Rivano Melania, Mengato Daniele, Chiumente Marco, Messori Andrea
Binaghi Hospital, 09126 Cagliari, Italy.
Hospital Pharmacy Department, Azienda Ospedale-Università of Padova, Via Giustiniani 2, 35128 Padua, Italy.
Hematol Rep. 2023 Nov 26;15(4):670-683. doi: 10.3390/hematolrep15040068.
In Philadelphia chromosome-positive B-cell (Ph+) acute lymphoblastic leukemia (LLA), growing evidence has accumulated regarding the efficacy of low-intensity and chemo-free regimens. Our objective was to analyze all recent trials evaluating these treatments and to compare them in terms of efficacy. We applied the Shiny method, an artificial intelligence technique, to analyze Kaplan-Meier curves and reconstruct patient-level data. Reconstructed patient data were then evaluated through standard survival statistics and subjected to indirect head-to-head treatment comparisons. The endpoint was progression-free survival (PFS). Based on 432 reconstructed patients, eight trials were analyzed. The survival data from these trials were pooled into three types of treatments: (i) treatments based on tyrosine kinase inhibitors (TKIs) combined with reduced-intensity chemotherapy (denoted as TKICHE); (ii) TKIs associated with steroids with no chemotherapy (TKISTE); (iii) chemotherapy-free combinations of blinatumomab plus TKIs (TKIBLI). According to the Shiny method, the three PFS curves were reported in a single Kaplan-Meier graph and subjected to survival statistics. In terms of PFS, TKIBLI ranked first, TKICHE second, and TKISTE third; the differences between these three regimens were statistically significant. This multi-treatment Kaplan-Meier graph, generated through the Shiny method, summarized the current evidence on these treatments in both qualitative and quantitative terms.
在费城染色体阳性B细胞(Ph+)急性淋巴细胞白血病(ALL)中,关于低强度和无化疗方案疗效的证据越来越多。我们的目标是分析所有评估这些治疗方法的近期试验,并在疗效方面对它们进行比较。我们应用了人工智能技术Shiny方法来分析Kaplan-Meier曲线并重建患者层面的数据。然后通过标准生存统计评估重建的患者数据,并进行间接的直接治疗比较。终点是无进展生存期(PFS)。基于432例重建患者,分析了八项试验。这些试验的生存数据被汇总为三种治疗类型:(i)基于酪氨酸激酶抑制剂(TKIs)联合降低强度化疗的治疗方法(表示为TKICHE);(ii)与类固醇联合使用且无化疗的TKIs(TKISTE);(iii)博纳吐单抗加TKIs的无化疗组合(TKIBLI)。根据Shiny方法,三条PFS曲线在单个Kaplan-Meier图中报告并进行生存统计。在PFS方面,TKIBLI排名第一,TKICHE第二,TKISTE第三;这三种方案之间的差异具有统计学意义。通过Shiny方法生成的这种多治疗Kaplan-Meier图,从定性和定量两方面总结了目前关于这些治疗方法的证据。