早期中期PET上的SUV与原发性可手术HER2阳性乳腺癌症的无复发生存率和总生存率的相关性(TBCRC026试验)。

IF 9.1 1区 医学 Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING Journal of Nuclear Medicine Pub Date : 2023-11-01 Epub Date: 2023-08-31 DOI:10.2967/jnumed.123.265853
Maeve A Hennessy, Jeffrey P Leal, Chiung-Yu Huang, Lilja B Solnes, Rita Denbow, Vandana G Abramson, Lisa A Carey, Minetta C Liu, Mothaffar Rimawi, Jennifer Specht, Anna Maria Storniolo, Vicente Valero, Christos Vaklavas, Eric P Winer, Ian E Krop, Antonio C Wolff, Ashley Cimino-Mathews, Richard L Wahl, Vered Stearns, Roisin M Connolly
{"title":"早期中期PET上的SUV与原发性可手术HER2阳性乳腺癌症的无复发生存率和总生存率的相关性(TBCRC026试验)。","authors":"Maeve A Hennessy,&nbsp;Jeffrey P Leal,&nbsp;Chiung-Yu Huang,&nbsp;Lilja B Solnes,&nbsp;Rita Denbow,&nbsp;Vandana G Abramson,&nbsp;Lisa A Carey,&nbsp;Minetta C Liu,&nbsp;Mothaffar Rimawi,&nbsp;Jennifer Specht,&nbsp;Anna Maria Storniolo,&nbsp;Vicente Valero,&nbsp;Christos Vaklavas,&nbsp;Eric P Winer,&nbsp;Ian E Krop,&nbsp;Antonio C Wolff,&nbsp;Ashley Cimino-Mathews,&nbsp;Richard L Wahl,&nbsp;Vered Stearns,&nbsp;Roisin M Connolly","doi":"10.2967/jnumed.123.265853","DOIUrl":null,"url":null,"abstract":"<p><p>Predictive biomarkers of response to human epidermal growth factor receptor 2 (HER2)-directed therapy are essential to inform treatment decisions. The TBCRC026 trial reported that early declines in tumor SUVs corrected for lean body mass (SUL<sub>max</sub>) on <sup>18</sup>F-FDG PET/CT predicted a pathologic complete response (pCR) to HER2 therapy with neoadjuvant trastuzumab and pertuzumab (HP) without chemotherapy in estrogen receptor (ER)-negative, HER2-positive breast cancer. We hypothesized that <sup>18</sup>F-FDG PET/CT SUL<sub>max</sub> parameters would predict recurrence-free survival (RFS) and overall survival (OS). <b>Methods:</b> Patients with stage II/III ER-negative, HER2-positive breast cancer received neoadjuvant HP (<i>n</i> = 88). pCR after HP alone was 22% (18/83), additional nonstudy neoadjuvant therapy was administered in 28% (25/88), and the majority received adjuvant therapy per physician discretion. <sup>18</sup>F-FDG PET/CT was performed at baseline and at cycle 1, day 15 (C1D15). RFS and OS were summarized using the Kaplan-Meier method and compared between subgroups using logrank tests. Associations between <sup>18</sup>F-FDG PET/CT (≥40% decline in SUL<sub>max</sub> between baseline and C1D15, or C1D15 SUL<sub>max</sub> ≤ 3) and pCR were evaluated using Cox regressions, where likelihood ratio CIs were reported because of the small numbers of events. <b>Results:</b> Median follow-up was 53.7 mo (83/88 evaluable), with 6 deaths and 14 RFS events. Estimated RFS and OS at 3 y was 84% (95% CI, 76%-92%) and 92% (95% CI, 87%-98%), respectively. A C1D15 SUL<sub>max</sub> of 3 or less was associated with improved RFS (hazard ratio [HR], 0.36; 95% CI, 0.11-1.05; <i>P</i> = 0.06) and OS (HR, 0.14; 95% CI, 0.01-0.85; <i>P</i> = 0.03), the latter statistically significant. The association of an SUL<sub>max</sub> decline of at least 40% (achieved in 59%) with RFS and OS did not reach statistical significance. pCR was associated with improved RFS (HR, 0.25; 95% CI, 0.01-1.24; <i>P</i> = 0.10) but did not reach statistical significance. <b>Conclusion:</b> For the first time, we report a potential association between a C1D15 SUL<sub>max</sub> of 3 or less on <sup>18</sup>F-FDG PET/CT and RFS and OS outcomes in patients with ER-negative, HER2-positive breast cancer receiving neoadjuvant HP alone. If confirmed in future studies, this imaging-based biomarker may facilitate early individualization of therapy.</p>","PeriodicalId":16758,"journal":{"name":"Journal of Nuclear Medicine","volume":" ","pages":"1690-1696"},"PeriodicalIF":9.1000,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Correlation of SUV on Early Interim PET with Recurrence-Free Survival and Overall Survival in Primary Operable HER2-Positive Breast Cancer (the TBCRC026 Trial).\",\"authors\":\"Maeve A Hennessy,&nbsp;Jeffrey P Leal,&nbsp;Chiung-Yu Huang,&nbsp;Lilja B Solnes,&nbsp;Rita Denbow,&nbsp;Vandana G Abramson,&nbsp;Lisa A Carey,&nbsp;Minetta C Liu,&nbsp;Mothaffar Rimawi,&nbsp;Jennifer Specht,&nbsp;Anna Maria Storniolo,&nbsp;Vicente Valero,&nbsp;Christos Vaklavas,&nbsp;Eric P Winer,&nbsp;Ian E Krop,&nbsp;Antonio C Wolff,&nbsp;Ashley Cimino-Mathews,&nbsp;Richard L Wahl,&nbsp;Vered Stearns,&nbsp;Roisin M Connolly\",\"doi\":\"10.2967/jnumed.123.265853\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Predictive biomarkers of response to human epidermal growth factor receptor 2 (HER2)-directed therapy are essential to inform treatment decisions. The TBCRC026 trial reported that early declines in tumor SUVs corrected for lean body mass (SUL<sub>max</sub>) on <sup>18</sup>F-FDG PET/CT predicted a pathologic complete response (pCR) to HER2 therapy with neoadjuvant trastuzumab and pertuzumab (HP) without chemotherapy in estrogen receptor (ER)-negative, HER2-positive breast cancer. We hypothesized that <sup>18</sup>F-FDG PET/CT SUL<sub>max</sub> parameters would predict recurrence-free survival (RFS) and overall survival (OS). <b>Methods:</b> Patients with stage II/III ER-negative, HER2-positive breast cancer received neoadjuvant HP (<i>n</i> = 88). pCR after HP alone was 22% (18/83), additional nonstudy neoadjuvant therapy was administered in 28% (25/88), and the majority received adjuvant therapy per physician discretion. <sup>18</sup>F-FDG PET/CT was performed at baseline and at cycle 1, day 15 (C1D15). RFS and OS were summarized using the Kaplan-Meier method and compared between subgroups using logrank tests. Associations between <sup>18</sup>F-FDG PET/CT (≥40% decline in SUL<sub>max</sub> between baseline and C1D15, or C1D15 SUL<sub>max</sub> ≤ 3) and pCR were evaluated using Cox regressions, where likelihood ratio CIs were reported because of the small numbers of events. <b>Results:</b> Median follow-up was 53.7 mo (83/88 evaluable), with 6 deaths and 14 RFS events. Estimated RFS and OS at 3 y was 84% (95% CI, 76%-92%) and 92% (95% CI, 87%-98%), respectively. A C1D15 SUL<sub>max</sub> of 3 or less was associated with improved RFS (hazard ratio [HR], 0.36; 95% CI, 0.11-1.05; <i>P</i> = 0.06) and OS (HR, 0.14; 95% CI, 0.01-0.85; <i>P</i> = 0.03), the latter statistically significant. The association of an SUL<sub>max</sub> decline of at least 40% (achieved in 59%) with RFS and OS did not reach statistical significance. pCR was associated with improved RFS (HR, 0.25; 95% CI, 0.01-1.24; <i>P</i> = 0.10) but did not reach statistical significance. <b>Conclusion:</b> For the first time, we report a potential association between a C1D15 SUL<sub>max</sub> of 3 or less on <sup>18</sup>F-FDG PET/CT and RFS and OS outcomes in patients with ER-negative, HER2-positive breast cancer receiving neoadjuvant HP alone. If confirmed in future studies, this imaging-based biomarker may facilitate early individualization of therapy.</p>\",\"PeriodicalId\":16758,\"journal\":{\"name\":\"Journal of Nuclear Medicine\",\"volume\":\" \",\"pages\":\"1690-1696\"},\"PeriodicalIF\":9.1000,\"publicationDate\":\"2023-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Nuclear Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2967/jnumed.123.265853\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/8/31 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Nuclear Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2967/jnumed.123.265853","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/8/31 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING","Score":null,"Total":0}
引用次数: 1

摘要

对人类表皮生长因子受体2(HER2)导向治疗反应的预测性生物标志物对治疗决策至关重要。TBCRC026试验报告,在18F-FDG PET/CT上校正为瘦体重(SULmax)的肿瘤SUVs的早期下降预测了在雌激素受体(ER)阴性、HER2阳性的癌症中,使用新辅助曲妥珠单抗和帕妥珠单抗(HP)进行HER2治疗而不进行化疗的病理学完全反应(pCR)。我们假设18F-FDG PET/CT SULmax参数可以预测无复发生存期(RFS)和总生存期(OS)。方法:Ⅱ/Ⅲ期ER阴性、HER2阳性的癌症患者接受新辅助HP治疗(n=88)。单独HP后的pCR为22%(18/83),额外的非研究性新辅助治疗为28%(25/88),大多数患者根据医生的判断接受辅助治疗。18F-FDG PET/CT在基线和第1周期第15天(C1D15)进行。使用Kaplan-Meier方法总结RFS和OS,并使用logrank检验在亚组之间进行比较。18F-FDG PET/CT(基线与C1D15之间SULmax下降≥40%,或C1D15 SULmax≤3)与pCR之间的相关性使用Cox回归进行评估,其中由于事件数量较少,报告了似然比CI。结果:中位随访为53.7 mo(83/88可评估),6例死亡,14例RFS事件。预计RFS和OS在3 y分别为84%(95%可信区间,76%-92%)和92%(95%置信区间,87%-98%)。C1D15 SULmax等于或小于3与RFS(危险比[HR],0.36;95%可信区间,0.11-1.05;P=0.06)和OS(HR,0.14;95%置信区间,0.01-0.85;P=0.03)改善相关,后者具有统计学意义。SULmax下降至少40%(达到59%)与RFS和OS的相关性没有达到统计学意义。pCR与RFS改善相关(HR,0.25;95%CI,0.01-1.24;P=0.10),但没有达到统计学意义。结论:我们首次报道了18F-FDG PET/CT上3或更少的C1D15 SULmax与单独接受新辅助HP的ER-阴性、HER2-阳性乳腺癌症患者的RFS和OS结果之间的潜在关联。如果在未来的研究中得到证实,这种基于成像的生物标志物可能有助于早期个性化治疗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Correlation of SUV on Early Interim PET with Recurrence-Free Survival and Overall Survival in Primary Operable HER2-Positive Breast Cancer (the TBCRC026 Trial).

Predictive biomarkers of response to human epidermal growth factor receptor 2 (HER2)-directed therapy are essential to inform treatment decisions. The TBCRC026 trial reported that early declines in tumor SUVs corrected for lean body mass (SULmax) on 18F-FDG PET/CT predicted a pathologic complete response (pCR) to HER2 therapy with neoadjuvant trastuzumab and pertuzumab (HP) without chemotherapy in estrogen receptor (ER)-negative, HER2-positive breast cancer. We hypothesized that 18F-FDG PET/CT SULmax parameters would predict recurrence-free survival (RFS) and overall survival (OS). Methods: Patients with stage II/III ER-negative, HER2-positive breast cancer received neoadjuvant HP (n = 88). pCR after HP alone was 22% (18/83), additional nonstudy neoadjuvant therapy was administered in 28% (25/88), and the majority received adjuvant therapy per physician discretion. 18F-FDG PET/CT was performed at baseline and at cycle 1, day 15 (C1D15). RFS and OS were summarized using the Kaplan-Meier method and compared between subgroups using logrank tests. Associations between 18F-FDG PET/CT (≥40% decline in SULmax between baseline and C1D15, or C1D15 SULmax ≤ 3) and pCR were evaluated using Cox regressions, where likelihood ratio CIs were reported because of the small numbers of events. Results: Median follow-up was 53.7 mo (83/88 evaluable), with 6 deaths and 14 RFS events. Estimated RFS and OS at 3 y was 84% (95% CI, 76%-92%) and 92% (95% CI, 87%-98%), respectively. A C1D15 SULmax of 3 or less was associated with improved RFS (hazard ratio [HR], 0.36; 95% CI, 0.11-1.05; P = 0.06) and OS (HR, 0.14; 95% CI, 0.01-0.85; P = 0.03), the latter statistically significant. The association of an SULmax decline of at least 40% (achieved in 59%) with RFS and OS did not reach statistical significance. pCR was associated with improved RFS (HR, 0.25; 95% CI, 0.01-1.24; P = 0.10) but did not reach statistical significance. Conclusion: For the first time, we report a potential association between a C1D15 SULmax of 3 or less on 18F-FDG PET/CT and RFS and OS outcomes in patients with ER-negative, HER2-positive breast cancer receiving neoadjuvant HP alone. If confirmed in future studies, this imaging-based biomarker may facilitate early individualization of therapy.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Journal of Nuclear Medicine
Journal of Nuclear Medicine 医学-核医学
CiteScore
13.00
自引率
8.60%
发文量
340
审稿时长
1 months
期刊介绍: The Journal of Nuclear Medicine (JNM), self-published by the Society of Nuclear Medicine and Molecular Imaging (SNMMI), provides readers worldwide with clinical and basic science investigations, continuing education articles, reviews, employment opportunities, and updates on practice and research. In the 2022 Journal Citation Reports (released in June 2023), JNM ranked sixth in impact among 203 medical journals worldwide in the radiology, nuclear medicine, and medical imaging category.
期刊最新文献
C-X-C Motif Chemokine Receptor 4-Directed Scintigraphy of Multiple Myeloma Using [99mTc]Tc-PentixaTec. Debating the Future of Nuclear Medicine: The Greek Experience. Peptide Receptor Radionuclide Therapy Is Effective for Clinical Control of Symptomatic Metastatic Insulinoma: A Long-Term Retrospective Analysis Identification of (R)-[18F]YH134 for Monoacylglycerol Lipase Neuroimaging and Exploration of Its Use for Central Nervous System and Peripheral Drug Development Value of68Ga-FAPI-04 and18F-FDG PET/CT in Early Prediction of Pathologic Response to Neoadjuvant Chemotherapy in Locally Advanced Gastric Cancer
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1