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The association between radiological response and overall survival (OS) was retrospectively evaluated in patients treated with lenvatinib as a first-line systemic treatment for unresectable hepatocellular carcinoma. A total of 182 patients with Child–Pugh class A liver function and an Eastern Cooperative Oncology Group performance status of zero or one were enrolled. Radiological evaluation was performed using Response Evaluation Criteria in Solid Tumors (RECIST) and modified Response Evaluation Criteria in Solid Tumors (mRECIST). Initial radiological evaluation confirmed significant stratification of OS by efficacy judgment with both RECIST and mRECIST, and that initial radiological response was an independent prognostic factor for OS on multivariate analysis. Furthermore, in patients with stable disease (SD) at initial evaluation, macrovascular invasion at the initial evaluation on RECIST and modified albumin–bilirubin grade at initial evaluation on mRECIST were independent predictors of OS on multivariate analysis. In conclusion, if objective response is obtained at the initial evaluation, continuation of treatment appears desirable because prolonged OS can be expected; but, if SD is obtained at the initial evaluation, one should determine whether to continue or switch to the next treatment, with careful consideration of factors related to the tumor and hepatic reserve at the initial evaluation.

Objective: The objective of this study was to construct a large language model (LLM) for the Response Evaluation Criteria in Solid Tumors (RECIST) assessment using exclusively longitudinal radiology report text. Methods: This study included 258 patients with solid tumors, encompassing 2065 longitudinal CT/MRI examination time points. We developed WiNGPT-32B, an open-source and locally deployable LLM, by infusing it with domain-specific medical knowledge and optimizing it via knowledge distillation, using GPT-4 as the teacher model. Central to its architecture is the Chained Task Execution (CTE) framework, which structures RECIST assessment into four modular components: lesion diameter extraction, sum of longest diameter computation, tumor response classification, and report generation. Model performance (accuracy, recall, precision, and F1 score) was benchmarked against GPT-4 and a single radiologist, utilizing the consensus of three independent radiologists as the reference standard. Results: The number of patients with imaging time points was 212 (82.2%) with 4–10, 36 (13.9%) with 11–20, and 10 (3.9%) with >20 time points. For target lesions, the successful extraction rate of WiNGPT-32B was 0.934 (95% CI: 0.922–0.944), which was slightly higher than that of GPT-4 0.920 (0.907–0.931; p = 0.083). In five-category RECIST classification (complete response, partial response, stable disease, progressive disease, and not evaluable), WiNGPT-32B achieved an overall accuracy of 0.805 (0.786–0.823), significantly higher than GPT-4 (0.699, 0.678–0.720; p < 0.001) but lower than the radiologist (0.915, 0.901–0.928; p < 0.001). For progressive disease, WiNGPT-32B had an F1 score of 0.841 (0.813–0.870), significantly outperforming GPT-4’s 0.755 (0.720–0.790), and approaching the radiologist’s 0.922 (0.902–0.942). Conclusions: WiNGPT-32B demonstrates the feasibility of a text-only, open-source LLM with the CTE framework for longitudinal RECIST assessment, with promising performance in detecting disease progression.

A wide range of cancer immunotherapy approaches has been developed including non-specific immune-stimulants such as cytokines, cancer vaccines, immune checkpoint inhibitors (ICIs), and adoptive T cell therapy. Among them, ICIs are the most commonly used and intensively studied. Since 2011, these drugs have received marketing authorisation for melanoma, lung, bladder, renal, and head and neck cancers, with remarkable and long-lasting treatment response in some patients. The novel mechanism of action of ICIs, with immune and T cell activation, leads to unusual patterns of response on imaging, with the advent of so-called pseudoprogression being more pronounced and frequently observed when compared to other anticancer therapies. Pseudoprogression, described in about 2–10% of patients treated with ICIs, corresponds to an increase of tumour burden and/or the appearance of new lesions due to infiltration by activated T cells before the disease responds to therapy. To overcome the limitation of response evaluation criteria in solid tumors (RECIST) to assess these specific changes, new imaging criteria—so-called immune-related response criteria and then immune-related RECIST (irRECIST)—were proposed. The major modification involved the inclusion of the measurements of new target lesions into disease assessments and the need for a 4-week re-assessment to confirm or not confirm progression. The RECIST working group introduced the new concept of “unconfirmed progression”, into the irRECIST. This paper reviews current immunotherapeutic approaches and summarises radiologic criteria to evaluate new patterns of response to immunotherapy. Furthermore, imaging features of immunotherapy-related adverse events and available predictive biomarkers of response are presented.

We investigated the association between early tumor shrinkage (ETS) and treatment outcome in patients with hepatocellular carcinoma treated with lenvatinib (LEN). A retrospective analysis was performed in 104 patients. ETS was defined as tumor shrinkage at the first evaluation in the sum of target lesions’ longest diameters from baseline according to the Response Evaluation Criteria in Solid Tumors (RECIST). The median overall survival (OS) was not reached, whereas the median progression-free survival (PFS) was 5.0 months. The receiver operating characteristic curve analysis in differentiating long-term responders (PFS ≥ 5.0 months) from short-term responders (PFS < 5.0 months) revealed an ETS cut-off value of 10%. ETS ≥ 10% was significantly correlated with better PFS and OS compared with ETS < 10%. Additionally, ETS ≥ 10% showed a better discrimination ability on prognosis compared with modified RECIST-based objective response at the first evaluation. Multivariate analysis confirmed ETS ≥ 10% as an independent predictor of better OS, as well as a Child–Pugh score of 5 and macrovascular invasion. In conclusion, ETS ≥ 10% was strongly associated with outcome in patients treated with LEN. This biomarker could allow earlier assessment of the treatment response and guide treatment decision-making for HCC.

ObjectiveTo evaluate the safety and preliminary efficacy of YSCH-01 (Recombinant L-IFN adenovirus) in subjects with advanced solid tumors.MethodsIn this single-center, open-label, investigator-initiated trial of YSCH-01, 14 patients with advanced solid tumors were enrolled. The study consisted of two distinct phases: (1) the dose escalation phase and (2) the dose expansion phase; with three dose groups in the dose escalation phase based on dose levels (5.0×109 viral particles (VP)/subject, 5.0×1010 VP/subject, and 5.0×1011 VP/subject). Subjects were administered YSCH-01 injection via intratumoral injections. The safety was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events V.5.0, and the efficacy evaluation was performed using Response Evaluation Criteria in Solid Tumor V.1.1.Results14 subjects were enrolled in the study, including 9 subjects in the dose escalation phase and 5 subjects in the dose expansion phase. Of the 13 subjects included in the full analysis set, 4 (30.8%) were men and 9 (69.2%) were women. The most common tumor type was lung cancer (38.5%, 5 subjects), followed by breast cancer (23.1%, 3 subjects) and melanoma (23.1%, 3 subjects). During the dose escalation phase, no subject experienced dose-limiting toxicities. The content of recombinant L-IFN adenovirus genome and recombinant L-IFN protein in blood showed no trend of significant intergroup changes. No significant change was observed in interleukin-6 and interferon-gamma. For 11 subjects evaluated for efficacy, the overall response rate with its 95% CI was 27.3% (6.02% to 60.97%) and the disease control rate with its 95% CI was 81.8% (48.22% to 97.72%). The median progression-free survival was 4.97 months, and the median overall survival was 8.62 months. In addition, a tendency of decrease in the sum of the diameters of target lesions was observed. For 13 subjects evaluated for safety, the overall incidence of adverse events (AEs) was 92.3%, the overall incidence of adverse drug reactions (ADRs) was 84.6%, and the overall incidence of >Grade 3 AEs was 7.7%, while no AEs/ADRs leading to death occurred. The most common AEs were fever (69.2%), nausea (30.8%), vomiting (30.8%), and hypophagia (23.1%).ConclusionsThe study shows that YSCH-01 injections were safe and well tolerated and exhibited preliminary efficacy in patients with advanced solid tumors, supporting further investigation to evaluate its efficacy and safety.Trial registration numberNCT05180851.

BackgroundWhile concomitant medications can affect the efficacy of immune checkpoint inhibitors (ICIs), few studies have assessed associations of concomitant medications with the occurrence and profile of immune-related adverse events (irAEs).MethodsThis study assessed associations of concomitant medication (antibiotics/proton pump inhibitors (PPIs)/corticosteroids)-based risk model termed the “drug score” with survival and the occurrence and profile of irAEs in 851 patients with advanced cancer treated with ICIs (with or without other agents). The study also assessed the survival impact of the occurrence of irAEs, using a landmark analysis to minimize immortal time bias. Multivariable Cox proportional hazard analyses were conducted for progression-free survival (PFS) and overall survival (OS).ResultsThe drug score classified patients into three risk groups, with significantly different PFS and OS. Notably, the score’s predictive capability was better in patients treated with ICIs only than in those treated with ICIs plus other agents. The landmark analysis showed that patients who developed irAEs had significantly longer PFS and OS than those without irAEs. Generally, concomitant medications were negatively associated with the occurrence of irAEs, especially endocrine irAEs, whereas PPI use was positively associated with gastrointestinal irAEs, as an exception.ConclusionsUsing a large pan-cancer cohort, the prognostic ability of the drug score was validated, as well as that of the occurrence of irAEs. The negative association between concomitant medications and irAE occurrence could be an indirect measure of the detrimental effect on the immune system induced by one or more concomitant drugs.

Therapies targeting the programmed cell death protein-1/programmed death-ligand 1 (PD-L1) (abbreviated as PD-(L)1) axis are a significant advancement in the treatment of many tumor types. However, many patients receiving these agents fail to respond or have an initial response followed by cancer progression. For these patients, while subsequent immunotherapies that either target a different axis of immune biology or non-immune combination therapies are reasonable treatment options, the lack of predictive biomarkers to follow-on agents is impeding progress in the field. This review summarizes the current knowledge of mechanisms driving resistance to PD-(L)1 therapies, the state of biomarker development along this axis, and inherent challenges in future biomarker development for these immunotherapies. Innovation in the development and application of novel biomarkers and patient selection strategies for PD-(L)1 agents is required to accelerate the delivery of effective treatments to the patients most likely to respond.

Atezolizumab plus bevacizumab combination therapy (Atezo + Beva) is currently positioned as the first-line therapy for unresectable hepatocellular carcinoma (u-HCC). It may be difficult to decide whether to continue this treatment if radiological response is assessed as stable disease (SD). Therefore, the relationship between radiological response and prognosis was analyzed. A total of 109 patients with u-HCC and Child–Pugh Score of 5–7 received this treatment. Radiological response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) and modified RECIST at the first and second evaluations. Of SD patients (n = 71) at the first RECIST evaluation, partial response, SD, and progressive disease (PD) were seen in 10, 55, and 6 patients, respectively, at the second evaluation. On multivariate analysis, in patients with SD at the first RECIST evaluation, a 25% or greater increase in the alpha-fetoprotein (AFP) value from initiation of treatment (odds ratio, 7.38; p = 0.037) was the independent factor for PD at the second evaluation. In patients with SD (n = 59) at the second RECIST evaluation, decreased AFP from initiation of treatment (hazard ratio, 0.46; p = 0.022) was the independent factor related to progression-free survival on multivariate analysis. AFP trends could help decide the Atezo + Beva treatment strategy.

Objective Percutaneous cryoablation (PC) has been incorporated among first-line treatment options for desmoid-type fibromatosis (DF). Loco-regional therapies, including PC, induce tissue changes that may precede measurable tumor shrinkage, thereby limiting the reliability of purely dimensional response criteria. To address this limitation, we compared response evaluation criteria in solid tumors (RECIST) 1.1 and magnetic resonance imaging (MRI)-adapted (M-)RECIST in patients with DF treated with PC. Materials and methods We retrospectively identified all consecutive patients with progressing extra-abdominal DF treated with PC. Responses were assessed with RECIST 1.1 and M-RECIST, the latter relying on T2- and diffusion-weighted imaging, as well as unenhanced and contrast-enhanced T1-weighted imaging, to define residual viable tumor. Non-progression (NPR) and overall response rates (ORR) were defined as the percentage of patients without radiological progression and partial/complete responses, respectively. Results Thirty-four patients (females/males, 26/8) and 37 procedures were identified. RECIST 1.1 and M-RECIST were applicable in 35 and 34 procedures, respectively. At a median follow-up of 15.7 months (interquartile range [IQR] 19.5), RECIST 1.1. Responses were: 10/35 (28.6%) partial response (PR), 22/35 (62.9%) stable disease (SD), and 3/35 (8.6%) progressive disease (PD), with ORR 28.6% and NPR 91.4%. At a median follow-up of 16.0 months (IQR 20.5), M-RECIST responses were: 15/34 (44.1%) complete response (CR), 12/34 (35.3%) PR, 4/34 (11.8%) SD, and 3/34 (8.8%) PD, with ORR 79.4% and NPR 91.2%. Overall concordance was negligible. Conclusion M-RECIST yielded higher NPR/ORR than RECIST 1.1. These findings pave the way for studies addressing whether this shift in response categorization associates with improved outcomes prediction. Relevance statement This work provides supporting evidence for the implementation of residual viable disease assessment in evaluating DF responses to PC. Key Points In patients with DF, responses to cryoablation can be characterized using purely dimensional and viability-based criteria. RECIST 1.1 and M-RECIST yielded complete agreement for PD. M-RECIST may refine response categorization below the progression threshold. Graphical Abstract

Background/Objectives: Portal vein tumor thrombus (PVTT) is a severe complication of hepatocellular carcinoma (HCC) and is associated with poor outcomes. This study aimed to describe the imaging and clinical characteristics observed among HCC patients with PVTT who survived longer than one year following combined systemic therapy and radiotherapy. Methods: This retrospective, single-center study included 26 consecutive HCC patients with PVTT who survived more than one year after combined treatment. Baseline characteristics included PVTT extent classified according to the Liver Cancer Study Group of Japan—VP1 (segmental portal vein invasion), VP2 (second-order portal vein invasion), VP3 (first-order portal vein invasion), and VP4 (main portal trunk or contralateral PV invasion) and liver function assessed by Child–Pugh class and ALBI grade. Contrast-enhanced CT or MRI was evaluated at baseline and 6 months after treatment using RECIST 1.1 criteria. Results: The cohort was predominantly male (69%), and most patients had extensive PVTT (VP3–VP4, n = 19). Preserved liver function was common at baseline (Child–Pugh class A, n = 24; ALBI grade I, n = 14). Tumor response was observed in 23 patients (88%) during follow-up. Frequently observed post-treatment imaging findings included portal vein recanalization (n = 12), collateral circulation (present in 7 patients at baseline and 6 at follow-up), and compensatory liver hypertrophy (n = 6). Conclusions: Among HCC patients with PVTT who survived longer than one year after combined therapy, portal vein recanalization, collateral circulation, and compensatory liver hypertrophy were commonly observed imaging features. Given the retrospective design and survivor-selection nature of the study, these findings should be interpreted as descriptive observations rather than evidence of treatment efficacy or prognostic determinants.