Medical HQs, Eisai Co., Ltd., Tokyo, Japan.
Division of Gastroenterology, Department of Internal Medicine, Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima, Japan.
Helicobacter. 2018 Apr;23(2):e12474. doi: 10.1111/hel.12474. Epub 2018 Mar 4.
Helicobacter pylori eradication therapy was approved in Japan for the first-line, standard treatment of H. pylori-positive gastric mucosa-associated lymphoid tissue (MALT) lymphoma. Although several retrospective studies or small-scale single-center studies have been reported, a prospective, large-scale, nationwide, multicenter study has not been reported from Japan.
We conducted a prospective, nationwide, multicenter study to evaluate the clinical efficacy of rabeprazole-based triple H. pylori eradication therapy for patients with localized gastric MALT lymphoma in practice-based clinical trial. A total of 108 H. pylori-positive patients with stage I/II gastric MALT lymphoma underwent H. pylori eradication therapy. The primary endpoints were complete remission (CR) rate and the rate of transfer to secondary treatment. The secondary endpoints were CR maintenance duration and overall survival (OS).
CR of lymphoma was achieved in 84 of 97 patients (86.6%), during the period 2.0-44.7 months (median, 5.3 months) after starting H. pylori eradication treatment. CR was maintained in 77 of 81 patients (95.1%) for 0.4-53.2 months (median, 33.1 months). Secondary treatments (radiotherapy, rituximab, or gastrectomy) for gastric MALT lymphoma were needed in 10 of the 97 patients (10.31%). During follow-up, OS rate was 96.9% (94/97) and the causes of 3 deaths were not related to lymphoma.
Rabeprazole-based H. pylori eradication therapy demonstrated a high CR rate, long CR maintenance, and a good OS for patients with localized gastric MALT lymphoma in this prospective, practice-based, multicenter study.
幽门螺杆菌根除疗法在日本被批准用于治疗幽门螺杆菌阳性胃黏膜相关淋巴组织(MALT)淋巴瘤的一线标准治疗。尽管已经有几项回顾性研究或小规模单中心研究报告,但日本尚未报告前瞻性、大规模、全国性、多中心研究。
我们进行了一项前瞻性、全国性、多中心研究,以评估基于雷贝拉唑的三联幽门螺杆菌根除疗法在基于实践的临床试验中对局限性胃 MALT 淋巴瘤患者的临床疗效。共有 108 例 I/II 期胃 MALT 淋巴瘤的幽门螺杆菌阳性患者接受了幽门螺杆菌根除治疗。主要终点是完全缓解(CR)率和转至二线治疗的比率。次要终点是 CR 维持时间和总生存期(OS)。
97 例患者中有 84 例(86.6%)在开始幽门螺杆菌根除治疗后 2.0-44.7 个月(中位 5.3 个月)时实现了淋巴瘤的 CR。81 例中有 77 例(95.1%)在 0.4-53.2 个月(中位 33.1 个月)时维持了 CR。97 例中有 10 例(10.31%)需要对胃 MALT 淋巴瘤进行二线治疗(放疗、利妥昔单抗或胃切除术)。在随访期间,OS 率为 96.9%(94/97),3 例死亡的原因与淋巴瘤无关。
在这项前瞻性、基于实践的多中心研究中,雷贝拉唑为基础的幽门螺杆菌根除疗法显示出了对局限性胃 MALT 淋巴瘤患者较高的 CR 率、较长的 CR 维持时间和良好的 OS。