Division of Hematology & Rheumatology, Nihon University School of Medicine, 30-1 Oyaguchi, Itabashi-ku, Tokyo, 173-8617, Japan.
Department of Internal Medicine, Toyohashi Medical Center, Toyohashi, Japan.
Ann Hematol. 2018 Sep;97(9):1535-1545. doi: 10.1007/s00277-018-3323-8. Epub 2018 Apr 24.
The Japan Adult Leukemia Study Group (JALSG) Ph+ALL202 study reported a high complete remission (CR) rate for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) patients treated with imatinib-combined chemotherapy. However, the long-term treatment efficacy remains uncertain. Here, we report a final analysis of the JALSG Ph+ALL202 study. The outcomes were compared with those of the JALSG ALL93 and ALL97 studies, which were conducted in the pre-imatinib era. Ninety-nine newly diagnosed Ph+ALL patients were enrolled in Ph+ALL202 (median age, 45 years; median follow-up, 4.5 years). CR was achieved in 96/99 (97%) patients. Fifty-nine of these 96 patients (61%) underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) in their first CR (CR1). The 5-year overall and disease-free survival (DFS) rates were 50 and 43%, respectively, which were significantly higher compared to those in the pre-imatinib era (15 and 19%, respectively). Multivariate analysis revealed that imatinib administration, allo-HSCT in CR1, and a white blood cell count < 30 × 10/L were favorable independent prognostic factors for long-term DFS. Improved odds of receiving allo-HSCT and a lower relapse rate leaded to good long-term outcomes. The 3-year DFS tended to be higher in PCR-negative than that in PCR-positive patients (29 vs. 14%) in the non-HSCT patients, and this tendency was also seen in the allo-HSCT patients (59 vs. 50%). The higher rate of CR upon imatinib use may have contributed to these improvements.
日本成人白血病研究组（JALSG）Ph+ALL202 研究报告称，接受伊马替尼联合化疗治疗的费城染色体阳性急性淋巴细胞白血病（Ph+ALL）患者完全缓解（CR）率较高。然而，长期治疗效果仍不确定。在此，我们报告了 JALSG Ph+ALL202 研究的最终分析结果。将这些结果与 JALSG ALL93 和 ALL97 研究进行比较，这些研究是在伊马替尼时代之前进行的。Ph+ALL202 研究共纳入 99 例新诊断的 Ph+ALL 患者（中位年龄 45 岁；中位随访时间 4.5 年）。99 例患者中 96 例（97%）达到 CR。这 96 例患者中有 59 例（61%）在首次 CR（CR1）时接受了异基因造血干细胞移植（allo-HSCT）。5 年总生存率和无病生存率（DFS）分别为 50%和 43%，显著高于伊马替尼时代的分别为 15%和 19%。多因素分析显示，伊马替尼治疗、CR1 时行 allo-HSCT 和白细胞计数<30×10/L 是长期 DFS 的有利独立预后因素。更好的 allo-HSCT 接受机会和更低的复发率导致了良好的长期结果。在未接受 allo-HSCT 的患者中，PCR 阴性患者的 3 年 DFS 倾向于高于 PCR 阳性患者（29% vs. 14%），allo-HSCT 患者也存在这种趋势（59% vs. 50%）。伊马替尼治疗后更高的 CR 率可能促成了这些改善。
