Dartmouth Hitchcock Medical Center, Hanover, New Hampshire, USA.
Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
Acta Haematol. 2020;143(1):40-50. doi: 10.1159/000500666. Epub 2019 Jul 17.
Outcomes for patients with peripheral T-cell lymphoma (PTCL) who fail to achieve complete response (CR) or relapse after front-line therapy are poor with lack of prospective outcomes data.
COMPLETE is a prospective registry of 499 patients enrolled at academic and community sites in the United States detailing patient demographics, treatment and outcomes for patients with aggressive T cell lymphomas. We report results for patients with primary refractory and relapsed disease.
Primary refractory disease was defined as an evaluable best response to initial treatment (induction ± maintenance or consolidation/transplant) other than CR, and included a partial response, progressive disease, or no response/stable disease. Relapsed disease was defined as an evaluable best response to initial treatment of CR, followed by disease progression at a later date, irrespective of time to progression. Patients were included in the analysis if initial treatment began within 30 days of enrollment and treatment duration was ≥4 days.
Of 420 evaluable patients, 97 met the definition for primary refractory and 58 with relapsed disease. In the second-line setting, relapsed patients received single-agent therapies more often than refractory patients (52 vs. 28%; p = 0.01) and were more likely to receive single-agent regimens (74 vs. 53%; p = 0.03). The objective response rate to second-line therapy was higher in relapsed patients (61 vs. 40%; p = 0.04) as was the proportion achieving a CR (41 vs. 14%; p = 0.002). Further, relapsed patients had longer overall survival (OS) compared to refractory patients, with a median OS of 29.1 versus 12.3 months.
Despite the availability of newer active single agents, refractory patients were less likely to receive these therapies and continue to have inferior outcomes compared to those with relapsed disease. PTCL in the real world remains an unmet medical need, and improvements in front-line therapies are needed.
对于未能达到完全缓解（CR）或一线治疗后复发的外周 T 细胞淋巴瘤（PTCL）患者，由于缺乏前瞻性结果数据，其预后较差。
COMPLETE 是一项在美国学术和社区站点入组的 499 例患者的前瞻性登记研究，详细描述了侵袭性 T 细胞淋巴瘤患者的患者特征、治疗和结局。我们报告原发性难治性和复发性疾病患者的结果。
原发性难治性疾病定义为初始治疗（诱导+维持或巩固/移植）除 CR 以外的最佳反应可评估，包括部分缓解、进展性疾病或无反应/稳定疾病。复发性疾病定义为初始治疗 CR 的最佳反应，随后在以后的时间出现疾病进展，无论进展时间如何。如果初始治疗在入组后 30 天内开始且治疗持续时间≥4 天，则患者纳入分析。
在 420 例可评估患者中，97 例符合原发性难治性定义，58 例患有复发性疾病。在二线治疗中，复发性疾病患者接受单药治疗的比例高于难治性疾病患者（52%比 28%；p=0.01），且更有可能接受单药治疗方案（74%比 53%；p=0.03）。二线治疗的客观缓解率在复发性疾病患者中更高（61%比 40%；p=0.04），达到 CR 的比例也更高（41%比 14%；p=0.002）。此外，复发性疾病患者的总生存（OS）长于难治性疾病患者，中位 OS 分别为 29.1 个月和 12.3 个月。
尽管有新型有效单药治疗，但难治性疾病患者接受这些治疗的可能性较小，与复发性疾病患者相比，其结局仍较差。现实世界中的 PTCL 仍然是一种未满足的医疗需求，需要改进一线治疗。
