The Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU), United Kingdom.
The Royal Marsden NHS Foundation Trust, United Kingdom.
Radiother Oncol. 2019 Jul;136:190-196. doi: 10.1016/j.radonc.2019.03.022. Epub 2019 Apr 20.
Seroma describes a collection of serous fluid within a cavity, occurring following surgery. Seroma is associated with normal tissue effects (NTE) following breast radiotherapy, as reported by clinicians and on photographs. This study investigates the association between seroma and the NTE breast appearance change collected using patient-reported outcome measures (PROMs) in IMPORT HIGH, as well as investigating the association between breast appearance change and patient/tumour/treatment factors.
Case-control methodology was used for seroma analysis within IMPORT HIGH. Cases were patients reporting moderate/marked breast appearance change and controls reported none/mild changes at year-3. One control was selected at random for each case. Seromas were graded as not visible/subtle or visible/highly visible on CT radiotherapy planning scans. Logistic regression tested associations, adjusting for patient/tumour/treatment factors.
1078/1149 patients consented to PROMs, of whom 836 (78%) reported whether they had 3-year breast appearance change; 231 cases and 231 controls were identified. 304/462 (66%) patients received chemotherapy. Seroma prevalence was 20% (41/202) in cases and 16% (32/205) in controls, and less frequent in patients receiving adjuvant chemotherapy [10% (24/246) compared with 29% (40/138) without]. Visible seroma was not significantly associated with breast appearance change [OR 1.38 (95%CI 0.83-2.29), p = 0.219]. Larger tumour size, haematoma, current smoking and body image concerns at baseline were independent risk factors.
Seroma was not associated with patient-reported breast appearance change, but haematoma and smoking were significant risk factors. Lack of association may be related to lower prevalence of seroma compared with previous reports, perhaps reflecting patients receiving adjuvant chemotherapy in whom seroma resolves prior to radiotherapy.
血清肿是指手术后在腔隙中积聚浆液性液体。据临床医生和照片报道,血清肿与乳腺癌放疗后的正常组织效应(NTE)有关。本研究调查了 IMPORT HIGH 中使用患者报告的结果测量(PROM)收集的血清肿与 NTE 乳房外观变化之间的关联,以及调查乳房外观变化与患者/肿瘤/治疗因素之间的关联。
在 IMPORT HIGH 中使用病例对照方法进行血清肿分析。病例是报告中度/明显乳房外观变化的患者,对照是报告 3 年时无/轻度变化的患者。每个病例随机选择一个对照。在 CT 放疗计划扫描上,血清肿被评为不可见/轻微或可见/高度可见。Logistic 回归检验了关联,调整了患者/肿瘤/治疗因素。
1149 名患者中有 1078 名同意进行 PROM,其中 836 名(78%)报告了他们是否有 3 年的乳房外观变化;确定了 231 例病例和 231 例对照。304/462 名(66%)患者接受了化疗。病例中血清肿的患病率为 20%(41/202),对照中为 16%(32/205),而接受辅助化疗的患者较少[10%(24/246),而无化疗者为 29%(40/138)]。可见的血清肿与乳房外观变化无显著相关性[OR 1.38(95%CI 0.83-2.29),p=0.219]。肿瘤较大、血肿、当前吸烟和基线时的身体形象担忧是独立的危险因素。
血清肿与患者报告的乳房外观变化无关,但血肿和吸烟是显著的危险因素。缺乏关联可能与血清肿的患病率低于以前的报告有关,这也许反映了接受辅助化疗的患者在放疗前血清肿得到解决。