ABVD 方案对比 BEACOPP 方案用于计划大剂量挽救治疗的霍奇金淋巴瘤。

ABVD versus BEACOPP for Hodgkin's lymphoma when high-dose salvage is planned.

机构信息

Milan Cancer Institute, Milan, Italy.

出版信息

N Engl J Med. 2011 Jul 21;365(3):203-12. doi: 10.1056/NEJMoa1100340.

DOI:10.1056/NEJMoa1100340

PMID:21774708

Abstract

BACKGROUND

BEACOPP, an intensified regimen consisting of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone, has been advocated as the new standard of treatment for advanced Hodgkin's lymphoma, in place of the combination of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).

METHODS

We randomly assigned 331 patients with previously untreated and unfavorable Hodgkin's lymphoma (stage IIB, III, or IV, or an international prognostic score of ≥3 on a scale of 0 to 7, with higher scores indicating increased risk), to receive either BEACOPP or ABVD, each followed by local radiotherapy when indicated. Patients with residual or progressive disease after the initial therapy were to be treated according to a state-of-the-art high-dose salvage program. The median follow-up period was 61 months.

RESULTS

The 7-year rate of freedom from first progression was 85% among patients who had received initial treatment with BEACOPP and 73% among those who had received initial treatment with ABVD (P=0.004), and the 7-year rate of event-free survival was 78% and 71%, respectively (P=0.15). A total of 65 patients (20 in the BEACOPP group, and 45 in the ABVD group) went on to receive the intended high-dose salvage regimen. As of the cutoff date, 3 of the 20 patients in the BEACOPP group and 15 of the 45 in the ABVD group who had had progressive disease or relapse after the initial therapy were alive and free of disease. After completion of the overall planned treatment, including salvage therapy, the 7-year rate of freedom from a second progression was 88% in the BEACOPP group and 82% in the ABVD group (P=0.12), and the 7-year rate of overall survival was 89% and 84%, respectively (P=0.39). Severe adverse events occurred more frequently in the BEACOPP group than in the ABVD group.

CONCLUSIONS

Treatment with BEACOPP, as compared with ABVD, resulted in better initial tumor control, but the long-term clinical outcome did not differ significantly between the two regimens. (Funded by Fondazione Michelangelo; ClinicalTrials.gov number, NCT01251107.).

摘要

背景

博来霉素、依托泊苷、多柔比星、环磷酰胺、长春新碱、洛莫司汀和泼尼松组成的 BEACOPP 方案，被推荐为治疗晚期霍奇金淋巴瘤的新标准治疗方案，替代阿霉素、博来霉素、长春碱和达卡巴嗪（ABVD）方案。

方法

我们将 331 例未经治疗且预后不良的霍奇金淋巴瘤患者（IIB 期、III 期或 IV 期，或国际预后评分≥7 分[0-7 分，评分越高表示风险越高]）随机分为 BEACOPP 组或 ABVD 组，两组均在有指征时接受局部放疗。初始治疗后疾病残留或进展的患者，将按照先进的大剂量挽救治疗方案进行治疗。中位随访时间为 61 个月。

结果

BEACOPP 组初始治疗后 7 年无疾病进展率为 85%，ABVD 组为 73%（P=0.004）；7 年无事件生存率分别为 78%和 71%（P=0.15）。共有 65 例患者（BEACOPP 组 20 例，ABVD 组 45 例）接受了计划中的大剂量挽救治疗方案。截至截止日期，BEACOPP 组 20 例患者中有 3 例，ABVD 组 45 例患者中有 15 例在初始治疗后疾病进展或复发，目前仍存活且无疾病。完成包括挽救治疗在内的整体计划治疗后，BEACOPP 组和 ABVD 组 7 年无二次进展率分别为 88%和 82%（P=0.12），7 年总生存率分别为 89%和 84%（P=0.39）。BEACOPP 组发生严重不良事件的频率高于 ABVD 组。