Jin Jie, Okamoto Rumiko, Yoon Sung-Soo, Shih Lee-Yung, Zhu Jun, Liu Ting, Hong Xiaonan, Pei Lixia, Rooney Brendan, van de Velde Helgi, Huang Huiqiang
Department of Hematology, The First Affiliated Hospital of Zhejiang University College of Medicine, Hangzhou, Zhejiang, China.
Key Laboratory of Hematologic Malignancies, Diagnosis and Treatment, Hangzhou, Zhejiang, China.
Onco Targets Ther. 2018 Jul 6;11:3869-3882. doi: 10.2147/OTT.S150339. eCollection 2018.
This subgroup analysis of the LYM-3002 Phase III study (NCT00722137) investigated whether substituting bortezomib for vincristine in frontline R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy could improve outcomes in East Asian patients with newly diagnosed mantle-cell lymphoma (MCL).
A total of 121 East Asian patients from China, Taiwan, Japan, and the Republic of Korea with stage II-IV MCL who were ineligible or not considered for stem-cell transplantation were enrolled to six to eight 21-day cycles of R-CHOP or VR-CAP (R-CHOP with bortezomib replacing vincristine).
The primary end point was progression-free survival. After a median follow-up of 42.4 months, median progression-free survival in East Asian patients was 13.9 (R-CHOP) versus 28.6 (VR-CAP) months (HR 0.7, =0.157; 43% improvement with VR-CAP). Secondary end points (R-CHOP vs VR-CAP), including complete response rate (47% vs 63%), duration of complete response (median 16.6 vs 46.7 months), and treatment-free interval (median 21 vs 46.5 months), were improved with VR-CAP. VR-CAP was associated with increased but manageable toxicity. The most frequent adverse events were hematologic toxicities.
VR-CAP was effective in East Asian patients with newly diagnosed MCL, and could be considered for patients in whom stem-cell transplantation is not an option.
LYM-3002 III期研究（NCT00722137）的这项亚组分析调查了在一线R-CHOP（利妥昔单抗加环磷酰胺、多柔比星、长春新碱和泼尼松）治疗中用硼替佐米替代长春新碱是否能改善新诊断的套细胞淋巴瘤（MCL）东亚患者的预后。
共有121名来自中国、台湾、日本和韩国的II-IV期MCL东亚患者，他们不符合干细胞移植条件或未被考虑进行干细胞移植，被纳入接受6至8个21天周期的R-CHOP或VR-CAP（用硼替佐米替代长春新碱的R-CHOP）治疗。
主要终点是无进展生存期。经过中位42.4个月的随访，东亚患者的中位无进展生存期在R-CHOP组为13.9个月，在VR-CAP组为28.6个月（风险比0.7，P=0.157；VR-CAP组改善了43%）。次要终点（R-CHOP组与VR-CAP组相比），包括完全缓解率（47%对63%）、完全缓解持续时间（中位16.6个月对46.7个月）和无治疗间期（中位21个月对46.5个月），VR-CAP组均有改善。VR-CAP与毒性增加但可控制相关。最常见的不良事件是血液学毒性。
VR-CAP对新诊断的MCL东亚患者有效，对于不适合干细胞移植的患者可以考虑使用。
