The University of Texas MD Anderson Cancer Center, Houston, Texas.
The University of Texas MD Anderson Cancer Center, Houston, Texas.
Int J Radiat Oncol Biol Phys. 2021 Apr 1;109(5):1414-1420. doi: 10.1016/j.ijrobp.2020.11.070. Epub 2020 Dec 10.
We report the long-term results of a prospective trial conducted to determine the efficacy and safety of radiation therapy (RT) alone in treating localized mucosa-associated lymphoid tissue (MALT) lymphoma.
Patients with localized MALT lymphoma were eligible and treated with involved field RT to doses of 24 to 39.6 Gy. Relapse-free survival (RFS) was the primary endpoint. Kaplan-Meier analysis was used to estimate RFS, progression-free survival (PFS), and overall survival (OS) defined from time of study entry. Preplanned subgroup analyses were performed based on site of involvement.
From 2000 to 2012, 75 patients were accrued; 73 received protocol-specified RT. Median follow-up was 9.8 years. Thirty-four patients had gastric MALT, 17 orbital, 13 head and neck nonorbit, 4 skin, and 5 disease of other sites. Thirteen of 34 patients with gastric MALT were Helicobacter pylori positive at the time of initial diagnosis and underwent 1 to 3 courses of triple antibiotic therapy. All gastric MALT patients had documented persistent MALT without H. pylori on endoscopy before enrollment in the study. All patients achieved a complete response with a median time of 3 months. Eleven patients (15%) had disease relapse, 9 of which were at sites outside the RT field with median time to progression of 38.3 months. Median PFS was 17.5 years, and median RFS and OS were not reached. The 10-year relapse-free rate was 83% (95% confidence interval [CI], 74%-93%). The 10-year PFS rate was 71% (95% CI, 60%-84%). The 10-year OS rate was 86% (95% CI, 77%-96%). RFS, PFS, and OS did not differ by disease site (P = .17, .43, and .50, respectively). All relapses were successfully salvaged. One patient developed metastatic gastric adenocarcinoma and was found to also have recurrent MALT on biopsy. Otherwise, all relapsed patients were alive without evidence of disease at last follow-up, and no patient died of MALT lymphoma. Sixty-seven patients (92%) experienced acute toxicity during radiation, all of which were grade 1 and 2, with only 1 grade 3 toxicity. Twenty-two patients (30%) experienced late toxicity, with only 1 grade 3 toxicity.
This prospective study confirms that RT for MALT lymphoma provides excellent long-term RFS with acceptable rates of toxicity. Current efforts are focused on RT de-escalation in an effort to further avoid treatment-related morbidity. CLINICALTRIALS.GOV: NCT04465162.
我们报告了一项前瞻性试验的长期结果，该试验旨在确定单纯放疗治疗局限性黏膜相关淋巴组织（MALT）淋巴瘤的疗效和安全性。
符合条件的患者为局限性 MALT 淋巴瘤，采用累及野放疗，剂量为 24 至 39.6 Gy。无复发生存（RFS）是主要终点。采用 Kaplan-Meier 分析估计从研究入组时间开始的 RFS、无进展生存（PFS）和总生存（OS）。根据受累部位进行了预设的亚组分析。
2000 年至 2012 年，共入组 75 例患者；73 例患者接受了规定的放疗。中位随访时间为 9.8 年。34 例患者为胃 MALT，17 例为眼眶，13 例为头颈部非眼眶，4 例为皮肤，5 例为其他部位。34 例胃 MALT 患者中有 13 例在初始诊断时幽门螺杆菌阳性，并接受了 1 至 3 个疗程的三联抗生素治疗。所有胃 MALT 患者在入组前均经内镜证实存在持续性 MALT，无幽门螺杆菌。所有患者均获得完全缓解，中位时间为 3 个月。11 例（15%）患者出现疾病复发，其中 9 例为放疗野外部位，中位进展时间为 38.3 个月。中位 PFS 为 17.5 年，中位 RFS 和 OS 未达到。10 年无复发生存率为 83%（95%置信区间[CI]，74%-93%）。10 年 PFS 率为 71%（95%CI，60%-84%）。10 年 OS 率为 86%（95%CI，77%-96%）。疾病部位对 RFS、PFS 和 OS 无影响（P=0.17、0.43 和 0.50）。所有复发均成功挽救。1 例患者发生转移性胃腺癌，并在活检中发现复发性 MALT。否则，所有复发患者均存活，最后一次随访时无疾病证据，无患者死于 MALT 淋巴瘤。67 例（92%）患者在放疗期间出现急性毒性，均为 1 级和 2 级，仅有 1 例 3 级毒性。22 例（30%）患者出现晚期毒性，仅有 1 例 3 级毒性。
这项前瞻性研究证实，MALT 淋巴瘤的放疗可提供优异的长期 RFS，且毒性发生率可接受。目前的努力集中在放疗的降级，以进一步避免与治疗相关的发病率。临床试验.gov：NCT04465162。
