Background: Cisplatin (CDDP) concomitant to radiotherapy (RT) is one of the main treatments for locally advanced head and neck squamocellular carcinoma (LA HNSCC); nevertheless, elderly patients are underrepresented in trials and frequently receive less intensive and suboptimal treatments, which often are unimodal, even if it is well demonstrated how chemoradiotherapy (CRT) with CDDP is superior to RT alone. We aim to analyze clinical feasibility in terms of acute toxicity and treatment adherence in patients receiving concurrent high-dose CDDP and RT with curative or adjuvant intent, comparing elderly (≥65 years) with young (<65 years) patients. Methods: This is a monocentric, observational, prospective study of consecutive LA HNSCC patients treated with high dose CDDP concomitant to RT, from January 2017 to June 2024. The primary aim is to compare the performance of elderly patients with young patients in terms treatment adherence and toxicity, while the secondary aim is to assess treatment efficacy in terms of OS and PFS endpoints. The LA HNSCC patients were selected only by treatment, so all patients who did not receive chemoradiation were excluded. No difference in terms of compliance and toxicity events >G1 in the elderly versus young population is the null hypothesis. Data were analyzed using MedCal statistical software 14.12. Ap< 0.05 was considered statistically significant. Results: A total of 170 patients were included in the study, according to the selection criteria stated. Only 7 elderly (12.3%) patients received a dose < 200 mg/m2, whereas 163 patients (87.7%) received ≥ 200 mg/m2and all elderly patients completed RT, indicating a high level of adherence and effective management of treatment protocols, in front of a comparable incidence of acute toxicity to young patients (p-value: 0.84). OS and PFS were not statistically different between elderly and young patients (p= 0.20 andp= 0.72, respectively). Conclusions: Our findings suggest the feasibility of curative oncological treatment for elderly individuals with LA HNSCC, if they are well selected and adequately supported. Future studies should focus on validating and expanding these results to improve patient care and outcomes.
背景:顺铂联合放疗是局部晚期头颈部鳞状细胞癌的主要治疗手段之一;然而,老年患者在临床试验中代表性不足,且常接受强度较低的非最优治疗(多为单模式治疗),尽管已有充分证据表明顺铂放化疗的疗效优于单纯放疗。本研究旨在分析接受根治性或辅助性高剂量顺铂同步放化疗的老年(≥65岁)与年轻(<65岁)患者在急性毒性和治疗依从性方面的临床可行性。 方法:本研究为单中心、观察性、前瞻性研究,纳入2017年1月至2024年6月连续收治的接受高剂量顺铂同步放疗的局部晚期头颈部鳞状细胞癌患者。主要目的是比较老年与年轻患者的治疗依从性和毒性反应,次要目的是评估总生存期和无进展生存期的疗效终点。患者筛选仅基于治疗方案,未接受放化疗者均被排除。研究假设为老年与年轻患者在治疗依从性和>1级毒性事件方面无差异。采用MedCal 14.12统计软件分析数据,以p<0.05为具有统计学意义。 结果:根据筛选标准共纳入170例患者。仅7例老年患者(12.3%)接受<200 mg/m²剂量治疗,163例患者(87.7%)接受≥200 mg/m²剂量,且所有老年患者均完成放疗,表明在急性毒性发生率与年轻患者相当(p=0.84)的前提下,治疗方案具有高依从性和有效管理。老年与年轻患者的总生存期和无进展生存期均无统计学差异(分别为p=0.20和p=0.72)。 结论:本研究提示经过充分筛选和适当支持的局部晚期头颈部鳞状细胞癌老年患者接受根治性肿瘤治疗具有可行性。未来研究应致力于验证和拓展这些结果,以优化患者护理和临床结局。