Purpose
To compare the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, the adapted Prostate Cancer Working Group Criteria 3 (aPCWG3), the adapted Positron Emission Tomography Response ...Criteria in Solid Tumors (aPERCIST), the PSMA PET Progression (PPP), and the Response Evaluation Criteria In PSMA-Imaging (RECIP) 1.0 for response evaluation using prostate-specific membrane antigen (PSMA)-PET/CT in men with metastatic castration-resistant prostate cancer (mCRPC) treated with
177
Lu-PSMA radioligand therapy.
Methods
A total of 124 patients were included in this multicenter retrospective study. All patients received
177
Lu-PSMA and underwent PSMA-PET/CT scans at baseline (bPET) and at 12 weeks (iPET). Imaging responses according to RECIST 1.1, aPCWG3, aPERCIST, PPP, and RECIP 1.0 were interpreted by consensus among three blinded readers. Changes in total tumor burden were obtained using the semi-automatic qPSMA software. The response according to each criterion was classified to progressive disease (PD) vs no-PD. Primary outcome measure was the prognostic value (by Cox regression analysis) for overall survival (OS). Secondary outcome measure was the inter-reader reliability (by Cohen’s
κ
coefficient).
Results
A total of 43 (35%) of patients had non-measurable disease according to RECIST 1.1. Sixteen (13%), 66 (52%), 72 (58%), 69 (56%), and 39 (32%) of 124 patients had PD according to RECIST 1.1, aPCWG3, aPERCIST, PPP, and RECIP, respectively. PD vs no-PD had significantly higher risk of death according to aPCWG3 (HR = 2.37; 95%CI, 1.62–3.48;
p
< 0.001), aPERCIST (HR = 2.48; 95%CI, 1.68–3.66;
p
< 0.001), PPP (HR = 2.72; 95%CI, 1.85–4.01;
p
< 0.001), RECIP 1.0 (HR = 4.33; 95%CI, 2.80–6.70;
p
< 0.001), but not according to RECIST 1.1 (HR = 1.29; 95%CI, 0.73–2.27;
p
= 0.38). The
κ
index of RECIST 1.1, aPCWG3, aPERCIST 1.0, PPP, and RECIP 1.0 for identifying PD vs no-PD were 0.50 (95%CI, 0.32–0.76), 0.72 (95%CI, 0.63–0.82), 0.68 (95%CI, 0.63–0.73), 0.73 (95%CI, 0.63–0.83), and 0.83 (95%CI, 0.77–0.88), respectively.
Conclusion
PSMA-PET-specific criteria for early response evaluation in men with mCRPC treated with
177
Lu-PSMA achieved higher prognostic values and inter-reader reliabilities in comparison to conventional CT assessment or to criteria adapted to PSMA-PET from other imaging modalities. RECIP 1.0 identified the fewest patients with PD and achieved the highest risk of death for PD vs. no-PD, suggesting that other classification methods tend to overcall progression. Prospective validation of our findings on an independent patient cohort is warranted.
Our meta‐analytic review investigates how employee participation in democratic enterprises is related to psychological outcomes. We gathered 60 studies through a systematic literature search of ...quantitative field studies (published between January 1970 and May 2017) and extracted 138 effect sizes related to three indicators of organisational democracy (OD) and 15 psychological outcomes. The overall findings suggest that employees’ individually perceived participation in organisational decision making (IPD) had a stronger relation to job satisfaction (ρ = .25), job involvement/work motivation (ρ = .36), prosocial work behaviours (ρ = .24), civic and democratic behaviours (ρ = .21) and perceived supportive climate (ρ = .44) than the other two OD indicators: structurally anchored employee participation (SAEP) and employee participation in collective ownership (EO). This was not the case for value‐based commitment: the relations of SAEP (ρ = .40), EO (ρ = .34), and IPD (ρ = .46) with commitment were nearly equal. Mediation analyses indicated that IPD partially mediated most of the effects of SAEP and EO on the outcomes mentioned. The cross‐sectional database and a small number of studies for some of the outcomes are the main limitations of this study.
PET with the glucose analog (18)F-FDG is increasingly used to monitor tumor response in patients undergoing chemotherapy and chemoradiotherapy. Numerous studies have shown that (18)F-FDG PET is an ...accurate test for differentiating residual viable tumor tissue from therapy-induced fibrosis. Furthermore, quantitative assessment of therapy-induced changes in tumor (18)F-FDG uptake may allow the prediction of tumor response and patient outcome very early in the course of therapy. Treatment may be adjusted according to the chemosensitivity and radiosensitivity of the tumor tissue in an individual patient. Thus, (18)F-FDG PET has an enormous potential to reduce the side effects and costs of ineffective therapy. This review focuses on the practical aspects of (18)F-FDG PET for treatment monitoring and on how to perform a quantitative assessment of tumor (18)F-FDG uptake in clinical studies.
What Is Theranostics? Weber, Wolfgang A; Barthel, Henryk; Bengel, Frank ...
The Journal of nuclear medicine (1978),
05/2023, Letnik:
64, Številka:
5
Journal Article
Fibroblast activation protein (FAP) is frequently expressed in the tumor stroma, whereas expression by normal organs is highly restricted. Despite these promising features, FAP-targeted therapies ...have shown limited success so far. FAP imaging offers new opportunities to select patients for FAP-targeted therapies and monitor tumor response. See related article by Lee et al., p. 5330.
The purpose of these guidelines is to assist physicians in recommending, performing, interpreting and reporting the results of FDG PET/CT for oncological imaging of adult patients. PET is a ...quantitative imaging technique and therefore requires a common quality control (QC)/quality assurance (QA) procedure to maintain the accuracy and precision of quantitation. Repeatability and reproducibility are two essential requirements for any quantitative measurement and/or imaging biomarker. Repeatability relates to the uncertainty in obtaining the same result in the same patient when he or she is examined more than once on the same system. However, imaging biomarkers should also have adequate reproducibility, i.e. the ability to yield the same result in the same patient when that patient is examined on different systems and at different imaging sites. Adequate repeatability and reproducibility are essential for the clinical management of patients and the use of FDG PET/CT within multicentre trials. A common standardised imaging procedure will help promote the appropriate use of FDG PET/CT imaging and increase the value of publications and, therefore, their contribution to evidence-based medicine. Moreover, consistency in numerical values between platforms and institutes that acquire the data will potentially enhance the role of semiquantitative and quantitative image interpretation. Precision and accuracy are additionally important as FDG PET/CT is used to evaluate tumour response as well as for diagnosis, prognosis and staging. Therefore both the previous and these new guidelines specifically aim to achieve standardised uptake value harmonisation in multicentre settings.
Reply: PSMA Is Not Specific to Prostate Cancer Notohamiprodjo, Susan; Eiber, Matthias; Lohrmann, Christian ...
The Journal of nuclear medicine (1978),
08/2023, Letnik:
64, Številka:
8
Journal Article
Summary Background In patients with locally advanced adenocarcinoma of the oesophagogastric junction (AEG), early metabolic response defined by 18-fluorodeoxyglucose-PET (18 FFDG-PET) during ...neoadjuvant chemotherapy is predictive of histopathological response and survival. We aimed to assess the feasibility of a PET-response-guided treatment algorithm and its potential effect on prognosis. Methods Between May 27, 2002, and Aug 4, 2005, 119 patients with locally advanced adenocarcinoma of AEG type 1 (distal oesophageal adenocarcinoma) or type 2 (gastric cardia adenocarcinoma) were recruited into this prospective, single-centre study. All patients were assigned to 2 weeks of platinum and fluorouracil-based induction chemotherapy (evaluation period). Those with decreases in tumour glucose standard uptake values (SUVs), predefined as decreases of 35% or more at the end of the evaluation period and measured by PET, were defined as metabolic responders. Responders continued to receive neoadjuvant chemotherapy of folinic acid and fluorouracil plus cisplatin, or folinic acid and fluorouracil plus cisplatin and paclitaxel, or folinic acid and fluorouracil plus oxaliplatin for 12 weeks and then proceeded to surgery. Metabolic non-responders discontinued chemotherapy after the 2-week evaluation period and proceeded to surgery. The primary endpoint was median overall survival of metabolic responders and non-responders. Secondary endpoints were median event-free survival, postoperative complications and mortality, number of residual tumour-free (R0) resections, and histopathological responses. This study has been registered in the European Clinical Trials Database (EudraCT) as trial 2007-003356-11. Findings 110 patients were evaluable for metabolic responses. 54 of these patients had metabolic responses (ie, decrease of 35% or more in tumour glucose SUV) after 2 weeks of induction chemotherapy, corresponding to a response of 49% (95% CI 39–59). 104 patients had tumour resection (50 in the responder group and 54 in the non-responder group). After a median follow-up of 2·3 years (IQR 1·7–3·0), median overall survival was not reached in metabolic responders, whereas median overall survival was 25·8 months (19·4–32·2) in non-responders (HR 2·13 1·14–3·99, p=0·015). Median event-free survival was 29·7 months (95% CI 23·6–35·7) in metabolic responders and 14·1 months (7·5–20·6) in non-responders (hazard ratio HR 2·18 1·32–3·62, p=0·002). Major histological remissions (<10% residual tumour) were noted in 29 of 50 metabolic responders (58% 95% CI 48–67), but no histological response was noted in metabolic non-responders. Interpretation This study confirmed prospectively the usefulness of early metabolic response evaluation, and shows the feasibility of a PET-guided treatment algorithm. These findings might enable tailoring of multimodal treatment in accordance with individual tumour biology in future randomised trials.
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