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早期乳腺癌 5 分次立体定向部分乳腺照射 1 期剂量递增研究的美容结果。

Cosmetic Outcomes of a Phase 1 Dose Escalation Study of 5-Fraction Stereotactic Partial Breast Irradiation for Early Stage Breast Cancer.

机构信息

Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas.

Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas.

出版信息

Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):772-782. doi: 10.1016/j.ijrobp.2021.01.015. Epub 2021 Jan 18.

DOI:10.1016/j.ijrobp.2021.01.015
PMID:33476737
Abstract

PURPOSE

Our purpose was to evaluate cosmetic changes after 5-fraction adjuvant stereotactic partial breast irradiation (S-PBI).

METHODS AND MATERIALS

Seventy-five women with in situ or invasive breast cancer stage 0, I, or II, with tumor size ≤3 cm, were enrolled after lumpectomy in a phase 1 dose escalation trial of S-PBI into cohorts receiving 30, 32.5, 35, 37.5, or 40 Gy in 5 fractions. Before S-PBI, 3 to 4 gold fiducial markers were placed in the lumpectomy cavity for tracking with the Synchrony respiratory tracking system. S-PBI was delivered with a CyberKnife robotic radiosurgery system. Patients and physicians evaluated global cosmesis using the Harvard Breast Cosmesis Scale. Eight independent panelists evaluated digital photography for global cosmesis and 10 subdomains at baseline and follow-up. McNemar tests were used to evaluate change in cosmesis, graded as excellent/good or fair/poor, from baseline to year 3. Wilcoxon signed rank tests were used to evaluate change in subdomains. Cohen's kappa (κ) statistic was used to estimate interobserver agreement (IOA) between raters, and Fleiss' κ was used to estimate IOA between panelists.

RESULTS

Median cosmetic follow-up was 5, 5, 5, 4, and 3 years for the 30, 32.5, 35, 37.5, and 40 Gy cohorts. Most patients reported excellent/good cosmesis at both baseline (86.3%) and year 3 (89.8%). No dose cohort had significantly worsened cosmesis by year 3 on McNemar analysis. No cosmetic subdomain had significant worsening by year 3. IOA was fair for patient-physician (κ = 0.300, P < .001), patient-panel (κ = 0.295, P < .001), physician-panel (κ = 0.256, P < .001), and individual panelists (Fleiss κ = 0.327, P < .001).

CONCLUSIONS

Dose escalation of S-PBI from 30 to 40 Gy in 5 fractions for early stage breast cancer was not associated with a detectable change in cosmesis by year 3. S-PBI is a promising modality for treatment of early stage breast cancer.

摘要

目的

我们的目的是评估 5 个疗程辅助立体定向部分乳房照射(S-PBI)后的美容变化。

方法与材料

75 例接受保乳手术后的原位或浸润性乳腺癌 0 期、I 期或 II 期患者,肿瘤大小≤3cm,参加了 S-PBI 的 1 期剂量递增试验,入组患者分别接受 30、32.5、35、37.5 或 40Gy 分 5 次的治疗。在 S-PBI 之前,在切除腔中放置 3 到 4 个金基准标记物,以便使用 Synchrony 呼吸跟踪系统进行跟踪。S-PBI 使用 CyberKnife 机器人放射外科系统进行治疗。患者和医生使用哈佛乳房美容量表评估整体美容效果。8 名独立的专家组在基线和随访时评估整体美容和 10 个亚域的数字摄影。使用 McNemar 检验评估从基线到第 3 年美容效果的变化,美容效果分为优秀/良好或一般/较差。Wilcoxon 符号秩检验用于评估亚域的变化。Cohen's kappa(κ)统计量用于评估评分者之间的观察者间一致性(IOA),Fleiss' κ用于评估专家组之间的 IOA。

结果

30Gy、32.5Gy、35Gy、37.5Gy 和 40Gy 剂量组的中位美容随访时间分别为 5 年、5 年、5 年、4 年和 3 年。大多数患者在基线时(86.3%)和第 3 年(89.8%)报告美容效果优秀/良好。在 McNemar 分析中,没有剂量组在第 3 年的美容效果显著恶化。在第 3 年时,没有美容亚域有显著恶化。患者-医生(κ=0.300,P<0.001)、患者-专家组(κ=0.295,P<0.001)、医生-专家组(κ=0.256,P<0.001)和个别专家组(Fleiss κ=0.327,P<0.001)的 IOA 为一般。

结论

对于早期乳腺癌,S-PBI 的剂量从 30Gy 递增至 40Gy 分 5 次,在第 3 年时未发现美容效果有明显变化。S-PBI 是治疗早期乳腺癌的一种有前途的方法。

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