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Abstract：
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.
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.
摘要：
对于外周T细胞淋巴瘤（PTCL）患者，使用环磷酰胺一线治疗的结果，阿霉素,长春新碱,和泼尼松（CHOP）或CHOP样疗法通常较差。ECHELON-2研究表明，本妥昔单抗vedotin加环磷酰胺，阿霉素,对于全身性间变性大细胞淋巴瘤或其他CD30阳性PTCL患者的一线治疗,泼尼松(A+CHP)在每次独立中心审查中的无进展生存期(PFS)均具有统计学上的优势,并且与CHOP相比,总体生存期的改善也在统计学上优于CHOP.
ECHELON-2是双盲，双假人,随机化，安慰剂对照,主动比较器第三阶段研究。我们提出了ECHELON-2研究的探索性更新，包括意向治疗分析组中每名研究者的5年PFS分析.
总共452名患者被随机(1:1)分为六个或八个周期的A+CHP(N=226)或CHOP(N=226)。中位随访时间为47.6个月，A+CHP的5年PFS率为51.4%[95%置信区间（CI）：42.8%至59.4%]，CHOP的5年PFS率为43.0%（95%CI：35.8%至50.0%）（风险比=0.70；95%CI：0.53-0.91），A+CHP组的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).PFS和OS在关键亚组之间通常是一致的。A+CHP组72%(84/117)的患者和CHOP组78%(97/124)的患者周围神经病变得到解决或改善。在复发并随后接受本妥昔单抗vedotin的患者中，A+CHP后接受本妥昔单抗vedotin治疗的客观缓解率为59%,CHOP后接受本妥昔单抗vedotin治疗的客观缓解率为50%.
在ECHELON-2的5年更新中，用A+CHP治疗PTCL患者的一线治疗继续在PFS和OS方面与CHOP相比提供有临床意义的改善。具有可管理的安全性，包括周围神经病变的持续消退或改善。
ECHELON-2是双盲，双假人,随机化，安慰剂对照,主动比较器第三阶段研究。我们提出了ECHELON-2研究的探索性更新，包括意向治疗分析组中每名研究者的5年PFS分析.
总共452名患者被随机(1:1)分为六个或八个周期的A+CHP(N=226)或CHOP(N=226)。中位随访时间为47.6个月，A+CHP的5年PFS率为51.4%[95%置信区间（CI）：42.8%至59.4%]，CHOP的5年PFS率为43.0%（95%CI：35.8%至50.0%）（风险比=0.70；95%CI：0.53-0.91），A+CHP组的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).PFS和OS在关键亚组之间通常是一致的。A+CHP组72%(84/117)的患者和CHOP组78%(97/124)的患者周围神经病变得到解决或改善。在复发并随后接受本妥昔单抗vedotin的患者中，A+CHP后接受本妥昔单抗vedotin治疗的客观缓解率为59%,CHOP后接受本妥昔单抗vedotin治疗的客观缓解率为50%.
在ECHELON-2的5年更新中，用A+CHP治疗PTCL患者的一线治疗继续在PFS和OS方面与CHOP相比提供有临床意义的改善。具有可管理的安全性，包括周围神经病变的持续消退或改善。
