通过淋巴结分子评估来优化放疗（OPTIMAL）：一项随机开放标签试验。
OPTimizing Irradiation through Molecular Assessment of Lymph node (OPTIMAL): a randomized open label trial.
机构信息
Radiation Oncology Department, Del Mar Hospital, Autonomous University of Barcelona, Hospital del Mar Medical Research Institute, Passeig Maritim, 25, 08003, Barcelona, Spain.
Radiation Oncology Department, Virgen del Rocío University Hospital, Seville, Spain.
出版信息
Radiat Oncol. 2020 Oct 2;15(1):229. doi: 10.1186/s13014-020-01672-7.
BACKGROUND
Conservative surgery followed by breast and nodal irradiation is the standard loco-regional early breast cancer (BC) treatment for patients with four or more involved lymph nodes. However, the treatment strategy when fewer nodes are involved remains unclear, especially when lymphadenectomy has not been performed. Sensitive nodal status assessment molecular techniques as the One-Step Nucleic Acid Amplification (OSNA) assay can contribute to the definition and standardization of the treatment strategy. Therefore, the OPTIMAL study aims to demonstrate the feasibility of incidental irradiation of axillary nodes in patients with early-stage BC and limited involvement of the SLN.
METHODS
BC patients who underwent conservative surgery and whose SLN total tumour load assessed with OSNA ranged between 250-15,000 copies/µL will be eligible. Patients will be randomized to receive irradiation on the breast, tumour bed, axillary and supraclavicular lymph node areas (intentional arm) or only on the breast and tumour bed (incidental arm). All areas, including the internal mammary chain, will be contoured. The mean, median, D5% and D95% doses received in all volumes will be calculated. The primary endpoint is the non-inferiority of the incidental irradiation of axillary nodes compared to the intentional irradiation in terms of 5-year disease free survival. Secondary endpoints comprise the comparison of acute and chronic toxicity and loco-regional and distant disease recurrence rates.
DISCUSSION
Standardizing the treatment and diagnosis of BC patients with few nodes affected is crucial due to the lack of consensus. Hence, the quantitative score for the metastatic burden of SLN provided by OSNA can contribute by improving the discrimination of which BC patients with limited nodal involvement can benefit from incidental radiation as an adjuvant treatment strategy.
TRIAL REGISTRATION
ClinicalTrial.gov, NCT02335957; https://clinicaltrials.gov/ct2/show/NCT02335957.
背景
对于有 4 个或更多受累淋巴结的患者，保乳手术联合乳房和淋巴结照射是局部区域早期乳腺癌（BC）的标准治疗方法。然而，当涉及的淋巴结较少时，治疗策略仍不清楚，特别是当未进行淋巴结切除术时。敏感的淋巴结状态评估分子技术，如一步核酸扩增（OSNA）检测，可以有助于确定和规范治疗策略。因此，OPTIMAL 研究旨在证明在早期 BC 且 SLN 受累有限的患者中，意外照射腋窝淋巴结的可行性。
方法
接受保乳手术且 OSNA 评估 SLN 总肿瘤负荷在 250-15,000 拷贝/µL 之间的 BC 患者将有资格入组。患者将被随机分配接受照射乳房、肿瘤床、腋窝和锁骨上淋巴结区域（意向照射组）或仅照射乳房和肿瘤床（意外照射组）。所有区域，包括内乳链，都将进行勾画。将计算所有体积中接受的平均、中位数、D5%和 D95%剂量。主要终点是意外照射腋窝淋巴结与意向照射在 5 年无病生存率方面的非劣效性。次要终点包括比较急性和慢性毒性以及局部区域和远处疾病复发率。
讨论
由于缺乏共识，对少数淋巴结受累的 BC 患者进行标准化治疗和诊断至关重要。因此，OSNA 提供的 SLN 转移负担的定量评分可以通过提高对哪些有限淋巴结受累的 BC 患者可以从意外放疗作为辅助治疗策略中获益的区分能力来做出贡献。
试验注册
ClinicalTrials.gov，NCT02335957；https://clinicaltrials.gov/ct2/show/NCT02335957。
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