Dataset Information

Early radiological response evaluation with response evaluation criteria in solid tumors 1.1 stratifies survival in hepatocellular carcinoma patients treated with lenvatinib.

ABSTRACT:

Background and aim

Lenvatinib (LEN) has an antitumor effect with an early reduction in contrast enhancement for unresectable hepatocellular carcinoma (HCC). The aim of this study was to reveal the most useful radiological response evaluation for overall survival (OS) in patients treated with LEN.

Methods

Patients receiving LEN therapy (n = 80) were retrospectively recruited from April 2018 to January 2020. Enhanced computed tomography scans were performed at baseline and every 4-8?weeks. OS and radiological response were evaluated using response evaluation criteria in solid tumors (RECIST 1.1), modified RECIST (mRECIST), and Choi criteria. To be eligible for study, a minimal cumulative duration of LEN was 4?weeks. A total of 62 patients were included in the analysis.

Results

The median OS was 469?days. The RECIST 1.1, mRECIST, and Choi criteria identified 14 (22.5%), 30 (48.3%), and 33 (53.2%) patients with an objective response, respectively. In the univariate analysis, Child-Pugh class B, major vascular invasion, and high alpha-fetoprotein (>200) were statistically significant poor prognostic factors. Radiological response was a significantly better prognostic factor in each criterion (RECIST, mRECIST, and Choi). In the multivariate analysis, radiological response evaluated by RECIST (hazard ratio, 0.259; 95% confidence interval, 0.0723-0.928; P = 0.038) was an independent factor. Furthermore, only RECIST significantly stratified prognosis (P = 0.041) when limited to the first evaluation.

Conclusion

RECIST 1.1 was useful even as early therapeutic evaluation for HCC patients treated with LEN. Understanding the characteristics of radiological response over time may contribute to improving the prognosis of patients with HCC.

SUBMITTER: Kaneko S

PROVIDER: S-EPMC7731835 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Early radiological response evaluation with response evaluation criteria in solid tumors 1.1 stratifies survival in hepatocellular carcinoma patients treated with lenvatinib.

Kaneko Shun S Tsuchiya Kaoru K Yasui Yutaka Y Inada Kento K Kirino Sakura S Yamashita Koji K Osawa Leona L Hayakawa Yuka Y Sekiguchi Shuhei S Higuchi Mayu M Takaura Kenta K Maeyashiki Chiaki C Tamaki Nobuharu N Takeguchi Takaya T Takeguchi Yuko Y Nakanishi Hiroyuki H Itakura Jun J Takahashi Yuka Y Himeno Yoshiro Y Kurosaki Masayuki M Izumi Namiki N

JGH open : an open access journal of gastroenterology and hepatology 20201016 6

<h4>Background and aim</h4>Lenvatinib (LEN) has an antitumor effect with an early reduction in contrast enhancement for unresectable hepatocellular carcinoma (HCC). The aim of this study was to reveal the most useful radiological response evaluation for overall survival (OS) in patients treated with LEN.<h4>Methods</h4>Patients receiving LEN therapy (<i>n</i> = 80) were retrospectively recruited from April 2018 to January 2020. Enhanced computed tomography scans were performed at baseline and ev ...[more]

PMID: 33319054

Similar Datasets

Project description:BackgroundAxitinib, a selective and potent tyrosine kinase inhibitor of vascular endothelial growth factor receptors, was available to patients from Canada and Australia, prior to regulatory approval of axitinib in these countries, for treatment of clear-cell metastatic renal cell carcinoma (mRCC) after failure of one prior systemic regimen.MethodsThis single-arm, open-label study of axitinib evaluated the efficacy, safety, and quality of life (QoL) in patients with mRCC whose disease progressed after one prior systemic first-line regimen. Primary objective was objective response rate evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) and Choi criteria. Progression-free survival, overall survival, safety, and QoL were secondary end points. Due to the small study size, analyses comprised of descriptive statistics.ResultsFifteen patients were recruited, five from Canada and ten from Australia, over a limited recruitment period. Thirteen patients received sunitinib as prior therapy. All patients had clear-cell carcinoma, eleven had prior nephrectomy. Liver, lung, and lymph nodes were the most frequent sites of metastases; one patient had brain metastasis. Median time on axitinib was 118.0 days (range: 3.5-645.0 days); estimated survival probability at 12 months was 57.8%. Two (13.3%) patients had objective responses per RECIST versus nine (60.0%) per Choi criteria. Six patients had progressive disease based on RECIST versus three per Choi criteria. Nine (60.0%) events of progression or death occurred by the end of study, and three patients continued to receive the study drug. Fatigue (33%) and diarrhea (20%) were the most common grade ≥3 all-causality, treatment-emergent adverse events. The mean change in European Quality of Life - 5 Dimensions score from baseline to end of treatment was -0.0837.ConclusionThe small number of patients and lack of a comparator arm limit the ability to draw definitive conclusions; however, safety and efficacy profiles of axitinib were consistent with reports from previous studies in patients with mRCC, and patients generally maintained QoL. The sizeable difference observed in objective response rate by RECIST versus Choi criteria merits further research.

Project description:Accurate appraisal of treatment response in metastatic castrate-resistant prostate cancer (mCRPC) is challenging in view of remarkable tumor heterogeneity and the available choices among many established and novel therapeutic approaches. The purpose of this single-center prospective study was to evaluate the comparative prognostic utility of PERCIST 1.0 in predicting overall survival (OS) in patients with mCRPC compared to RECIST 1.1 and prostate-specific antigen (PSA)-based treatment response assessments. Methods: Patients with mCRPC were prospectively enrolled if they were beginning systemic medical therapy or transitioning to new systemic therapy after not responding to a prior treatment. All patients underwent a baseline 18F-fluorodeoxyglucose (FDG) positron emission tomography/ computed tomography (PET/CT) prior to the initiation of treatment and again 4 months after the start of therapy. Patients' responses to treatment at 4 months compared to baseline were evaluated with RECIST 1.1, PERCIST 1.0 and PSA response criteria. The associations between patients' response categories and OS were evaluated. OS was defined as the duration in time between the date of baseline PET/CT to death from any cause. Patients with different response status were compared with logrank tests. Survival probabilities were calculated using the Kaplan-Meier method. Results: Patients with progressive disease by PSA response criteria at 4 months demonstrated significantly shorter OS (24-month OS probability: 18% ± 11%) compared to patients with stable disease, SD, (44% ± 19%, p=0.03) and complete response, CR, or partial response, PR, (53% ± 11%, p=0.03). RECIST 1.1 response criteria demonstrated a similar trend in OS, however no statistically significant differences were noted between patients with PD (25% ± 15%) compared to SD/non-CR, non-PD (54% ± 13%) and CR/PR (54% ± 14%) (p=0.13). PERCIST 1.0 criteria demonstrated significant differences in OS between responders, CMR/PMR (56% ± 12%), compared to SMD (38% ± 17%, p=0.03) and PMD (21% ± 10%, p=0.01). Patients with progressive disease by both PERICST 1.0 and PSA response criteria demonstrated significantly worse OS (24-month OS: 0%, 12-month OS: 31% ± 14%) compared to patients with progressive disease by either response criteria. Conclusion: PERCIST 1.0 may provide significant prognostic information for patients with mCRPC undergoing systemic chemotherapy, particularly when incorporated with PSA treatment response criteria.

Dataset Information

Early radiological response evaluation with response evaluation criteria in solid tumors 1.1 stratifies survival in hepatocellular carcinoma patients treated with lenvatinib.

Background and aim

Methods

Results

Conclusion

Publications

Early radiological response evaluation with response evaluation criteria in solid tumors 1.1 stratifies survival in hepatocellular carcinoma patients treated with lenvatinib.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets