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首页> 外文期刊>EBioMedicine >Radiation-induced CD8 T-lymphocyte Apoptosis as a Predictor of Breast Fibrosis After Radiotherapy: Results of the Prospective Multicenter French Trial
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Radiation-induced CD8 T-lymphocyte Apoptosis as a Predictor of Breast Fibrosis After Radiotherapy: Results of the Prospective Multicenter French Trial

机译：辐射诱导的CD8 T淋巴细胞凋亡作为放疗后乳腺癌纤维化的预测因子：前瞻性多中心法国试验的结果

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Background: Monocentric cohorts suggested that radiation-induced CD8 T-lymphocyte apoptosis (RILA) can predict late toxicity after curative intent radiotherapy (RT). We assessed the role of RILA as a predictor of breast fibrosis (bf+) after adjuvant breast RT in a prospective multicenter trial. Methods: A total of 502 breast-cancer patients (pts) treated by conservative surgery and adjuvant RT were recruited at ten centers. RILA was assessed before RT by flow cytometry. Impact of RILA on bf+ (primary endpoint) or relapse was assessed using a competing risk method. Receiver-operator characteristic (ROC) curve analyses were also performed in intention to treat. This study is registered with ClinicalTrials.gov, number NCT00893035 and final analyses are presented here. Findings: Four hundred and fifty-six pts (90.8%) were included in the final analysis. One hundred and eight pts (23.7%) received whole breast and node irradiation. A boost dose of 10-16Gy was delivered in 449 pts (98.5%). Adjuvant hormonotherapy was administered to 349 pts (76.5%). With a median follow-up of 38.6months, grade >=2 bf+ was observed in 64 pts (14%). A decreased incidence of grade >=2 bf+ was observed for increasing values of RILA (p=0.012). No grade 3 bf+ was observed for patients with RILA >=12%. The area under the ROC curve was 0.62. For cut-off values of RILA >=20% and =2 bf+ was equal to 91% for RILA >=20% and positive predictive value was equal to 22% for RILA =2 bf+ was estimated at 14%. A significant decrease in the risk of grade >=2 bf+ was found if patients had no adjuvant hormonotherapy (sHR=0.31, p=0.007) and presented a RILA >=12% (sHR=0.45, p=0.002). Interpretation: RILA significantly predicts the risk of breast fibrosis. This study validates the use of RILA as a rapid screening test before RT delivery and will change definitely our daily clinical practice in radiation oncology. Funding: The French National Cancer Institute (INCa) through the ''Program Hospitalier de Recherche Clinique (PHRC)''.
机译：背景：单中心研究表明，辐射诱导的CD8 T淋巴细胞凋亡（RILA）可以预测根治性放疗（RT）后的晚期毒性。在一项前瞻性多中心试验中，我们评估了RILA作为辅助性乳腺癌放疗后乳腺纤维化（bf +）预测因子的作用。方法：在十个中心招募了502例接受保守手术和辅助放疗的乳腺癌患者。在RT之前通过流式细胞术评估RILA。使用竞争风险方法评估了RILA对bf +（主要终点）或复发的影响。还进行了接收者-操作者特征（ROC）曲线分析以进行治疗。该研究已在ClinicalTrials.gov上注册，编号为NCT00893035，此处提供了最终分析结果。结果：最终分析中包括456分（90.8％）。接受全乳和淋巴结照射的患者为10​​8名（23.7％）。 10到16Gy的加强剂量在449分（98.5％）中递送。进行了349点（76.5％）的辅助性激素疗法。中位随访时间为38.6个月，在64分（14％）中观察到了> = 2 bf +的评分。对于RILA值升高，观察到等级> = 2 bf +的发生率降低（p = 0.012）。 RILA> = 12％的患者未观察到3 bf +级。 ROC曲线下的面积为0.62。对于RILA> = 20％和= 2 bf +的临界值，对于RILA> = 20％，bf +等于91％，对于RILA = 2，bf +的阳性预测值等于22％，估计为14％。如果没有辅助性激素疗法（sHR = 0.31，p = 0.007）并且RILA> = 12％（sHR = 0.45，p = 0.002），则发现≥2bf +的风险显着降低。解释：RILA显着预测了乳腺纤维化的风险。这项研究验证了RILA在RT交付之前作为快速筛查测试的用途，并且肯定会改变我们在放射肿瘤学方面的日常临床实践。资金来源：法国国家癌症研究所（INCa）通过“计划医院临床研究（PHRC）”。

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