Jaulerry C, Rodriguez J, Brunin F, Jouve M, Mosseri V, Point D, Pontvert D, Validire P, Zafrani B, Blaszka B
Department of Radiation Oncology, Institut Curie, Paris, France.
Int J Radiat Oncol Biol Phys. 1992;23(3):483-9. doi: 10.1016/0360-3016(92)90002-y.
From March 1983 to December 1989, 208 patients with locally advanced squamous cell carcinoma of the head and neck were successively included into two randomized induction chemotherapy trials. The chemotherapy regimen of the first trial, which included 100 patients, consisted of two cycles of a combination of cisplatin, bleomycin, vindesine and mitomycin C; while that of the second trial, which included 108 patients, consisted of three cycles of a combination cisplatin, 5-fluorouracil by continuous infusion and vindesine. Local treatment was the same in the two trials: primary radiotherapy in all patients. The response was then evaluated; in the case of a poor response at 55 Grays surgery was performed; otherwise, radiotherapy was continued to full doses (possibly followed by salvage surgery). The tumor and lymph node responses to chemotherapy (complete and partial response) were higher in the second trial than in the first: 70% versus 50% for primary lesions, 47% versus 25% for lymph nodes. The toxicity of the two chemotherapy regimens was minimal. In the two trials, an initial major response to chemotherapy predicted subsequent efficacy of irradiation in 80% of the patients. The significance of the complete response at the end of the irradiation varies with the previous response to the chemotherapy. With a median follow-up of 60 months with the first chemotherapy regimen and 30 months with the second, overall survival and disease-free interval were very similar in the two groups. The incidence of distant metastasis was significantly reduced (p less than 0.03) with chemotherapy. This trial suggests the need to test new chemotherapy protocols according to new schemes of treatment, with chemotherapy given concurrently with or following the completion of standard treatment by means of multicenter randomized trials.
1983年3月至1989年12月，208例局部晚期头颈部鳞状细胞癌患者先后被纳入两项随机诱导化疗试验。第一项试验纳入100例患者，其化疗方案为顺铂、博来霉素、长春地辛和丝裂霉素C联合使用两个周期；第二项试验纳入108例患者，其化疗方案为顺铂、持续输注5-氟尿嘧啶和长春地辛联合使用三个周期。两项试验中的局部治疗相同：所有患者均接受原发灶放疗。然后评估反应情况；如果在55格雷剂量时反应不佳，则进行手术；否则，继续给予全剂量放疗（可能随后进行挽救性手术）。第二项试验中肿瘤和淋巴结对化疗的反应（完全缓解和部分缓解）高于第一项试验：原发灶分别为70%和50%，淋巴结分别为47%和25%。两种化疗方案的毒性均最小。在两项试验中，化疗初期的主要反应预测了80%患者后续放疗的疗效。放疗结束时完全缓解的意义因先前对化疗的反应而异。第一项化疗方案的中位随访时间为60个月，第二项为30个月，两组的总生存期和无病间期非常相似。化疗显著降低了远处转移的发生率（p<0.03）。该试验表明，需要根据新的治疗方案测试新的化疗方案，通过多中心随机试验在标准治疗期间或完成后同时给予化疗。
