Avilés A, Díaz-Maqueo J C, Talavera A, Nambo M J, García E L
Department of Hematology, Oncology Hospital, National Medical Centre México, DF, Mexico.
Leuk Lymphoma. 1998 Aug;30(5-6):651-6. doi: 10.3109/10428199809057577.
We performed a randomized clinical trial to assess the efficacy and toxicity of interferon alfa 2b (IFN) as maintenance therapy in patients with advanced Hodgkin's disease in complete remission (CR) after conventional chemotherapy. One hundred and thirty-five patients (stage IIIB-IV B) were initially treated with EBVD (epirubicin, bleomycin, vinblastine, dacarbazine). IF CR was achieved they were randomly assigned to receive either maintenance therapy with IFN 5.0 MU three times a week for one year or no further treatment (control group). Clinical and laboratory characteristics at diagnosis were quite similar in both groups. After a median follow-up of 74.3 months (range 49 to 108), 61 out of 68 patients (91%; 95% confidence interval (CI): 76% to 97%) remain in first complete remission in the IFN-treated group compared to 38 out of 67 (58%; 95% CI: 49% to 71%) in the control group (p<.01). Overall survival was also better in the IFN treated group: 62 patients (92%; 95% CI: 82% to 97%) are alive free of disease at 7-years compared to 40 patients (67%, 95%: 55% to 76%) in the control group (p<.01). Toxicity secondary to IFN administration was mild and no dose modification was necessary during treatment. All patients received the planned dose of IFN. This was not an intent-to treat analysis. IFN administration as maintenance therapy was appears to be the only cause of improvement in outcome in these patients. We feel that IFN should be considered as maintenance therapy in patients with advanced Hodgkin's disease because this treatment improves the final outcome without the excessive toxicities of more aggressive therapeutic approaches such as bone marrow transplantation during first CR. We hope that IFN will be considered in future randomized clinical trials in order to define it's role in the treatment of Hodgkin's disease.
我们进行了一项随机临床试验，以评估干扰素α2b（IFN）作为维持治疗对晚期霍奇金病患者在接受传统化疗后达到完全缓解（CR）时的疗效和毒性。135例患者（ⅢB - ⅣB期）最初接受EBVD（表柔比星、博来霉素、长春花碱、达卡巴嗪）治疗。若达到CR，则将他们随机分配，一组接受IFN 5.0 MU每周三次，共一年的维持治疗，另一组不再接受进一步治疗（对照组）。两组患者诊断时的临床和实验室特征相当相似。经过中位随访74.3个月（范围49至108个月），IFN治疗组68例患者中有61例（91%；95%置信区间（CI）：76%至97%）仍处于首次完全缓解，而对照组67例中有38例（58%；95% CI：49%至71%）（p<0.01）。IFN治疗组的总生存率也更高：7年时62例患者（92%；95% CI：82%至97%）无病存活，而对照组为40例患者（67%，95%：55%至76%）（p<0.01）。IFN给药引起的毒性较轻，治疗期间无需调整剂量。所有患者均接受了计划剂量的IFN。这不是一项意向性分析。IFN作为维持治疗似乎是这些患者预后改善的唯一原因。我们认为IFN应被视为晚期霍奇金病患者的维持治疗方法，因为这种治疗可改善最终预后，而不会出现如首次CR期间进行骨髓移植等更积极治疗方法那样的过度毒性。我们希望未来的随机临床试验能考虑使用IFN，以明确其在霍奇金病治疗中的作用。
