Noordijk E M, Carde P, Mandard A M, Mellink W A, Monconduit M, Eghbali H, Tirelli U, Thomas J, Somers R, Dupouy N
Ann Oncol. 1994;5 Suppl 2:107-12. doi: 10.1093/annonc/5.suppl_2.s107.
In this phase III trial, 770 patients with clinical stage I-II Hodgkin's disease (HD) have been enrolled since November 1988. Preliminary results are given for the 605 (79%) patients who have completed their initial therapy. Patients were grouped according to 6 pretreatment prognostic characteristics. In the very favourable (VF) group, treatment consisted of mantle field alone. In the favourable (F) group, patients were randomized to either subtotal nodal irradiation (STNI), or 6 cycles of EBVP (epirubicin, bleomycin, vinblastine, prednisone) followed by involved-field irradiation (IF-RT). Unfavourable (U) patients were randomized to either 6 cycles of EBVP plus IF-RT, or to 6 cycles of MOPP/ABV hybrid plus IF-RT. Of the 35 VF patients, none have progressed during radiotherapy. Four patients relapsed and were salvaged. Three-year failure-free survival (FFS) was 82%; overall survival (OS) was 100%. Of the 254 F patients, 130 were treated with STNI and 124 with EBVP plus IF-RT. At 3 years, FFS rates were 81% (1 progression, 14 relapses) and 79% (5 progressions, 8 relapses), respectively. Corresponding OS rates were 99% and 100%. Of the 316 U patients, 160 received EBVP and 156 MOPP/ABV. At 3 years, FFS rates were 72% (18 progressions, 20 relapses) and 88% (7 progressions, 6 relapses), respectively (p < 0.001). Although OS rates were identical (92%), the entry in the U-EBVP arm was stopped in November 1992. We conclude that a treatment strategy based on prognostic factors allows the use of less aggressive treatment in favourable patients.(ABSTRACT TRUNCATED AT 250 WORDS)
在这项III期试验中，自1988年11月起招募了770例临床I-II期霍奇金淋巴瘤（HD）患者。给出了605例（79%）完成初始治疗患者的初步结果。患者根据6个预处理预后特征分组。在非常有利（VF）组，治疗仅包括斗篷野照射。在有利（F）组，患者被随机分为次全淋巴结照射（STNI），或6周期的EBVP（表柔比星、博来霉素、长春花碱、泼尼松）后行受累野照射（IF-RT）。不利（U）患者被随机分为6周期的EBVP加IF-RT，或6周期的MOPP/ABV混合方案加IF-RT。35例VF患者中，放疗期间无进展。4例复发并得到挽救。3年无失败生存（FFS）率为82%；总生存（OS）率为100%。254例F患者中，130例接受STNI治疗，124例接受EBVP加IF-RT治疗。3年时，FFS率分别为81%（1例进展，14例复发）和79%（5例进展，8例复发）。相应的OS率分别为99%和100%。316例U患者中，160例接受EBVP治疗，156例接受MOPP/ABV治疗。3年时，FFS率分别为72%（18例进展，20例复发）和88%（7例进展，6例复发）（p<0.001）。虽然OS率相同（92%），但U-EBVP组的入组在1992年11月停止。我们得出结论，基于预后因素的治疗策略允许在有利患者中使用侵袭性较小的治疗。（摘要截短至250字）
