可切除 p16+局部晚期口咽癌的经口手术联合低剂量调强放疗的 II 期随机试验：一项 ECOG-ACRIN 癌症研究组试验（E3311）。
Phase II Randomized Trial of Transoral Surgery and Low-Dose Intensity Modulated Radiation Therapy in Resectable p16+ Locally Advanced Oropharynx Cancer: An ECOG-ACRIN Cancer Research Group Trial (E3311).
机构信息
UPMC Hillman Cancer Center, Pittsburgh, PA.
Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA.
出版信息
J Clin Oncol. 2022 Jan 10;40(2):138-149. doi: 10.1200/JCO.21.01752. Epub 2021 Oct 26.
PURPOSE
Definitive or postoperative chemoradiation (CRT) is curative for human papillomavirus-associated (HPV+) oropharynx cancer (OPC) but induces significant toxicity. As a deintensification strategy, we studied primary transoral surgery (TOS) and reduced postoperative radiation therapy (RT) in intermediate-risk HPV+ OPC.
METHODS
E3311 is a phase II randomized trial of reduced- or standard-dose postoperative RT for resected stage III-IVa (American Joint Committee on Cancer-seventh edition) HPV+ OPC, determined by pathologic parameters. Primary goals were feasibility of prospective multi-institutional study of TOS for HPV+ OPC, and oncologic efficacy (2-year progression-free survival) of TOS and adjuvant therapy in intermediate-risk patients after resection. TOS plus 50 Gy was considered promising if the lower limit of the exact 90% binomial confidence intervals exceeded 85%. Quality of life and swallowing were measured by functional assessment of cancer therapy-head and neck and MD Anderson Dysphagia Index.
RESULTS
Credentialed surgeons performed TOS for 495 patients. Eligible and treated patients were assigned as follows: arm A (low risk, n = 38) enrolled 11%, intermediate risk arms B (50 Gy, n = 100) or C (60 Gy, n = 108) randomly allocated 58%, and arm D (high risk, n = 113) enrolled 31%. With a median 35.2-month follow-up for 359 evaluable (eligible and treated) patients, 2-year progression-free survival Kaplan-Meier estimate is 96.9% (90% CI, 91.9 to 100) for arm A (observation), 94.9% (90% CI, 91.3 to 98.6]) for arm B (50 Gy), 96.0% (90% CI, 92.8 to 99.3) for arm C (60 Gy), and 90.7% (90% CI, 86.2 to 95.4) for arm D (66 Gy plus weekly cisplatin). Treatment arm distribution and oncologic outcome for ineligible or step 2 untreated patients (n = 136) mirrored the 359 evaluable patients. Exploratory comparison of functional assessment of cancer therapy-head and neck total scores between arms B and C is presented.
CONCLUSION
Primary TOS and reduced postoperative RT result in outstanding oncologic outcome and favorable functional outcomes in intermediate-risk HPV+ OPC.
目的
对于人乳头瘤病毒相关性（HPV+）口咽癌（OPC），明确或术后放化疗（CRT）是有治愈效果的，但会引起显著的毒性。作为一种减量化策略，我们研究了接受原发经口手术（TOS）和减少术后放疗（RT）的中危 HPV+ OPC。
方法
E3311 是一项关于中危 HPV+ OPC 患者接受切除术后标准或低剂量术后 RT 的 II 期随机试验，HPV+的确定取决于病理参数。主要目标是前瞻性多机构研究 HPV+ OPC 患者的 TOS 的可行性，以及 TOS 和辅助治疗在切除术后中危患者中的肿瘤疗效（2 年无进展生存率）。如果精确 90%二项置信区间的下限超过 85%，则认为 TOS 加 50 Gy 有前景。通过癌症治疗头颈部功能评估和 MD 安德森吞咽指数测量生活质量和吞咽功能。
结果
合格的外科医生为 495 名患者进行了 TOS。符合条件并接受治疗的患者被分配如下：A 组（低危，n = 38）占 11%，B 组（50 Gy，n = 100）或 C 组（60 Gy，n = 108）随机分配 58%，D 组（高危，n = 113）占 31%。对 359 名可评估（符合条件并接受治疗）患者进行了中位 35.2 个月的随访，A 组（观察）2 年无进展生存率 Kaplan-Meier 估计值为 96.9%（90%CI，91.9 至 100），B 组（50 Gy）为 94.9%（90%CI，91.3 至 98.6]），C 组（60 Gy）为 96.0%（90%CI，92.8 至 99.3），D 组（66 Gy 加每周顺铂）为 90.7%（90%CI，86.2 至 95.4）。无法评估或未进行 2 期治疗的患者（n = 136）的治疗分组和肿瘤学结果与可评估的 359 名患者相似。报告了 B 组和 C 组之间癌症治疗头颈部功能评估总评分的探索性比较。
结论
原发 TOS 和减少术后 RT 为中危 HPV+ OPC 带来了出色的肿瘤学结果和良好的功能结果。
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