第二次同侧乳腺肿瘤事件的处理：倡导随机试验。

IF 1.5 4区医学 Q4 ONCOLOGY

Cancer Radiotherapie Pub Date : 2024-04-01 DOI:10.1016/j.canrad.2023.11.001

J.-M. Hannoun-Lévi , A. Savignoni , J.-G. Féron , C. Malhaire , C. Ezzili , A. Brédart , P. Loap , Y. Kirova

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引用次数: 0

摘要

对于第二次同侧乳腺肿瘤事件，挽救性乳房切除术是标准的治疗方法，而第二次保守治疗是可能的选择。然而，由于缺乏 1 级证据，导致对可以接受第二次保守治疗的患者实施挽救性乳房切除术，从而避免挽救性乳房切除术对患者心理/生活质量造成不良影响。我们需要进行一项第 3 期随机试验，比较挽救性乳房切除术和第二次保守治疗。在此，我们将讨论此类试验的最佳设计，以确认两种挽救方案之间的非劣效性，重点关注患者特征和统计问题的方法学方面。

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Management of second ipsilateral breast tumor event: An advocacy for a randomized trial

For a second ipsilateral breast tumor event, salvage mastectomy is the standard of care while second conservative treatment is a possible option. However, level 1 proofs are missing, leading to perform salvage mastectomy for patients who could receive second conservative treatment and consequently avoid psychological/quality of life salvage mastectomy deleterious impacts. A phase 3 randomized trial comparing salvage mastectomy to second conservative treatment is needed. Here we discuss what would be to us the optimal design of such trial to confirm the non-inferiority between the two salvage options, with a focus on methodological aspects in terms of patient characteristics and statistical issues.

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来源期刊

Cancer Radiotherapie 医学-核医学

CiteScore

2.20

自引率

23.10%

发文量

129

审稿时长

63 days

期刊介绍： Cancer/radiothérapie se veut d''abord et avant tout un organe francophone de publication des travaux de recherche en radiothérapie. La revue a pour objectif de diffuser les informations majeures sur les travaux de recherche en cancérologie et tout ce qui touche de près ou de loin au traitement du cancer par les radiations : technologie, radiophysique, radiobiologie et radiothérapie clinique.