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Toxicity and cosmetic outcome after hypofractionated whole breast irradiation and boost-IOERT in early stage breast cancer (HIOB): First results of a prospective multicenter trial (NCT01343459)
Radiotherapy and Oncology ( IF 4.9 ) Pub Date : 2020-05-01 , DOI: 10.1016/j.radonc.2020.02.001
Gerd Fastner 1 , Roland Reitsamer 2 , Bartosz Urbański 3 , Peter Kopp 1 , Dawid Murawa 4 , Beata Adamczyk 5 , Aldona Karzcewska 6 , Piotr Milecki 7 , Eva Hager 8 , Juliann Reiland 9 , Antonella Ciabattoni 10 , Christiane Matuschek 11 , Wilfried Budach 11 , Kerri Nowell 12 , Claudia Schumacher 13 , Angelika Ricke 14 , Vincenzo Fusco 15 , Cristiana Vidali 16 , Marina Alessandro 17 , Giovanni B Ivaldi 18 , Ingrid Ziegler 1 , Christoph Fussl 1 , Franz Zehentmayr 1 , Brane Grambozov 1 , Andreas Sir 2 , Wolfgang Hitzl 19 , Umberto Ricardi 20 , Felix Sedlmayer 1
Affiliation  

BACKGROUND AND PURPOSE To assess the role of intraoperative radiation with electrons (IOERT) as tumor bed boost followed by hypofractionated whole breast irradiation (HWBI) after breast conserving surgery (BCS) of patients with low to intermediate risk breast cancer focusing on acute/late toxicity and cosmetic outcome. MATERIAL AND METHODS In 2011, a prospective multicenter trial (NCT01343459) was started. Treatment consisted of BCS, IOERT (11.1 Gy) and HWBI (40.5 Gy in 15 fractions). In a single-arm design, 5-year IBR-rates are benchmarked by a sequential ratio test (SQRT) against best published evidences in 3 age groups (35-40 y, 41-50 y, >50 y). Acute/late toxicity and cosmesis were evaluated by validated scorings systems. RESULTS Of 627 eligible patients, 44 were excluded, leaving 583 to analyze. After a median follow-up (FUP) of 45 months (range 0-74), for acute effects CTCAE-score 0/1 was noted in 91% (end of HWBI) and 92% (4 weeks later), respectively. Late toxicity Grading 0/1 (mean values, ranges) by LENT-SOMA criteria were observed in 92.7% (89-97.3) at 4/5 months, rising to 96.5% (91-100) at 6 years post HWBI. Baseline cosmesis after wound healing prior to HWBI was scored as excellent/good in 86% of cases by subjective (patient) and in 74% by objective (doctor) assessment with no impairment thereafter. CONCLUSIONS Acute and late treatment tolerance of a combined Boost-IOERT/HWBI regimen is excellent in short/mid-term assessment. Postoperative cosmetic appearance is not impaired after 3 years FUP.

中文翻译:

早期乳腺癌 (HIOB) 大分割全乳照射和加强 IOERT 后的毒性和美容效果:前瞻性多中心试验的初步结果 (NCT01343459)

背景和目的 评估术中电子放射(IOERT)作为肿瘤床推量的作用,然后是低至中度风险乳腺癌患者保乳手术(BCS)后大分割全乳照射(HWBI),重点关注急性/晚期毒性和美容效果。材料与方法 2011 年,一项前瞻性多中心试验 (NCT01343459) 启动。治疗包括 BCS、IOERT(11.1 Gy)和 HWBI(40.5 Gy,15 次)。在单臂设计中,5 年 IBR 率通过顺序比率测试 (SQRT) 与 3 个年龄组(35-40 岁、41-50 岁、>50 岁)中已发表的最佳证据进行基准测试。通过验证的评分系统评估急性/晚期毒性和美容作用。结果 627 名符合条件的患者中,44 名被排除,剩下 583 名需要分析。在 45 个月(范围 0-74)的中位随访 (FUP) 后,91%(HWBI 结束)和 92%(4 周后)的急性效应 CTCAE 评分分别为 0/1。在 4/5 个月时,92.7% (89-97.3) 观察到 LENT-SOMA 标准的 0/1 级(平均值,范围)的晚期毒性,在 HWBI 后 6 年上升到 96.5% (91-100)。HWBI 之前伤口愈合后的基线美容在 86% 的病例中通过主观(患者)评分为优秀/良好,在 74% 的客观(医生)评估中评分为优秀/良好,此后无损伤。结论 Boost-IOERT/HWBI 联合方案的急性和晚期治疗耐受性在短期/中期评估中非常出色。术后 3 年 FUP 后美容外观未受损。在 4/5 个月时,92.7% (89-97.3) 观察到 LENT-SOMA 标准的 0/1 级(平均值,范围)的晚期毒性,在 HWBI 后 6 年上升到 96.5% (91-100)。HWBI 之前伤口愈合后的基线美容在 86% 的病例中通过主观(患者)评分为优秀/良好,在 74% 的客观(医生)评估中评分为优秀/良好,此后无损伤。结论 Boost-IOERT/HWBI 联合方案的急性和晚期治疗耐受性在短期/中期评估中非常出色。术后 3 年 FUP 后美容外观未受损。在 4/5 个月时,92.7% (89-97.3) 观察到 LENT-SOMA 标准的 0/1 级(平均值,范围)的晚期毒性,在 HWBI 后 6 年上升到 96.5% (91-100)。HWBI 之前伤口愈合后的基线美容在 86% 的病例中通过主观(患者)评分为优秀/良好,在 74% 的客观(医生)评估中评分为优秀/良好,此后无损伤。结论 Boost-IOERT/HWBI 联合方案的急性和晚期治疗耐受性在短期/中期评估中非常出色。术后 3 年 FUP 后美容外观未受损。HWBI 之前伤口愈合后的基线美容在 86% 的病例中通过主观(患者)评分为优秀/良好,在 74% 的客观(医生)评估中评分为优秀/良好,此后无损伤。结论 Boost-IOERT/HWBI 联合方案的急性和晚期治疗耐受性在短期/中期评估中非常出色。术后 3 年 FUP 后美容外观未受损。HWBI 之前伤口愈合后的基线美容在 86% 的病例中通过主观(患者)评分为优秀/良好,在 74% 的客观(医生)评估中评分为优秀/良好,此后无损伤。结论 Boost-IOERT/HWBI 联合方案的急性和晚期治疗耐受性在短期/中期评估中非常出色。术后 3 年 FUP 后美容外观未受损。
更新日期:2020-05-01
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