Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.
Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.
Int J Radiat Oncol Biol Phys. 2020 Jul 1;107(3):469-477. doi: 10.1016/j.ijrobp.2020.02.637. Epub 2020 Mar 14.
This study describes the long-term survival and toxicity outcomes of a multicenter randomized phase 2 trial comparing radiation therapy (RT) plus cisplatin (CDDP) or cetuximab (CTX) as first line treatment in locally advanced head and neck cancer (LASCCHN).
Between January 2011 and August 2014, 70 patients were enrolled and randomized to receive RT plus weekly CDDP (40 mg/m) or CTX (250 mg/m plus a loading dose of 400 mg/m). This updated series focuses on late toxicities (graded by using Common Terminology Criteria for Adverse Events version 4.0) and long-term survival outcomes in terms of local control, overall survival, cancer-specific survival, and metastasis-free survival (MFS). A supplementary analysis based on human papilloma virus (HPV) status was also performed.
No statistically significant difference was found in terms of late effects (xerostomia, fibrosis, mucosal atrophy, weight loss). In the CDDP arm and the CTX arm, 5-year local control rates were 67% and 48%; 5-year MFS rates were 83% and 97%; 5-year overall survival rates were 61% and 52%; and 5-year cancer-specific survival rates were 70% and 59%, respectively. None of these differences reached statistical significance. A subgroup analysis by HPV status and anatomic subsites revealed that in HPV+ oropharyngeal carcinoma, better survival was obtained in the CDDP arm (although statistical tests were not performed owing to the small sample size). Conversely, no statistically significant differences were observed in HPV- oropharyngeal carcinoma and other anatomic subsites, except for the confirmed better MFS rates of the CTX arm.
Long-term results are in line with current literature suggesting that RT + CTX is inferior to RT + CDDP for the definitive treatment of LASCCHN. However, if not as an alternative to CDDP, CTX might still play a role in LASCCHN, particularly in HPV- cases.
本研究描述了一项多中心随机 2 期临床试验的长期生存和毒性结果，该试验比较了放疗 (RT) 加顺铂 (CDDP) 或西妥昔单抗 (CTX) 作为局部晚期头颈部癌症 (LASCCHN) 的一线治疗。
2011 年 1 月至 2014 年 8 月，共纳入 70 例患者并进行随机分组，接受 RT 加每周 CDDP（40mg/m）或 CTX（250mg/m 加 400mg/m 的负荷剂量）治疗。本更新系列重点关注晚期毒性（采用不良事件通用术语标准 4.0 分级）和局部控制、总生存、癌症特异性生存和无转移生存 (MFS) 的长期生存结果。还进行了基于人乳头瘤病毒 (HPV) 状态的补充分析。
在晚期效应（口干症、纤维化、黏膜萎缩、体重减轻）方面，两组之间没有统计学上的显著差异。在 CDDP 组和 CTX 组中，5 年局部控制率分别为 67%和 48%；5 年 MFS 率分别为 83%和 97%；5 年总生存率分别为 61%和 52%；5 年癌症特异性生存率分别为 70%和 59%。这些差异均无统计学意义。基于 HPV 状态和解剖部位的亚组分析显示，在 HPV+口咽癌中，CDDP 组的生存获益更好（尽管由于样本量小，未进行统计学检验）。相反，在 HPV-口咽癌和其他解剖部位中，未观察到统计学上的显著差异，除了 CTX 组确认的更好的 MFS 率。
长期结果与目前的文献一致，提示 RT+CTX 不如 RT+CDDP 适用于局部晚期头颈部癌症的确定性治疗。然而，如果 CTX 不是 CDDP 的替代方案，它在 LASCCHN 中可能仍有作用，特别是在 HPV-病例中。
