Messori Andrea, Rivano Melania, Mengato Daniele, Chiumente Marco
Health Technology Assessment (HTA) Unit, Regione Toscana, Firenze, ITA.
Clinical Oncology Pharmacy Department, Armando (A) Businco Hospital, Cagliari, ITA.
Cureus. 2022 Dec 31;14(12):e33169. doi: 10.7759/cureus.33169. eCollection 2022 Dec.
Background and objectives Glofitamab, tafasitamab, loncastuximab tesirine, polatuzumab, and selinexor have been proposed for the treatment of relapsed-refractory diffuse large B-cell lymphoma (DLBCL). We studied the pattern of overall survival (OS) for these five agents. Methods We reconstructed patient-level data from the Kaplan-Meier OS graphs published in five pivotal trials. For this purpose, we used an artificial intelligence technique (the Shiny method). Reconstructed survival curves were subjected to standard statistics to perform cross-trial indirect comparisons; medians and hazard ratios (HRs) with 95% confidence interval (CI) were estimated for each treatment. Results Using glofitamab (a bispecific antibody) as a common comparator, our analysis of OS yielded the following results: a) tafasitamab plus lenalidomide, HR: 0.514 (95% CI: 0.341 to 0.776; P=0.0015); b) polatuzumab vedotin, HR: 0.822 (95% CI: 0.509 to 1.327); c) selinexor, HR: 1.170 (95% CI: 0.852 to 1.603); and d) loncastuximab tesirine, HR: 1.120 (95% CI: 0.868 to 1.659). Medians were estimated as follows: a) tafasitamab plus lenalidomide, 26.5 months (95% CI: 18.9 to NA); b) polatuzumab vedotin, 12.5 months (95% CI: 9.03 to NA); c) glofitamab, 11.7 months (95% CI: 7.96 to 18.0); d) loncastuximab tesirine, 10.2 months (95% CI: 6.97 to 11.6); and e) selinexor, 10.1 months (95% CI: 6.72 to 14.2). Conclusions These comparative results represent an original finding generated by the Shiny method. Although these comparisons are indirect, our analysis offers a useful synthesis of the outcomes of these treatments. According to these results, glofitamab, despite its improved mechanism of action, does not seem to confer any OS advantage compared with the other four treatments.
已提出使用戈利木单抗、塔法西单抗、朗卡斯图单抗西瑞因、泊洛妥珠单抗和塞利尼索治疗复发难治性弥漫性大B细胞淋巴瘤（DLBCL）。我们研究了这五种药物的总生存期（OS）模式。方法：我们从五项关键试验中发表的Kaplan-Meier OS图重建了患者水平的数据。为此，我们使用了一种人工智能技术（Shiny方法）。对重建的生存曲线进行标准统计以进行跨试验间接比较；估计每种治疗的中位数和危险比（HR）以及95%置信区间（CI）。结果：以戈利木单抗（一种双特异性抗体）作为共同对照，我们对OS的分析得出以下结果：a）塔法西单抗加来那度胺，HR：0.514（95%CI：0.341至0.776；P = 0.0015）；b）泊洛妥珠单抗，HR：0.822（95%CI：0.509至1.327）；c）塞利尼索，HR：1.170（95%CI：0.852至1.603）；d）朗卡斯图单抗西瑞因，HR：1.120（95%CI：0.868至1.659）。中位数估计如下：a）塔法西单抗加来那度胺，26.5个月（95%CI：18.9至无可用数据）；b）泊洛妥珠单抗，12.5个月（95%CI：9.03至无可用数据）；c）戈利木单抗，11.7个月（95%CI：7.96至18.0）；d）朗卡斯图单抗西瑞因，10.2个月（95%CI：6.97至11.6）；e）塞利尼索，10.1个月（95%CI：6.72至14.2）。结论：这些比较结果是Shiny方法产生的一项原创发现。尽管这些比较是间接的，但我们的分析为这些治疗的结果提供了有用的综合。根据这些结果，戈利木单抗尽管其作用机制有所改进，但与其他四种治疗相比似乎并未带来任何OS优势。
