Haffty B G, Son Y H, Papac R, Sasaki C T, Weissberg J B, Fischer D, Rockwell S, Sartorelli A C, Fischer J J
Department of Therapeutic Radiology, Yale University School of Medicine, New Haven, CT 06520-8040, USA.
J Clin Oncol. 1997 Jan;15(1):268-76. doi: 10.1200/JCO.1997.15.1.268.
Two consecutive randomized trials were run at our institution using the bioreductive alkylating agent mitomycin as an adjunct to radiation therapy in an effort to improve outcome in patients with squamous cell carcinoma of the head and neck.
Between 1980 and 1992, two consecutive randomized trials using mitomycin (trial 1) and mitomycin with dicumarol (trial 2) as an adjunct to radiation therapy in patients with squamous cell carcinoma of the head and neck were conducted at our institution. The patients were stratified by intent of therapy, extent of disease, and primary tumor site. Within each strata, patients were randomized to receive radiation therapy with or without mitomycin (trial 1) or mitomycin/dicumarol (trial 2).
A total of 203 patients were enrolled onto both trials, 195 of whom were eligible for analysis. Patients were equally balanced with respect to sex, age, extent of disease, primary site, radiation dose, and total duration of radiation treatment. Hematologic toxicities were more frequently noted in the drug-treated arms, but were acceptable with no drug-related treatment deaths. Nonhematologic toxicities were acceptable and not significantly different between the two arms. As of September 1995, with a median follow-up of 138 months, a statistically significant benefit occurred in the mitomycin arms with respect to cause-specific survival (0.74 +/- 0.05 v 0.51 +/- 0.05; P = .005), local recurrence-free survival (0.85 +/- 0.04 v 0.66 +/- 0.05; P = .002), and local regional recurrence-free survival (0.76 +/- 0.05 v 0.54 +/- 0.05; P = .003). No statistically significant difference in overall survival was obtained (0.48 +/- 0.05 mitomycin arms v 0.42 +/- 0.05 radiation alone).
The bioreductive alkylating agent mitomycin is a safe and effective adjunct to radiation therapy in the treatment of squamous cell carcinoma of the head and neck. The statistically and clinically significant improvement in local regional relapse and cause-specific survival obtained support the use of mitomycin as an adjunct to radiation therapy in the management of squamous cell carcinoma of the head and neck.
我们机构进行了两项连续的随机试验，使用生物还原烷基化剂丝裂霉素作为放射治疗的辅助手段，以改善头颈部鳞状细胞癌患者的治疗效果。
1980年至1992年间，我们机构对两项连续的随机试验进行了研究，在头颈部鳞状细胞癌患者中，分别使用丝裂霉素（试验1）和丝裂霉素联合双香豆素（试验2）作为放射治疗的辅助手段。患者按治疗意图、疾病范围和原发肿瘤部位进行分层。在每个分层中，患者被随机分配接受放射治疗加或不加丝裂霉素（试验1）或丝裂霉素/双香豆素（试验2）。
共有203名患者参与了这两项试验，其中195名符合分析条件。患者在性别、年龄、疾病范围、原发部位、放射剂量和放射治疗总时长方面分布均衡。血液学毒性在药物治疗组中更常出现，但可接受，且无药物相关的治疗死亡。非血液学毒性可接受，两组之间无显著差异。截至1995年9月，中位随访时间为138个月，丝裂霉素组在特定病因生存率（0.74±0.05对0.51±0.05；P = 0.005）、局部无复发生存率（0.85±0.04对0.66±0.05；P = 0.002）和局部区域无复发生存率（0.76±0.05对0.54±0.05；P = 0.003）方面有统计学显著益处。总生存率无统计学显著差异（丝裂霉素组0.48±0.05对单纯放疗组0.42±0.05）。
生物还原烷基化剂丝裂霉素是头颈部鳞状细胞癌放射治疗的一种安全有效的辅助手段。在局部区域复发和特定病因生存率方面取得的统计学和临床显著改善支持将丝裂霉素用作头颈部鳞状细胞癌管理中放射治疗的辅助手段。
