scholarly journals Quantitative bone scan lesion area as an early surrogate outcome measure indicative of overall survival in metastatic prostate cancer

2018 ◽  
Vol 5 (01) ◽  
pp. 1 ◽  
Author(s):  
Matthew S. Brown ◽  
Grace Hyun J. Kim ◽  
Gregory H. Chu ◽  
Bharath Ramakrishna ◽  
Martin Allen-Auerbach ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Bone Scan ◽  
Metastatic Prostate Cancer ◽  
Outcome Measure ◽  
Lesion Area ◽  
Surrogate Outcome ◽  
Surrogate Outcome Measure

Quantitative bone scan lesion area as an early surrogate outcome measure indicative of overall survival in metastatic castration-resistant prostate cancer.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 179-179
Author(s):  
Matthew S. Brown ◽  
Hyun J. Kim ◽  
Gregory H. Chu ◽  
Martin Allen-Auerbach ◽  
Cheryce Fischer ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Bone Scan ◽  
Post Treatment ◽  
Whole Body ◽  
Treatment Trial ◽  
Castration Resistant Prostate Cancer ◽  
Lesion Area ◽  
Surrogate Outcome ◽  
Castration Resistant

179 Background: Bone Scan Lesion Area (BSLA) is a biomarker that can be computed semi-automatically from whole-body scintigraphic imaging as a measure of overall bone tumor burden. Initial development and validation, including correlation with outcomes, was performed in trial cohorts from a single drug treatment with controls in subjects with metastatic castrate-resistant prostate cancer (CRPC). A 30% increase/decrease in BSLA was defined as progression/response on bone scan. We hypothesize that, when applied to an independent treatment trial cohort with a different mechanism of drug action, baseline BSLA and Week 12 change post-treatment are predictive of a subject's overall survival. Methods: From an anonymized imaging research database a cohort of 198 CRPC subjects was identified who enrolled in a treatment trial (127 treated, 71 placebo). This cohort was independent of those used for biomarker development and initial validation, and involved a different mechanism of drug action. Subjects underwent standard of care whole-body bone scintigraphy with 99mTc-Methyl diphosphonate (99mTc-MDP). BSLA was calculated at baseline and response at Week 12. Multivariate Cox regression was used to test whether (1) baseline BSLA, and (2) early changes in BSLA (12 weeks post treatment) were predictive of overall survival. Results: BSLA < 2000 mm2 at baseline was a prognostic factor (HR=0.6; p=0.003) and predictive of longer survival (HR=0.4; p<0.001). Subjects without PD by BSLA at Week 12 had significantly longer survival than subjects with PD: median 170 days vs. 186 days in the placebo group and 260 days vs. 392 days in the treatment group. The overall survival rates between non-PD and PD subjects were statistically different (HR=0.64, p=0.007). Conclusions: BSLA is calculated semi-automatically from bone scans and provides a quantitative and objective treatment response assessment. Baseline BSLA and early changes post treatment were found to be predictive of overall survival in patients with metastatic castration-resistant prostate cancer. BSLA has now been demonstrated to be an early surrogate outcome for overall survival in different drug treatments.

A novel artificial intelligence biomarker: Validation of the automated bone scan index (aBSI) in veterans with metastatic prostate cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17507-e17507
Author(s):  
Vipal P. Durkal ◽  
Nicholas George Nickols ◽  
Matthew Rettig
Keyword(s):  
Prostate Cancer ◽  
Artificial Intelligence ◽  
Overall Survival ◽  
Bone Scan ◽  
Metastatic Prostate Cancer ◽  
Unmet Need ◽  
Bone Scan Index ◽  
Cancer Specific Survival ◽  
Cancer Specific Mortality ◽  
Bone Scans

e17507 Background: Prostate cancer commonly metastasizes to the bone and is associated with reduced survival, pathologic fractures and bone pain. The assessment of bone lesions is made with the technetium Tc99m(99mTc) bone scan, which relies on the subjective interpretation of radiologists and has a wide interobserver variability. There is an unmet need for a more objective and quantifiable measurement tool. Progenics Pharmaceuticals has introduced an automated bone scan index (aBSI), which employs artificial intelligence to quantify skeletal tumor burden. The automated bone scan index has been prospectively validated and is reproducible in large Phase III studies. The aBSI was validated by our study in the Veteran population at the West LA VA Medical Center. Methods: The first positive technetium 99 Tc99m bone scans of veterans diagnosed with metastatic, castration-sensitive prostate cancer were evaluated. Since 2011, a total of 107 evaluable patient bone scans were studied (n = 107). Patients with visceral metastases were excluded to evaluate only those with skeletal metastases. An automated bone scan index (aBSI) was generated for each scan using the Progenics Pharmaceuticals’ artificial intelligence platform. Multivariate analysis of aBSI with overall survival, prostate cancer specific survival, time from diagnosis to first positive bone scan, age at diagnosis, ethnicity, and Gleason score was assessed. Results: The study demonstrated a wide range of aBSI values (Range 0-16.84). Values calculated above the Median aBSI value (1.0) were prognostic for Overall Survival (p = 0.0009) and Prostate Cancer-Specific Survival (p = 0.0011). Patients in the highest quartile of aBSI values (range 5.2-16.84) showed a statistically significant Prostate Cancer-Specific Mortality (p = 0.0300) when compared to the lowest two quartiles (Range 0-1.07). The time from diagnosis to the first positive Tc99m bone scan statistically correlated with aBSI values (p = 0.0016). Multivariate analysis using Cox regression was utilized in the final statistical analysis of prostate cancer-specific mortality and overall survival. Conclusions: The automated Bone Scan Index provides a quantifiable and validated artificial intelligence biomarker to address an unmet need among metastatic prostate cancer patients. This tool was validated among Veterans, a pertinent population that is commonly affected by metastatic prostate cancer.

Abstract 353: Performance of SOFA Score to Predict Mortality at Hospital Discharge After Cardiac Arrest

Circulation ◽  
2018 ◽  
Vol 138 (Suppl_2) ◽  
Author(s):  
Anne V Grossestreuer ◽  
Tuyen Yankama ◽  
Ari Moskowitz ◽  
Anthony Mahoney-Pacheco ◽  
Varun Konanki ◽  
...  
Keyword(s):  
Cardiac Arrest ◽  
Hospital Discharge ◽  
Sofa Score ◽  
Statistical Power ◽  
Goodness Of Fit ◽  
Outcome Measure ◽  
Model Performance ◽  
Surrogate Outcome ◽  
Surrogate Outcome Measure ◽  
Good Calibration

Introduction: Cardiac arrest (CA) outcomes, when dichotomized as survival/non-survival, limit statistical power of interventional studies and do not acknowledge hospital-level factors independent of post-CA sequelae. We explored the Sequential Organ Failure Assessment (SOFA) score at 72 hours post-CA as a surrogate outcome measure for mortality. We also assessed methods to account for death <72 hours post-CA in SOFA score computation. Methods: This was a single center retrospective study of post-CA patients from 1/08-12/17. SOFA score components were abstracted at baseline, 24, 48, and 72h post-CA. Thirteen ways of accounting for missing data were assessed. The outcome was mortality at hospital discharge. Model performance was assessed using area under the receiver-operator characteristic (AUC) curves and Hosmer-Lemeshow goodness of fit statistics. Results: Of 847 patients, 528 (62%) had complete baseline SOFA scores and 205 (24%) had complete scores at 72h. Death <72h occurred in 28%; 45% survived to hospital discharge. SOFA score at 72h without accounting for death had an AUC of 0.62. The best performing SOFA model at 72h with good calibration imputed a 20% increase over the last observed SOFA score in patients who expired <72h with an AUC of 0.79 (95% CI: 0.74-0.83). In terms of change in SOFA at 72h from baseline, the best performing model with good calibration imputed death <72h as the highest possible score (AUC: 0.88 [95% CI: 0.84-0.92]). These results were consistent when analyzing in- and out-of-hospital CA separately, although the change from baseline model was not well calibrated in in-hospital arrests. Conclusions: Without consideration of death, SOFA scores at 72 hours post-CA perform poorly. Imputing for early mortality improved the model. If this imputation structure is validated prospectively, SOFA could provide a scoring system to predict death at hospital discharge and serve as a surrogate outcome measure in interventional studies.

scholarly journals Local and systemic morbidities of de novo metastatic prostate cancer in Singapore: insight from 685 consecutive patients from a large prospective Uro-oncology registry

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034331 ◽  
Author(s):  
Yu Guang Tan ◽  
Leonard Pang ◽  
Farhan Khalid ◽  
Randy Poon ◽  
Hong Hong Huang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Metastatic Prostate Cancer ◽  
Group Performance ◽  
De Novo ◽  
Eastern Cooperative Oncology Group ◽  
Specific Antigen ◽  
High Volume ◽  
Secondary Outcome ◽  
Systemic Complications

ObjectiveTo evaluate the incidence and management of local and systemic complications afflicting patients with de novo metastatic prostate cancer (mPCa) in Singapore.DesignRetrospective analysis of a large prospective Uro-oncology registry of mPCa.SettingThis study is carried out in a tertiary hospital in Singapore.ParticipantsWe reviewed our institution’s prospectively maintained database of 685 patients with mPCa over a 20-year period (1995–2014). Patients with non-mPCa or those progressed to metastatic disease after previous curative local treatments were excluded.Primary and secondary outcome measuresThe primary outcome was to evaluate the systemic and local morbidity rates associated with mPCa. Local complication was defined as the need for palliative procedures to relieve urinary obstruction, worsening renal function or refractory haematuria, while systemic complication was related to radiographic evidence of skeletal-related pathological fractures. Secondary outcomes analysed were the management and overall survival patterns over 20 years.Results237 (34.6%) patients required local palliative treatments. 88 (12.8%) patients presented with acute urinary retention, 23 patients (9.7%) required repetitive local palliative treatments. On multivariate analyses, prostate-specific antigen >100 (p=0.02) and prostate volume >50 g (p=0.03) were independent prognostic factors for significant obstruction requiring palliative procedures. 118 (17.2%) patients developed skeletal fractures, with poor Eastern Cooperative Oncology Group Performance (ECOG) status (p=0.01) and high volume bone metastasis (p<0.01) independently predictive of skeletal fractures. Altogether, 653 (95.3%) patients received androgen deprivation therapy (ADT), with the median time to castrate resistance of 21.4 months (IQR 7–27). The median overall survival was 45 months (IQR 20–63), with prostate cancer mortality of 81.4%. Improved overall survival was observed from 41.6 months (1995–1999) to 47.8 months (2010–2014) (p<0.01).ConclusionMorbidities and complications arising from mPCa are more common and debilitating than we thought, often requiring immediate palliative treatments, while many necessitate repeated interventions with progression.

scholarly journals Overall survival and second primary malignancies in men with metastatic prostate cancer

PLoS ONE ◽  
2020 ◽  
Vol 15 (2) ◽  
pp. e0227552 ◽  
Author(s):  
Juha Mehtälä ◽  
Jihong Zong ◽  
Zdravko Vassilev ◽  
Gunnar Brobert ◽  
Montse Soriano Gabarró ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Metastatic Prostate Cancer ◽  
Second Primary ◽  
Second Primary Malignancies

Clinical and radiological characteristics of metastatic prostate cancer (mPCa) patients (pts) with liver metastases (LM) and association with overall survival (OS).

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 5043-5043
Author(s):  
Diletta Bianchini ◽  
Nuria Porta ◽  
Nina Tunariu ◽  
Raquel Perez ◽  
Zafeiris Zafeiriou ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Liver Metastases ◽  
Metastatic Prostate Cancer

Association of PET index quantifying skeletal uptake in NaF PET/CT images with overall survival in prostate cancer patients.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 178-178
Author(s):  
Sarah Lindgren Belal ◽  
May Sadik ◽  
Reza Kaboteh ◽  
Nezar Hasani ◽  
Olof Enqvist ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Survival Time ◽  
Median Survival Time ◽  
Bone Scan ◽  
Ct Images ◽  
Imaging Biomarker ◽  
Pet Ct ◽  
Bone Scans ◽  
Pet Index

178 Background: Bone Scan Index (BSI) derived from 2D whole-body bone scans is considered an imaging biomarker of bone metastases burden carrying prognostic information. Sodium fluoride (NaF) PET/CT is more sensitive than bone scan in detecting bone changes due to metastases. We aimed to develop a semi-quantitative PET index similar to the BSI for NaF PET/CT imaging and to study its relationship to BSI and overall survival in patients with prostate cancer. Methods: NaF PET/CT and bone scans were analyzed in 48 patients (aged 53-92 years) with prostate cancer. Thoracic and lumbar spines, sacrum, pelvis, ribs, scapulae, clavicles, and sternum were automatically segmented from the CT images, representing approximately 1/3 of the total skeletal volume. Hotspots in the PET images, within the segmented parts in the CT images, were visually classified and hotspots interpreted as metastases were included in the analysis. The PET index was defined as the quotient obtained as the hotspot volume from the PET images divided by the segmented bone tissue volume from the CT images. BSI was automatically calculated using EXINIboneBSI. Results: The correlation between the PET index and BSI was r2= 0.54. The median BSI was 0.39 (IQR 0.08-2.05). The patients with a BSI ≥ 0.39 had a significantly shorter median survival time than patients with a BSI < 0.39 (2.3 years vs. not reached after 5 years). BSI was significantly associated with overall survival (HR 1.13, 95% CI 1.13 to 1.41; p < 0.001), and the C-index was 0.68. The median PET index was 0.53 (IQR 0.02-2.62). The patients with a PET index ≥ 0.53 had a significantly shorter median survival time than patients with a PET index < 0.53 (2.5 years vs. not reached after 5 years). The PET index was significantly associated with overall survival (HR 1.18, 95% CI 1.01 to 1.30; p < 0.001) and C-index was 0.68. Conclusions: PET index based on NaF PET/CT images was correlated to BSI and significantly associated with overall survival in patients with prostate cancer. Further studies are needed to evaluate the clinical value of this novel 3D PET index as a possible future imaging biomarker.

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