Abstract：
External beam radiotherapy is effective for stage I orbital mucosa-associated lymphoid tissue lymphoma (MALToma). Hence, very-low-dose radiotherapy is increasingly being investigated. We conducted a single-center prospective phase II trial to evaluate the effectiveness of very-low-dose radiotherapy of 4 Gy (2 Gy × 2 fractions) in pathologically confirmed stage I orbital MALToma. In this first prospective trial, patients with complete response were observed after 3-6 months of follow-up. For patients without complete remission, a radiation dose of 24 Gy/12 fractions was additionally delivered. The primary endpoint was complete response rate; secondary endpoints were overall survival, local control, and progression-free survival. Seventeen patients were screened and three patients refused enrollment during October 2018-October 2021. Thus, 14 patients (17 eyes) were analyzed (median follow-up, 28.2 months). The overall response rate was 100% (complete remission: 11 lesions; partial remission: six lesions). In all lesions with residual disease, additional radiation therapy (dose: 24 Gy) was performed. One local failure was observed. Therefore, 4 Gy ultralow-dose radiation therapy for orbital MALToma was safely performed with a planned second-line treatment in patients without complete remission. This is the first prospective study to report the effectiveness of ultralow-dose radiotherapy of 4 Gy for stage I orbital MALToma treatment.
摘要：
外束放疗对Ⅰ期眶粘膜相关淋巴组织淋巴瘤（MALToma）有效。因此，极低剂量放射治疗正在被越来越多的研究。我们进行了一项单中心前瞻性II期试验，以评估4Gy（2Gy×2分数）的极低剂量放疗在病理证实的I期眼眶MALToma中的有效性。在第一次前瞻性试验中,随访3~6个月后观察到完全缓解的患者.对于没有完全缓解的患者，另外提供了24Gy/12分的辐射剂量.主要终点是完全缓解率；次要终点是总生存期，本地控制,和无进展生存期。在2018年10月至2021年10月期间，17名患者接受了筛查，3名患者拒绝登记。因此，分析了14例患者(17只眼)(中位随访，28.2个月）。总反应率为100％（完全缓解：11个病灶；部分缓解：6个病灶）。在所有残留病变中，进行了额外的放射治疗(剂量:24Gy).观察到一个局部故障。因此,4Gy对眼眶MALToma的超低剂量放射治疗安全进行了计划的二线治疗，但未完全缓解。这是第一项前瞻性研究，报道了4Gy的超低剂量放射疗法用于I期眼眶MALToma治疗的有效性。
