Advani Ranjana H, Hong Fangxin, Fisher Richard I, Bartlett Nancy L, Robinson K Sue, Gascoyne Randy D, Wagner Henry, Stiff Patrick J, Cheson Bruce D, Stewart Douglas A, Gordon Leo I, Kahl Brad S, Friedberg Jonathan W, Blum Kristie A, Habermann Thomas M, Tuscano Joseph M, Hoppe Richard T, Horning Sandra J
Ranjana H. Advani, Richard T. Hoppe, and Sandra J. Horning, Stanford University, Stanford; Joseph M. Tuscano, University of California, Davis Cancer Center, Sacramento, CA; Fangxin Hong, Dana-Farber Cancer Institute, Boston, MA; Richard I. Fisher and Jonathan W. Friedberg, University of Rochester, Rochester, NY; Nancy L. Bartlett, Washington University School of Medicine, St Louis, MO; K. Sue Robinson, Queen Elizabeth II Health Science Center, Halifax, Nova Scotia; Randy D. Gascoyne, British Columbia Cancer Agency, Vancouver, British Columbia; Douglas A. Stewart, Tim Baker Cancer Institute, Calgary, Alberta, Canada; Henry Wagner Jr, Penn State Cancer Institute, Hershey, PA; Patrick J. Stiff, Loyola University Medical Center, Maywood; Leo I. Gordon, Northwestern University, Chicago, IL; Bruce D. Cheson, Georgetown University Hospital, Washington, DC; Brad S. Kahl, University of Wisconsin, Madison, WI; Kristie A. Blum, Ohio State University, Columbus, OH; and Thomas M. Habermann, Mayo Clinic, Rochester, MN.
J Clin Oncol. 2015 Jun 10;33(17):1936-42. doi: 10.1200/JCO.2014.57.8138. Epub 2015 Apr 20.
The phase III North American Intergroup E2496 Trial (Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma) compared doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) with mechlorethamine, doxorubicin, vincristine, bleomycin, vinblastine, etoposide, and prednisone (Stanford V). We report results of a planned subgroup analysis in patients with stage I or II bulky mediastinal Hodgkin lymphoma (HL).
Patients were randomly assigned to six to eight cycles of ABVD every 28 days or Stanford V once per week for 12 weeks. Two to 3 weeks after completion of chemotherapy, all patients received 36 Gy of modified involved field radiotherapy (IFRT) to the mediastinum, hila, and supraclavicular regions. Patients on the Stanford V arm received IFRT to additional sites ≥ 5 cm at diagnosis. Primary end points were failure-free survival (FFS) and overall survival (OS).
Of 794 eligible patients, 264 had stage I or II bulky disease, 135 received ABVD, and 129 received Stanford V. Patient characteristics were matched. The overall response rate was 83% with ABVD and 88% with Stanford V. At a median follow-up of 6.5 years, the study excluded a difference of more than 21% in 5-year FFS and more than 16% in 5-year OS between ABVD and Stanford V (5-year FFS: 85% v 79%; HR, 0.68; 95% CI, 0.37 to 1.25; P = .22; 5-year OS: 96% v 92%; HR, 0.49; 95% CI, 0.16 to 1.47; P = .19). In-field relapses occurred in < 10% of the patients in each arm.
For patients with stage I or II bulky mediastinal HL, no substantial statistically significant differences were detected between the two regimens, although power was limited. To the best of our knowledge, this is the first prospective trial reporting outcomes specific to this subgroup, and it sets a benchmark for comparison of ongoing and future studies.
北美肿瘤协作组E2496Ⅲ期试验（多柔比星、博来霉素、长春碱和达卡巴嗪联合化疗治疗霍奇金淋巴瘤患者或联合放疗与单纯化疗的疗效对比）比较了多柔比星、博来霉素、长春碱和达卡巴嗪（ABVD方案）与氮芥、多柔比星、长春新碱、博来霉素、长春碱、依托泊苷和泼尼松（斯坦福V方案）。我们报告了针对Ⅰ期或Ⅱ期伴有巨大纵隔肿块的霍奇金淋巴瘤（HL）患者进行的一项计划亚组分析的结果。
患者被随机分配接受每28天进行6至8个周期的ABVD方案化疗，或每周一次共12周的斯坦福V方案化疗。化疗完成后2至3周，所有患者均接受36 Gy的改良受累野放疗（IFRT），照射纵隔、肺门和锁骨上区域。斯坦福V方案组的患者在诊断时若有其他部位≥5 cm的病灶，也接受IFRT照射。主要终点为无失败生存（FFS）和总生存（OS）。
在794例符合条件的患者中，264例为Ⅰ期或Ⅱ期伴有巨大肿块的疾病，135例接受ABVD方案治疗，129例接受斯坦福V方案治疗。患者特征相匹配。ABVD方案的总缓解率为83%，斯坦福V方案为88%。中位随访6.5年，该研究排除了ABVD方案与斯坦福V方案在5年FFS方面超过21%的差异以及在5年OS方面超过16%的差异（5年FFS：85%对79%；风险比[HR]，0.68；95%置信区间[CI]，0.37至1.25；P = 0.22；5年OS：96%对92%；HR，0.49；95% CI，0.16至1.47；P = 0.19）。每组中<10%的患者出现野内复发。
对于Ⅰ期或Ⅱ期伴有巨大纵隔肿块的HL患者，尽管检验效能有限，但两种方案之间未检测到具有统计学意义的实质性差异。据我们所知，这是第一项报告该亚组特定结局的前瞻性试验，为正在进行的和未来的研究比较设定了基准。
