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首页> 外文期刊>Journal of Hematology and Oncology >Bortezomib plus rituximab versus rituximab in patients with high-risk, relapsed, rituximab-na?ve or rituximab-sensitive follicular lymphoma: subgroup analysis of a randomized phase 3 trial
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Bortezomib plus rituximab versus rituximab in patients with high-risk, relapsed, rituximab-na?ve or rituximab-sensitive follicular lymphoma: subgroup analysis of a randomized phase 3 trial

机译：硼替佐米联合利妥昔单抗与利妥昔单抗治疗高危，复发，利妥昔单抗初治或利妥昔单抗敏感的滤泡性淋巴瘤的患者：一项随机3期试验的亚组分析

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Background The randomized phase 3 LYM3001 trial in relapsed follicular lymphoma (FL) demonstrated higher overall (ORR) and complete response (CR) rates and prolonged progression-free survival (PFS) with bortezomib-rituximab versus rituximab. We report findings in high-risk patients (FL International Prognostic Index [FLIPI] score ≥3, and high tumor burden by modified Groupe d’Etude des Lymphomas Folliculaires [GELF] criteria). Methods Patients aged ≥18 years with grade 1/2 FL, ≥1 measurable lesion, and documented relapse or progression following prior therapy, rituximab-na?ve or rituximab-sensitive, were enrolled at 164 centers in 29 countries across Europe, the Americas, and Asia-Pacific. Patients were randomized (1:1) to five 5-week cycles of bortezomib-rituximab (bortezomib 1.6 mg/m2, days 1, 8, 15, and 22, all cycles; rituximab 375 mg/m2, days 1, 8, 15, and 22, cycle 1, and day 1, cycles 2–5; N=336) or rituximab alone (N=340). Randomization was stratified by FLIPI score, prior rituximab, time since last dose of anti-lymphoma therapy, and geographical region. The primary endpoint of the study was PFS. Results 103 bortezomib-rituximab and 98 rituximab patients had high-risk FL. The ORR was 59% versus 37% (p=0.002), the CR/CRu rate was 13% versus 6% (p=0.145), and the durable response rate was 45% versus 26% (p=0.008) with bortezomib-rituximab versus rituximab. Median PFS was 9.5 versus 6.7 months (hazard ratio [HR] 0.667, p=0.012) with bortezomib-rituximab versus rituximab; median time to progression was 10.9 versus 6.8 months (HR 0.656, p=0.009); median time to next anti-lymphoma treatment was 14.8 versus 9.1 months (HR 0.762, p=0.103); and the 1-year Overall Survival rate was 83.1% versus 76.6%. Overall, 51% of bortezomib-rituximab and 32% of rituximab patients reported grade ≥3 adverse events, including neutropenia (18%, 6%), anemia (4%, 5%), diarrhea (8%, 0%), thrombocytopenia (5%, 2%), and sensory neuropathy (1%, 0%). Conclusions High-risk FL patients treated with bortezomib-rituximab had significantly higher ORR and longer PFS than patients receiving rituximab alone, with greater clinical benefit than in the overall study population; additional toxicity was acceptable and did not affect treatment feasibility. Trial registration The phase 3 LYM3001 trial is registered with ClinicalTrials.gov, with the identifier NCT00312845.
机译：背景复发性滤泡性淋巴瘤（FL）的3期LYM3001随机试验显示，硼替佐米-利妥昔单抗与利妥昔单抗相比，总体（ORR）和完全缓解（CR）率更高，无进展生存期（PFS）延长。我们报告了高危患者的发现（FL国际预后指数[FLIPI]得分≥3，并且根据改良的Groupe d'Etude des淋巴瘤滤泡术[GELF]标准，肿瘤负荷较高）。方法在欧洲，美洲的29个国家/地区的164个中心招募了年龄≥18岁，1/2 FL级，≥1可测量的病灶并记录了先前治疗后利妥昔单抗或利妥昔单抗敏感的复发或进展的患者，以及亚太地区。患者被随机分配（1：1）到5个5周的硼替佐米-利妥昔单抗治疗周期中（硼替佐米1.6 mg / m2，第1、8、15和22天，所有周期;利妥昔单抗375 mg / m2，第1、8、15天，以及22，第1周期和第1天，第2-5周期; N = 336）或单独使用利妥昔单抗（N = 340）。根据FLIPI评分，先前的利妥昔单抗，自最后一次抗淋巴瘤治疗以来的时间以及地理区域对随机分组进行分层。该研究的主要终点是PFS。结果103例硼替佐米-利妥昔单抗和98例利妥昔单抗患者发生高危FL。硼替佐米治疗组的ORR为59％对37％（p = 0.002），CR / CRu率为13％对6％（p = 0.145），持久响应率为45％对26％（p = 0.008）。利妥昔单抗与利妥昔单抗。硼替佐米-利妥昔单抗与利妥昔单抗的中位PFS分别为9.5个月和6.7个月（危险比[HR] 0.667，p = 0.012）;中位进展时间为10.9对6.8个月（HR 0.656，p = 0.009）;下次接受抗淋巴瘤治疗的中位时间为14.8对9.1个月（HR 0.762，p = 0.103）;而1年总生存率为83.1％，而同期为76.6％。总体而言，硼替佐米-利妥昔单抗的51％和利妥昔单抗的32％的患者报告≥3级不良事件，包括中性粒细胞减少症（18％，6％），贫血（4％，5％），腹泻（8％，0％），血小板减少（5％，2％）和感觉神经病（1％，0％）。结论与单独接受利妥昔单抗的患者相比，接受硼替佐米-利妥昔单抗治疗的高危FL患者的ORR显着更高，且PFS更长，与整体研究人群相比，其临床获益更大;额外的毒性是可以接受的，并且不会影响治疗的可行性。试验注册LYM3001 3期试验已在ClinicalTrials.gov上注册，标识为NCT00312845。

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