Clinical Impact of Intraoperative Margin Assessment in Breast-Conserving Surgery With a Novel Pegulicianine Fluorescence-Guided System: A Nonrandomized Controlled Trial.
Clinical Impact of Intraoperative Margin Assessment in Breast-Conserving Surgery With a Novel Pegulicianine Fluorescence-Guided System: A Nonrandomized Controlled Trial.
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DOI：
10.1001/jamasurg.2022.1075
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发表时间：
2022-07-01
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影响因子：
16.9
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新型pegulicianine荧光引导系统（pFGS）在改善保乳手术患者结局方面是否安全有效？在这项包括230例患者的非随机对照试验中，1例有造影剂过敏史的患者发生速发过敏反应，并痊愈无后遗症。pFGS显示出对残留肿瘤的高敏感性，并且在接受pFGS引导刮除切除的患者中避免了19%的再次切除的需要。pFGS具有极好的安全性，并降低了接受保乳手术的患者的再次切除率。这项非随机对照试验评估了新型pegulicianine荧光引导系统在识别接受保乳手术的女性患者肿瘤床中残留癌症方面的安全性和有效性。保乳手术（BCS）后的阳性切缘通常在标准病理学评估中确定。乳房肿瘤切除术腔的术中评估有可能减少残留疾病或真实的BCS标准治疗后的再切除率。收集新型pegulicianine荧光引导系统（pFGS）用于识别接受BCS的女性患者肿瘤床中残留癌的安全性和初始疗效数据。这项前瞻性单臂开放标签研究是在美国16个学术或社区乳腺中心进行的非随机多中心对照试验。纳入了接受BCS的18岁及以上新诊断的原发性浸润性乳腺癌或原位导管癌DCIS女性患者，排除了既往接受过乳腺癌手术和染料过敏史的患者。在招募的283名连续合格患者中，234名接受了pegulicianine注射，并被纳入安全性分析;其中230名被纳入疗效分析。患者在2018年2月6日至2020年4月10日期间入组，并进行30天随访。数据分析时间为2020年4月10日至2021年8月5日。受试者在手术前平均（SD）3.2（0.9）小时接受1 mg/kg剂量的新型显像剂（pegulicianine）注射。在完成标准治疗（SOC）切除后，使用pFGS扫描肿块切除术腔，以指导切除额外的剃除边缘。不良事件与敏感性、特异性和再切除率。在入组的234例女性患者（中位[IQR]年龄，62.0 [55.0-69.0]岁）中，230例完成了试验，1例有造影剂过敏史的患者发生速发过敏反应，恢复后无后遗症。在每个切缘分析中，pFGS与最终切缘状态的相关性显示，与主要肿块切除术标本的标准病理学评估相比，灵敏度显著提高（分别为69.4%和38.2%）。在每个患者的水平上，pFGS的假阴性率为23.7%（9/38），灵敏度为76.3%（29/38）。在32名接受pFGS引导剃除的患者中，pFGS避免了6名（19%）患者再次切除的需要。在这项初步可行性研究中，pegulicianine的安全性特征与BCS中使用的其他显像剂一致，并且与接受pFGS引导刨削的术中额外切除的患者的二次手术需求减少相关。这些发现支持在前瞻性随机试验中进一步开发和评估pFGS的临床性能。ClinicalTrials.gov标识符：NCT 03321929
Is the novel pegulicianine fluorescence–guided system (pFGS) safe and effective in improving outcome for patients undergoing breast-conserving surgery? In this nonrandomized controlled trial including 230 patients, 1 patient with a history of allergy to contrast agents had an anaphylactic reaction and recovered without sequelae. pFGS showed a high sensitivity rate for residual tumor, and averted the need for reexcision by 19% among patients who underwent excision of pFGS-guided shaves. pFGS had an excellent safety profile and reduced the reexcision rate for patients undergoing breast-conserving surgery. This nonrandomized controlled trial evaluates the safety and efficacy of the novel pegulicianine fluorescence–guided system in identifying residual cancer in the tumor bed of female patients undergoing breast-conserving surgery. Positive margins following breast-conserving surgery (BCS) are often identified on standard pathology evaluation. Intraoperative assessment of the lumpectomy cavity has the potential to reduce residual disease or reexcision rate following standard of care BCS in real time. To collect safety and initial efficacy data on the novel pegulicianine fluorescence–guided system (pFGS) when used to identify residual cancer in the tumor bed of female patients undergoing BCS. This prospective single-arm open-label study was conducted as a nonrandomized multicenter controlled trial at 16 academic or community breast centers across the US. Female patients 18 years and older with newly diagnosed primary invasive breast cancer or ductal carcinoma in situ DCIS undergoing BCS were included, excluding those with previous breast cancer surgery and a history of dye allergies. Of 283 consecutive eligible patients recruited, 234 received a pegulicianine injection and were included in the safety analysis; of these, 230 were included in the efficacy analysis. Patients were enrolled between February 6, 2018, and April 10, 2020, and monitored for a 30-day follow-up period. Data were analyzed from April 10, 2020, to August 5, 2021. Participants received an injection of a novel imaging agent (pegulicianine) a mean (SD) of 3.2 (0.9) hours prior to surgery at a dose of 1 mg/kg. After completing standard of care (SOC) excision, pFGS was used to scan the lumpectomy cavity to guide the removal of additional shave margins. Adverse events and sensitivity, specificity, and reexcision rate. Of 234 female patients enrolled (median [IQR] age, 62.0 [55.0-69.0] years), 230 completed the trial and 1 patient with a history of allergy to contrast agents had an anaphylactic reaction and recovered without sequelae. Correlation of pFGS with final margin status on a per-margin analysis showed a marked improvement in sensitivity over standard pathology assessment of the main lumpectomy specimen (69.4% vs 38.2%, respectively). On a per-patient level, the false-negative rate of pFGS was 23.7% (9 of 38), and sensitivity was 76.3% (29 of 38). Among 32 patients who underwent excision of pFGS-guided shaves, pFGS averted the need for reexcision in 6 (19%). In this pilot feasibility study, the safety profile of pegulicianine was consistent with other imaging agents used in BCS, and was associated with a reduced need for second surgery in patients who underwent intraoperative additional excision of pFGS-guided shaves. These findings support further development and clinical performance assessment of pFGS in a prospective randomized trial. ClinicalTrials.gov Identifier: NCT03321929