Results of a prospective randomized clinical trial of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by radiation therapy (RT) versus ABVD alone for stages I, II, and IIIA nonbulky Hodgkin disease
Results of a prospective randomized clinical trial of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by radiation therapy (RT) versus ABVD alone for stages I, II, and IIIA nonbulky Hodgkin disease
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DOI：
10.1182/blood-2004-04-1311
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发表时间：
2004-12-01
期刊：
影响因子：
20.3
通讯作者：
Yahalom, J
中科院分区：
文献类型：
--
作者：
Straus, DJ;Portlock, CS;Yahalom, J
为了确定联合治疗（CMT）是否上级单独化疗（CT），将152例临床分期（CS）IA、IB、IIA、IIB和IIIA且无大块病变的未经治疗的霍奇金病患者前瞻性随机分配至6个周期的多柔比星、博莱霉素、长春碱、克拉肼（ABVD）单药治疗或6个周期的ABVD后放疗（RT）（3600 cGy：11例患者涉及野，其余患者改良扩展野）。在随机接受FIT的76例患者中，65例实际接受了FIT，11例未接受（4例进展，1例博莱霉素毒性，6例拒绝）。对于ABVD + RT，完全缓解（CR）百分比为94%，无主要缓解，6%。对于ABVD单药治疗，94%达到CR; 1.5%达到部分缓解（PR）; 4.5%无重大缓解。在60个月CR持续时间、无进展（FFP）和总生存期（OS）方面，ABVD + FIT与ABVD单药相比分别为91%与87%（P = 0.61）、86%与81%（P = 0.61）和97%与90%（P = 0.08）（对数秩）。5年时CR持续时间、FFP和OS差异的95%置信区间分别为-8%至15%、-8%至18%和-4%至12%。尽管未观察到显著差异，但在更大规模的试验中，可能会观察到WIT的结局获益小于20%。
To determine whether combined modality therapy (CMT) is superior to chemotherapy (CT) alone, 152 untreated Hodgkin disease patients with clinical stages (CSs) IA, IB, IIA, IIB, and IIIA without bulk disease were prospectively randomized to 6 cycles of doxorubicin, bleomycin, vinblastine, clacarbazine (ABVD) alone or 6 cycles of ABVD followed by radiation therapy (RT) (3600 cGy: involved field for 11 patients, modified extended field for the rest). Of 76 patients randomized to receive FIT, 65 actually received it, and 11 did not (4 progressed, 1 had bleomycin toxicity, 6 refused). For ABVD + RT, the complete remission (CR) percentage was 94% and no major response, 6%. For ABVD alone, 94% achieved a CR; 1.5%, a partial response (PR); and 4.5%, no major response. At 60 months CR duration, freedom from progression (FFP), and overall survival (OS) for ABVD + FIT versus ABVD alone are 91% versus 87% (P =.61), 86% versus 81 % (P =.61), and 97% versus 90% (P =.08), respectively (log-rank). The 95% confidence intervals for CR duration, FFP, and OS differences at 5 years were -8% to 15%, -8% to 18%, and -4% to 12%, respectively. Although significant differences were not seen, it is possible that a benefit in outcome of less than 20% for WIT might be seen in a larger trial.