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同时整合推量调强与序贯推量常规放疗用于乳腺癌辅助治疗的生活质量:多中心随机 IMRT-MC2 试验的 2 年结果。

Quality of life after simultaneously integrated boost with intensity-modulated versus conventional radiotherapy with sequential boost for adjuvant treatment of breast cancer: 2-year results of the multicenter randomized IMRT-MC2 trial.

机构信息

Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.

Department of Radiation Oncology, Heidelberg University Hospital, Germany.

出版信息

Radiother Oncol. 2021 Oct;163:165-176. doi: 10.1016/j.radonc.2021.08.019. Epub 2021 Sep 1.

Abstract

BACKGROUND

We recently published 2-year results of the prospective, randomized IMRT-MC2 trial, showing non-inferior local control and cosmesis in breast cancer patients after conventionally fractionated intensity-modulated radiotherapy with simultaneously integrated boost (IMRT-SIB), compared to 3D-conformal radiotherapy with sequential boost (3D-CRT-seqB). Here, we report on 2-year quality of life results.

PATIENTS AND METHODS

502 patients were enrolled and randomized to IMRT-SIB (50.4 Gy in 1.8 Gy fractions with a 64.4 Gy SIB to the tumor bed) or to 3D-CRT-seqB (50.4 Gy in 1.8 Gy fractions, followed by a sequential boost of 16 Gy in 2 Gy fractions). For quality of life (QoL) assessment, patients completed the QLQ-C30 and QLQ-BR23 questionnaires at baseline, 6 weeks and 2 years after radiotherapy.

RESULTS

Significant differences between treatment arms were seen 6 weeks after radiotherapy for pain (22.3 points for IMRT vs. 27.0 points for 3D-CRT-seqB; p = 0.033) and arm symptoms (18.1 points for IMRT vs. 23.6 points for 3D-CRT-seqB; p = 0.013), both favoring IMRT-SIB. Compared to baseline values, both arms showed significant improvement in global score (IMRT: p = 0.009; 3D-CRT: p = 0.001) after 2 years, with slight deterioration on the role (IMRT: p = 0.008; 3-D-CRT: p = 0.001) and social functioning (IMRT: p = 0.013, 3D-CRT: p = 0.001) as well as the future perspectives scale (IMRT: p = 0.003; 3D-CRT: p = 0.0034).

CONCLUSION

This is the first randomized phase III trial demonstrating that IMRT-SIB was associated with slightly superior QoL compared to 3-D-CRT-seqB. These findings further support the clinical implementation of SIB in adjuvant breast cancer treatment.

摘要

背景

我们最近公布了前瞻性、随机的调强适形放疗-多野同时整合推量(intensity-modulated radiotherapy-MC2,IMRT-MC2)试验的 2 年结果,与三维适形放疗-序贯推量(3D conformal radiotherapy-sequential boost,3D-CRT-seqB)相比,乳腺癌患者接受常规分割调强适形放疗同时整合推量(intensity-modulated radiotherapy-SIB,IMRT-SIB)治疗后,局部控制和美容效果无差异。在此,我们报告了 2 年的生活质量结果。

患者和方法

共纳入 502 例患者,并随机分为 IMRT-SIB 组(50.4Gy,1.8Gy 分次,64.4Gy 肿瘤床推量)和 3D-CRT-seqB 组(50.4Gy,1.8Gy 分次,随后 2Gy 分次 16Gy 序贯推量)。为了评估生活质量(quality of life,QoL),患者在放疗前、放疗后 6 周和 2 年时完成了 EORTC QLQ-C30 和 QLQ-BR23 问卷。

结果

放疗后 6 周,IMRT 组的疼痛(22.3 分 vs. 3D-CRT-seqB 组 27.0 分;p=0.033)和手臂症状(18.1 分 vs. 3D-CRT-seqB 组 23.6 分;p=0.013)均优于 3D-CRT-seqB 组。与基线相比,2 年后,2 组的总体评分均显著改善(IMRT 组:p=0.009;3D-CRT 组:p=0.001),角色功能(IMRT 组:p=0.008;3D-CRT 组:p=0.001)和社会功能(IMRT 组:p=0.013;3D-CRT 组:p=0.001)以及未来展望评分(IMRT 组:p=0.003;3D-CRT 组:p=0.0034)略有恶化。

结论

这是第一项随机 III 期试验,证明与 3D-CRT-seqB 相比,IMRT-SIB 与稍高的生活质量相关。这些发现进一步支持在辅助乳腺癌治疗中采用 SIB。

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