Treatment of Follicular Lymphoma With CHOP and Anti-CD20 Therapy: 15-Year Follow-Up of the SWOG S0016 Trial.

Background

To provide 15-year follow-up data from the SWOG S0016 trial that evaluated the potential for long-term remission and cure following chemoimmunotherapy with cyclophosphamide, hydroxydaunorubicin/doxorubicin, oncovin, and prednisone/prednisolone (CHOP)-based regimens.

提供SWOG S0016试验的15年随访数据，该试验评估了接受环磷酰胺、羟基柔红霉素/多柔比星、长春新碱和泼尼松/泼尼松龙（CHOP）为基础方案的化疗免疫治疗后长期缓解和治愈的潜力。

DESIGN, SETTING, AND PARTICIPANTS: This multicenter, intergroup study was conducted at academic and community practice locations throughout the US and enrolled patients with untreated, advanced-stage FL.

设计、设置和参与者：这项多中心、跨组研究在美国的学术和社区实践地点进行，招募了患有未治疗、晚期滤泡性淋巴瘤（FL）的患者。

Cure modeling, which involves estimating the proportion of patients cured of the disease, was conducted by incorporating background mortality rates to estimate the proportion of patients cured of FL during the S0016 trial. Patients were enrolled between May 2001 and October 2008 and followed up for a median (IQR) of 15.5 (13.6-16.9) years.

治愈建模，涉及估计治愈疾病的患者比例，通过纳入背景死亡率来估计S0016试验期间治愈FL的患者比例。患者招募时间为2001年5月至2008年10月，中位随访时间为15.5（13.6-16.9）年。

The 15-year analysis was conducted in June 2025.

2025年6月进行了15年的分析。

Methods

Patients were randomized to receive either rituximab plus CHOP (R-CHOP) or CHOP followed by radioimmunotherapy (CHOP-RIT).

患者被随机分配接受利妥昔单抗加CHOP（R-CHOP）或CHOP后接受放射免疫治疗（CHOP-RIT）。

main_outcomes

The main outcomes were 15-year progression free survival (PFS) and overall survival(OS).

主要结果包括15年的无进展生存（PFS）和总生存（OS）。

Secondary outcomes included cure modeling.

次要结果包括治愈模型分析。

Results

A total of 531 eligible patients (242 female patients [46%]; median [IQR] age, 53 [45-61] years) were included in the final analysis (267 [50%] received R-CHOP and 264 [50%] CHOP-RIT).

共有531名符合条件的患者（242名女性患者[46%]；中位年龄[四分位数间距]为53[45-61]岁）纳入最终分析（267名[50%]接受了R-CHOP治疗，264名[50%]接受了CHOP-RIT治疗）。

The overall 15-year OS was 70%, with no significant difference between treatment arms, and the 15-year PFS was 40% (95% CI, 36.0%-44.7%).

总体15年总生存率为70%，治疗组之间没有显著差异，15年无进展生存率为40%（95%置信区间，36.0%-44.7%）。

CHOP-RIT demonstrated superior 15-year PFS (47% vs 34%; P = .004) compared with R-CHOP.

CHOP-RIT显示出比R-CHOP更优越的15年无进展生存率（47%对比34%；P = .004）。

Cure modeling estimated an overall cure rate of 42%, with the highest cure rates observed in patients with low Follicular Lymphoma International Prognostic Index scores and normal β2 microglobulin levels.

治愈模型估计总体治愈率为42%，在Follicular Lymphoma International Prognostic Index评分低和β2微球蛋白水平正常的患者中观察到最高的治愈率。

The rate of relapse declined substantially over time, from 6.8% during the first 5 years to 0.6% between 15 to 20 years.

复发率随着时间的推移显著下降，从最初的5年内6.8%降至15至20年间的0.6%。

conclusions_and_relevance

The results of this secondary analysis suggest that a subset of patients with advanced-stage FL can achieve cure with CHOP-based chemoimmunotherapy, as relapse rates decline over time.

这项次要分析的结果表明，随着复发率随时间下降，一部分晚期滤泡性淋巴瘤（FL）患者可以通过基于CHOP的化疗免疫治疗实现治愈。

This finding represents a paradigm shift in the understanding of and approach to FL, with implications for initial patient discussions and future research strategies.

这一发现代表了对滤泡性淋巴瘤（FL）理解和处理方式的根本性转变，对初步患者讨论和未来研究策略具有重要意义。

trial_registration

ClinicalTrials.gov Identifier: NCT00006721.

ClinicalTrials.gov注册号：NCT00006721。