Engert Andreas, Schiller Petra, Josting Andreas, Herrmann Richard, Koch Peter, Sieber Markus, Boissevain Friederike, De Wit Maike, Mezger Jorg, Duhmke Eckhart, Willich Normann, Muller Rolf-Peter, Schmidt Bernhard F, Renner Helmut, Muller-Hermelink Hans Konrad, Pfistner Beate, Wolf Jurgen, Hasenclever Dirk, Loffler Markus, Diehl Volker
Department I of Internal Medicine, University Hospital Cologne, Cologne 50924, Germany.
J Clin Oncol. 2003 Oct 1;21(19):3601-8. doi: 10.1200/JCO.2003.03.023. Epub 2003 Aug 11.
To investigate whether radiotherapy can be reduced without loss of efficacy from extended field (EF) to involved field (IF) after four cycles of chemotherapy.
Between 1993 and 1998, patients with newly diagnosed early-stage unfavorable HD were enrolled onto this multicenter study. Patients were randomly assigned to receive cyclophosphamide, vincristine, procarbazine, and prednisone (COPP) + doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) for two cycles followed by radiotherapy of 30 Gy EF + 10 Gy to bulky disease (arm A) or 30 Gy IF + 10 Gy to bulky disease (arm B).
Of 1,204 patients randomly assigned to treatment, 1,064 patients were informative and eligible for the arm comparison (532 patients in arm A; 532 patients in arm B). The median observation time was 54 months. Five years after random assignment, the overall survival (OSran) for all eligible patients was 91% and freedom from treatment failure (FFTFran) was 83%. Survival rates at 5 years after start of radiotherapy revealed no differences for arms A and B, respectively, in terms of FFTF (85.8% and 84.2%) and OS at 5 years (90.8% and 92.4%). There also were no differences between arms A and B, respectively, in terms of complete remission (98.5% and 97.2%), progressive disease (0.8% and 1.9%), relapse (6.4% and 7.7%), death (8.1% and 6.4%), and secondary neoplasia (4.5% and 2.8%). In contrast, acute side effects including leukopenia, thrombocytopenia, nausea, gastrointestinal toxicity, and pharyngeal toxicity were more frequent in the EF arm.
Radiotherapy volume size reduction from EF to IF after COPP + ABVD chemotherapy for two cycles produces similar results and less toxicity in patients with early-stage unfavorable HD.
研究在四个周期化疗后，放疗范围能否从扩大野（EF）缩小至受累野（IF）而不影响疗效。
1993年至1998年期间，新诊断的早期预后不良霍奇金淋巴瘤（HD）患者被纳入这项多中心研究。患者被随机分配接受环磷酰胺、长春新碱、丙卡巴肼和泼尼松（COPP）+多柔比星、博来霉素、长春碱和达卡巴嗪（ABVD）化疗两个周期，随后接受30 Gy扩大野放疗 + 10 Gy针对大肿块病灶的放疗（A组）或30 Gy受累野放疗 + 10 Gy针对大肿块病灶的放疗（B组）。
在随机分配接受治疗的1204例患者中，1064例患者信息完整且符合组间比较条件（A组532例患者；B组532例患者）。中位观察时间为54个月。随机分组五年后，所有符合条件患者的总生存率（OSran）为91%，无治疗失败生存率（FFTFran）为83%。放疗开始五年后的生存率显示，A组和B组在无治疗失败生存率（分别为85.8%和84.2%）和五年总生存率（分别为90.8%和92.4%）方面无差异。A组和B组在完全缓解率（分别为98.5%和97.2%）、疾病进展率（分别为0.8%和1.9%）、复发率（分别为6.4%和7.7%）、死亡率（分别为8.1%和6.4%）以及第二肿瘤发生率（分别为4.5%和2.8%）方面也无差异。相比之下，扩大野组的急性副作用，包括白细胞减少、血小板减少、恶心、胃肠道毒性和咽部毒性更为常见。
对于早期预后不良的霍奇金淋巴瘤患者，在接受COPP + ABVD化疗两个周期后，将放疗范围从扩大野缩小至受累野可产生相似的结果且毒性更小。
