ImportanceRadiation therapy to doses of 24 to 36 Gy is currently used to treat indolent B-cell lymphoma of the ocular adnexa; however, ocular adverse effects are common.ObjectiveTo determine if a response-adapted radiation therapy strategy will result in excellent disease outcomes while reducing orbital morbidity.Design, Setting, and ParticipantsThis single-institution, phase 2 prospective nonrandomized controlled trial of a response-adapted strategy involved 50 evaluable patients with stage I to IV indolent B-cell lymphoma of the ocular adnexa enrolled between July 2015 and January 2021. This treatment approach was also retrospectively evaluated with a separate 55-patient cohort treated between March 2013 and October 2021. All data were analyzed between November 2021 and December 2023.InterventionsPatients were treated with ultralow-dose radiation therapy to 4 Gy in 2 fractions and assessed for response at 3-month intervals. Patients with persistent orbital lymphoma were offered an additional 20 Gy in 10 fractions to complete the response-adapted treatment.Main Outcome and MeasuresThe primary end point was 2-year local orbital control within the irradiated field after response-adapted therapy. Secondary end points included overall survival and complete response rate.ResultsThe 50 prospective patients were a median (range) of 63 (29-88) years old, and 31 (62%) were female. Among the 50 patients, 32 (64%) had mucosa-associated lymphoid tissue lymphoma, 12 (24%) had follicular lymphoma, and 6 (12%) had unclassifiable low-grade B-cell lymphoma. Thirty-one patients (62%) had stage I disease, and 36 (72%) were newly diagnosed. At a median follow-up of 37.4 (95% CI, 33.7-52.5) months, the 2-year local control rate was 89.4% (95% CI, 81.0%-98.7%), and the 2-year overall survival rate was 98.0% (95% CI, 94.1%-100%); 45 patients (90.0%; 95% CI, 78.2%-96.7%) experienced a complete response to response-adapted radiation, including 44 patients with a complete response to ultralow-dose radiation and 1 patient with a complete response after an additional 20 Gy. No local recurrences were observed among patients with a complete response to response-adapted therapy. No grade 3 or higher toxic effects were observed. In a planned subset analysis of 22 patients with newly diagnosed, untreated stage I mucosa-associated lymphoid tissue lymphoma, the 2-year local control rate was 90.7% (95% CI, 79.2%-100%), and the 2-year freedom from distant relapse rate was 95.2% (95% CI, 86.6%-100%).Conclusion and RelevanceIn this nonrandomized controlled trial, response-adapted ultralow-dose therapy for indolent orbital B-cell lymphoma resulted in reduced radiation exposure, negligible toxic effects, and excellent disease outcomes.Trial RegistrationClinicalTrials.gov Identifier: NCT02494700

中文翻译：

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眼眶惰性 B 细胞淋巴瘤的适应反应超低剂量放射治疗


重要性目前使用 24 至 36 Gy 剂量的放射治疗来治疗眼附件惰性 B 细胞淋巴瘤；然而，眼部不良反应很常见。目的确定适应反应的放射治疗策略是否会带来良好的疾病结果，同时降低眼眶发病率。设计、设置和参与者这项针对反应适应的单一机构、2 期前瞻性非随机对照试验该策略涉及 2015 年 7 月至 2021 年 1 月期间入组的 50 名可评估的眼附件 I 至 IV 期惰性 B 细胞淋巴瘤患者。这种治疗方法还通过 2013 年 3 月至 2021 年 10 月期间治疗的单独的 55 名患者队列进行了回顾性评估。对 2021 年 11 月至 2023 年 12 月期间的数据进行分析。 干预措施 患者接受 2 次 4 Gy 的超低剂量放射治疗，并每隔 3 个月评估疗效。持续性眼眶淋巴瘤患者分 10 次额外接受 20 Gy 照射，以完成适应反应的治疗。主要结果和措施主要终点是适应反应的治疗后 2 年照射野内的局部眼眶控制。次要终点包括总生存率和完全缓解率。 结果 50 名前瞻性患者的中位年龄（范围）为 63 (29-88) 岁，其中 31 名 (62%) 为女性。在 50 名患者中，32 名（64%）患有粘膜相关淋巴组织淋巴瘤，12 名（24%）患有滤泡性淋巴瘤，6 名（12%）患有无法分类的低度 B 细胞淋巴瘤。 31 名患者（62%）患有 I 期疾病，36 名患者（72%）是新诊断的。中位随访时间为 37.4 (95% CI, 33.7-52.5) 个月，2 年局部控制率为 89.4% (95% CI, 81.0%-98)。7%），2年总生存率为98.0%（95% CI，94.1%-100%）； 45 名患者 (90.0%; 95% CI, 78.2%-96.7%) 对适应适应放疗出现完全缓解，其中 44 名患者对超低剂量放疗完全缓解，1 名患者在额外 20 Gy 后获得完全缓解。在对反应适应治疗完全缓解的患者中没有观察到局部复发。未观察到 3 级或更高级别的毒性作用。在对 22 名新诊断、未经治疗的 I 期粘膜相关淋巴组织淋巴瘤患者进行的计划亚组分析中，2 年局部控制率为 90.7%（95% CI，79.2%-100%），2 年自由度为远处复发率为 95.2%（95% CI，86.6%-100%）。结论和相关性在这项非随机对照试验中，惰性眼眶 B 细胞淋巴瘤的适应反应超低剂量治疗导致辐射暴露减少，毒性作用可以忽略不计，以及出色的疾病结果。试验注册临床试验。政府标识符：NCT02494700