Lymphoma Unit, Department of Onco-Hematology.
Ophthalmology Unit, and.
Blood Adv. 2020 Mar 24;4(6):1013-1019. doi: 10.1182/bloodadvances.2020001459.
Patients with indolent conjunctival lymphomas exhibit good prognosis, with exceptional cases of dissemination, and are suitable candidates for intralesional therapies. We report the first prospective phase 2 trial using intralesional rituximab supplemented with autologous serum in adults with relapsed/refractory indolent CD20+ lymphoma of the conjunctiva (NCT01514344). Patients received 4 weekly intralesional injections of rituximab, followed by 6 monthly injections; 500 μL of autologous serum was added to rituximab in patients with lymphoma unresponsive to weekly doses. Safety, activity, and antitumor effect of autologous serum were investigated. Twenty patients with mucosa-associated lymphoid tissue (MALT)-type lymphoma were enrolled. Tolerability was excellent, with only 3 mild local reactions. After weekly injections, 11 patients achieved tumor regression, 8 had stable disease, and 1 experienced progressive disease; 9 patients received autologous serum, with response improvement in 4 cases (3 complete responses, 1 partial response). At the end of treatment, 12 patients achieved a complete remission, and 1 achieved a partial response, with an overall response rate of 65% (95% confidence interval, 45-85). At a median follow-up of 42 months (range, 10-78), 12 patients remain relapse free, with 5-year progression-free survival and time-to-next-treatment rates of 59% ± 11% and 69% ± 11%, respectively. Three patients with local relapse were retreated with intralesional rituximab and serum; 2 achieved a complete response that lasted 25+ and 38+ months. Thus, intralesional rituximab is a safe and active therapy in patients with relapsed conjunctival MALT lymphoma. The addition of autologous serum improves response in some cases. Retreatment of local relapses can result in a second durable remission.
惰性结膜淋巴瘤患者预后良好，偶有播散病例，适合接受局部治疗。我们报告了首例前瞻性 2 期临床试验，使用局部利妥昔单抗联合自体血清治疗复发性/难治性惰性 CD20+结膜淋巴瘤成人患者（NCT01514344）。患者接受每周 1 次、共 4 次的局部利妥昔单抗注射，随后每 6 个月 1 次；每周剂量无反应的患者中，将 500μL 自体血清加入利妥昔单抗。评估安全性、活性和自体血清的抗肿瘤作用。共纳入 20 例黏膜相关淋巴组织（MALT）型淋巴瘤患者。耐受性极好，仅 3 例出现轻微局部反应。每周注射后，11 例患者肿瘤消退，8 例疾病稳定，1 例疾病进展；9 例患者接受自体血清治疗，4 例（3 例完全缓解，1 例部分缓解）反应改善。治疗结束时，12 例患者完全缓解，1 例部分缓解，总缓解率为 65%（95%置信区间，45%-85%）。中位随访 42 个月（范围，10-78）时，12 例患者无疾病复发，5 年无进展生存率和至下次治疗时间率分别为 59%±11%和 69%±11%。3 例局部复发患者接受局部利妥昔单抗和血清治疗，2 例获得持续 25+和 38+个月的完全缓解。因此，局部利妥昔单抗治疗复发性结膜 MALT 淋巴瘤是一种安全有效的治疗方法。在某些情况下，添加自体血清可提高反应率。局部复发的再治疗可导致第二次持久缓解。
