Proposal of early CT morphological criteria for response of liver metastases to systemic treatments in gastroenteropancreatic neuroendocrine tumors: Alternatives to RECIST

RECIST 1.1 criteria are commonly used with computed tomography (CT) to evaluate the efficacy of systemic treatments in patients with neuroendocrine tumors (NETs) and liver metastases (LMs), but their relevance is questioned in this setting. We aimed to explore alternative criteria using different nu...

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Published in:	Journal of neuroendocrinology Vol. 35; no. 6; pp. e13311 - n/a
Main Authors:	Mestier, Louis, Resche‐Rigon, Matthieu, Dromain, Clarisse, Lamarca, Angela, La Salvia, Anna, Baker, Lesley, Fehrenbach, Uli, Pusceddu, Sara, Colao, Annamaria, Borbath, Ivan, Haas, Robbert, Rinzivillo, Maria, Zerbi, Alessandro, Funicelli, Luigi, Herder, Wouter W., Selberherr, Andreas, Wagner, Anna Dorothea, Manoharan, Prakash, De Cima, Andrea, Lybaert, Willem, Jann, Henning, Prinzi, Natalie, Faggiano, Antongiulio, Annet, Laurence, Walenkamp, Annemiek, Panzuto, Francesco, Pedicini, Vittorio, Pitoni, Maria Giovanna, Siebenhuener, Alexander, Mayerhoefer, Marius E., Ruszniewski, Philippe, Vullierme, Marie‐Pierre
Format:	Journal Article
Language:	English
Published:	United States Wiley Subscription Services, Inc 01-06-2023
Subjects:	Chemotherapy Clinical trials Computed tomography Humans Liver Liver Neoplasms - diagnostic imaging Liver Neoplasms - drug therapy Metastases Metastasis Neuroendocrine tumors Neuroendocrine Tumors - diagnostic imaging Neuroendocrine Tumors - drug therapy Patients response evaluation Response Evaluation Criteria in Solid Tumors Retrospective Studies Small intestine Somatostatin systemic treatments Tomography, X-Ray Computed computed tomography response evaluation systemic treatments neuroendocrine tumors
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Summary:	RECIST 1.1 criteria are commonly used with computed tomography (CT) to evaluate the efficacy of systemic treatments in patients with neuroendocrine tumors (NETs) and liver metastases (LMs), but their relevance is questioned in this setting. We aimed to explore alternative criteria using different numbers of measured LMs and thresholds of size and density variation. We retrospectively studied patients with advanced pancreatic or small intestine NETs with LMs, treated with systemic treatment in the first‐and/or second‐line, without early progression, in 14 European expert centers. We compared time to treatment failure (TTF) between responders and non‐responders according to various criteria defined by 0%, 10%, 20% or 30% decrease in the sum of LM size, and/or by 10%, 15% or 20% decrease in LM density, measured on two, three or five LMs, on baseline (≤1 month before treatment initiation) and first revaluation (≤6 months) contrast‐enhanced CT scans. Multivariable Cox proportional hazard models were performed to adjust the association between response criteria and TTF on prognostic factors. We included 129 systemic treatments (long‐acting somatostatin analogs 41.9%, chemotherapy 26.4%, targeted therapies 31.8%), administered as first‐line (53.5%) or second‐line therapies (46.5%) in 91 patients. A decrease ≥10% in the size of three LMs was the response criterion that best predicted prolonged TTF, with significance at multivariable analysis (HR 1.90; 95% CI: 1.06–3.40; p = .03). Conversely, response defined by RECIST 1.1 did not predict prolonged TTF (p = .91), and neither did criteria based on changes in LM density. A ≥10% decrease in size of three LMs could be a more clinically relevant criterion than the current 30% threshold utilized by RECIST 1.1 for the evaluation of treatment efficacy in patients with advanced NETs. Its implementation in clinical trials is mandatory for prospective validation. Criteria based on changes in LM density were not predictive of treatment efficacy. Clinical Trial Registration Registered at CNIL‐CERB, Assistance publique hopitaux de Paris as “E‐NETNET‐L‐E‐CT” July 2018. No number was assigned. Approved by the Medical Ethics Review Board of University Medical Center Groningen. A European study of liver metastases with CT in 14 expert centers in NET treatment has shown that a ≥10% decrease in size of three liver metastases could be a more clinically relevant criterion than the current 30% threshold utilized by RECIST 1.1 for the evaluation of treatment efficacy in patients with advanced NETs. Its implementation in clinical trials is mandatory for prospective validation. Criteria based on changes in liver metastases CT‐density were not predictive of treatment efficacy.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0953-8194 1365-2826
DOI:	10.1111/jne.13311