Tubiana M, Henry-Amar M, Carde P, Burgers J M, Hayat M, Van der Schueren E, Noordijk E M, Tanguy A, Meerwaldt J H, Thomas J
Institut Gustave-Roussy, Villejuif, France.
Blood. 1989 Jan;73(1):47-56.
From 1964 to 1987, the EORTC Lymphoma Group conducted four consecutive controlled clinical trials on clinical stages I and II Hodgkin's disease in which 1,579 patients were entered. From the onset the main aim of these trials was to identify the subsets of patients who could be treated safely by regional radiotherapy (RT). Therefore, several prognostic indicators were prospectively registered and progressively used in the trial protocols for the delineation of the favorable and unfavorable subgroups as soon as they were recognized of high predictive value. In the H2 trial (1972 to 1976), the histologic subtype was the only variable taken into account for the therapeutic strategy and the staging laparotomy findings were found to be of prognostic value only in patients with favorable prognostic indicators. In the H5 trial (1977 to 1982), patients were subdivided into two subgroups according to six prognostic indicators. Patients with favorable features were submitted to a staging laparotomy (lap); lap negative patients were randomized between mantle field RT and mantle field plus paraaortic RT. Disease free survival (DFS) and total survival (S) were similar in the two arms. Among patients with unfavorable features, DFS and S were significantly higher in the arm treated by combination of mechlorethamine, vincristine, procarbazine, prednisone (MOPP) chemotherapy (CT) and RT than in the arm treated by total nodal irradiation. Nevertheless, in patients below the age of 40, the overall survival rates were equivalent in the two arms. In the H6 trial, the delineation of the favorable subgroup was based on (a) absence of systemic symptoms and elevated ESR, (b) no more than one or two lymph node areas involved. The aim of the study was to assess the impact on survival of a therapeutic strategy including staging laparotomy. At a 4-year follow-up, no difference in survival was evidenced. In patients with unfavorable prognostic indicators, 3 MOPP-RT-3 MOPP were compared with 3 ABVD-RT-3 ABVD. From H1 to H5 trials, the proportion of patients having received CT during the course of the disease gradually decreased; the data suggest that a further reduction in the proportion of patients aggressively treated is conceptually possible. On the basis of the prognostic factors identified, one can delineate three subsets of patients and modulate toxic cost of the initial treatment according to the characteristics of these subsets. In the most favorable subgroup, RT alone produces high survival and CT is not justified.(ABSTRACT TRUNCATED AT 400 WORDS)
1964年至1987年，欧洲癌症研究与治疗组织（EORTC）淋巴瘤研究组对临床I期和II期霍奇金病连续进行了四项对照临床试验，共有1579例患者入组。从一开始，这些试验的主要目的就是确定可以安全地接受区域放射治疗（RT）的患者亚组。因此，一些预后指标被前瞻性地记录下来，并在试验方案中逐步使用，一旦被认为具有高预测价值，就用于划分预后良好和不良的亚组。在H2试验（1972年至1976年）中，组织学亚型是治疗策略中唯一考虑的变量，分期剖腹探查结果仅在预后指标良好的患者中具有预后价值。在H5试验（1977年至1982年）中，根据六个预后指标将患者分为两个亚组。具有良好特征的患者接受分期剖腹探查（lap）；lap阴性的患者在斗篷野放疗和斗篷野加腹主动脉旁放疗之间随机分组。两组的无病生存率（DFS）和总生存率（S）相似。在具有不良特征的患者中，接受氮芥、长春新碱、丙卡巴肼、泼尼松（MOPP）联合化疗（CT）和放疗的组的DFS和S显著高于接受全淋巴结照射的组。然而，在40岁以下的患者中，两组的总生存率相当。在H6试验中，预后良好亚组的划分基于：（a）无全身症状且血沉升高；（b）受累淋巴结区域不超过一两个。该研究的目的是评估包括分期剖腹探查在内的治疗策略对生存率的影响。在4年的随访中，未发现生存率有差异。在预后指标不良的患者中，比较了3个周期MOPP-放疗-3个周期MOPP与3个周期阿霉素、博来霉素、长春新碱、达卡巴嗪（ABVD）-放疗-3个周期ABVD的疗效。从H1到H5试验，在疾病过程中接受CT治疗的患者比例逐渐下降；数据表明，从概念上讲，进一步降低积极治疗患者的比例是可能的。根据确定的预后因素，可以划分出三个患者亚组，并根据这些亚组的特征调整初始治疗的毒性成本。在最有利的亚组中，单纯放疗可产生高生存率，使用CT治疗不合理。（摘要截断于400字）
