Washington University, St Louis, MO.
Mayo Clinic, Phoenix, AZ.
J Clin Oncol. 2019 Oct 1;37(28):2548-2555. doi: 10.1200/JCO.19.00186. Epub 2019 Jun 27.
The volume treated with postoperative radiation therapy (PORT) is a mediator of toxicity, and reduced volumes result in improved quality of life (QOL). In this phase II trial, treatment volumes were reduced by omitting PORT to the pathologically negative (PN0) neck in patients with primary head and neck squamous cell carcinoma.
Patients with head and neck squamous cell carcinoma who underwent surgical resection and neck dissection with a PN0 neck and high-risk features mandating PORT to the primary and/or involved neck were eligible. The primary end point was greater than 90% disease control in the unirradiated neck. QOL was evaluated using the MD Anderson Dysphagia Inventory and the University of Michigan patient-reported xerostomia questionnaire.
Seventy-three patients were enrolled, and 72 were evaluable. Median age was 56 years (range, 31 to 81 years); 58 patients were male, and 47 (65%) had a smoking history. Sites included oral cavity (n = 14), oropharynx (n = 37), hypopharynx (n = 4), larynx (n = 16), and unknown primary tumor (n = 1). According to the American Joint Committee on Cancer Staging Manual (7 edition), 67 patients (93%) had stage III/IV disease, and 71% of tumors involved or crossed midline. No patient had contralateral neck PORT. In 17 patients (24%), only the primary site was treated. At a median follow-up of 53 months, two patients experienced treatment failure of the PN0 unirradiated neck; they also experienced treatment failure locally. Unirradiated neck control was 97% (95% CI, 93.4% to 100.0%). Five-year rates of local control, regional control, progression-free survival, and overall survival were 84%, 93%, 60%, and 64%, respectively. QOL measures were not significantly different from baseline at 12 and 24 months post-PORT ( > .05).
Eliminating PORT to the PN0 neck resulted in excellent control rates in the unirradiated neck without long-term adverse effects on global QOL.
术后放疗（PORT）的治疗体积是毒性的中介，减少体积可提高生活质量（QOL）。在这项 II 期试验中，通过省略病理阴性（PN0）颈部的 PORT，对原发性头颈部鳞状细胞癌患者的颈部进行治疗。
接受手术切除和颈部解剖，且颈部为 PN0 且存在高危特征，需要对原发灶和/或受累颈部进行 PORT 的头颈部鳞状细胞癌患者符合条件。主要终点是未放疗颈部的疾病控制率大于 90%。使用 MD 安德森吞咽障碍量表和密歇根大学患者报告的口干问卷评估 QOL。
共纳入 73 例患者，72 例可评估。中位年龄为 56 岁（范围，31 至 81 岁）；58 例为男性，47 例（65%）有吸烟史。部位包括口腔（n=14）、口咽（n=37）、下咽（n=4）、喉（n=16）和未知原发灶（n=1）。根据美国癌症联合委员会癌症分期手册（第 7 版），67 例患者（93%）为 III/IV 期疾病，71%的肿瘤累及或穿过中线。无患者行对侧颈部 PORT。17 例（24%）仅治疗原发灶。中位随访 53 个月时，2 例患者发生未放疗的 PN0 颈部治疗失败；他们也发生局部治疗失败。未放疗颈部的控制率为 97%（95%CI，93.4%至 100.0%）。5 年局部控制率、区域控制率、无进展生存率和总生存率分别为 84%、93%、60%和 64%。PORT 后 12 个月和 24 个月的 QOL 测量与基线相比无显著差异（>.05）。
省略 PN0 颈部的 PORT 可在不影响全球 QOL 的情况下，获得未放疗颈部的优异控制率。
