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Prognostic value of bone scan index as an imaging biomarker in metastatic prostate cancer: a meta-analysis.

ABSTRACT: The prognostic value of the bone scan index (BSI) in metastatic prostate cancer (mPCa) remained controversial. Therefore, we performed a meta-analysis to determine the predictive value of BSI and survival in patients with mPCa.A literature search was performed in PubMed, Embase, Web of Science and Cochrane library databases. Hazard ratios (HRs), concordance indices (C-indices) were extracted to estimate the relationship between BSI and survival in patients with mPCa. Subgroup analyses were conducted on different types of mPCa, ethnics, cut-off values and sample sizes.14 high quality studies involving 1295 patients with mPCa were included in this meta-analysis. The pooled results indicated that high basline BSI and elevated BSI change on treatment (?BSI) were significantly predictive of poor overall survial (HR = 1.29, P < 0.001; HR = 1.27, P < 0.001, respectively). Baseline BSI was also significantly related to cancer specific survival (HR = 1.65, P = 0.019) and prostate specific antigen recurrence survival (HR = 2.26, P < 0.001). Subgroup analysis supported main results. Moreover, BSI could increase the C-indices of predictive models.Baseline BSI and ?BSI may be beneficial to mPCa prognosis in clinical monitor and treatment. Further high quality studies with larger sample size are required in the future.

SUBMITTER: Li D

PROVIDER: S-EPMC5663610 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Prognostic value of bone scan index as an imaging biomarker in metastatic prostate cancer: a meta-analysis.

Li Dongyang D Lv Hang H Hao Xuanyu X Dong Yudi Y Dai Huixu H Song Yongsheng Y

Oncotarget 20170729 48

<h4>Background</h4>The prognostic value of the bone scan index (BSI) in metastatic prostate cancer (mPCa) remained controversial. Therefore, we performed a meta-analysis to determine the predictive value of BSI and survival in patients with mPCa.<h4>Materials and methods</h4>A literature search was performed in PubMed, Embase, Web of Science and Cochrane library databases. Hazard ratios (HRs), concordance indices (C-indices) were extracted to estimate the relationship between BSI and survival in ...[more]

PMID: 29137438

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Project description:Importance:Prostate cancer commonly metastasizes to bone, and bone metastases are associated with pathologic fractures, pain, and reduced survival. Bone disease is routinely visualized using the technetium Tc 99m (99mTc) bone scan; however, the standard interpretation of bone scan data relies on subjective manual assessment of counting metastatic lesion numbers. There is an unmet need for an objective and fully quantitative assessment of bone scan data. Objective:To clinically assess in a prospectively defined analysis plan of a clinical trial the automated Bone Scan Index (aBSI) as an independent prognostic determinant of overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC). Design, Setting, and Participants:This investigation was a prospectively planned analysis of the aBSI in a phase 3 multicenter randomized, double-blind, placebo-controlled clinical trial of tasquinimod (10TASQ10). Men with bone metastatic chemotherapy-naïve CRPC were recruited at 241 sites in 37 countries between March 2011 and August 2015. The statistical analysis plan to clinically evaluate the aBSI was prospectively defined and locked before unmasking of the 10TASQ10 study. The analysis of aBSI was conducted between May 25, 2016, and June 3, 2017. Main Outcomes and Measures:The associations of baseline aBSI with OS, radiographic progression-free survival (rPFS), time to symptomatic progression, and time to opiate use for cancer pain. Results:Of the total 1245 men enrolled, 721 were evaluable for the aBSI. The mean (SD) age (available for 719 men) was 70.6 (8.0) years (age range, 47-90 years). The aBSI population was representative of the total study population based on baseline characteristics. The aBSI (median, 1.07; range, 0-32.60) was significantly associated with OS (hazard ratio [HR], 1.20; 95% CI, 1.14-1.26; P < .001). The median OS by aBSI quartile (lowest to highest) was 34.7, 27.3, 21.7, and 13.3 months, respectively. The discriminative ability of the aBSI (C index, 0.63) in prognosticating OS was significantly higher than that of the manual lesion counting (C index, 0.60) (P = .03). In a multivariable survival model, a higher aBSI remained independently associated with OS (HR, 1.06; 95% CI, 1.01-1.11; P = .03). A higher aBSI was also independently associated with time to symptomatic progression (HR, 1.18; 95% CI, 1.13-1.23; P < .001) and time to opiate use for cancer pain (HR, 1.21; 95% CI, 1.14-1.30; P < .001). Conclusions and Relevance:To date, this investigation is the largest prospectively analyzed study to validate the aBSI as an independent prognostic imaging biomarker of survival in mCRPC. These data support the prognostic utility of the aBSI as an objective imaging biomarker in the design and eligibility of clinical trials of systemic therapies for patients with mCRPC. Trial Registration:ClinicalTrials.gov Identifier: NCT01234311.

Project description:BackgroundProstate radiotherapy (RT) is a first-line option for newly diagnosed men with low-burden metastatic prostate cancer. The current criterion to define this clinical state is based on manual bone metastasis counts, but enumeration of bone metastases is limited by interobserver variations, and it does not account for metastasis volume or lesional coalescence. The automated bone scan index (aBSI) is a quantitative method of evaluating bone metastatic burden in a standardised and reproducible manner.ObjectiveTo evaluate whether aBSI has utility as a predictive imaging biomarker to define a newly diagnosed metastatic prostate cancer population that might benefit from the addition of prostate RT to standard of care (SOC) systemic therapy.Design, setting, and participantsThis is an exploratory analysis of men with newly diagnosed metastatic prostate cancer randomised in a 1:1 ratio to either SOC or SOC + prostate RT within the STAMPEDE "M1|RT comparison".InterventionThe SOC was lifelong androgen deprivation therapy, with up-front docetaxel permitted from December 2015. Men allocated RT received either a daily or a weekly schedule that was nominated before randomisation.Outcome measurements and statistical analysisBaseline bone scans were evaluated retrospectively to calculate aBSI. We used overall (OS) and failure-free (FFS) survival as the end points. Treatment-aBSI interaction was evaluated using the multivariable fractional polynomial interaction (MFPI) and subpopulation treatment effect pattern plot. Further analysis was done in aBSI quartiles using Cox regression models adjusted for stratification factors.Results and limitationsBaseline bone scans for 660 (SOC: 323 and SOC + RT: 337) of 2061 men randomised within the "M1|RT comparison" met the software requirements for aBSI calculation. The median age was 68 yr, median PSA was 100 ng/mL, median aBSI was 0.9, and median follow-up was 39 mo. Baseline patient characteristics including aBSI were balanced between the treatment groups. Using the MFPI procedure, there was evidence of aBSI-treatment interaction for OS (p = 0.04, MFPI procedure) and FFS (p < 0.01, MFPI procedure). Graphical evaluation of estimated treatment effect plots showed that the OS and FFS benefit from prostate RT was greatest in patients with a low aBSI. Further analysis in quartiles based on aBSI supported this finding.ConclusionsA low automated bone scan index is predictive of survival benefit associated with prostate RT in men with newly diagnosed metastatic prostate cancer.Patient summaryThe widely used bone scan can be evaluated using an automated technique to potentially select men with newly diagnosed metastatic prostate cancer who might benefit from prostate radiotherapy.

Dataset Information

Prognostic value of bone scan index as an imaging biomarker in metastatic prostate cancer: a meta-analysis.

Publications

Prognostic value of bone scan index as an imaging biomarker in metastatic prostate cancer: a meta-analysis.

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