CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：Survival Outcomes with Cilta-cel Versus Conventional Treatment Regimens for Patients with Lenalidomide-Refractory Multiple Myeloma Using Inverse Probability of Treatment Weighting.
Survival Outcomes with Cilta-cel Versus Conventional Treatment Regimens for Patients with Lenalidomide-Refractory Multiple Myeloma Using Inverse Probability of Treatment Weighting.
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这项更新分析证实了此前观察到的 cilta-cel 在 PFS 和缓解结局方面显著优于常见方案，同时显示在该人群中具有显著的 OS 获益。这些发现支持 cilta-cel 作为来那度胺难治性 RRMM 患者尽早于二线使用的有效治疗。
3期CARTITUDE-4试验表明，在既往接受过1-3线治疗且对来那度胺耐药的复发/难治性多发性骨髓瘤（RRMM）患者中，ciltacabtagene autoleucel（cilta-cel）优于daratumumab、pomalidomide和dexamethasone方案，或pomalidomide、bortezomib和dexamethasone方案。此前已对cilta-cel与其他常用方案的比较疗效进行过评估。在此，我们呈现更新的比较疗效评估，包括OS，比较cilta-cel（CARTITUDE-4 34个月中位随访）与常用方案。
个体患者数据来自CARTITUDE-4（cilta-cel）、CASTOR（daratumumab、bortezomib和dexamethasone [DVd]）、CANDOR（daratumumab、carfilzomib和dexamethasone [DKd]以及carfilzomib和dexamethasone [Kd]）和APOLLO（pomalidomide和dexamethasone [Pd]）。采用逆概率治疗加权（IPTW）来调整关键基线患者特征的不平衡。相对疗效通过缓解率比和缓解率的95%置信区间（CI）进行估计，PFS和OS则通过风险比（HR）和95% CI进行估计。探索了使用替代统计方法的敏感性分析。
在排除53例既往接受过抗CD38治疗的患者后，将cilta-cel（n = 155）与DVd（n = 44）、DKd（n = 98）、Kd（n = 46）和Pd（n = 92）进行比较。经过IPTW后，各队列间的基线协变量总体均衡良好。与所有方案相比，cilta-cel在PFS（HR 0.21-0.58；p ≤ 0.01）和OS（HR 0.31-0.55；p < 0.05）方面均显示出显著改善。随着随访时间延长，cilta-cel相对于其他方案在更深缓解水平上的相对获益进一步增加。尽管除ORR外，所有结果均显著有利于cilta-cel，但DKd比较提供了最为保守的估计。
Individual patient data were available from CARTITUDE-4 (cilta-cel), CASTOR (daratumumab, bortezomib and dexamethasone [DVd]), CANDOR (daratumumab, carfilzomib and dexamethasone [DKd] and carfilzomib and dexamethasone [Kd]) and APOLLO (pomalidomide and dexamethasone [Pd]). Inverse probability of treatment weighting (IPTW) was used to adjust for key baseline patient characteristic imbalances. Relative efficacies were estimated with response rate ratios and 95% confidence intervals (CIs) for response rates, with hazard ratios (HRs) and 95% CIs for PFS and OS. Sensitivity analyses using alternative statistical approaches were explored.
After excluding 53 patients with prior anti-CD38 therapy exposure, cilta-cel (n = 155) was compared with DVd (n = 44), DKd (n = 98), Kd (n = 46) and Pd (n = 92). Baseline covariates were generally well balanced across cohorts after IPTW. Cilta-cel showed significant improvements in PFS (HR 0.21-0.58; p ≤ 0.01) and OS (HR 0.31-0.55; p < 0.05) vs all regimens. With longer follow-up, the relative benefit of cilta-cel versus other regimens further increased on deeper levels of response. Although all results, except ORR, significantly favored cilta-cel, the DKd comparison provided the most conservative estimates.
This updated analysis confirms previously observed significant superiority of PFS and response outcomes of cilta-cel while showing significant OS benefit compared with common regimens for this population. These findings support cilta-cel as an effective treatment for lenalidomide-refractory RRMM patients as early as second line. TRIAL REGISTRATION: CARTITUDE-4 ClinicalTrials.gov ID: NCT04181827.
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