Lymphoma Program, Massachusetts General Hospital Cancer Center, Boston, MA.
Division of Hematology, Mayo Clinic, Rochester, MN.
Blood Adv. 2022 Dec 13;6(23):5969-5979. doi: 10.1182/bloodadvances.2022008106.
Lisocabtagene maraleucel (liso-cel) has shown promising efficacy in clinical trials for patients with relapsed/refractory large B-cell lymphoma (LBCL). We present health-related quality of life (HRQOL) results from the TRANSFORM study, the first comparative analysis of liso-cel vs standard of care (SOC) as second-line therapy in this population. Adults with LBCL refractory or relapsed ≤12 months after first-line therapy and eligible for autologous stem cell transplantation were randomized 1:1 to the liso-cel or SOC arms (3 cycles of immunochemotherapy in which responders proceeded to high-dose chemotherapy and autologous stem cell transplantation). HRQOL was assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - 30 items and the Functional Assessment of Cancer Therapy-Lymphoma subscale. Patients with baseline and ≥1 postbaseline assessment were analyzed (liso-cel, n = 47; SOC, n = 43). The proportion of patients with meaningful improvement in global health status/quality of life (QOL) was higher, whereas deterioration was lower in the liso-cel arm vs SOC arm from day 126 to month 6. Mean change scores showed meaningful worsening in global health status/QOL at month 6, fatigue at day 29 and month 6, and pain at month 6 with SOC; mean scores for other domains were maintained or improved in both arms. Time to confirmed deterioration favored the liso-cel arm vs SOC arm in global health status/QOL (median: not reached vs 19.0 weeks, respectively; hazard ratio, 0.47; 95% confidence interval, 0.24-0.94). HRQOL was either improved or maintained from baseline in patients with relapsed/refractory LBCL in the liso-cel arm vs SOC arm as second-line treatment. This study is registered at clinicaltrials.gov as #NCT0357531.
利妥昔单抗注射用细胞（liso-cel）在复发/难治性大 B 细胞淋巴瘤（LBCL）患者的临床试验中显示出良好的疗效。我们报告了 TRANSFORM 研究的健康相关生活质量（HRQOL）结果，这是首次在该人群中比较 liso-cel 与标准治疗（SOC）作为二线治疗的分析。一线治疗后 12 个月内复发/难治的 LBCL 成人，且有资格接受自体干细胞移植，按 1:1 随机分配至 liso-cel 或 SOC 组（3 个周期免疫化疗，其中有反应者进行高剂量化疗和自体干细胞移植）。HRQOL 通过欧洲癌症研究与治疗组织生活质量问卷-30 项和癌症治疗功能评估-淋巴瘤亚量表进行评估。分析了有基线和≥1 个基线后评估的患者（liso-cel，n=47；SOC，n=43）。从第 126 天到第 6 个月，liso-cel 组比 SOC 组有更多患者的全球健康状况/生活质量（QOL）有显著改善，恶化更少。第 6 个月时，SOC 组的全球健康状况/QOL、乏力（第 29 天和第 6 个月）和疼痛（第 6 个月）的平均变化评分明显恶化，而两组的其他领域的评分保持或改善。从第 126 天到第 6 个月，SOC 组的全球健康状况/QOL 确认恶化的时间较 liso-cel 组长（中位时间：SOC 组未达到，liso-cel 组为 19.0 周；风险比，0.47；95%置信区间，0.24-0.94）。二线治疗时，复发/难治性 LBCL 患者的 liso-cel 组与 SOC 组的 HRQOL 要么改善，要么保持基线水平。这项研究在 clinicaltrials.gov 注册，编号为 #NCT0357531。
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