研究动态
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早期乳腺癌中与内分泌疗法相比的全乳腺放疗--基于已发表的随机对照试验的直接和网络荟萃分析。

Whole Breast Irradiation in Comparison to Endocrine Therapy in Early Stage Breast Cancer-A Direct and Network Meta-Analysis of Published Randomized Trials.

发表日期:2023 Aug 30
作者: Jan Haussmann, Wilfried Budach, Stefanie Corradini, David Krug, Edwin Bölke, Balint Tamaskovics, Danny Jazmati, Alexander Haussmann, Christiane Matuschek
来源: PHYSICAL THERAPY & REHABILITATION JOURNAL

摘要:

多个随机试验已经确立了早期乳腺癌中术后辅助内分泌治疗(ET)和乳腺整体照射(WBI)作为保留乳房手术(BCS)后的标准方法。多个试验研究了省略WBI的效果,结果显示缺失了局部控制,但生存率仍然保持不变,因此已经被多个指南中采用作为特定患者的治疗选择。省略WBI而不是ET也可能是一种有价值的选择,因为这两种治疗的副作用明显不同。然而,BCS + ET与BCS + WBI之间的临床结果尚未得到正式分析。我们进行了系统文献回顾,搜索并筛选了2000年以后发表的在低风险乳腺癌患者中比较BCS + ET与BCS + WBI的随机试验。我们排除了使用任何形式化疗、局部淋巴放疗和乳房切除术的试验。我们采用了两步法进行荟萃分析。首先,我们提取了所有可用的发表事件率和效应大小,作为研究终点进行了总体和乳腺癌特异性生存率(OS、BCSS)、局部(LR)和区域复发、无病生存率、远处转移无病间隔、对侧乳腺癌和除乳腺癌外的第二癌以及乳房切除术间隔的比较,通过网络荟萃分析进行了比较。其次,我们使用了早期乳腺癌试验协作组(EBCTCG)的发表的个体患者数据,以比较OS和BCSS。我们确定了三项研究,其中一项直接比较了BCS + ET与BCS + WBI(n = 1059),另外九项研究对额外的7207名患者进行了BCS或BCS + WBI + ET的随机分组,从而可以进行四组比较。在网络分析中,LR在BCS + WBI组中明显低于BCS + ET组(HR = 0.62; CI-95%:0.42-0.92; p = 0.019)。我们未发现OS(HR = 0.93; CI-95%:0.53-1.62; p = 0.785)和BCSS(OR = 1.04; CI-95%:0.45-2.41; p = 0.928)之间的任何差异。此外,我们发现在BCS + WBI组中,远处转移无病间隔更短,对侧乳腺癌的发生率更高,乳房切除术间隔更短。使用EBCTCG数据,BCS + ET与BCS + WBI在10年后的OS和BCSS之间没有显著差异(OS:OR = 0.85; CI-95%:0.59-1.22; p = 0.369)(BCSS:OR = 0.72; CI-95%:0.38-1.36; p = 0.305)。直接和间接比较的证据表明,BCS + WBI可能是一种与BCS + ET相当的逐步缩减策略,适用于低风险乳腺癌。还需进一步比较这两种方法之间的不良事件和生活质量评估。
Multiple randomized trials have established adjuvant endocrine therapy (ET) and whole breast irradiation (WBI) as the standard approach after breast-conserving surgery (BCS) in early-stage breast cancer. The omission of WBI has been studied in multiple trials and resulted in reduced local control with maintained survival rates and has therefore been adapted as a treatment option in selected patients in several guidelines. Omitting ET instead of WBI might also be a valuable option as both treatments have distinctly different side effect profiles. However, the clinical outcomes of BCS + ET vs. BCS + WBI have not been formally analyzed.We performed a systematic literature review searching for randomized trials comparing BCS + ET vs. BCS + WBI in low-risk breast cancer patients with publication dates after 2000. We excluded trials using any form of chemotherapy, regional nodal radiation and mastectomy. The meta-analysis was performed using a two-step process. First, we extracted all available published event rates and the effect sizes for overall and breast-cancer-specific survival (OS, BCSS), local (LR) and regional recurrence, disease-free survival, distant metastases-free interval, contralateral breast cancer, second cancer other than breast cancer and mastectomy-free interval as investigated endpoints and compared them in a network meta-analysis. Second, the published individual patient data from the Early Breast Cancer Trialists' Collaborative Group (EBCTCG) publications were used to allow a comparison of OS and BCSS.We identified three studies, including a direct comparison of BCS + ET vs. BCS + WBI (n = 1059) and nine studies randomizing overall 7207 patients additionally to BCS only and BCS + WBI + ET resulting in a four-arm comparison. In the network analysis, LR was significantly lower in the BCS + WBI group in comparison with the BCS + ET group (HR = 0.62; CI-95%: 0.42-0.92; p = 0.019). We did not find any differences in OS (HR = 0.93; CI-95%: 0.53-1.62; p = 0.785) and BCSS (OR = 1.04; CI-95%: 0.45-2.41; p = 0.928). Further, we found a lower distant metastasis-free interval, a higher rate of contralateral breast cancer and a reduced mastectomy-free interval in the BCS + WBI-arm. Using the EBCTCG data, OS and BCSS were not significantly different between BCS + ET and BCS + WBI after 10 years (OS: OR = 0.85; CI-95%: 0.59-1.22; p = 0.369) (BCSS: OR = 0.72; CI-95%: 0.38-1.36; p = 0.305).Evidence from direct and indirect comparison suggests that BCS + WBI might be an equivalent de-escalation strategy to BCS + ET in low-risk breast cancer. Adverse events and quality of life measures have to be further compared between these approaches.