Ganesan Prasanth, Ganesan Trivadi S, Radhakrishnan Venkatraman, Sagar Tenali Gnana, Kannan Krishnarathinam, Dhanushkodi Manikandan, Kalayarasi Jayachandran Perumal, Mehra Nikita
Department of Medical Oncology, Cancer Institute, Chennai, India.
Indian J Hematol Blood Transfus. 2019 Jan;35(1):37-42. doi: 10.1007/s12288-018-1009-y. Epub 2018 Sep 8.
Recent reports suggest that in the TKI era, the survival of chronic myeloid leukemia approaches that of general population. The real-world situation may be different. We analyzed patients (≥ 18 years) with chronic phase (CP) CML enrolled over a 7-year period (2002-2008) in an imatinib access program. Event was defined as non-achievement/loss of complete hematological response (CHR), loss of cytogenetic response or progression to accelerated (AP)/blast phase (BC). Progression was defined as development of AP/BC. Any delay of ≥ 1 week in reporting for drug refills was categorized as non-adherence. Of the 443 patients with CP-CML who started imatinib [median age: 36 years (18-70); High risk: 32% (Sokal) and 14% (Hasford/EUTOS)], 162 (37%) had received prior therapy [mostly hydroxyurea (N = 153]. CHR was achieved by 430 (97%). After a median follow up of 109.5 months (3.4-184.3), the EFS, PFS and OS at 10 years was 43%, 75% and 76% respectively. Superior EFS was predicted by low-risk Hasford score and adherence to therapy. Adherence to therapy was the only factor which predicted EFS on multivariate analysis (HR 0.64, 95% CI 0.50-0.83, = 0.001). Long-term follow up of patients with CP-CML reflects poorer survival than those reported from clinical trials and reflects multiple issues that affect "real-world" patients. The continued drop in EFS, noted during long-term follow up, might take time to impact the PFS and OS due to the chronic nature of the disease. Sustained adherence to therapy is important for optimum long-term outcomes.
近期报告显示，在酪氨酸激酶抑制剂（TKI）时代，慢性髓性白血病患者的生存率已接近普通人群。但现实情况可能有所不同。我们分析了在一项伊马替尼准入项目中，于7年期间（2002 - 2008年）纳入的慢性期（CP）慢性髓性白血病患者（≥18岁）。事件定义为未实现/丧失完全血液学缓解（CHR）、细胞遗传学反应丧失或进展为加速期（AP）/急变期（BC）。进展定义为AP/BC的发生。药物 refill报告中任何≥1周的延迟被归类为不依从。在443例开始使用伊马替尼的CP - CML患者中[中位年龄：36岁（18 - 70岁）；高危：32%（索卡尔评分）和14%（哈斯福德/EUTOS评分）]，162例（37%）曾接受过先前治疗[主要是羟基脲（N = 153）]。430例（97%）实现了CHR。中位随访109.5个月（3.4 - 184.3个月）后，10年时的无事件生存期（EFS）、无进展生存期（PFS）和总生存期（OS）分别为43%、75%和76%。低风险哈斯福德评分和治疗依从性可预测较好的EFS。在多变量分析中，治疗依从性是唯一预测EFS的因素（风险比0.64，95%置信区间0.50 - 0.83，P = 0.001）。CP - CML患者的长期随访显示其生存率低于临床试验报告的结果，并反映出影响“现实世界”患者的多个问题。长期随访期间EFS持续下降，由于疾病的慢性性质，可能需要时间才能影响PFS和OS。持续坚持治疗对于获得最佳长期疗效很重要。
