临床试验通常包括在不同时间成熟的多个终点。初次报告,通常基于主要终点,当尚未获得关键计划的共同主要或次要分析时,可能会发布。临床试验更新提供了传播其他研究结果的机会,发表在JCO或其他地方,已经报告了主要终点。对局部霍奇金淋巴瘤H10试验的早期正电子发射断层扫描(ePET)反应适应治疗的主要分析表明,在ePET阴性患者中,当忽略淋巴结放疗(INRT)时,复发风险增加,而在ePET阳性患者中,从阿霉素转换,博来霉素,长春碱,和达卡巴嗪(ABVD)到博来霉素,依托泊苷,阿霉素,环磷酰胺,长春新碱,丙卡巴嗪,和泼尼松(BEACOPPesc)显着改善了5年无进展生存期(PFS)。这里,我们在为期10年的随访中报告了预先计划的分析的最终结果.在有利的(F)ePET-阴性基团中,10年PFS率为98.8%对85.4%(风险比[HR],13.2;95%CI,3.1至55.8;非劣效性的P值=.9735;差异检验P<.0001)有利于ABVDINRT;在不利(U)ePET阴性组中,10年PFS率分别为91.4%和86.5%(HR,1.52;95%CI,0.84至2.75;非劣效性P值=.8577;差异检验P=.1628)。在ePET阳性患者中,标准ABVD和强化BEACOPPesc之间的PFS差异不再具有统计学意义(HR,0.67;95%CI,0.37至1.20;P=.1777)。总之,目前的长期分析证实,在ePET阴性的患者中,INRT的遗漏与较低的10年PFS相关。相反,在ePET阳性患者中,尽管BEACOPPesc强化是安全的,但标准臂和实验臂之间没有显着差异,晚期不良事件没有增加,即,第二恶性肿瘤。
Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical
Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.The primary analysis of the Early positron emission tomography (ePET) Response-Adapted Treatment in localized Hodgkin Lymphoma H10
Trial demonstrated that in ePET-negative patients, the risk of relapse increased when involved-node radiotherapy (INRT) was omitted and that in ePET-positive patients, switching from doxorubicin,
bleomycin, vinblastine, and dacarbazine (ABVD) to
bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) significantly improved 5-year progression-free survival (PFS). Here, we report the final results of a preplanned analysis at a 10-year follow-up. In the favorable (F) ePET-negative group, the 10-year PFS rates were 98.8% versus 85.4% (hazard ratio [HR], 13.2; 95% CI, 3.1 to 55.8; P value for noninferiority = .9735; difference test P < .0001) in favor of ABVD + INRT; in the unfavorable (U) ePET-negative group, the 10-year PFS rates were 91.4% and 86.5% (HR, 1.52; 95% CI, 0.84 to 2.75; P value for noninferiority = .8577; difference test P = .1628). In ePET-positive patients, the difference in terms of PFS between standard ABVD and intensified BEACOPPesc was no longer statistically significant (HR, 0.67; 95% CI, 0.37 to 1.20; P = .1777). In conclusion, the present long-term analysis confirms that in ePET-negative patients, the omission of INRT is associated with lower 10-year PFS. Instead, in ePET-positive patients, no significant difference between standard and experimental arms emerged although intensification with BEACOPPesc was safe, with no increase in late adverse events, namely, second malignancies.