Efficacy and safety of obinutuzumab in patients with previously untreated follicular lymphoma: a subgroup analysis of patients enrolled in Japan in the randomized phase III GALLIUM trial.
Efficacy and safety of obinutuzumab in patients with previously untreated follicular lymphoma: a subgroup analysis of patients enrolled in Japan in the randomized phase III GALLIUM trial.
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obinutuzumab 对既往未经治疗的滤泡性淋巴瘤患者的疗效和安全性：对在日本参加随机 III 期镓试验的患者进行的亚组分析。
DOI：
10.1007/s12185-018-2497-0
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发表时间：
2018
期刊：
影响因子：
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通讯作者：
Murayama T,
中科院分区：
文献类型：
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作者：
Ohmachi K;Tobinai K;Kinoshita T;Ishikawa T;Hatake K;Ichikawa S;Ohmine K;Kamitsuji Y;Choi I;Chou T;Tsukasaki K;Kumagai K;Taniwaki M;Uchida T;Kikukawa Y;Kubo K;Mihara K;Tsukamoto N;Izutsu K;Yoshida I;Ishida F;Usui N;Iida S;Murayama T,
镓是一项全球性的III期研究，该研究表明，在以前未接受治疗的滤泡性淋巴瘤(FL)患者中，使用obinutuzumab加化疗(G-Chemo)与利妥昔单抗加化疗(R-Chemo)相比，无进展生存率(PFS)有统计上的显著和临床上有意义的改善。在这项单一国家亚组分析中，我们探索了参加日本镓研究(日本亚组)的患者的疗效和安全性模式。患者随机接受G-化疗或R-化疗的开放标记诱导治疗。应答者接受了长达2年的随机抗体维持单一治疗。主要终点是调查者评估的PFS。总的来说，123名FL患者被随机分为日本化疗组(G化疗组，n= 65；R化疗组，n= 58)。大多数患者接受环磷酰胺、阿霉素、长春新碱和强的松化疗(全球镓FL人群中82.9%对33.1%)。3年后化疗PFS为89.9%，R化疗为74.7%；危险比为0.42；95%可信区间为0.15，1.15；P= 0.08。G-化疗组3-5级不良事件发生率(96.9%比89.7%)和严重不良事件发生率(35.4%比22.4%)分别高于R-化疗组(P<0.05)。中性粒细胞减少症在日本亚群中常见(92.3%为G-化疗，79.3%为R-化疗)。总体而言，日本亚组的结果与全球镓人口的结果一致。
GALLIUM is a global phase III study that demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with obinutuzumab plus chemotherapy (G-chemo) versus rituximab plus chemotherapy (R-chemo) in previously untreated patients with follicular lymphoma (FL). In this single-country subgroup analysis, we explored patterns of efficacy and safety in patients enrolled in the GALLIUM study in Japan (Japanese subgroup). Patients were randomized to open-label induction treatment with G-chemo or R-chemo. Responders received maintenance monotherapy with their randomized antibody for up to 2 years. The primary endpoint was investigator-assessed PFS. Overall, 123 patients with FL were randomized in the Japanese subgroup (G-chemo,n= 65; R-chemo,n= 58). The majority of patients received cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy (82.9 vs 33.1% in the global GALLIUM FL population). PFS at 3 years was 89.9% (G-chemo) vs. 74.7% (R-chemo); hazard ratio 0.42; 95% confidence interval 0.15, 1.15;P= 0.08. Higher rates of grade 3–5 adverse events (96.9 vs. 89.7%) and serious adverse events (35.4 vs. 22.4%) were observed with G-chemo vs R-chemo, respectively. Neutropenia was frequent in the Japanese subgroup (92.3% G-chemo; 79.3% R-chemo). Overall, the results in the Japanese subgroup were consistent with those in the global GALLIUM population.