The impact of Charlson Comorbidity Index on survival outcomes in men with prostate cancer who underwent definitive prostate radiotherapy.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 114-114
Author(s):  
Ahmed I. Ghanem ◽  
Remonda M Khalil ◽  
Gehan Abd Elatti Khedr ◽  
Amy Tang ◽  
Amr A. Elsaid ◽  
...  

114 Background: Life expectancy is very essential in deciding treatment options in men with prostate cancer (PCa); however, the impact of comorbidities on outcomes is not well-established. We investigated the influence of Charlson Comorbidity Index (CCI) on survival endpoints in men with localized PCa who were treated with prostate radiotherapy (RT). Methods: Men with intermediate and high risk PCa who were treated with definitive RT between 1/2007 and 12/2012 were included. Groups were created according to their baseline CCI score at diagnosis into no, mild and severe comorbidity (CCI 0, 1 or 2+). The groups were then compared based on patients’ characteristics and prognostic factors. Kaplan-Meier curves and Uni/multivariate analyses (MVA) were used to examine the impact of CCI groups on overall (OS), disease specific (DSS), and biochemical relapse free (BRFS) survival. Results: 257 patients were identified after excluding low risk, metastatic cases and those with inadequate follow up. Median follow-up was 92 months (range: 2-135) and median age was 73 years (range: 48-85). 53% of the cases were black and 67% were of intermediate risk. Median RT dose was 76 Gy and 47% received androgen deprivation therapy. CCI groups 0, 1 and 2+ encompassed 76 (30%), 54 (21%) and 127 (49%) patients, respectively. Groups were generally well-balanced. 10 and 15 years OS was significantly different across CCI groups (76% & 53%, 46% & 31% and 55% & 14%, for CCI-0, 1 and 2+ respectively; p < 0.001). CCI-0 had better DSS than CCI-2+ ( p = 0.03) with no difference for CCI-0 vs 1 ( p = 0.1). BRFS was non-different among CCI groups ( p = 0.99). On MVA, increased CCI was deterministic for OS ( p < 0.001) after adjusting for age, Gleason’s score and T-stage. For DSS, only age and T3 vs T1/2 were independently prognostic ( p < 0.001); whereas CCI-1 vs 0 was only marginal ( p = 0.05). Conclusions: Higher CCI was a significant predictor of shorter OS in intermediate and high-risk PCa. Baseline comorbidities should be taken into consideration during patient counselling for treatment options and in designing prospective trials for men with localized prostate cancer.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 215-215
Author(s):  
Michael Andre Liss ◽  
Kathryn Osann ◽  
Ross Moskowitz ◽  
Adam Kaplan ◽  
John Billimek ◽  
...  

215 Background: Comorbidities significantly influence how physicians approach the treatment of prostate cancer and should be evaluated prior to the prostate biopsy. The Total Illness Burden Index for Prostate Cancer (TIBI-CaP) patient questionnaire and Charlson Comorbidity Index (CCI) usually calculated by the physician, may provide information on competing risks but have not been compared prospectively. Methods: A prospective observational cohort study was performed of 133 participants prior to obtaining a transrectal ultrasound guided prostate biopsy. Eleven patients had incomplete data or missing follow-up; therefore, a total of 122 (92%) patients were retained for a mean of 21 months (range 4 – 31 months). The TIBI-CaP and CCI scores were compared between subgroups defined by non-elective hospital admission, elective surgery, non-prostate malignancy and survival status using t-tests. Results: Patients averaged 64.5 years at enrollment. One patient died in the study from a metastatic sarcoma. The overall hospital admission rate was 17% (21/122), most commonly from cardiovascular or pulmonary complications. Forty-six men (38%) were diagnosed with cancer on the prostate biopsy. The most common treatments were prostatectomy (39%), active surveillance (26%), or external beam radiation therapy (20%). Twenty-three percent (28/122) had elective surgery and 5% (6/122) were diagnosed with a non-prostate malignancy. Mean TIBI-CaP scores were higher in men who were admitted to the hospital (5.1 vs. 3.5, p=0.03), had elective surgery (4.8 vs. 3.4, p=0.05) or non-prostate cancer (5.5 vs 3.7, p=0.17). No significant differences were observed in CCI scores In stepwise logistic regression, a TIBI-CaP score > 5.0 was associated with 3.5 times higher risk for hospital admission (95% CI: 1.3–10.0, p=0.02). Conclusions: The patient-reported measure of comorbidity (TIBI-CaP) identified patients at high risk for non-elective hospital admission over at 20 month average follow up period and may aid medical decision making specifically in the prostate biopsy population better than that of the Charlson Comorbidity Index.


2021 ◽  
Vol 10 (20) ◽  
pp. 4682
Author(s):  
Antonio Vena ◽  
Giovanni Cenderello ◽  
Elisa Balletto ◽  
Laura Mezzogori ◽  
Alessandro Santagostino Santagostino Barbone ◽  
...  

Monoclonal antibodies, such as bamlanivimab and etesevimab combination (BEC), have been proposed for patients with mild or moderate coronavirus disease 2019 (COVID-19). However, few studies have assessed the factors associated with the early administration of BEC or the impact of early BEC treatment on the clinical evolution of the patients. We conducted a retrospective cohort study of all adults with COVID-19 who received BEC at three institutions in the Liguria region. The primary endpoint was to investigate the clinical variables associated with early BEC infusion. Secondary endpoints were 30-day overall mortality and the composite endpoint of requirement of hospital admission or need for supplemental oxygen during the 30-day follow-up period. A total of 127 patients (median age 70 years; 56.7% males) received BEC. Of those, 93 (73.2%) received BEC within 5 days from symptoms onset (early BEC). Patients with a higher Charlson comorbidity index were more likely to receive early treatment (odds ratio (OR) 1.60, 95% confidence interval (CI) 1.04–2.45; p = 0.03) in contrast to those reporting fever at presentation (OR 0.26, 0.08–0.82; p = 0.02). Early BEC was associated with lower likelihood of hospital admission or need for supplemental oxygen (OR 0.19, 0.06–0.65; p = 0.008). Five patients who received early BEC died during the follow-up period, but only one of them due to COVID-19-related causes. Early bamlanivimab and etesevimab combination was more frequently administered to patients with a high Charlson comorbidity index. Despite this, early BEC was associated with a lower rate of hospital admission or need for any supplementary oxygen compared to late administration. These results suggest that efforts should focus on encouraging early BEC use in patients with mild–moderate COVID-19 at risk for complications.


2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 192-192
Author(s):  
J. P. Ciezki ◽  
C. A. Reddy ◽  
P. Kupelian ◽  
E. A. Klein

192 Background: Routine screening for prostate cancer (CaP) was first advocated in 1993 in the US. Opponents of screening argue that the implementation of routine screening has not resulted in a meaningful improvement in survival. Since we are essentially unable to cure metastatic disease, the best measure of the efficacy of screening may not be overall survival but instead its ability to lessen the metastatic disease burden of the screened population. We assess the effect of screening on this endpoint. Methods: From 1986-1996, 1,721 patients with CaP were definitively treated with radical prostatectomy (RP) or radiotherapy (RT) at our institution. The cohort was divided into a pre screening era group (1986-1992; PRE, n=575) and a post screening era group (1993-1996; POST, n=1,146). Due to the potential for an imbalance in follow up time between the two groups, all patients were censored at ten years. Kaplan- Meier analysis was used to calculate the ten year metastases free survival rates (MFSR). Cox proportional hazards regression was used to examine if screening era along with disease, treatment, and follow-up characteristics was associated with an increased risk of developing metastatic disease. Results: The median follow up for all patients was 10 yrs (range: 0.1-10), 9.6 yrs (range: 0.1-10) for PRE patients, and 10 yrs (range: 0.1-10) for POST patients. The distribution by NCCN risk classification for the PRE patients was 44% high risk (H), 21% intermediate risk (I) and 28% low risk (L) vs. 36% H, 27% I, and 37% L for the POST patients (p < 0.0001). Within 10 years of treatment, 13% of all patients had developed metastatic disease. The 10 year MFSR for high risk PRE vs POST patients was 58% vs. 82% (p < 0.0001), 79% vs. 93% for I (p < 0.0001), and 90% vs. 98% (p = 0.0001) for L patients. On multivariable analysis, screening era (p < 0.0001, HR = 4.6, 95% CI = 3.4-6.1), T-stage, biopsy Gleason score, and post-treatment PSA testing frequency were significant. Conclusions: Screening for CaP results in a significant decrease in the risk of a patient developing metastatic disease within 10 years of treatment even after controlling for severity of disease. This risk reduction may yield improved quality of life and a cost savings to the medical care system. No significant financial relationships to disclose.


2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 158-158 ◽  
Author(s):  
Jodi Lyn Layton ◽  
Angela Marie Plette ◽  
Joseph F. Renzulli ◽  
E. Bradley Miller ◽  
Howard Safran ◽  
...  

158 Background: Potential benefits of neoadjuvant chemotherapy are tumor downstaging and treatment of micrometastatic disease. A prior study using docetaxel yielded no pathologic complete responses and concerns for increased operative morbidity. In Phase II studies, ixabepilone has promising activity in metastatic prostate cancer. Our study is a Phase I/II clinical trial evaluating neoadjuvant, weekly ixabepilone in men with high-risk prostate cancer opting for radical prostatectomy. Methods: Men with high risk prostate cancer defined as either Gleason 8-10, cT3 disease, high volume Gleason 4+3 and a palpable nodule or a PSA>20 ng/ml were eligible. Men received weekly ixabepilone 16-20/m2 for 12-16 weeks prior to surgery. Fifteen men underwent robotic prostatectomy; one patient who had an open prostatectomy. Initial PSA response, post-operative PSA values, pathology, and evaluation of adverse events were recorded. Results: We enrolled 16 men with a mean follow-up of 15.25 months at time of review. All had pretreatment Gleason scores of 4+3 or higher. With neoadjuvant treatment, PSA values decreased in 14/16 men (mean 46.8%); increased in 2/16 men. None reached an undetectable pre-operative PSA. Nine men experienced an adverse event requiring dose modification or cessation of chemotherapy (neuropathy or allergic reaction). Only 5/16 men completed planned treatment. Mean operative time, EBL, and hospital stay were 189 minutes, 184mL, and1.5 days, respectively; all consistent with institutional and national norms. Post surgery 15/16 (94%) had pT3 disease, 8/16 (50%) had a positive surgical margin and 2/16 (12.5%) had positive regional lymph nodes. There were no pathologic complete responses. Only 1/16 (6.25%) had a biochemical relapse. Conclusions: While a PSA response is achieved, there is substantial toxicity with neoadjuvant weekly ixabepilone. Men were able to undergo prostatectomy without increased morbidity after neoadjuvant therapy. Extracapsular extension and positive surgical margins remained common in this population with high-risk disease. Assessment of biochemical recurrence rates and time to treatment failure will require longer, planned follow-up.


2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 111-111
Author(s):  
Jatinder Goyal ◽  
Gregory Russell Pond ◽  
Matt D. Galsky ◽  
Ryan Hendricks ◽  
Alexander C. Small ◽  
...  

111 Background: Clinical and laboratory factors, i.e. visceral metastasis, anemia, LDH, PSA, PSA-doubling time, bone scan progression, pain, performance status (PS), are recognized to be prognostic factors for overall survival (OS) in metastatic castration resistant prostate cancer (mCRPC). We sought to determine if the Charlson comorbidity Index (CCI) and hypertension (HTN) provide prognostic information independent of these known factors. Methods: We retrospectively evaluated 221 patients with mCRPC treated with docetaxel plus prednisone (DP) combined with AT-101 (bcl-2 antagonist) or placebo on a randomized phase II trial. Both arms of the trial were combined since no differences in outcomes or toxicities were observed. Wilcoxon rank sum test and Fisher’s exact tests were used to compare data by comorbidity groups (CCI as a continuous variable, CCI = 6 vs. CCI ≥7 and HTN vs. no HTN). Cox regression analysis was done to identify whether CCI or HTN independently predicted OS after adjusting for trial stratification factors (pain, performance status), nomogram, risk-groups and PCWG-2 clinical sub-types. Results: CCI was 6 in 116 patients (52.7%) whereas it was 7 in 70 (31.8%), 8 in 23 (10.5%), 9 in (1.8%) and 10 in 7 patients (3.2%) respectively. HTN was present in 107 (48.6%) patients. Patients with HTN had increased CCI (mean CCI 7.0 vs. 6.43, p < 0.001). Patients with CCI of ≥7 were older and exhibited worse ECOG-PS and anemia than patients with CCI of 6 (p<0.05). CCI was not found to be independently predictive of OS on univariable and multivariable analyses. HTN alone or in combination with CCI was borderline significantly associated with OS (p~0.08) on both univariable and multivariable analyses. Conclusions: CCI did not predict OS independent of known prognostic factors in mCRPC. Age, performance status and anemia may adequately capture comorbidities in the context of mCRPC, given their association with higher CCI. Further analysis of HTN in a larger dataset may be warranted given its borderline independent association with OS.


BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043844
Author(s):  
Natalia Araujo ◽  
Samantha Morais ◽  
Ana Rute Costa ◽  
Raquel Braga ◽  
Ana Filipa Carneiro ◽  
...  

IntroductionProstate cancer is the most prevalent oncological disease among men in industrialised countries. Despite the high survival rates, treatments are often associated with adverse effects, including metabolic and cardiovascular complications, sexual dysfunction and, to a lesser extent, cognitive decline. This study was primarily designed to evaluate the trajectories of cognitive performance in patients with prostate cancer, and to quantify the impact of the disease and its treatments on the occurrence of cognitive decline.MethodsParticipants will be recruited from two main hospitals providing care to approximately half of the patients with prostate cancer in Northern Portugal (Portuguese Institute of Oncology of Porto and São João Hospital Centre), and will comprise a cohort of recently diagnosed patients with prostate cancer proposed for different treatment plans, including: (1) radical prostatectomy; (2) brachytherapy and/or radiotherapy; (3) radiotherapy in combination with androgen deprivation therapy and (4) androgen deprivation therapy (with or without chemotherapy). Recruitment began in February 2018 and is expected to continue until the first semester of 2021. Follow-up evaluations will be conducted at 1, 3, 5, 7 and 10 years. Sociodemographic, behavioural and clinical characteristics, anxiety and depression, health literacy, health status, quality of life, and sleep quality will be assessed. Blood pressure and anthropometrics will be measured, and a fasting blood sample will be collected. Participants’ cognitive performance will be evaluated before treatments and throughout follow-up (Montreal Cognitive Assessment and Cube Test as well as Brain on Track for remote monitoring). All participants suspected of cognitive impairment will undergo neuropsychological tests and clinical observation by a neurologist.Ethics and disseminationThe study was approved by the Ethics Committee of the hospitals involved. All participants will provide written informed consent, and study procedures will be developed to ensure data protection and confidentiality. Results will be disseminated through publication in peer-reviewed journals and presentation in scientific meetings.


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