Phase II Evaluation of Aggressive Dose De-Escalation for Adjuvant Chemoradiotherapy in Human Papillomavirus-Associated Oropharynx Squamous Cell Carcinoma

被引:177
作者
Ma, Daniel J. [1 ]
Price, Katharine A. [1 ]
Moore, Eric J. [1 ]
Patel, Samir H. [2 ]
Hinni, Michael L. [2 ]
Garcia, Joaquin J. [1 ]
Graner, Darlene E. [1 ]
Foster, Nathan R. [1 ]
Ginos, Brenda [1 ]
Neben-Wittich, Michelle [1 ]
Garces, Yolanda I. [1 ]
Chintakuntlawar, Ashish V. [1 ]
Price, Daniel L. [1 ]
Olsen, Kerry D. [1 ]
Van Abel, Kathryn M. [1 ]
Kasperbauer, Jan L. [1 ]
Janus, Jeffrey R. [1 ]
Waddle, Mark [3 ]
Miller, Robert [3 ]
Shiraishi, Satomi [1 ]
Foote, Robert L. [1 ]
机构
[1] Mayo Clin, Rochester, MN USA
[2] Mayo Clin, Phoenix, AZ USA
[3] Mayo Clin, Jacksonville, FL 32224 USA
基金
美国国家卫生研究院;
关键词
TRANSORAL ROBOTIC SURGERY; LOCALLY ADVANCED HEAD; RADIATION-THERAPY; POSITIVE HEAD; RADIOTHERAPY; CANCER; CHEMOTHERAPY; SURVIVAL; ONCOLOGY; SENSITIVITY;
D O I
10.1200/JCO.19.00463
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
PURPOSEThe purpose of this study was to determine if dose de-escalation from 60 to 66 Gy to 30 to 36 Gy of adjuvant radiotherapy (RT) for selected patients with human papillomavirus-associated oropharyngeal squamous cell carcinoma could maintain historical rates for disease control while reducing toxicity and preserving swallow function and quality of life (QOL).PATIENTS AND METHODSMC1273 was a single-arm phase II trial testing an aggressive course of RT de-escalation after surgery. Eligibility criteria included patients with p16-positive oropharyngeal squamous cell carcinoma, smoking history of 10 pack-years or less, and negative margins. Cohort A (intermediate risk) received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m(2) docetaxel once per week. Cohort B included patients with extranodal extension who received the same treatment plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day. The primary end point was locoregional tumor control at 2 years. Secondary end points included 2-year progression-free survival, overall survival, toxicity, swallow function, and patient-reported QOL.RESULTSAccrual was from September 2013 to June 2016 (N = 80; cohort A, n = 37; cohort B, n = 43). Median follow-up was 36 months, with a minimum follow-up of 25 months. The 2-year locoregional tumor control rate was 96.2%, with progression-free survival of 91.1% and overall survival of 98.7%. Rates of grade 3 or worse toxicity at pre-RT and 1 and 2 years post-RT were 2.5%, 0%, and 0%. Swallowing function improved slightly between pre-RT and 12 months post-RT, with one patient requiring temporary feeding tube placement.CONCLUSIONAggressive RT de-escalation resulted in locoregional tumor control rates comparable to historical controls, low toxicity, and little decrement in swallowing function or QOL.
引用
收藏
页码:1909 / +
页数:12
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