Eur J Surg Oncol. 1986 Sep;12(3):289-95.
This report concerns the design and results of a randomized prospective trial (SECOG 1) in the treatment of advanced Stage III and IV head and neck cancer with radical radiotherapy combined with polychemotherapy. Synchronous administration of chemotherapy and radiotherapy was compared with sequential chemotherapy and radiotherapy and VBM (vincristine, bleomycin and methotrexate) compared with VBM plus 5-fluorouracil in a 2 X 2 standard factorial design. Two-hundred-and-seventy patients were entered and 267 were included in the analysis. Treatment did not present serious problems of toxicity. The addition of 5-fluorouracil to VBM produced a significant improvement in disease-free survival (P = 0.04) though not in overall survival. Synchronous chemotherapy was similarly better than sequential chemotherapy, though not significantly so (P = 0.1). A new study (SECOG II), based on this was started in February 1984, and one-third of the patients are now being allocated to treatment by radiotherapy as the sole method of treatment.
本报告涉及一项随机前瞻性试验（SECOG 1）的设计与结果，该试验旨在采用根治性放疗联合多药化疗治疗晚期III期和IV期头颈癌。在2×2标准析因设计中，对同步放化疗与序贯放化疗进行了比较，以及对长春新碱、博来霉素和甲氨蝶呤（VBM）与VBM加5-氟尿嘧啶进行了比较。共纳入270例患者，267例纳入分析。治疗未出现严重的毒性问题。VBM加用5-氟尿嘧啶虽未使总生存率显著提高，但无病生存率有显著改善（P = 0.04）。同步化疗同样优于序贯化疗，不过差异不显著（P = 0.1）。基于此，1984年2月启动了一项新的研究（SECOG II），目前有三分之一的患者被分配接受单纯放疗。
