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非常加速部分乳房照射(VAPBI)I-II 期 GEC-ESTRO 试验的 5 年结果。

Five-year results of the very accelerated partial breast irradiation VAPBI phase I-II GEC-ESTRO trial.

机构信息

Department of Radiation Oncology, Foundation Instituto Valenciano de Oncologia (IVO), Valencia, Spain.

Department of Radiation Oncology, Catalan Institute of Oncology, Barcelona, Spain.

出版信息

Radiother Oncol. 2024 Dec;201:110543. doi: 10.1016/j.radonc.2024.110543. Epub 2024 Sep 24.

Abstract

BACKGROUND AND PURPOSE

The standard partial breast postoperative treatment for early breast carcinomas with multi-catheter interstitial brachytherapy (MIBT) requires 7-8 fractions in 4-5 days as used in the APBI GEC-ESTRO phase III trial. In 2017 the GEC-ESTRO Breast Cancer Working Group started a Phase I-II trial to study if very accelerated partial breast irradiation (VAPBI) using 3-4 fractions could be equivalent.

MATERIAL

81 patients with low-risk invasive carcinomas underwent high dose rate MIBT. Mean age was 68 (51-90); 33 women received 4 fractions of 6.25 Gy in 2-3 days, and 48 subsequent patients 3 fractions of 7.45 Gy in 2 days, 36 perioperatively and 45 postoperatively.

RESULTS

Median follow-up was 62 months, with 5-year actuarial breast recurrence of 3.4 % (two cases). One patient died due to metastasis. Pigmentation changes in the entrance of tubes remained visible only in 12.3 % in long term (skin G1 toxicity). Fibrosis or slight induration (G1) in 22.2 % and G2 in 9.9 %. No case of telangiectasia has been described. Cosmetic outcome is good or excellent in 95 % and fair in 5 %. Four tumors located in the retroareolar area showed nipple retraction.

CONCLUSION

VAPBI with MIBT using four fractions of 6.25 Gy or three fractions of 7.45 Gy in two or three days offers good local control, with a 5-year rate of fibrosis G2 similar to the GEC ESTRO phase III trial. VAPBI in two days is a good choice to decrease the total time of treatment, which is beneficial for the patient and reduces the workload.

摘要

背景与目的

早期乳腺癌多导管间质近距离放疗(MIBT)的标准部分乳房术后治疗需要 7-8 个疗程,每个疗程 4-5 天,这与 APBI GEC-ESTRO 三期试验相同。2017 年,GEC-ESTRO 乳腺癌工作组开始了一项 I- II 期试验,以研究是否可以用 3-4 个疗程的非常加速部分乳房照射(VAPBI)达到等效效果。

材料

81 例低危浸润性乳腺癌患者接受高剂量率 MIBT。平均年龄 68 岁(51-90 岁);33 例患者接受 4 个疗程,每个疗程 6.25Gy,2-3 天内完成;48 例患者接受 3 个疗程,每个疗程 7.45Gy,2 天内完成,其中 36 例在手术期间进行,45 例在术后进行。

结果

中位随访时间为 62 个月,5 年无复发生存率为 3.4%(2 例)。1 例患者因转移死亡。管腔入口处的色素沉着改变仅在 12.3%的患者中长期可见(皮肤 G1 毒性)。纤维化或轻微硬结(G1)占 22.2%,G2 占 9.9%。无毛细血管扩张症病例描述。美容效果好或优秀占 95%,一般占 5%。4 例肿瘤位于乳晕后区,出现乳头回缩。

结论

MIBT 采用 4 个疗程 6.25Gy 或 3 个疗程 7.45Gy,在 2-3 天内完成,可获得良好的局部控制效果,5 年纤维化 G2 发生率与 GEC ESTRO 三期试验相似。2 天内完成 VAPBI 是减少总治疗时间的一个较好选择,这对患者有益,并减轻工作量。

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