Simmonds P D, Mead G M, Sweetenham J W, O'Callaghan A, Smartt P, Kerr J, Hamilton C R, Golding P F, Milne A E, Whitehouse J M
CRC Wessex Medical Oncology Unit, Royal South Hants Hospital, Southampton, UK.
Ann Oncol. 1997 Mar;8(3):259-66. doi: 10.1023/a:1008282020341.
This study was designed to evaluate the efficacy and toxicity of a 12-week alternating weekly chemotherapy regimen for advanced Hodgkin's disease. Consolidative irradiation of residual masses was used in selected cases.
Eighty-three patients with newly diagnosed advanced Hodgkin's disease (bulky stage IIA, stage IIB-IVB) or with progressive disease after extended field radiotherapy for early stage disease were included in this study. The patients were treated for 12 weeks with PACE BOM comprising oral prednisolone together with intravenous doxorubicin, cyclophosphamide and etoposide alternating weekly with intravenous bleomycin, vincristine and methotrexate. Limited field adjuvant radiotherapy was also given to 21 patients with localised persistent radiological abnormalities visible on chest X-ray after chemotherapy. The study end points were overall survival, failure free survival (FFS) and toxicity, particularly with respect to reproductive function.
With a median post treatment follow up of 52 months the actuarial 5-year overall survival is 90% (confidence interval 81%-95%) and FFS is 64% (52%-74%). This treatment was well tolerated and fertility was maintained in a high proportion of young adults.
The brief duration PACE BOM regimen with or without radiotherapy appears to be comparable in efficacy to other doxorubicin containing regimens, with a favourable toxicity profile. Randomised clinical trials are now needed to evaluate the role of this and comparable initial treatment approaches to advanced Hodgkin's disease.
本研究旨在评估一种为期12周的交替周疗化疗方案对晚期霍奇金病的疗效和毒性。部分病例采用了对残留肿块的巩固性放疗。
本研究纳入了83例新诊断的晚期霍奇金病患者(大肿块IIA期、IIB - IVB期)或早期疾病扩大野放疗后疾病进展的患者。患者接受了为期12周的PACE BOM方案治疗,该方案包括口服泼尼松龙以及静脉注射阿霉素、环磷酰胺和依托泊苷,每周与静脉注射博来霉素、长春新碱和甲氨蝶呤交替使用。21例化疗后胸部X线可见局部持续性放射学异常的患者还接受了局限性野辅助放疗。研究终点为总生存期、无失败生存期(FFS)和毒性,尤其涉及生殖功能。
中位治疗后随访52个月,5年总生存精算率为90%(置信区间81% - 95%),FFS为64%(52% - 74%)。该治疗耐受性良好,高比例的年轻成人维持了生育能力。
短期的PACE BOM方案无论是否联合放疗,疗效似乎与其他含阿霉素的方案相当,且毒性特征良好。现在需要进行随机临床试验来评估该方案及类似的晚期霍奇金病初始治疗方法的作用。