儿童和青少年低危霍奇金淋巴瘤的应答依赖性和减少治疗，来自儿童肿瘤学组的 P9426 研究报告。
Response-dependent and reduced treatment in lower risk Hodgkin lymphoma in children and adolescents, results of P9426: a report from the Children's Oncology Group.
机构信息
Division of Pediatric Hematology/Oncology, University of South Florida School of Medicine, Tampa, Florida, USA.
出版信息
Pediatr Blood Cancer. 2012 Dec 15;59(7):1259-65. doi: 10.1002/pbc.24279. Epub 2012 Aug 21.
BACKGROUND
Hodgkin lymphoma is highly curable but associated with significant late effects. Reduction of total treatment would be anticipated to reduce late effects. This aim of this study was to demonstrate that a reduction in treatment was possible without compromising survival outcomes.
METHODS
Protocol P9426, a response-dependent and reduced treatment for low risk Hodgkin lymphoma (stages I, IIA, and IIIA(1) ) was designed in 1994 based on a previous pilot project. Patients were enrolled from October 15, 1996 to September 19, 2000. Patients were randomized to receive or not receive dexrazoxane and received two cycles of chemotherapy consisting of doxorubicin, bleomycin, vincristine, and etoposide. After two cycles, patients were evaluated for response. Those in complete response (CR) received 2,550 cGy of involved field radiation therapy (IFRT). Patient with partial response or stable disease, received two more cycles of chemotherapy and IFRT at 2,550 cGy.
RESULTS
There were 294 patients enrolled, with 255 eligible for analysis. The 8-year event free survival (EFS) between the dexrazoxane randomized groups did not differ (EFS 86.8 ± 3.1% with DRZ, and 85.7 ± 3.3% without DRZ (P = 0.70). Forty-five percent of patients demonstrated CR after two cycles of chemotherapy. There was no difference in EFS by histology, rapidity of response, or number of cycles of chemotherapy. Six of the eight secondary malignancies in this study have been previously reported.
CONCLUSIONS
Despite reduced therapy and exclusion of most patients with lymphocyte predominant histology, EFS and overall survival are similar to other reported studies. The protocol documents that it is safe and effective to reduce therapy in low-risk Hodgkin lymphoma based on early response to chemotherapy with rapid responding patients having the same outcome as slower-responding patients when given 50% of the chemotherapy.
背景
霍奇金淋巴瘤的治愈率很高，但与之相关的晚期效应也很显著。减少总治疗量预计会降低晚期效应。本研究的目的是证明在不影响生存结果的情况下减少治疗量是可行的。
方法
1994 年，根据一项先前的试点项目，设计了一项针对低危霍奇金淋巴瘤（I 期、IIA 期和 IIIA(1)期）的基于反应的、减少治疗的方案（Protocol P9426）。患者于 1996 年 10 月 15 日至 2000 年 9 月 19 日入组。患者被随机分为接受或不接受地塞米松治疗，并接受两个周期包含多柔比星、博来霉素、长春新碱和依托泊苷的化疗。两个周期后，评估患者的反应。完全缓解（CR）的患者接受 2550cGy 受累野放疗（IFRT）。部分缓解或疾病稳定的患者接受两个周期的化疗和 2550cGy 的 IFRT。
结果
共有 294 例患者入组，其中 255 例可进行分析。地塞米松随机分组的 8 年无事件生存（EFS）无差异（DRZ 组的 EFS 为 86.8±3.1%，无 DRZ 组为 85.7±3.3%（P=0.70）。45%的患者在两个周期的化疗后达到 CR。组织学、反应速度或化疗周期数对 EFS 无影响。本研究中的 8 种继发性恶性肿瘤中有 6 种已在之前的报告中报道过。
结论
尽管治疗量减少且排除了大多数淋巴细胞为主型组织学患者，但 EFS 和总生存率与其他报道的研究相似。该方案证明了基于化疗早期反应减少低危霍奇金淋巴瘤治疗量是安全有效的，快速反应患者的结果与反应较慢患者接受 50%化疗剂量时的结果相同。
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