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Nomograms to predict outcomes after 177Lu-PSMA therapy in men with metastatic castration-resistant prostate cancer: an international, multicentre, retrospective study
Open accessAbstract
Background Lutetium-177 ( 177 Lu) prostate-specific membrane antigen ( 177 Lu-PSMA) is a novel targeted treatment for patients with metastatic castration-resistant prostate cancer (mCRPC). Predictors of outcomes after 177 Lu-PSMA to enhance its clinical implementation are yet to be identified. We aimed to develop nomograms to predict outcomes after 177 Lu-PSMA in patients with mCRPC. Methods In this multicentre, retrospective study, we screened patients with mCRPC who had received 177 Lu-PSMA between Dec 10, 2014, and July 19, 2019, as part of the previous phase 2 trials (NCT03042312, ACTRN12615000912583) or compassionate access programmes at six hospitals and academic centres in Germany, the USA, and Australia. Eligible patients had received intravenous 6·0–8·5 GBq 177 Lu-PSMA once every 6–8 weeks, for a maximum of four to six cycles, and had available baseline [ 68 Ga]Ga-PSMA-11 PET/CT scan, clinical data, and survival outcomes. Putative predictors included 18 pretherapeutic clinicopathological and [ 68 Ga]Ga-PSMA-11 PET/CT variables. Data were collected locally and centralised. Primary outcomes for the nomograms were overall survival and prostate-specific antigen (PSA)-progression-free survival. Nomograms for each outcome were computed from Cox regression models with LASSO penalty for variable selection. Model performance was measured by examining discrimination (Harrell's C-index), calibration (calibration plots), and utility (patient stratification into low-risk vs high-risk groups). Models were validated internally using bootstrapping and externally by calculating their performance on a validation cohort. Findings Between April 23, 2019, and Jan 13, 2020, 414 patients were screened; 270 (65%) of whom were eligible and were divided into development (n=196) and validation (n=74) cohorts. The median duration of follow-up was 21·5 months (IQR 13·3–30·7). Predictors included in the nomograms were time since initial diagnosis of prostate cancer, chemotherapy status, baseline haemoglobin concentration, and [ 68 Ga]Ga-PSMA-11 PET/CT parameters (molecular imaging TNM classification and tumour burden). The C-index of the overall survival model was 0·71 (95% CI 0·69–0·73). Similar C-indices were achieved at internal validation (0·71 [0·69–0·73]) and external validation (0·72 [0·68–0·76]). The C-index of the PSA-progression-free survival model was 0·70 (95% CI 0·68–0·72). Similar C-indices were achieved at internal validation (0·70 [0·68–0·72]) and external validation (0·71 [0·68–0·74]). Both models were adequately calibrated and their predictions correlated with the observed outcome. Compared with high-risk patients, low-risk patients had significantly longer overall survival in the validation cohort (24·9 months [95% CI 16·8–27·3] vs 7·4 months [4·0–10·8]; p<0·0001) and PSA-progression-free survival (6·6 months [6·0–7·1] vs 2·5 months [1·2–3·8]; p=0·022). Interpretation These externally validated nomograms that are predictive of outcomes after 177 Lu-PSMA in patients with mCRPC might help in clinical trial design and individual clinical decision making, particularly at institutions where 177 Lu-PSMA is introduced as a novel therapeutic option. Funding Prostate Cancer Foundation.
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Metadata
- Authors
- Gafita, A., Calais, J., Grogan, T. R., Hadaschik, B., Wang, H., Weber, M., Sandhu, S., Kratochwil, C., Esfandiari, R., Tauber, R., Zeldin, A., Rathke, H., Armstrong, W. R., Robertson, A., Thin, P., D'Alessandria, C., Rettig, M. B., Delpassand, E. S., Haberkorn, U., Elashoff, D., Herrmann, K., Czernin, J., Hofman, M. S., Fendler, W. P., & Eiber, M.
- Affiliations
- University of California, Los Angeles (US)
- Essen University Hospital (DE)
- TUM Klinikum (DE)
- The University of Melbourne (AU)
- University Hospital Heidelberg (DE)
- Excel Diagnostics Imaging (US)
- Ronald Reagan UCLA Medical Center (US)
- Corresponding author
- Gafita, Andrei
- ORCID
- Venue
- The Lancet Oncology
- Publisher
- Elsevier BV
- Published
- 2021-08
- Volume
- 22
- Issue
- 8
- Pages
- 1115-1125
- ISSN
- 1470-2045 (ISSN-L)
- OpenAlex
- W3180641083
- Cited by
- 271
- References
- 35
- Citations by year
- 2026: 49 · 2025: 61 · 2024: 50 · 2023: 63 · 2022: 37 · 2021: 10
- FWCI
- 21.14
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- The Lancet Oncology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- HAL (submittedVersion, other-oa)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion, cc-by-nc-nd)
- Minerva Access (University of Melbourne) (submittedVersion, cc-by-nc-nd)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion, other-oa)
- Funders
- Prostate Cancer Foundation
- Topics
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Radiopharmaceutical Chemistry and Applications
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Prostate Cancer Treatment and Research
- Health Sciences › Medicine › Urology › Prostate Cancer Diagnosis and Treatment
- Keywords
- 177Lu-PSMA, metastatic castration-resistant prostate cancer, nomogram, outcome prediction, overall survival, PSA progression-free survival, prognostic factors, risk stratification, targeted radionuclide therapy, LASSO feature selection, model validation
- MeSH terms
- Humans, Lutetium, Male, Retrospective Studies, Treatment Outcome, Prostate-Specific Antigen, Nomograms, Prostatic Neoplasms, Castration-Resistant
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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