Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA.
School of Medicine, Georgetown University, Washington, DC.
Blood Adv. 2022 Aug 23;6(16):4740-4762. doi: 10.1182/bloodadvances.2022007425.
Optimal treatment strategies for (relapsed and refractory [R/R]) peripheral T-cell lymphoma (PTCL) have not been well defined, and with the approval of several novel single agents (SA), the comparative efficacy of combination chemotherapy (CC) to single-agent strategies remains unclear. We conducted a meta-analysis to evaluate overall response rates (ORR) and toxicities of SA to CC. MEDLINE, Embase, Web of Science Core Collection, and Cochrane were systematically searched for phase I, phase II, and phase III trials investigating a defined SA or an anthracycline-, ifosfamide-, gemcitabine-, and platinum-based regimens. One hundred and fifty-one articles were included, encompassing single and combinations of 60 phase I trials involving 1075 patients, 95 phase II trials involving 3246, and 23 phase III trials involving 1888 patients. There was a high degree of heterogeneity in the trials. Using a random-effects model, the estimated ORR for SA in phase I trials were 40% (95% confidence interval [CI], 34.7%, 46.9%) relative to 41% for CC (95% CI, 27.4%, 56.1%; P = .97) and in phase II trials 34.4% (95% CI, 30.4%, 38.7%) for SA vs 55.3% (95% CI, 31%, 77.2%; P = .1) for CC. There were significant subgroup differences in ORR between histological subtypes of PTCL and drug classes. Our results highlight SA as an attractive outpatient option for R/R PTCL, and their incorporation in the development of upfront treatment paradigms merits urgent consideration. Our results underscore enrollment in clinical trials of SA as a critical strategy for R/R PTCL.
（复发/难治性 [R/R]）外周 T 细胞淋巴瘤（PTCL）的最佳治疗策略尚未明确，随着几种新型单药（SA）的批准，联合化疗（CC）与单药策略的相对疗效仍不清楚。我们进行了一项荟萃分析，以评估 SA 对 CC 的总体缓解率（ORR）和毒性。系统地检索了 MEDLINE、Embase、Web of Science Core Collection 和 Cochrane 中的 I 期、II 期和 III 期试验，以评估明确的 SA 或蒽环类药物、异环磷酰胺、吉西他滨和铂类药物方案。纳入了 151 篇文章，包括 60 项 I 期试验（涉及 1075 例患者）、95 项 II 期试验（涉及 3246 例患者）和 23 项 III 期试验（涉及 1888 例患者），这些试验的组合。试验中存在高度异质性。使用随机效应模型，I 期试验中 SA 的估计 ORR 为 40%（95%置信区间 [CI]，34.7%，46.9%），而 CC 为 41%（95% CI，27.4%，56.1%；P =.97）；II 期试验中，SA 的 ORR 为 34.4%（95% CI，30.4%，38.7%），CC 为 55.3%（95% CI，31%，77.2%；P =.1）。PTCL 的组织学亚型和药物类别之间存在显著的亚组差异。我们的结果强调了 SA 作为 R/R PTCL 有吸引力的门诊选择，并且迫切需要考虑将其纳入一线治疗模式的开发中。我们的结果强调了参与 R/R PTCL 的 SA 临床试验是一项关键策略。
