Marandino Laura, Capozza Antonella, Bandini Marco, Raggi Daniele, Farè Elena, Pederzoli Filippo, Gallina Andrea, Capitanio Umberto, Bianchi Marco, Gandaglia Giorgio, Fossati Nicola, Colecchia Maurizio, Giannatempo Patrizia, Serafini Gianluca, Padovano Barbara, Salonia Andrea, Briganti Alberto, Montorsi Francesco, Alessi Alessandra, Necchi Andrea
Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Department of Nuclear Medicine - PET Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Urol Oncol. 2021 Apr;39(4):235.e15-235.e21. doi: 10.1016/j.urolonc.2020.09.035. Epub 2020 Oct 16.
Data regarding the role of positron emission tomography/computed tomography (PET/CT) to stage lymph nodes in patients receiving neoadjuvant immunotherapy before radical cystectomy are lacking. The aim of this study is to evaluate the role of PET/CT to predict the pathologic lymph node involvement (LNI) in patients with MIBC receiving neoadjuvant pembrolizumab within the PURE-01 trial (NCT02736266).
Three courses of pembrolizumab were administered before radical cystectomy and extended pelvic lymph node dissection in clinical T2-4aN0M0 MIBC based on contrast-enhanced CT scan. LNI was also assessed with PET/CT before and after treatment. PET/CT results were compared with histopathological findings. The ability of baseline and post-therapy PET/CT to evaluate LNI was assessed, and univariate logistic regression analyses were performed.
From February 2017 to August 2019, a total of 108 patients and 105 patients had evaluable baseline and post-pembrolizumab scans, respectively. The sensitivity to detect LNI was 27% and 37.5% for pre- and post-pembrolizumab PET/CT, and specificity was 97% and 98%, respectively. In total, 4 of 7 patients (57%) showing baseline FDG-uptake had LNI vs. 11 of 101 (11%) with no baseline uptake. All but 1 of the 7 patients did not respond to pembrolizumab. Both pre- and post-pembrolizumab PET/CT significantly predicted LNI (P = 0.004 and P < 0.001) at univariate analyses. Our results warrant further validation in larger datasets.
PET/CT performance does not justify its use in routine practice for cN0 MIBC. However, our preliminary data revealed opportunities for the use of baseline PET/CT, within clinical trials, to optimally select patients with MIBC who are best suited for neoadjuvant immunotherapy strategies. Validation in larger datasets, as well as a cost analysis, are needed.
关于正电子发射断层扫描/计算机断层扫描（PET/CT）在根治性膀胱切除术前行新辅助免疫治疗患者的淋巴结分期中的作用的数据尚缺。本研究的目的是在PURE-01试验（NCT02736266）中评估PET/CT在预测接受新辅助派姆单抗治疗的肌层浸润性膀胱癌（MIBC）患者病理淋巴结转移（LNI）中的作用。
基于增强CT扫描，在临床T2-4aN0M0 MIBC患者的根治性膀胱切除术和扩大盆腔淋巴结清扫术前给予三个疗程的派姆单抗。治疗前后也用PET/CT评估LNI。将PET/CT结果与组织病理学结果进行比较。评估基线和治疗后PET/CT评估LNI的能力，并进行单因素逻辑回归分析。
从2017年2月至2019年8月，分别有108例和105例患者有可评估的基线和派姆单抗治疗后的扫描结果。派姆单抗治疗前和治疗后PET/CT检测LNI的敏感性分别为27%和37.5%，特异性分别为97%和98%。7例显示基线FDG摄取的患者中有4例（57%）有LNI，而101例无基线摄取的患者中有11例（11%）有LNI。7例患者中除1例外均对派姆单抗无反应。在单因素分析中，派姆单抗治疗前和治疗后PET/CT均能显著预测LNI（P = 0.004和P < 0.001）。我们的结果有待在更大的数据集中进一步验证。
PET/CT的性能并不支持其在cN0 MIBC的常规实践中的应用。然而，我们的初步数据揭示了在临床试验中使用基线PET/CT来优化选择最适合新辅助免疫治疗策略的MIBC患者的机会。需要在更大的数据集中进行验证以及进行成本分析。
