First Department of Internal Medicine, University Hospital Cologne, Cologne; German Hodgkin Study Group, Cologne, Germany.
German Hodgkin Study Group, Cologne, Germany.
Ann Oncol. 2012 Nov;23(11):2953-2959. doi: 10.1093/annonc/mds110. Epub 2012 Jul 5.
To evaluate long-term toxicity and efficacy of a combined modality strategy including extended-field radiotherapy (EF-RT) or involved-field radiotherapy (IF-RT), the German Hodgkin Study Group carried out a follow-up analysis in patients with early unfavorable Hodgkin's lymphoma (HL).
One thousand two hundred and four patients were randomized to four cycles of chemotherapy followed by either 30 Gy EF- or 30 Gy IF-RT (HD8 trial); 532 patients in each treatment arm were eligible.
At 10 years, no arm differences were revealed with respect to freedom from treatment failure (FFTF) (79.8% versus 79.7%), progression-free survival (79.8% versus 80.0%), and overall survival (86.4% versus 87.3%). Non-inferiority of IF-RT was demonstrated for the primary end point FFTF (95% confidence interval for hazard ratio 0.72-1.25). Elderly patients had a poorer outcome when treated with EF-RT. So far, 15.0% of patients in arm A and 12.2% in arm B died, mostly due to secondary malignancies (5.3% versus 3.4%) or HL (3.2% versus 3.4%). After EF-RT, there were more secondary malignancies overall (58 versus 45), especially acute myeloid leukemias (11 versus 4).
Radiotherapy intensity reduction to IF-RT does not result in poorer long-term outcome but is associated with less acute toxicity and might be associated with less secondary malignancies.
为了评估包括扩展野放疗(EF-RT)或累及野放疗(IF-RT)的联合治疗策略的长期毒性和疗效,德国 Hodgkin 研究组对早期预后不良的霍奇金淋巴瘤(HL)患者进行了随访分析。
1204 例患者被随机分为四周期化疗后接受 30 Gy EF-RT 或 30 Gy IF-RT(HD8 试验);每个治疗臂有 532 例患者符合条件。
10 年时,在无治疗失败(FFTF)(79.8%与 79.7%)、无进展生存(79.8%与 80.0%)和总生存(86.4%与 87.3%)方面,两组之间没有差异。IF-RT 在主要终点 FFTF 上表现出非劣效性(95%置信区间的危险比为 0.72-1.25)。接受 EF-RT 治疗的老年患者预后较差。迄今为止,A 臂组的 15.0%和 B 臂组的 12.2%的患者死亡,主要原因是继发性恶性肿瘤(5.3%与 3.4%)或 HL(3.2%与 3.4%)。接受 EF-RT 后,总体上继发性恶性肿瘤更多(58 例与 45 例),尤其是急性髓系白血病(11 例与 4 例)。
放疗强度降低至 IF-RT 不会导致长期预后更差,但与较低的急性毒性相关,并且可能与较少的继发性恶性肿瘤相关。