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Comparative prognostic implication of treatment response assessments in mCRPC: PERCIST 1.0, RECIST 1.1, and PSA response criteria.

ABSTRACT: 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.

SUBMITTER: Velez EM

PROVIDER: S-EPMC7053201 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Comparative prognostic implication of treatment response assessments in mCRPC: PERCIST 1.0, RECIST 1.1, and PSA response criteria.

Velez Erik M EM Desai Bhushan B Ji Lingyun L Quinn David I DI Colletti Patrick M PM Jadvar Hossein H

Theranostics 20200210 7

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 a ...[more]

PMID: 32194866

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Project description:BACKGROUND:In imaging-based clinical trials, it is common practice to perform double reads for each image, discrepant interpretations can result from these two different evaluations. In this study we analyzed discrepancies that occurred between local investigators (LI) and blinded independent central review (BICR) by comparing reader-selected imaging scans and lesions. Our goal was to identify the causes of discrepant declarations of progressive disease (PD) between LI and BICR in a clinical trial. METHODS:We retrospectively analyzed imaging data from a RECIST 1.1-based, multi-sites, phase II clinical trial of 179 patients with adult small cell lung cancer, treated with Cabazitaxel compared to Topotecan. Any discrepancies in the determination of PD between LI and BICR readers were reviewed by a third-party adjudicator. For each imaging time point and reader, we recorded the selected target lesions, non-target lesions, and new lesions. Odds ratios were calculated to measure the association between discrepant declarations of PD and the differences in reviewed imaging scans (e.g. same imaging modality but with different reconstruction parameters) and selected lesions. Reasons for discrepancies were analyzed. RESULTS:The average number of target lesions found by LI and BICR was respectively 2.9 and 3.4 per patient (p <?0.05), 18.4% of these target lesions were actually non-measurable. LI and BICR performed their evaluations based on different baseline imaging scans for 59% of the patients, they selected at least one different target lesion in 85% of patients. A total of 36.7% of patients required adjudication. Reasons of adjudication included differences in 1) reporting new lesions (53.7%), 2) the measured change of the tumor burden (18.5%), and 3) the progression of non-target lesions (11.2%). The rate of discrepancy was not associated with the selection of non-measurable target lesions or with the readers' assessment of different images. Paradoxically, more discrepancies occurred when LI and BICR selected exactly the same target lesions at baseline compared to when readers selected not exactly the same lesions. CONCLUSIONS:For a large proportion of evaluations, LI and BICR did not select the same imaging scans and target lesions but with a limited impact on the rate of discrepancy. The majority of discrepancies were explained by the difference in detecting new lesions. TRIAL REGISTRATION:ARD12166 ( https://clinicaltrials.gov/ct2/show/NCT01500720 ).

Project description:PurposeTo develop a novel criterion based on the response evaluation criteria in solid tumors (RECIST) 1.1 and alpha fetoprotein (AFP) and evaluate its performance in tumor response for patients with unresectable hepatocellular carcinoma (uHCC) receiving conversion-radiotherapy before hepatectomy.MethodFrom June 2012 to December 2020, a total of 39 patients with uHCC, who received intensity-modulated radiotherapy (IMRT) before hepatectomy, were retrospectively included in this study. Pre- and post-treatment contrast-enhanced magnetic resonance imaging (CE-MRI) scans were performed in all patients. Eight modified criteria were developed with the combination of RECIST 1.1, modified RECIST (mRECIST), and the percentage change of AFP, baseline AFP. The endpoint events were recurrence-free survival (RFS).ResultsThe median RFS and OS was 26.5 (IQR, 15.7-43.1), 38.8 (IQR, 18.4-53.6) months. An optimal revised evaluation criterion named α-RECIST (alpha fetoprotein-RECIST 1.1) was developed by combining the RECIST 1.1 with the AFPΔ (cut-off value, 76%). Patients defined as responders by α-RECIST showed significantly better RFS and OS than those defined as non-responders (p = 0.035, 0.048). The other criteria (RECIST 1.1, mRECIST, αΔ-mRECIST, α&Δ-RECIST, α&Δ-mRECIST, αBL-RECIST, αBL-mRECIST, α&BL-RECIST, α&BL-mRECIST) all failed to identify responders from non-responders (p = 0.405, 0.201, 0.773, 0.424, 0.266, 0.060, 0.721, 0.644, 0.910, respectively) when correlated with RFS. Responders according to α-RECIST showed significant better RFS compared to non-responders [HR, 0.31 (95% CI: 0.10, 0.98); p=0.046], but no statistical significance was observed in terms of OS [HR, 0.33 (95% CI: 0.11, 1.05); p = 0.06].ConclusionsPatients identified as responders by α-RECIST provided significant better RFS. The α-RECIST criteria might be a promising tool for identifying tumor response of conversion-radiotherapy for unresectable hepatocellular carcinoma before hepatectomy.

Dataset Information

Comparative prognostic implication of treatment response assessments in mCRPC: PERCIST 1.0, RECIST 1.1, and PSA response criteria.

Publications

Comparative prognostic implication of treatment response assessments in mCRPC: PERCIST 1.0, RECIST 1.1, and PSA response criteria.

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