Department of Surgical Oncology, National Cancer Centre, Singapore; Cancer Therapeutics Research Laboratory, National Cancer Centre, Singapore.
Cancer. 2015 May 15;121(10):1599-607. doi: 10.1002/cncr.29251. Epub 2015 Jan 29.
The current study was performed to report the long-term results of a trial comparing concurrent chemotherapy and radiotherapy (CCRT) with surgery and adjuvant radiotherapy (RT) in patients with stage III/IV nonmetastatic head and neck squamous cell carcinoma.
Patients with stage III/IV resectable head and neck squamous cell carcinoma were randomized to surgery followed by RT or CCRT. The trial was halted prematurely due to poor accrual. Human papillomavirus status was tested on archival material using polymerase chain reaction sequencing.
Of the total of 119 patients, 60 patients were randomized to primary surgery (S arm) and 59 patients were randomized to CCRT (C arm). Human papillomavirus status was tested in 75 patients, and only 3 were found to be positive. The median follow-up for surviving patients was 13 years. Analysis of the entire cohort demonstrated no statistically significant difference in overall survival and disease-specific survival (DSS): 5-year rates were 45% versus 35% for overall survival (P = .262) and 56% versus 46% for DSS (P = .637) for the S arm and C arm, respectively. Analysis by subsites indicated that this difference favoring the S arm was mainly driven by survival data among patients with cancers of the oral cavity and maxillary sinus. For patients with oral cavity cancer, survival was significantly better in those who underwent primary surgery compared with CCRT; the 5-year DSS rate was 68% versus 12% for the S arm and C arm, respectively (P = .038). For patients with cancers of the maxillary sinus, the 5-year DSS rate was 71% for patients on the S arm and 0% for patients on the C arm (P = .05).
These long-term results demonstrate a significant advantage for primary surgery in patients with cancers of the oral cavity or maxillary sinus, providing strong support for primary surgery as the main modality of treatment for these subsites. In other subsites, CCRT and surgery with adjuvant RT were found to demonstrate similar efficacy for survival in patients with advanced resectable tumors.
本研究旨在报告一项比较 III/IV 期非转移性头颈部鳞状细胞癌患者同期放化疗（CCRT）与手术加辅助放疗（RT）的临床试验的长期结果。
III/IV 期可切除的头颈部鳞状细胞癌患者被随机分为手术加 RT 组或 CCRT 组。由于入组人数不佳，该试验提前终止。使用聚合酶链反应测序检测存档标本的人乳头瘤病毒状态。
共 119 例患者中，60 例患者被随机分为原发手术（S 组），59 例患者被随机分为 CCRT（C 组）。对 75 例患者进行了人乳头瘤病毒状态检测，仅发现 3 例阳性。生存患者的中位随访时间为 13 年。对整个队列的分析显示，总生存率和疾病特异性生存率（DSS）无统计学差异：5 年总生存率分别为 S 组 45%和 C 组 35%（P=0.262），DSS 分别为 S 组 56%和 C 组 46%（P=0.637）。亚部位分析表明，S 组的这种优势主要是由口腔和上颌窦癌症患者的生存数据驱动的。对于口腔癌患者，原发手术组的生存明显优于 CCRT 组；S 组和 C 组的 5 年 DSS 率分别为 68%和 12%（P=0.038）。对于上颌窦癌患者，S 组的 5 年 DSS 率为 71%，而 C 组为 0%（P=0.05）。
这些长期结果表明，原发手术在口腔或上颌窦癌患者中具有显著优势，为这些亚部位的主要治疗方式提供了有力支持。在其他亚部位，CCRT 和手术加辅助 RT 在治疗可切除晚期肿瘤患者的生存方面显示出相似的疗效。
