Bachaud J M, Cohen-Jonathan E, Alzieu C, David J M, Serrano E, Daly-Schveitzer N
Department of Radiotherapy, Centre Claudius Regaud, Toulouse, France.
Int J Radiat Oncol Biol Phys. 1996 Dec 1;36(5):999-1004. doi: 10.1016/s0360-3016(96)00430-0.
To report the final results of a prospective randomized trial that aimed to evaluate efficacy and toxicity of concomitant postoperative radiotherapy and Cisplatin infusion in patients with Stage III or IV squamous cell carcinoma of the head and neck and histological evidence of extracapsular spread of tumor in lymph node metastase(s).
Radiotherapy was delivered using a daily dose of 1.7 Gy for the first 54 Gy and 1.8 to 2 Gy until the completion of the treatment. Cisplatin 50 mg i.v. with forced hydratation was given or not every week (i.e., seven to nine cycles) concurrently with radiotherapy. A total of 44 patients were treated by irradiation only (RT group) and 39 by irradiation with chemotherapy (CM group).
The RT group displayed a higher rate of loco-regional failures as compared to CM group (41 vs. 23%; p = 0.08). The overall survival, the survival corrected for deaths by intercurrent disease, and the disease-free survival were better in CM group as compared to RT group with statistically significant differences. Survival without loco-regional treatment failure was better in the CM group, the difference being close to the level of significance (p = 0.05). Survival without distant metastases were comparable in the two therapeutic groups. Ten severe late complications were observed, four in the RT group (17%) and six in the CM group (22%). Cox univariate analysis confirmed the importance of the therapeutic modality in predicting the overall survival, the survival corrected for deaths by intercurrent disease, and the disease-free survival.
The present final report of this phase III study confirms preliminary results. The concomitant use of 50 mg weekly Cisplatin infusion and postoperative radiation improved loco-regional control and survival. No significant increase of late radiation complications was observed in the CM group.
报告一项前瞻性随机试验的最终结果，该试验旨在评估术后同步放疗和顺铂输注对Ⅲ期或Ⅳ期头颈部鳞状细胞癌且有淋巴结转移灶肿瘤包膜外扩散组织学证据患者的疗效和毒性。
放疗开始时每日剂量为1.7 Gy，照射54 Gy后剂量改为1.8至2 Gy直至治疗结束。顺铂50 mg静脉注射并强制水化，每周（即7至9个周期）与放疗同时给予或不给予。仅接受放疗的患者共44例（RT组），接受放疗联合化疗的患者共39例（CM组）。
与CM组相比，RT组局部区域复发率更高（41%对23%；p = 0.08）。CM组的总生存率、校正并发疾病死亡后的生存率和无病生存率均优于RT组，差异具有统计学意义。CM组无局部区域治疗失败的生存率更高，差异接近显著性水平（p = 0.05）。两组无远处转移的生存率相当。观察到10例严重晚期并发症，RT组4例（17%），CM组6例（22%）。Cox单因素分析证实了治疗方式在预测总生存率、校正并发疾病死亡后的生存率和无病生存率方面的重要性。
本Ⅲ期研究的最终报告证实了初步结果。每周同步输注50 mg顺铂和术后放疗可改善局部区域控制和生存率。CM组未观察到晚期放疗并发症显著增加。
