Project Data Sphere: A first look at prostate cancer including concomitant medication use, prognosis, and toxicity.

Aim: Patients receiving checkpoint inhibitors (CPI) are frequently on other medications for co-morbidities. We explored the impact of concomitant medication use on outcomes. Materials & methods: 210 metastatic cancer patients on CPI were identified and association between concomitant medication use and immune-related adverse events with clinical outcomes was determined. Results: Aspirin, metformin, β-blockers and statins were not shown to have any statistically significant difference on clinical benefit. 26.3% patients with clinical benefit developed rash versus 11.8% without clinical benefit (p < 0.05) on multivariate analysis. Conclusion: Use of common prescription and nonprescription medications in patients with multiple co-morbidities appears safe and does not have an adverse effect on CPI efficacy. The presence of rash predicted for a better response.

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Concomitant Medication Use and New-Onset Diabetes Among Medicaid Beneficiaries with Chronic Obstructive Pulmonary Disease

Population Health Management ◽

10.1089/pop.2016.0047 ◽

2017 ◽

Vol 20 (3) ◽

pp. 224-232 ◽

Cited By ~ 3

Author(s):

Mayank Ajmera ◽

Chan Shen ◽

Usha Sambamoorthi

Keyword(s):

Chronic Obstructive Pulmonary Disease ◽

Pulmonary Disease ◽

Concomitant Medication ◽

Medication Use ◽

Chronic Obstructive ◽

Obstructive Pulmonary Disease ◽

Onset Diabetes ◽

Medicaid Beneficiaries ◽

New Onset

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Association of calcium channel blocker use with prostate cancer aggressiveness, progression-free survival, and overall survival.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e15204 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e15204-e15204

Author(s):

Michael Adam Poch ◽

Diana Mehedint ◽

Alexandra Curtis ◽

Kristopher Attwood ◽

Gregory E. Wilding ◽

...

Keyword(s):

Prostate Cancer ◽

Overall Survival ◽

Radical Prostatectomy ◽

Calcium Channel ◽

Cox Regression ◽

Medication Use ◽

Progression Free Survival ◽

Channel Blockers ◽

Free Survival ◽

Cancer Aggressiveness

e15204 Background: Epidemiological studies indicate that the use of calcium channel blockers (CCB) is inversely related to prostate cancer (PCa) incidence. The goal of this study was to examine the association between CCB use and PCa aggressiveness at the time of radical prostatectomy (RP) or outcome after RP. Methods: Information on medication use, PCa aggressiveness and outcome after RP was retrieved from a prospective database that contains clinical and follow-up (FU) data for all men that have undergone RP at the Department of Urology at Roswell Park Cancer Institute since 1992. The database was queried for anti-hypertensive medication use at the time of diagnosis for all patients with ≥ 1 year FU. Prostate cancer aggressiveness (risk status) and recurrence were defined using NCCN guideline definitions. Cox regression models were performed to compare the distribution of progression-free survival (PFS) and overall survival (OS) with adjustment for covariates. Chi-Square test was used to assess the relationship between CCB use and PCa aggressiveness. Results: 875 men were included in the study. At diagnosis, mean age was 60 (SD ± 7) years and mean serum PSA value was 7.4 (SD ±7.4) ng/ml. 48%, 37%, and 15% of patients had low risk, intermediate risk, or high risk PCa, respectively. 104 (12%) had a history of CCB use. CCB users and non-users were similar by PSA at diagnosis (p=0.97) and tumor aggressiveness (p=0.88). Patients taking CCB were more likely to be older (p=0.023), have a higher BMI (p=0.006) and use additional anti-hypertensive medications (p<0.01). Margin status after radical prostatectomy was similar (p=0.30) between the two groups. Median FU was 42 months. PFS (p=0.82, HR 95% CI: 0.63-1.44) and OS (p=0.72, HR 95% CI: 0.42-3.52) did not differ between the 2 groups. Adjusting for age and PCa aggressiveness did not alter the results observed for PFS (p=0.44, HR 95% CI: 0.62–1.41) and OS (p=0.50, HR 95% CI: 0.04-3.48). PCa aggressiveness was associated with PFS (p=0.001) in the multivariate model. Conclusions: CCB use does not affect PCa aggressiveness at time of diagnosis or improve PFS or OS.

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Clinical and biochemical parameters as predictors of response to checkpoint inhibitors (CPI): A single institution experience.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e14590 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e14590-e14590 ◽

Cited By ~ 1

Author(s):

Shipra Gandhi ◽

Manu Pandey ◽

Nischala Ammannagari ◽

Katy Wang ◽

Karen L Vona ◽

...

Keyword(s):

Clinical Benefit ◽

Concomitant Medication ◽

Checkpoint Inhibitors ◽

Financial Burden ◽

Objective Response ◽

Medication Use ◽

Absolute Lymphocyte Count ◽

Disease Assessment ◽

Laboratory Parameters ◽

Predictors Of Response

e14590 Background: The benefit of CPI is limited to a subgroup of patients. Significant toxicity and financial burden make it imperative to identify biomarkers predictive of clinical benefit. We aimed to analyze if immune related adverse events (irAE), laboratory parameters (besides PD-L1 status), prior chemotherapy and concomitant medication use could predict response to CPI. Methods: 216 consecutive patients treated at RPCI with single/multiple CPI from 2011 to 2016 were identified. Demographics, irAE (CTCAE v4.03), concomitant medication use, response (RECIST v1.1) and laboratory parameters were recorded. Progression free (PFS) and overall survival (OS) were calculated. Clinical benefit (responder) was defined as objective response or stable disease with PFS ≥ 6 months. Statistical analysis was performed using SAS v9.4. Results: 185/216 patients (86%) had clinical outcomes with first CPI available (55.7% melanoma, 28.1% lung, 10.8% kidney, 3.8% bladder, 1.6% others), 14% died before disease assessment. Median age was 61 years; 64% were males. 31% were responders (R); 69% non-responders (NR). Median PFS and OS for R were not reached and for NR were 4.7/7 months (p < 0.001). 26% R developed rash vs. 12% NR (p = 0.02). irAE diarrhea was associated with better OS (p = 0.03); rash with better PFS (p = 0.007) and OS (p = 0.05). Concomitant beta-blocker/NSAID use was noted in 35%/28% R vs 20%/12% NR (p = 0.04; p = 0.01). Higher median absolute eosinophil (AEC) and absolute lymphocyte count (ALC) were noted in R (400 and 2000/µl in R vs. 300 and 1600/µl in NR; p = 0.008 and 0.024). NR were noted to have a higher median lactate dehydrogenase (LDH) of 565 vs. 503 (p < 0.001). AEC > 100/µl and ALC > 1000/ µl were associated with better OS (P = 0.03; P = 0.001). Absolute neutrophil count (ANC) > 7500/µl and leucocyte count > 8750/ µl were associated with inferior PFS (p = 0.005; P = 0.02) and OS (p = 0.002; p = 0.03). Pre-CPI chemotherapy did not correlate with response to CPI. Conclusions: Among irAE, diarrhea and rash predicted improved outcomes. Eosinophilia, lymphocytosis, neutrophilia, leukocytosis and LDH could serve as potential prognostic biomarkers to CPI. Prospective studies are warranted to validate these findings.

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Biases in Recommendations for and Acceptance of Prostate Biopsy Significantly Affect Assessment of Prostate Cancer Risk Factors: Results From Two Large Randomized Clinical Trials

Journal of Clinical Oncology ◽

10.1200/jco.2016.68.1965 ◽

2016 ◽

Vol 34 (36) ◽

pp. 4338-4344 ◽

Cited By ~ 21

Author(s):

Catherine M. Tangen ◽

Phyllis J. Goodman ◽

Cathee Till ◽

Jeannette M. Schenk ◽

M. Scott Lucia ◽

...

Keyword(s):

Prostate Cancer ◽

Risk Factors ◽

Risk Factor ◽

Cancer Prevention ◽

Specific Antigen ◽

Medication Use ◽

Digital Rectal Examination ◽

Prostate Cancer Prevention ◽

Prevention Trials ◽

Statin Use

Purpose To identify factors related to who undergoes a prostate biopsy in a screened population and to estimate the impact of biopsy verification on risk factor–prostate cancer associations. Patients and Methods Men who were screened regularly from the placebo arms of two large prostate cancer prevention trials (Prostate Cancer Prevention Trial [PCPT] and Selenium and Vitamin E Cancer Prevention Trial [SELECT]) were examined to define incident prostate cancer cohorts. Because PCPT had an end-of-study biopsy, prostate cancer cases were categorized by a preceding prostate-specific antigen/digital rectal examination prompt (yes/no) and noncases by biopsy-proven negative status (yes v no). We estimated the association of risk factors (age, ethnicity, family history, body mass index, medication use) with prostate cancer and quantified differences in risk associations across cohorts. Results Men 60 to 69 years of age, those with benign prostatic hyperplasia, and those with a family history of prostate cancer were more likely, and those with a higher body mass index (≥ 25), diabetes, or a smoking history were less likely, to undergo biopsy, adjusting for age and longitudinal prostate-specific antigen and digital rectal examination. Medication use, education, and marital status also influenced who underwent biopsy. Some risk factor estimates for prostate cancer varied substantially across cohorts. Black ( v other ethnicities) had odds ratios (ORs) that varied from 1.20 for SELECT (community screening standards, epidemiologic-like cohort) to 1.83 for PCPT (end-of-study biopsy supplemented with imputed end points). Statin use in SELECT provided an OR of 0.65 and statin use in in PCPT provided an OR of 0.99, a relative difference of 34%. Conclusion Among screened men enrolled in prostate cancer prevention trials, differences in risk factor estimates for prostate cancer likely underestimate the magnitude of bias found in other cohorts with varying screening and biopsy recommendations and acceptance. Risk factors for prostate cancer derived from epidemiologic studies not only may be erroneous but may lead to misdirected research efforts.

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