肿瘤细胞治疗研究
英文原题：Second Primary Malignancy Risk in Patients with Multiple Myeloma Receiving CAR T-cell Therapy or Other Systemic Anticancer Treatments: A Real-World Comparative Study.
在这一随访时间相对较短的真实世界数据集中，与其他全身性抗肿瘤治疗相比，多发性骨髓瘤患者在接受 CAR-T 治疗后似乎具有更高的血液系统第二原发恶性肿瘤风险。
目的：比较接受嵌合抗原受体（CAR）T 细胞治疗与其他系统性抗肿瘤治疗（SACT）的多发性骨髓瘤患者发生第二原发恶性肿瘤（SPM）的风险。 研究设计：研究人员从 Komodo Health 理赔数据中识别开始接受 CAR-T 治疗或其他 SACT 的成年多发性骨髓瘤患者，并通过加权平衡基线特征。研究估算了 24 个月内 SPM 的累积发生率，并计算 0 至 24 个月期间差异的 P 值。 结果：研究纳入 435 例接受 CAR-T 治疗的患者和 12,268 例接受其他 SACT 的患者（中位随访时间为 11.8 个月）。与其他 SACT 相比，CAR-T 治疗与任何 SPM 风险相近（24 个月时为 24.1% vs. 22.3%；0–24 个月的 P 值 = 0.31），实体瘤 SPM 风险也相近（9.1% vs. 11.5%；0–24 个月的 P 值 = 0.32），但血液系统 SPM 风险显著更高（17.9% vs. 13.1%；0–24 个月的 P 值 = 0.04）。在一项要求通过 2 次理赔记录识别 SPM 的敏感性分析中，血液系统 SPM 风险差异减弱（5.5% vs. 4.9%；0–24 个月的 P 值 = 0.08）。值得注意的是，CAR-T 治疗后骨髓检查更常见（例如治疗后 0–3 个月为 47% vs. 13%）。 结论：在这组随访时间相对较短的真实世界数据中，与其他 SACT 相比，接受 CAR-T 治疗的多发性骨髓瘤患者似乎有更高的血液系统 SPM 风险。然而，不能排除分类错误和检测偏倚的影响。这一关联仍需进一步评估。医生应警惕 CAR-T 治疗后的髓系恶性肿瘤。
PURPOSE: This study aims to compare the risk of second primary malignancy (SPM) between patients with multiple myeloma who received chimeric antigen receptor T-cell (CAR T) therapy versus other systemic anticancer therapies (SACT). EXPERIMENTAL DESIGN: Adult patients with multiple myeloma who initiated CAR T therapy or other SACT were identified from Komodo Health claims data and weighted to balance baseline characteristics. Cumulative incidence of SPM was estimated over 24 months, and P values were calculated for the difference between 0 and 24 months. RESULTS: The study included 435 patients who received CAR T therapy and 12,268 patients who received other SACT (median follow-up, 11.8 months). Compared with other SACT, CAR T therapy was associated with similar risks of any SPM (at 24 months, 24.1% vs. 22.3%; P0-24 months = 0.31) and solid SPM (9.1% vs. 11.5%, P0-24 months = 0.32) but significantly higher risk of hematologic SPM (17.9% vs. 13.1%, P0-24 months = 0.04). In a sensitivity analysis requiring 2 claims to identify an SPM, difference in hematologic SPM risk was attenuated (5.5% vs. 4.9%, P0-24 months = 0.08). Notably, bone marrow examinations were more common after CAR T therapy (e.g., 47% vs. 13% at 0-3 months). CONCLUSIONS: In this real-world dataset with relatively short follow-up, patients with multiple myeloma seemed to have a higher risk of hematologic SPM after CAR T therapy compared with other SACT. However, misclassification and detection bias cannot be ruled out. The association warrants further evaluation. Physicians should be vigilant for myeloid malignancies after CAR T therapy.
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