Department of Radiation Oncology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
UNC Lineberger Comprehensive Cancer Center, University of North Carolina Hospitals, Chapel Hill, North Carolina.
Cancer. 2018 Jun 1;124(11):2347-2354. doi: 10.1002/cncr.31338. Epub 2018 Mar 26.
The purpose of the current study was to determine quality of life and tumor control from a prospective phase 2 clinical trial evaluating deintensified chemoradiotherapy for favorable risk, human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma.
Patients with T0-T3, N0-N2c, M0, p16-positive disease and a minimal smoking history were treated with 60 grays of intensity-modulated radiotherapy with concurrent weekly intravenous cisplatin (30 mg/m ). The primary study endpoint was the pathologic complete response rate based on biopsy of the primary site and dissection of pretreatment positive lymph node regions. The pathologic complete response rate as previously reported was 86%. Herein, the authors report secondary endpoint measures of local control, regional control, cause-specific survival, distant metastasis-free survival, and overall survival, and patient-reported outcomes (European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [EORTC QLQ-C30] and the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events [PRO-CTCAE]).
A total of 44 patients enrolled with a median follow-up of 36 months (88% with ≥2 years). The 3-year local control, regional control, cause-specific survival, distant metastasis-free survival, and overall survival rates were 100%, 100%, 100%, 100%, and 95%, respectively. The mean before and 3-year after EORTC QOL scores were: global: 80 of 78; swallowing: 11 of 11; dry mouth: 16 of 41; and sticky saliva: 6 of 29. The mean before and 3-year after PRO-CTCAE scores were: swallowing: 0.4 of 0.7; and dry mouth: 0.4 of 1.4. Approximately 39% of patients required a feeding tube (median duration, 15 weeks; none were permanent). There were no ≥grade 3 late adverse events reported.
For patients with favorable-risk human papillomavirus-associated oropharyngeal squamous cell carcinoma, a substantially decreased intensity of therapy with 60 grays of intensity-modulated radiotherapy and weekly low-dose cisplatin produced better preservation of quality of life compared with standard therapies while maintaining excellent 3-year tumor control and survival. Cancer 2018;124:2347-54. © 2018 American Cancer Society.
本研究旨在通过前瞻性 2 期临床试验评估低强度放化疗治疗低危、人乳头瘤病毒（HPV）相关口咽鳞状细胞癌的生活质量和肿瘤控制情况。
T0-T3、N0-N2c、M0、p16 阳性且有轻微吸烟史的患者接受 60 戈瑞强度调制放疗，同时每周静脉注射顺铂（30mg/m ）。主要研究终点是基于原发部位活检和治疗前阳性淋巴结区域清扫的病理完全缓解率。此前报道的病理完全缓解率为 86%。在此，作者报告了局部控制、区域控制、特异性生存、无远处转移生存和总生存的次要终点测量结果，以及患者报告的结果（欧洲癌症研究和治疗组织[EORTC]生活质量问卷[EORTC QLQ-C30]和患者报告的不良事件通用术语标准[PRO-CTCAE]版本）。
共有 44 例患者入组，中位随访 36 个月（88%的患者随访时间≥2 年）。3 年局部控制、区域控制、特异性生存、无远处转移生存和总生存率分别为 100%、100%、100%、100%和 95%。EORTC QOL 评分在治疗前后 3 年的平均值分别为：总体：80/78；吞咽：11/11；口干：16/41；唾液粘稠：6/29。PRO-CTCAE 评分在治疗前后 3 年的平均值分别为：吞咽：0.4/0.7；口干：0.4/1.4。约 39%的患者需要放置饲管（中位时间为 15 周，无永久性饲管）。无≥3 级晚期不良事件报告。
对于低危 HPV 相关口咽鳞状细胞癌患者，采用 60 戈瑞强度调制放疗和每周低剂量顺铂进行的治疗强度显著降低，与标准治疗相比，生活质量得到了更好的保留，同时保持了出色的 3 年肿瘤控制和生存。癌症 2018；124：2347-54。© 2018 美国癌症协会。
