rather than considering CR as a separate entity.
This practice led us to retrospectively examine the effect of CR on outcome in newly diagnosed AML, by using data from 6,283 patients treated on Eastern Cooperative Oncology Group (ECOG) and Southwest Oncology Group (SWOG) protocols or at M. D. Anderson Cancer Center. This effect was then contrasted with the effect of CRp in the M. D. Anderson Cancer Center cohort.
At least 94% of patients receiving cytarabine-based therapy and surviving for more than 3 or 5 years achieved a CR with either initial or salvage therapy; limited data suggest the same for patients receiving initial therapies that did not contain cytarabine. Patients with CR were more likely to live beyond 3 or 5 years than patients with CRp. The likelihood of achieving a CR rather than CRp was greater for patients with AML who had better prognosis. After adjustment for covariates, the relapse-free survival of patients achieving CR was longer than that of patients achieving CRp, whereas patients with CRp survived longer than those with resistant disease.
Our data indicate that CR is of unique clinical significance and should be reported as separate response in trials of newly diagnosed AML. Nonetheless, our findings validate CRp as a clinically meaningful response.
众所周知,完全缓解(CR)可延长急性髓系白血病(AML)患者的生存时间。2003 年,引入了不那么严格的缓解标准,其中最显著的是不完全血小板恢复的 CR(CRp)。尽管 CRp 对生存的意义仍不清楚,但 AML 试验报告经常将 CR 与 CRp 结合起来,而不是将 CR 视为单独的实体。
这种做法导致我们回顾性地检查了新诊断的 AML 中 CR 对结果的影响,使用了来自东部合作肿瘤学组(ECOG)和西南肿瘤学组(SWOG)方案或 M. D.安德森癌症中心治疗的 6283 名患者的数据。然后,我们将这一效果与 M. D.安德森癌症中心队列中 CRp 的效果进行了对比。
至少 94%接受基于阿糖胞苷的治疗并在 3 年或 5 年以上存活的患者,无论是初始治疗还是挽救性治疗,均达到 CR;有限的数据表明,未包含阿糖胞苷的初始治疗患者也有类似情况。与 CRp 患者相比,达到 CR 的患者更有可能存活 3 年或 5 年以上。预后较好的 AML 患者更有可能达到 CR,而不是 CRp。在调整了协变量后,达到 CR 的患者无复发生存时间长于达到 CRp 的患者,而达到 CRp 的患者比耐药患者存活时间更长。
我们的数据表明,CR 具有独特的临床意义,在新诊断的 AML 临床试验中应作为单独的反应进行报告。尽管如此,我们的发现还是验证了 CRp 是一种有临床意义的反应。