Dermatology Department, CHU Bordeaux, Bordeaux, France; INSERM U1053, Bordeaux Research in Translational Oncology, Team 3 oncogenesis of cutaneous lymphomas, Université de Bordeaux, Bordeaux, France.
Dermatology Department, CHU Bordeaux, Bordeaux, France.
J Invest Dermatol. 2018 Sep;138(9):1982-1989. doi: 10.1016/j.jid.2018.03.1516. Epub 2018 Mar 27.
Although the combination of rituximab and polychemotherapy has improved prognosis of primary cutaneous diffuse large B-cell lymphoma, leg type, the advanced age of patients limits therapeutic options in relapsing/refractory cases. A multicenter, single-arm, phase II trial was conducted to assess the benefits and safety of lenalidomide in refractory/relapsing primary cutaneous diffuse large B-cell lymphoma, leg type. The primary endpoint was the 6-month overall response rate. Secondary endpoints were 12-month overall response rate, overall and specific survival, duration of response, progression-free survival, safety, and identification of prognostic factors. Among the 19 patients included, the 6-month overall response rate was 26.3% (90% confidence interval [CI] = 11-47.6), including four complete responses and one partial response. At 12 months, there were still two complete responses and one partial response. Median progression-free survival was 4 months. Median overall and specific survivals were 19.4 and 23.8 months, respectively. Reduced doses tended to be associated with higher 6-month overall response rate and progression-free survival. Absence of the MYD88 mutation was associated with a higher overall response under treatment (80.0% vs. 33.3%; P = 0.05). The most common grade 3 adverse events were hematologic. Two grade 5 adverse events occurred (sepsis and pulmonary embolism). Lenalidomide at reduced doses may allow prolonged responses in a few patients and represents a therapeutic option in relapsing/refractory primary cutaneous diffuse large B-cell lymphoma, leg type.
尽管利妥昔单抗联合化疗改善了原发性皮肤弥漫性大 B 细胞淋巴瘤，腿型的预后，但患者的高龄限制了复发/难治性病例的治疗选择。一项多中心、单臂、II 期试验评估了来那度胺在难治性/复发性原发性皮肤弥漫性大 B 细胞淋巴瘤，腿型中的疗效和安全性。主要终点是 6 个月的总缓解率。次要终点是 12 个月的总缓解率、总生存率和特异性生存率、缓解持续时间、无进展生存期、安全性和预后因素的确定。在纳入的 19 例患者中，6 个月的总缓解率为 26.3%（90%置信区间[CI] 11-47.6），包括 4 例完全缓解和 1 例部分缓解。12 个月时，仍有 2 例完全缓解和 1 例部分缓解。无进展生存期的中位数为 4 个月。总生存率和特异性生存率的中位数分别为 19.4 个月和 23.8 个月。减少剂量与较高的 6 个月总缓解率和无进展生存率相关。缺乏 MYD88 突变与治疗下更高的总缓解率相关（80.0%比 33.3%；P = 0.05）。最常见的 3 级不良事件是血液学事件。发生了 2 例 5 级不良事件（败血症和肺栓塞）。减少剂量的来那度胺可能使少数患者获得更长的缓解时间，是复发性/难治性原发性皮肤弥漫性大 B 细胞淋巴瘤，腿型的一种治疗选择。
