The ECHELON-2 Trial: 5-year results of a randomized, phase III study of brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma.
The ECHELON-2 Trial: 5-year results of a randomized, phase III study of brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma.
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DOI：
10.1016/j.annonc.2021.12.002
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发表时间：
2022-03
期刊：
影响因子：
--
通讯作者：
中科院分区：
文献类型：
--
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对于外周T细胞淋巴瘤（PTCL）患者，使用环磷酰胺、多柔比星、长春新碱和泼尼松（CHOP）一线治疗或CHOP样治疗的结局通常较差。ECHELON-2研究表明，对于系统性间变性大细胞淋巴瘤或其他CD 30阳性PTCL患者的一线治疗，维布妥昔单抗+环磷酰胺、多柔比星和泼尼松（A+CHP）根据独立中心审查显示无进展生存期（PFS）具有统计学上级效性，并且总生存期改善优于CHOP。ECHELON-2是一项双盲、双模拟、随机化、安慰剂对照、活性对照药物III期研究。我们介绍了ECHELON-2研究的探索性更新，包括意向治疗分析组中研究者评估的5年PFS分析。共452例患者随机（1：1）接受6个或8个周期的A+CHP（N = 226）或CHOP（N = 226）。中位随访47.6个月时，A+CHP的5年PFS率为51.4% [95%置信区间（CI）：42.8%至59.4%]，而A+CHP为43.0%（95% CI：35.8%-50.0%），使用CHOP（风险比= 0.70; 95%CI：0.53-0.91），5年总生存率（OS）为70.1%（95% CI：63.3%-75.9%），CHOP组为61.0%（95% CI：54.0%-67.3%）（风险比= 0.72; 95% CI：0.53-0.99）。各关键亚组的PFS和OS基本一致。A+CHP组72%（84/117）的患者和CHOP组78%（97/124）的患者周围神经病变消退或改善。在复发并随后接受维布妥昔单抗治疗的患者中，A+CHP后维布妥昔单抗重新开始治疗的客观缓解率为59%，CHOP后维布妥昔单抗后续治疗的客观缓解率为50%。在ECHELON-2的这一5年更新中，PTCL患者接受A+CHP一线治疗后，PFS和OS相对于CHOP继续出现具有临床意义的改善，安全性特征可控，包括周围神经病变持续消退或改善。
For patients with peripheral T-cell lymphoma (PTCL), outcomes using frontline treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or CHOP-like therapy are typically poor. The ECHELON-2 study demonstrated that brentuximab vedotin plus cyclophosphamide, doxorubicin, and prednisone (A+CHP) exhibited statistically superior progression-free survival (PFS) per independent central review and improvements in overall survival versus CHOP for the frontline treatment of patients with systemic anaplastic large cell lymphoma or other CD30-positive PTCL. ECHELON-2 is a double-blind, double-dummy, randomized, placebo-controlled, active-comparator phase III study. We present an exploratory update of the ECHELON-2 study, including an analysis of 5-year PFS per investigator in the intent-to-treat analysis group. A total of 452 patients were randomized (1 : 1) to six or eight cycles of A+CHP (N = 226) or CHOP (N = 226). At median follow-up of 47.6 months, 5-year PFS rates were 51.4% [95% confidence interval (CI): 42.8% to 59.4%] with A+CHP versus 43.0% (95% CI: 35.8% to 50.0%) with CHOP (hazard ratio = 0.70; 95% CI: 0.53–0.91), and 5-year overall survival (OS) rates were 70.1% (95% CI: 63.3% to 75.9%) with A+CHP versus 61.0% (95% CI: 54.0% to 67.3%) with CHOP (hazard ratio = 0.72; 95% CI: 0.53–0.99). Both PFS and OS were generally consistent across key subgroups. Peripheral neuropathy was resolved or improved in 72% (84/117) of patients in the A+CHP arm and 78% (97/124) in the CHOP arm. Among patients who relapsed and subsequently received brentuximab vedotin, the objective response rate was 59% with brentuximab vedotin retreatment after A+CHP and 50% with subsequent brentuximab vedotin after CHOP. In this 5-year update of ECHELON-2, frontline treatment of patients with PTCL with A+CHP continues to provide clinically meaningful improvement in PFS and OS versus CHOP, with a manageable safety profile, including continued resolution or improvement of peripheral neuropathy.
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影响因子：
10.1
作者：
Bellei M;Foss FM;Shustov AR;Horwitz SM;Marcheselli L;Kim WS;Cabrera ME;Dlouhy I;Nagler A;Advani RH;Pesce EA;Ko YH;Martinez V;Montoto S;Chiattone C;Moskowitz A;Spina M;Biasoli I;Manni M;Federico M;International T-cell Project Network
通讯作者：
International T-cell Project Network
影响因子：
6.5
作者：
Chihara D;Fanale MA;Miranda RN;Noorani M;Westin JR;Nastoupil LJ;Hagemeister FB;Fayad LE;Romaguera JE;Samaniego F;Turturro F;Lee HJ;Neelapu SS;Rodriguez MA;Wang M;Fowler NH;Davis RE;Medeiros LJ;Hosing C;Nieto YL;Oki Y
通讯作者：
Oki Y
影响因子：
28.5
作者：
Bartlett NL;Chen R;Fanale MA;Brice P;Gopal A;Smith SE;Advani R;Matous JV;Ramchandren R;Rosenblatt JD;Huebner D;Levine P;Grove L;Forero-Torres A
通讯作者：
Forero-Torres A
影响因子：
20.3
作者：
Jacobsen, Eric D.;Sharman, Jeff P.;Bartlett, Nancy L.
通讯作者：
Bartlett, Nancy L.
影响因子：
20.3
作者：
Oflazoglu, Ezogelin;Stone, Ivan J.;Gerber, Hans-Peter
通讯作者：
Gerber, Hans-Peter