Laboratory of Oncology, University of Paris-Descartes, Paris, France.
Cancer. 2010 Sep 1;116(17):4054-62. doi: 10.1002/cncr.25295.
The combination of 3 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) and a tailored, extended irradiation schedule has been used to treat patients with early Hodgkin lymphoma (HL) in the authors' group since 1981. The randomized H97-E trial (1997-2004) was designed to assess the impact of a slightly reduced irradiation dose on the freedom from treatment failure (FFTF) rate.
Patients with supradiaphragmatic HL at clinical stages I and II who had </=2 affected lymph node areas and a mediastinal mass ratio <0.33 were randomized into an experimental arm (EA) and a control arm (CA). Patients in the EA received 3 cycles of ABVD followed by irradiation at 36 grays (Gy) to initially involved sites and 24 Gy to adjacent sites, the upper infradiaphragmatic area, and the spleen. Patients in the CA received the same chemotherapy regimen and the same irradiation given at doses of 40 Gy and 30 Gy, respectively. Two hundred two patients who had received the CA treatment in 2 previous trials served as a historic control group (HCG).
The 10-year FFTF and overall survival rates were similar for the 89 patients in the EA (88.6% and 97.8%, respectively), for the 99 patients in the CA (92.6% and 95%, respectively), and for the 202 patients in the HCG (91.9% and 92.9%, respectively). Surprisingly, the 10-year incidence of severe or fatal complications was nil in the EA but reached 15.5% in the CA (P < .003) and 11.1% in the HCG.
Slightly lowering the radiation dose did not have an impact on the excellent cure rate among patients with early HL but significantly reduced the rate of long-term, radiation-induced complications.
自 1981 年以来，作者所在团队一直采用多柔比星、博来霉素、长春花碱和达卡巴嗪（ABVD）联合 3 个周期，以及定制的、扩展的放疗方案治疗早期霍奇金淋巴瘤（HL）患者。随机 H97-E 试验（1997-2004 年）旨在评估略降低放疗剂量对无治疗失败（FFTF）率的影响。
临床 I 期和 II 期膈上 HL 患者，受累淋巴结区域数<=2，纵隔肿块比 <0.33，随机分为实验组（EA）和对照组（CA）。EA 组患者接受 3 个周期 ABVD 治疗，随后接受 36Gy 初始受累部位照射，24Gy 相邻部位照射、膈下上区和脾照射。CA 组患者接受相同的化疗方案和剂量分别为 40Gy 和 30Gy 的照射。202 例在 2 项先前试验中接受 CA 治疗的患者作为历史对照组（HCG）。
EA 组 89 例患者的 10 年 FFTF 和总生存率分别为 88.6%和 97.8%，CA 组 99 例患者分别为 92.6%和 95.0%，HCG 组 202 例患者分别为 91.9%和 92.9%。令人惊讶的是，EA 组 10 年严重或致命并发症发生率为 0，但 CA 组为 15.5%（P<.003），HCG 组为 11.1%。
略降低放疗剂量并未对早期 HL 患者的卓越治愈率产生影响，但显著降低了长期、放疗诱导并发症的发生率。
