■头颈部鳞状细胞癌(HNSCC)的当前标准治疗概念是基于使用2D和3D治疗计划的先前研究。然而,现代辐射技术允许更精确和单独的剂量应用。因此,在明确定义的患者群体中,研究了去强化的风险适应辐射。
■手术后新诊断的HNSCC(切除边缘≥1mm,cM0)并具有以下肿瘤分期(TNM第7版)的患者符合该研究的条件:口腔,口咽,或喉:pT1-3,pN0-pN2b;下咽:pT1-2,pN1。患者应具有较低的局部复发风险[≤pT2,切缘≥5mm,无瘤周淋巴管病(L0),且无神经周浸润]或对侧淋巴结转移(≤3同侧淋巴结转移,在侧口咽或口腔癌对侧cN0的情况下,否则pN0)。患者被分配到三种不同的治疗方案,减少治疗体积,辐射剂量,或者两者兼而有之,根据肿瘤分期和手术结果。主要目标是在2年后显示<10%的LRR。
■共纳入150例患者。肿瘤定位如下:n=53(35.3%),口腔;n=94(62.7%),口咽(82%HPV阳性);n=2(1.3%),下咽;n=1(0.7%),喉部.共61例(41.0%)为IVA期,81例(54.0%)为III期,第二阶段为8例(5.3%)。中位随访时间为36个月。在整个研究人群中,2y-LRR的累积发生率为5.6%(95%CI:1.7%-9.2%),在口腔癌患者中为14.1%(95%CI:3.8%-23.2%)。未照射或剂量减少区域的2y-LRR的累积发生率为3.5%(95%CI:0.4%-6.5%)。两年后,完整研究队列的无病生存率为92%(95%CI:87%-96%),总生存率为94%(95%CI:90%-98%).急性III°毒性如下:吞咽困难,30%;口干症,7%;黏膜炎,19%;和皮炎,4%。吞咽困难和口干症随时间减少。27个月后,晚期吞咽困难III°和口干症II°分别为1%和9%,分别。
■这项研究达到了其主要目标。在预定义的患者人群中,无论HPV状态如何,术后放疗的去强化都与有利的毒性特征相关,而不会损害LRR。在计划外的子群分析中,在口腔癌患者中观察到LRR的风险显著增加.在这些患者中,去强化放疗应谨慎应用。
UNASSIGNED: Current standard treatment concepts in head and neck squamous cell carcinoma (HNSCC) are based on former studies using 2D and 3D treatment plans. However, modern radiation techniques allow for a more precise and individual dose application. Therefore, in a clearly defined patient population, de-intensified risk-adapted radiation is investigated.
UNASSIGNED: Patients with newly diagnosed HNSCC after surgery (with resection margins ≥1 mm and cM0) with the following tumor stages (TNM 7th Edition) were eligible for the study: oral cavity, oropharynx, or larynx: pT1-3, pN0-pN2b; hypopharynx: pT1-2, pN1. The patients should have either a low risk of local recurrence [≤pT2, resection margin ≥5 mm, no peritumoral lymphangiosis (L0), and no perineural invasion] or contralateral lymph node metastasis (≤3 ipsilateral lymph node metastases, in case of well-lateralized oropharyngeal or oral cavity cancer contralateral cN0, otherwise pN0). Patients were assigned to three different treatment regimes with reduction of the treated volume, radiation dose, or both, according to tumor stage and results of surgery performed. The primary objective was to show an LRR of <10% after 2 years.
UNASSIGNED: A total of 150 patients were enrolled. Tumor localizations were as follows: n = 53 (35.3%), oral cavity; n = 94 (62.7%), oropharynx (82% HPV-positive); n = 2 (1.3%), hypopharynx; and n = 1 (0.7%), larynx. A total of 61 patients (41.0%) were stage IVA, 81 (54.0%) were stage III, and 8 (5.3%) were stage II. Median follow-up was 36 months. Cumulative incidence of 2y-LRR was 5.6% (95% CI: 1.7%-9.2%) in the whole study population and 14.1% (95% CI: 3.8%-23.2%) in patients with oral cavity cancer. Cumulative incidence of 2y-LRR in non-irradiated or dose-reduced regions was 3.5% (95% CI: 0.4%-6.5%). After 2 years, disease-free survival was 92% (95% CI: 87%-96%) and overall survival was 94% (95% CI: 90%-98%) for the complete study cohort. Acute III° toxicity was as follows: dysphagia, 30%; xerostomia, 7%; mucositis, 19%; and dermatitis, 4%. Dysphagia and xerostomia decrease over time. After 27 months, late dysphagia III° and xerostomia II° were 1% and 9%, respectively.
UNASSIGNED: The study met its primary objective. De-intensification of
postoperative radiotherapy irrespective of HPV status in a predefined patient population is associated with a favorable toxicity profile without compromising LRR. In an unplanned subgroup analysis, a significantly increased risk of LRR was observed in patients with oral cavity cancer. In these patients, de-intensified radiotherapy should be applied with caution.