Issoufaly Irfane, Petit Claire, Guihard Sébastien, Eugène Rémi, Jung Loic, Clavier Jean Baptiste, Servagi Vernat Stéphanie, Bellefqih Sara, Verret Benjamin, Bonnet Naïma, Deutsch Éric, Rivera Sofia
Department of Radiotherapy, Gustave Roussy, Université Paris-Saclay, 94805, Villejuif, France.
Radiotherapy, Paul Strauss, Strasbourg, France.
Radiat Oncol. 2022 Apr 20;17(1):80. doi: 10.1186/s13014-022-02044-z.
Moderately hypofractionated whole-breast radiotherapy (HFRT) has proven to be as safe and efficient as normofractionated radiotherapy (NFRT) in randomized trials resulting in major changes in clinical practice. Toxicity rates observed in selected clinical trial patients may differ from those observed in unselected patients with possible comorbidities and frailty in real-life. This study aimed to examine the influence of HFRT versus NFRT on acute toxicity and identify risks factors of dermatitis in real-life patients.
Prospective data from breast cancer patients, treated with locoregional radiotherapy were collected between November 2015 and February 2020 in 3 comprehensive cancer centers. Through a systematic data-farming strategy, acute toxicity evaluation forms (CTCAEv4.0) were prospectively completed and extracted electronically. The results from each center were then anonymously merged into a single database for analysis. A Chi-2 test was used to compare HFRT and NFRT. Furthermore, risk factors of dermatitis were identified in a sub-study (622 patients) by multivariate logistic regression analysis.
In total, 3518 T0-4 N0-3 mostly M0 (85.8%) breast cancer patients with a median age of 60.7 (24-96 years old) were analyzed. Acute grade 2-3 dermatitis, grade 1-3 breast oedema, and grade 1-2 hyperpigmentation were less frequent with HFRT versus NFRT: respectively 8.9% versus 35.1% (Chi-2 = 373.7; p < 0.001), 29.0% versus 37.0% (Chi-2 = 23.1; p < 0.001) and 27.0% versus 55.8% (Chi-2 = 279.2; p < 0.001). Fewer patients experienced pain with HFRT versus NFRT: 33.4% versus 53.7% respectively (Chi-2 = 137.1; p < 0.001). Factors such as high BMI (OR = 2.30 [95% CI, 1.28-4.26], p < 0.01), large breast size (OR = 1.88 [95% CI, 1.07-3.28], p < 0.01) and lumpectomy over mastectomy (OR = 0.52 [95% CI, 0.27-0.97], p < 0.05) were associated with greater risk factors of grade 2-3 dermatitis in multivariate analysis regardless of NFRT or HFRT.
The results of this study suggests that breast HFRT may be a better option even for patients with a high BMI or large breast size. Acute toxicity was low to mild, and lower with HFRT compared to NFRT. Results from real-life data were robust, and support the use of HFRT beyond randomized study populations. Long-term real-life data awaits further investigation.
在随机试验中，适度超分割全乳放疗（HFRT）已被证明与常规分割放疗（NFRT）一样安全有效，这导致了临床实践的重大改变。在选定的临床试验患者中观察到的毒性发生率可能与在现实生活中未选定的、可能存在合并症和身体虚弱的患者中观察到的不同。本研究旨在探讨HFRT与NFRT对急性毒性的影响，并确定现实生活中患者发生皮炎的风险因素。
2015年11月至2020年2月期间，在3个综合癌症中心收集了接受局部区域放疗的乳腺癌患者的前瞻性数据。通过系统的数据收集策略，前瞻性地完成急性毒性评估表（CTCAEv4.0）并进行电子提取。然后将每个中心的结果匿名合并到一个单一数据库中进行分析。使用卡方检验比较HFRT和NFRT。此外，在一项子研究（622例患者）中通过多因素逻辑回归分析确定皮炎的风险因素。
总共分析了3518例T0-4 N0-3（大多数为M0，占85.8%）的乳腺癌患者，中位年龄为60.7岁（24-96岁）。与NFRT相比，HFRT导致的急性2-3级皮炎、1-3级乳腺水肿和1-2级色素沉着较少：分别为8.9%对35.1%（卡方=373.7；p<0.001），29.0%对37.0%（卡方=23.1；p<0.001）和27.0%对55.8%（卡方=279.2；p<0.001）。与NFRT相比，HFRT患者经历疼痛的较少：分别为33.4%对53.7%（卡方=137.1；p<0.001）。在多因素分析中，无论NFRT还是HFRT，高体重指数（OR=2.30[95%CI，1.28-4.26]，p<0.01）、乳房体积大（OR=1.88[95%CI，1.07-3.28]，p<0.01）以及保乳手术与乳房切除术相比（OR=0.52[95%CI，0.27-0.97]，p<0.05）等因素与2-3级皮炎的风险因素增加相关。
本研究结果表明，即使对于高体重指数或乳房体积大的患者，乳腺HFRT可能也是一个更好的选择。急性毒性为低至轻度，与NFRT相比，HFRT更低。现实生活数据的结果很可靠，并支持在随机研究人群之外使用HFRT。长期的现实生活数据有待进一步研究。
