PS1-21:分子荧光引导Beva800手术评估原发性乳腺癌保乳手术期间肿瘤边缘(MARGIN-II)

H. Kolberg, C. Röhm, A. Stachs, F. Schütz, J. Blohmer, S. Wetzig, S. Hartmann, J. Heil, M. Hahn
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引用次数: 0

摘要

早期乳腺癌(EBC)保乳手术(BCS)的目标是全部切除肿瘤并尽可能多地保留正常乳腺组织。在20-50%的病例中,由于边缘受累,需要再次切除。重复手术不仅是患者身体上的负担,也是心理上的负担,并可能延迟推荐的辅助治疗。因此,在手术中准确确定肿瘤边缘是非常必要的。乳腺癌组织产生的VEGF-A明显高于健康组织。VEGF-A刺激肿瘤血管生成,因此是分子成像技术的靶标。荧光显像剂贝伐单抗-IRDye800CW (Beva800)是贝伐单抗和IRDye800CW的缀合物,特异性结合VEGF-A。Beva800提供了一种潜在的有效方法来成像BCS期间的标本和腔缘。我们正在进行一项II期研究,该研究将Beva800与SurgVision Explorer Air相机相结合,用于EBC BCS术中边缘评估。方法:MARGIN II是一项多中心开放标签单臂前瞻性临床试验,旨在评估Beva800对计划接受BCS的EBC女性肿瘤边缘的评估作用。该研究是一项患者内肿瘤边缘阳性率的比较,采用BCS标准护理边缘评估,与术中使用4.5 mg Beva800评估和使用SurgVision Explorer Air相机进行荧光成像进行比较。所有病人都接受了静脉注射。在手术前三天注射4.5毫克的Beva800。术中荧光信号采用近红外荧光成像(700-1000 nm)。护理标准边缘评估定义为目视检查,触诊,以及术前线标记的情况下,标本超声检查或乳房x光检查。Beva800的疗效是指使用Beva800进行荧光引导手术,但未使用标准护理BCS,病理证实的阳性边缘的患者数量。结果:49例患者被纳入5个中心。4例训练病例仅纳入安全性分析,45例患者可评价疗效分析。8例患者(17.8%)在标准护理BCS后出现边缘病变,其中4例术中通过分子荧光检测,导致边缘阳性患者减少50% (95% CI: 15.7%, 84.3%)。4例(8.9%);95% CI: 2.5%, 21.1%)因累及切缘需要再次切除。在27例(60.0%)患者中,额外的分子荧光引导空腔刮除未使切除状态从阳性变为阴性(假阳性)。49例患者中有16例(32.7%)报告了不良事件,但只有3例(6.1%)与Beva800有关(晕厥、潮热、高血压危象)。1例患者出现与治疗相关的SAE(高血压危象)。未检出抗beva800抗体。结论:在我们的分析中,使用Beva800和SurgVision Explorer Air相机,必要的第二次手术率降低了50%。安全性分析证实了先前研究中发现的Beva800的积极安全性。分子荧光引导手术有可能通过减少不必要的再切除来改变保乳手术的实践。未来的研究将不得不解决高假阳性率。引文格式:Hans-Christian Kolberg, Carmen Röhm, Angrit Stachs, Florian sch z, Jens-Uwe Blohmer, Sarah Wetzig, Steffi Hartmann, Jörg Heil, Markus Hahn。分子荧光引导下的BEVA800在原发乳腺癌保乳手术中评估肿瘤边缘(MARGIN-II)[摘要]。摘自:2022年圣安东尼奥乳腺癌研讨会论文集;2022年12月6日至10日;费城(PA): AACR;癌症杂志,2013;31(5增刊):02 - 02。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Abstract PS1-21: Molecular fluorescence-guided surgery using Beva800 for the assessment of tumor margins during breast conserving surgery of patients with primary breast cancer (MARGIN-II)
Introduction: The goal of breast conserving surgery (BCS) for early breast cancer (EBC) is to remove the tumor in toto and preserving as much of the normal breast tissue as possible. In 20-50% of cases a re-excision is necessary because of involved margins. Repeat surgeries are not only a burden to patients physically but also psychologically and can delay recommended adjuvant therapies. Accurate determination of tumor margins during surgery is therefore a critical need. Breast cancer tissue produces significantly higher amounts of VEGF-A than healthy tissue. VEGF-A stimulates tumor angiogenesis and is therefore a target for molecular imaging techniques. The fluorescence imaging agent bevacizumab-IRDye800CW (Beva800) is a conjugate of bevacizumab and IRDye800CW and binds specifically to VEGF-A. Beva800 provides a potentially efficacious approach to imaging specimen and cavity margins during BCS. We are presenting a phase II study that combined Beva800 with the SurgVision Explorer Air camera for intraoperative margin assessment during BCS for EBC. Methods: MARGIN II is a multicenter open-label single arm prospective clinical trial aimed at evaluating Beva800 for assessment of tumor margins in women with EBC scheduled for BCS. The study was a within-patient comparison of positive tumor margin rates using BCS standard of care margin assessment compared to intraoperative assessment with 4.5 mg Beva800 and fluorescence imaging with the SurgVision Explorer Air camera. All patients received an i.-v. bolus injection of 4.5 mg of Beva800 three days before surgery. The fluorescent signal was visualized during surgery using NIR fluorescence imaging (700–1000 nm). Standard of care margin assessment was defined as visual inspection, palpation and, in cases of pre-operative wire marking, specimen sonography or mammography. Beva800 efficacy was determined as the number of patients in which a pathology-confirmed positive margin was identified by fluorescence-guided surgery using Beva800 but not by standard of care BCS. Results: 49 patients were included in 5 centers. 4 training cases were only included in the safety analysis, 45 patients were evaluable for the efficacy analysis. 8 patients (17.8%) had involved margins after standard of care BCS, 4 of which were detected by molecular fluorescence intraoperatively resulting in the reduction of patients with positive margins by 50% (95% CI: 15.7%, 84.3%). 4 patients (8.9%; 95% CI: 2.5%, 21.1%) needed a re-excision because of involved margins. In 27 patients (60.0%) the additional molecular fluorescence guided cavity shaving did not change the resection status from positive to negative (false positive). Adverse events were reported by 16 of 49 patients (32.7%), but only 3 (6.1%) were related to Beva800 (syncope, hot flush, hypertensive crisis). One patient experienced a treatment related SAE (hypertensive crisis). No anti-Beva800 antibodies were detected. Conclusion: In our analysis the rate of necessary second operations was reduced by 50% using Beva800 and the SurgVision Explorer Air camera. The safety analysis confirmed the positive safety profile of Beva800 found in previous studies. Molecular fluorescence-guided surgery may have the potential to change the practice of breast conserving surgery by reducing unnecessary re-excisions. Future studies will have to address the high false positive rates. Citation Format: Hans-Christian Kolberg, Carmen Röhm, Angrit Stachs, Florian Schütz, Jens-Uwe Blohmer, Sarah Wetzig, Steffi Hartmann, Jörg Heil, Markus Hahn. MOLECULAR FLUORESCENCE-GUIDED SURGERY USING BEVA800 FOR THE ASSESSMENT OF TUMOR MARGINS DURING BREAST CONSERVING SURGERY OF PATIENTS WITH PRIMARY BREAST CANCER (MARGIN-II) [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-14-01.
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