[18F]Fluoro-Deoxy-Glucose positron emission tomography to evaluate lymph node involvement in patients with muscle-invasive bladder cancer receiving neoadjuvant pembrolizumab.

Aged Antibodies, Monoclonal, Humanized / therapeutic use Antineoplastic Agents, Immunological / therapeutic use Female Fluorodeoxyglucose F18 Humans Lymphatic Metastasis / diagnostic imaging Male Middle Aged Neoadjuvant Therapy Neoplasm Invasiveness Positron Emission Tomography Computed Tomography / methods Predictive Value of Tests Prospective Studies Radiopharmaceuticals Urinary Bladder Neoplasms / drug therapy

Lymph node involvement MIBC PET/CT Pembrolizumab

Journal

Urologic oncology

ISSN: 1873-2496

Titre abrégé: Urol Oncol

Pays: United States

ID NLM: 9805460

Informations de publication

Date de publication:
04 2021

Historique:

received: 03 06 2020

revised: 31 08 2020

accepted: 30 09 2020

pubmed: 20 10 2020

medline: 15 12 2021

entrez: 19 10 2020

Statut: ppublish

Résumé

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.

Sections du résumé

BACKGROUND

MATERIAL AND METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

Identifiants

DOI: 10.1016/j.urolonc.2020.09.035 PMID: 33071107

pubmed: 33071107

pii: S1078-1439(20)30472-5

doi: 10.1016/j.urolonc.2020.09.035

pii:

doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0

Antineoplastic Agents, Immunological 0

Radiopharmaceuticals 0

Fluorodeoxyglucose F18 0Z5B2CJX4D

pembrolizumab DPT0O3T46P

Banques de données

ClinicalTrials.gov

['NCT02736266']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

235.e15-235.e21

Commentaires et corrections

Type : CommentIn