降低对早期霍奇金淋巴瘤病人的治疗强度

中国肿瘤化疗  摘自：N Engl J Med. 2010 Aug 12;363(7):640-52

发布日期：2010-11-8

背景：对于预后良好的早期（Ⅰ或Ⅱ期）霍奇金淋巴瘤，目前仍不清楚是否可以降低治疗强度。为此我们进行了一项多中心随机临床试验，对4个治疗组进行比较，这4个治疗组包括了2种不同强度的联合化疗，以及随后的2种不同剂量水平的受累野放疗。武汉协和医院肿瘤中心刘红利

方法：我们将1370例新诊断的预后良好的早期霍奇金淋巴瘤病人随机分入下列4个治疗组之一：先接受4个周期的多柔比星、博来霉素、长春碱和达卡巴嗪（ABVD）治疗，随后接受30 Gy的放疗（第1组）；4个周期ABVD后接受20 Gy的放疗（第2组）；2个周期ABVD后接受30 Gy的放疗（第3组）；或2个周期ABVD后接受20 Gy的放疗（第4组）。主要研究终点是无治疗失败，次要研究终点包括治疗的疗效和毒性。

结果：在无治疗失败（P=0.39）或总生存（P=0.61）方面，两种强度的化疗没有显著差异。5年的无治疗失败率在4个周期ABVD方案组中为93.0%[95%可信区间（CI）为90.5~94.8]，在2个周期方案组中为91.1%（95%CI，88.3~93.2）。当比较20 Gy和30 Gy剂量的放疗效果时，就无治疗失败（P=1.00）或总生存（P=0.61）而言也没有显著差异。不良反应事件和治疗的急性毒性作用在接受4个周期ABVD和30 Gy放疗的病人（第1组）中最常见。

结论：在预后良好的早期霍奇金淋巴瘤病人中，2个周期ABVD治疗后进行20 Gy的受累野放疗，与4个周期ABVD后进行30 Gy的放疗一样有效，而且毒性较小。这些治疗的长期效果尚未得到充分评估。

Reduced treatment intensity in patients with early-stage Hodgkin"s lymphoma.

N Engl J Med. 2010 Aug 12;363(7):640-52.

Abstract
BACKGROUND: Whether it is possible to reduce the intensity of treatment in early (stage I or II) Hodgkin"s lymphoma with a favorable prognosis remains unclear. We therefore conducted a multicenter, randomized trial comparing four treatment groups consisting of a combination chemotherapy regimen of two different intensities followed by involved-field radiation therapy at two different dose levels.

METHODS: We randomly assigned 1370 patients with newly diagnosed early-stage Hodgkin"s lymphoma with a favorable prognosis to one of four treatment groups: four cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by 30 Gy of radiation therapy (group 1), four cycles of ABVD followed by 20 Gy of radiation therapy (group 2), two cycles of ABVD followed by 30 Gy of radiation therapy (group 3), or two cycles of ABVD followed by 20 Gy of radiation therapy (group 4). The primary end point was freedom from treatment failure; secondary end points included efficacy and toxicity of treatment.

RESULTS: The two chemotherapy regimens did not differ significantly with respect to freedom from treatment failure (P=0.39) or overall survival (P=0.61). At 5 years, the rates of freedom from treatment failure were 93.0% (95% confidence interval [CI], 90.5 to 94.8) with the four-cycle ABVD regimen and 91.1% (95% CI, 88.3 to 93.2) with the two-cycle regimen. When the effects of 20-Gy and 30-Gy doses of radiation therapy were compared, there were also no significant differences in freedom from treatment failure (P=1.00) or overall survival (P=0.61). Adverse events and acute toxic effects of treatment were most common in the patients who received four cycles of ABVD and 30 Gy of radiation therapy (group 1).

CONCLUSIONS: In patients with early-stage Hodgkin"s lymphoma and a favorable prognosis, treatment with two cycles of ABVD followed by 20 Gy of involved-field radiation therapy is as effective as, and less toxic than, four cycles of ABVD followed by 30 Gy of involved-field radiation therapy. Long-term effects of these treatments have not yet been fully assessed. (Funded by the Deutsche Krebshilfe and the Swiss Federal Government; ClinicalTrials.gov number, NCT00265018.)

PMID: 20818855