scholarly journals Clinical Trial Accrual at Initial Course of Therapy for Cancer and Its Impact on Survival

2019 ◽  
Vol 17 (11) ◽  
pp. 1309-1316 ◽  
Author(s):  
Nicholas G. Zaorsky ◽  
Ying Zhang ◽  
Vonn Walter ◽  
Leila T. Tchelebi ◽  
Vernon M. Chinchilli ◽  
...  

Background: This retrospective cohort study sought to characterize the accrual of patients with cancer into clinical trials at the time of diagnosis and analyze the impact of accrual on survival. Methods: The National Cancer Database (NCDB) was queried for patients enrolled in clinical trials at their initial course of treatment for 46 cancers from 2004 through 2015. Descriptive statistics were used to characterize the accrual of patients with cancer in clinical trials at diagnosis, and Kaplan-Meier graphical displays, log-rank tests, odds ratios, and stratified Cox proportional hazards models were used to analyze the impact of accrual on overall survival (OS). Strata were defined using 10 variables. Model-based adjusted survival curves of 2 groups were reverse-generated based on a Weibull distribution. Results: Of 12,097,681 patients in the NCDB, 11,576 (0.1%) were enrolled in trials. Patients in clinical trials typically had metastatic disease (30.9% vs 16.4%; P<.0001), were white (88.0% vs 84.8%; P<.0001), had private/managed care insurance (56.4% vs 41.8%; P<.0001), had fewer comorbidities (Charlson-Deyo score 0: 81.9% vs 75.7%; P<.0001, and Charlson-Deyo scores 1–3: 18.1% vs 24.3%; P<.0001) compared with those not in trials. At a median follow-up of 64 months, enrollment in a clinical trial was associated with improved OS in univariate and stratified analyses, with a median survival of 60.0 versus 52.5 months (hazard ratio, 0.876; 95% CI, 0.845–0.907; P<.0001). Stratified analysis with matched baseline characteristics between patients enrolled and not enrolled in a clinical trial showed superior OS at 5 years (95.0% vs 90.2%; P<.0001). Conclusions: Enrollment in clinical trials at first line of therapy in the United States is exceedingly low and favors young, healthy, white patients with metastatic disease and private insurance who are treated at academic medical centers. Patients with cancer treated in clinical trials live longer than those not treated in trials.

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4138-4138
Author(s):  
A. B. Siegel ◽  
R. McBride ◽  
D. Hershman ◽  
R. S. Brown ◽  
J. Emond ◽  
...  

4138 Background: Multiple case series have described the use of current therapies for hepatocellular carcinoma (HCC), but recent estimates of treatment utilization in the general population and the impact of various treatments on survival are not known. Methods: We first identified 2898 adults diagnosed with HCC with known tumor size and stage in the Surveillance, Epidemiology, and End-Results Program (SEER), from 1998–2002. Treatment was categorized as transplant, resection, ablation, or none of these. We created a second data set of 1856 HCC patients who were potentially operable, as defined by SEER. We used these patients to construct Kaplan-Meier survival curves and adjusted Cox proportional hazards models. Results: The median age of the larger cohort at HCC diagnosis was 62 (range:18–96). Approximately 42% were white, 32% Asian, 16% Hispanic, and 10% African American. Overall, 10% received a transplant, 18% resection, 8% ablation, and 65% none of these. Only 5% of African Americans with HCC received a transplant, versus 12% of whites, 10% of Hispanics, and 8% of Asians. Asians were most likely to receive resection (24%) and ablation (9%), and least likely to have non-surgical treatment (60%). Using the restricted cohort, improved survival in the multivariate analysis was seen with later year of diagnosis, younger age, female sex, Asian race, smaller tumor size, lower tumor grade, and localized disease. Treatment was highly correlated with survival. This was greatest in the transplanted group (1, 3, and 5-year survivals 93%, 79%, and 71%), followed by resection (70%, 45%, and 29%), and ablation (71%, 33%, and 18%). The non-surgical group had poor survival (33%, 9%, and 0%). Conclusions: Transplantation yields excellent survival on a population scale, similar to reported series, and resection gives relatively good outcomes as well. Asians are more likely to be resected and ablated than other groups. They also had better survival than other groups, perhaps due to underlying etiology of HCC (hepatitis B) and better preserved liver function. No significant financial relationships to disclose.


2017 ◽  
Vol 27 (3) ◽  
pp. 225-231 ◽  
Author(s):  
Mokshya Sharma ◽  
Aijaz Ahmed ◽  
Robert J. Wong

Introduction: The age of liver transplantation recipients in the United States is steadily increasing. However, the impact of age on liver transplant outcomes has demonstrated contradictory results. Research Questions: We aim to evaluate the impact of age on survival following liver transplantation among US adults. Design: Using data from the United Network for Organ Sharing registry, we retrospectively evaluated all adults undergoing liver transplantation from 2002 to 2012 stratified by age (aged 70 years and older vs aged <70 years), presence of hepatocellular carcinoma, and hepatitis C virus status. Overall survival was evaluated with Kaplan-Meier methods and multivariate Cox proportional hazards models. Results: Compared to patients aged <70 years, those aged 70 years and older had significantly lower 5-year survival following transplantation among all groups analyzed (hepatocellular carcinoma: 59.9% vs 68.6%, P < .01; nonhepatocellular carcinoma: 61.2% vs 74.2%, P < .001; hepatitis C: 60.7% vs 69.0%, P < .01; nonhepatitis C: 62.6% vs 78.5%, P < .001). On multivariate regression, patients aged 70 years and older at time of transplantation was associated with significantly higher mortality compared to those aged <70 years (hazards ratio: 1.67; 95% confidence interval: 1.48-1.87; P < .001). Conclusion: The age at the time of liver transplantation has continued to increase in the United States. However, patients aged 70 years and older had significantly higher mortality following liver transplantation. These observations are especially important given the aging cohort of patients with chronic liver disease in the United States.


RMD Open ◽  
2019 ◽  
Vol 5 (2) ◽  
pp. e001015 ◽  
Author(s):  
Fernando Pérez Ruiz ◽  
Pascal Richette ◽  
Austin G Stack ◽  
Ravichandra Karra Gurunath ◽  
Ma Jesus García de Yébenes ◽  
...  

ObjectiveTo determine the impact of achieving serum uric acid (sUA) of <0.36 mmol/L on overall and cardiovascular (CV) mortality in patients with gout.MethodsProspective cohort of patients with gout recruited from 1992 to 2017. Exposure was defined as the average sUA recorded during the first year of follow-up, dichotomised as ≤ or >0.36 mmol/L. Bivariate and multivariate Cox proportional hazards models were used to determine mortality risks, expressed HRs and 95% CIs.ResultsOf 1193 patients, 92% were men with a mean age of 60 years, 6.8 years’ disease duration, an average of three to four flares in the previous year, a mean sUA of 9.1 mg/dL at baseline and a mean follow-up 48 months; and 158 died. Crude mortality rates were significantly higher for an sUA of ≥0.36 mmol/L, 80.9 per 1000 patient-years (95% CI 59.4 to 110.3), than for an sUA of <0.36 mmol/L, 25.7 per 1000 patient-years (95% CI 21.3 to 30.9). After adjustment for age, sex, CV risk factors, previous CV events, observation period and baseline sUA concentration, an sUA of ≥0.36 mmol/L was associated with elevated overall mortality (HR=2.33, 95% CI 1.60 to 3.41) and CV mortality (HR=2.05, 95% CI 1.21 to 3.45).ConclusionsFailure to reach a target sUA level of 0.36 mmol/L in patients with hyperuricaemia of gout is an independent predictor of overall and CV-related mortality. Targeting sUA levels of <0.36 mmol/L should be a principal goal in these high-risk patients in order to reduce CV events and to extend patient survival.


2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 41-41
Author(s):  
Daniel Canter ◽  
Julia E. Reid ◽  
Maria Latsis ◽  
Margaret Variano ◽  
Shams Halat ◽  
...  

41 Background: Prostate cancer (PC) is the most common male malignancy. Prior data has suggested that African American (AA) men present with more aggressive disease relative to men of other ancestries. Here, we examined the effects of ancestry on clinical and molecular measures of disease aggressiveness as well as pathologic outcomes in men treated with radical prostatectomy (RP) for localized PC. Methods: Data was collected from patients undergoing RP at the Ochsner Clinic from 2006 to 2011. Formalin−fixed paraffin embedded biopsy tissue was analyzed for the RNA expression of 31 cell cycle progression (CCP) genes and 15 housekeeping genes to obtain a CCP score (a validated molecular measure of PC aggressiveness). Cancer of the Prostate Risk Assessment (CAPRA) scores were also determined based on clinicopathologic features at the time of diagnosis. Clinical (Gleason score, tumor stage, CAPRA score) and molecular (CCP score) measures of disease aggressiveness were compared based on ancestry (AA versus non−AA). Cox proportional hazards models were used to test association of ancestry to biochemical recurrence (BCR) and progression to metastatic disease. Fisher’s exact and Wilcoxon rank sum tests were used to compare ancestries. Results: A total of 384 patients were treated with RP, including 133 (34.8%) AA men. At the time of diagnosis, the median age was 62 years (interquartile range (IQR) 56, 66) and PSA was 5.4 ng/mL (IQR 4.2, 7.6). When compared by ancestry, there were no significant differences in biopsy Gleason score (p = 0.26), clinical stage (p = 0.27), CAPRA score (p = 0.58), or CCP score (p = 0.87). In addition, there was no significant difference in the risk of BCR between ancestries (p = 0.55). Only non−AA men progressed to metastatic disease within the ten years of follow−up. Conclusions: Contrary to prior reports, these data appears to indicate that men of AA ancestry do not necessarily present with or develop a more biologically aggressive form of PC. Although these data represents only one institution’s experience, it contains a highly robust AA population compared to prior reports. Further research is required to account for the discrepancy in the previously published literature.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15682-e15682
Author(s):  
Aman Opneja ◽  
Gino Cioffi ◽  
Asrar Alahmadi ◽  
Nirav Patil ◽  
David Lawrence Bajor ◽  
...  

e15682 Background: HCC is a common cause of mortality in the U.S. among men and women (5thand 7th, respectively) with overall five-year survival of ~18%. Sorafenib was the only FDA approved therapy for advanced HCC from 2007 until 2018. This study analyzes trends in the treatment and survival of advanced HCC before and after sorafenib approval. Methods: Adult patients ( > 18 years) with diagnosis of HCC treated with only chemotherapy from 2004 – 2014 were identified in NCDB database. Comparisons were made between 3 time frames: 2004 – 2007 (pre-sorafenib), 2008 – 2011 (early sorafenib) and 2012 – 2014 (late sorafenib). Patients treated with single or multi-agent chemotherapy were analyzed. Cox proportional hazards models were used for univariate and multivariable analyses. Kaplan-Meier method was used for survival analysis. Results: The NCDB contained 33,136 patients with HCC diagnosed between 2004 – 2014 and treated with chemotherapy alone. Patients were generally men (77.4%), over the age of 50 years (92.4%), with an elevated AFP at diagnosis (64.4%), and had limited co-morbidities (76.0%, Charlson/Deyo score of 0-1). The T-stages were T1 (26.3%), T2 (20.5%), T3 (25.6%), and T4 (16.2%). The number and proportion of patients treated with single agent chemotherapy increased significantly during the study period: 2,733 (45.3%) pre-sorafenib, 9,723 (72.7%) early sorafenib, and 13,502 (86.1%) late sorafenib. The proportion of all HCC patients in the NCDB receiving only chemotherapy increased from 17.2% to 26.4% to 28.3% across the 3 time frames. The survival of patients with advanced HCC treated only with chemotherapy improved significantly in the early and late sorafenib cohorts compared to the pre-sorafenib cohort (10.3 months (95% CI: 9.8-10.6) vs. 12.3 months (12.0-12.7) vs. 15.5 months (15.1-15.9), p-value < 0.001). Age > 70 years, male sex, higher Charlson/Deyo score ( > 1), elevated AFP at diagnosis, and higher T-stage were associated with worse survival (p value < 0.001). Conclusions: The approval of sorafenib has dramatically increased the use of chemotherapy for the treatment of advanced HCC and has resulted in a significant survival advantage.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18143-e18143
Author(s):  
Elysia Marie Alvarez ◽  
Frances Maguire ◽  
Helen M. Parsons ◽  
Cyllene Morris ◽  
Arti Parikh-Patel ◽  
...  

e18143 Background: Studies have shown that having public or no insurance at sarcoma diagnosis is associated with higher stage disease and poor survival. However, previous studies have not differentiated sarcoma patients who enrolled in Medicaid at diagnosis from those previously insured, groups with differing access to care. Therefore, we examined the impact of insurance on stage at diagnosis and overall survival for AYAs with soft tissue sarcoma (STS), osteosarcoma (OS) and Ewing sarcoma (EWS). Methods: Using Medicaid enrollment data linked to the California Cancer Registry, we identified AYAs with STS (n = 1782), OS (n = 458), and EWS (n = 348), diagnosed during 2005-14. Insurance was classified as Medicaid [1. Continuous (≥5 months prior to diagnosis), 2. Discontinuous, 3. At diagnosis (no coverage prior to diagnosis)], private, and uninsured. Logistic and Cox proportional hazards regression determined the association of insurance with metastatic stage (vs localized) and overall survival, respectively adjusting for sociodemographic factors, baseline comorbidities, type of facility, treatment (survival) and stage (survival). Results: Only 17.5% of sarcoma patients had continuous Medicaid prior to diagnosis, with 11% of STS, 17% of EWS and 19% of OS patients obtaining Medicaid at diagnosis. AYAs with Medicaid at diagnosis [Odds Ratio (OR) 3.03, 95% Confidence Interval (CI) 2.27-4.03; vs private] and discontinuous Medicaid (OR 2.25, CI 1.48-3.41) had a higher likelihood of metastatic disease. STS patients with Medicaid at diagnosis [Hazard Ratio (HR) 1.83, CI 1.44-2.33; vs private) and discontinuous Medicaid (HR 1.45, CI 1.01-2.08) had worse survival. Medicaid at diagnosis (HR 1.68, CI 1.07-2.63) also was associated with worse survival in OS patients, but this association was not observed in EWS patients. Conclusions: Lacking insurance prior to diagnosis is associated with metastatic disease at presentation and worse survival in AYA patients with sarcoma. Health insurance remained associated with worse survival even after adjusting for stage, highlighting the importance of continuous health insurance to improve outcomes for this patient population.


Lung ◽  
2022 ◽  
Author(s):  
Hyun J. Kim ◽  
Laurie D. Snyder ◽  
Megan L. Neely ◽  
Anne S. Hellkamp ◽  
David L. Hotchkin ◽  
...  

Abstract Purpose To assess the impact of concomitant emphysema on outcomes in patients with idiopathic pulmonary fibrosis (IPF). Methods The IPF-PRO Registry is a US registry of patients with IPF. The presence of combined pulmonary fibrosis and emphysema (CPFE) at enrollment was determined by investigators’ review of an HRCT scan. Associations between emphysema and clinical outcomes were analyzed using Cox proportional hazards models. Results Of 934 patients, 119 (12.7%) had CPFE. Compared with patients with IPF alone, patients with CPFE were older (median 72 vs 70 years); higher proportions were current/former smokers (88.2% vs 63.7%), used oxygen with activity (49.6% vs 31.9%) or at rest (30.8% vs 18.4%), had congestive heart failure (13.6% vs 4.8%) and had prior respiratory hospitalization (25.0% vs 16.7%); they had higher FVC (median 71.8 vs 69.4% predicted) and lower DLco (median 35.3 vs 43.6% predicted). In patients with CPFE and IPF alone, respectively, at 1 year, rates of death or lung transplant were 17.5% (95% CI: 11.7, 25.8) and 11.2% (9.2, 13.6) and rates of hospitalization were 21.6% (14.6, 29.6) and 20.6% (17.9, 23.5). There were no significant associations between emphysema and any outcome after adjustment for baseline variables. No baseline variable predicted outcomes better in IPF alone than in CPFE. Conclusion Approximately 13% of patients in the IPF-PRO Registry had CPFE. Physiologic characteristics and comorbidities of patients with CPFE differed from those of patients with IPF alone, but the presence of emphysema did not drive outcomes after adjustment for baseline covariates. Trial registration ClinicalTrials.gov, NCT01915511; registered August 5, 2013.


2020 ◽  
pp. bjophthalmol-2020-316617
Author(s):  
Samuel Berchuck ◽  
Alessandro Jammal ◽  
Sayan Mukherjee ◽  
Tamara Somers ◽  
Felipe A Medeiros

AimsTo assess the impact of anxiety and depression in the risk of converting to glaucoma in a cohort of glaucoma suspects followed over time.MethodsThe study included a retrospective cohort of subjects with diagnosis of glaucoma suspect at baseline, extracted from the Duke Glaucoma Registry. The presence of anxiety and depression was defined based on electronic health records billing codes, medical history and problem list. Univariable and multivariable Cox proportional hazards models were used to obtain HRs for the risk of converting to glaucoma over time. Multivariable models were adjusted for age, gender, race, intraocular pressure measurements over time and disease severity at baseline.ResultsA total of 3259 glaucoma suspects followed for an average of 3.60 (2.05) years were included in our cohort, of which 911 (28%) were diagnosed with glaucoma during follow-up. Prevalence of anxiety and depression were 32% and 33%, respectively. Diagnoses of anxiety, or concomitant anxiety and depression were significantly associated with risk of converting to glaucoma over time, with adjusted HRs (95% CI) of 1.16 (1.01, 1.33) and 1.27 (1.07, 1.50), respectively.ConclusionA history of anxiety or both anxiety and depression in glaucoma suspects was associated with developing glaucoma during follow-up.


2019 ◽  
Vol 6 (6) ◽  
pp. 451-462 ◽  
Author(s):  
Haley Gittleman ◽  
Quinn T Ostrom ◽  
L C Stetson ◽  
Kristin Waite ◽  
Tiffany R Hodges ◽  
...  

Abstract Background Glioblastoma (GBM) is the most common and most malignant glioma. Nonglioblastoma (non-GBM) gliomas (WHO Grades II and III) are invasive and also often fatal. The goal of this study is to determine whether sex differences exist in glioma survival. Methods Data were obtained from the National Cancer Database (NCDB) for years 2010 to 2014. GBM (WHO Grade IV; N = 2073) and non-GBM (WHO Grades II and III; N = 2963) were defined using the histology grouping of the Central Brain Tumor Registry of the United States. Non-GBM was divided into oligodendrogliomas/mixed gliomas and astrocytomas. Sex differences in survival were analyzed using Kaplan–Meier and multivariable Cox proportional hazards models adjusted for known prognostic variables. Results There was a female survival advantage in patients with GBM both in the unadjusted (P = .048) and adjusted (P = .003) models. Unadjusted, median survival was 20.1 months (95% CI: 18.7-21.3 months) for women and 17.8 months (95% CI: 16.9-18.7 months) for men. Adjusted, median survival was 20.4 months (95% CI: 18.9-21.6 months) for women and 17.5 months (95% CI: 16.7-18.3 months) for men. When stratifying by age group (18-55 vs 56+ years at diagnosis), this female survival advantage appeared only in the older group, adjusting for covariates (P = .017). Women (44.1%) had a higher proportion of methylated MGMT (O6-methylguanine-DNA methyltransferase) than men (38.4%). No sex differences were found for non-GBM. Conclusions Using the NCDB data, there was a statistically significant female survival advantage in GBM, but not in non-GBM.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14016-e14016
Author(s):  
Brian S. Seal ◽  
Benjamin Chastek ◽  
Mahesh Kulakodlu ◽  
Satish Valluri

e14016 Background: Improvements in survival for advanced-stage CRC patients who receive chemotherapy have been reported. We compared survival rates for patients with 3+ vs. <3 lines of therapy. Methods: Adult patients with a diagnosis of CRC between 01/01/05 and 05/31/10 were identified from the Impact Intelligence Oncology Management (IIOM) registry. Patients with either stage 4 CRC at original diagnosis or development of metastasis were included. Registry data included original stage and date of diagnosis. Linked healthcare claims from the Life Sciences Research Database, a large US health insurance database affiliated with OptumInsight, were used to identify lines of therapy after metastases and patient characteristics. Death data were obtained from the Social Security Administration’s master death file. Patients were categorized by number of lines of therapy received (0, 1, 2, 3+) and original stage at diagnosis (0-2, 3, 4, unknown). Survival following metastases was evaluated using Cox proportional hazards models controlling for lines of therapy received, stage, and other patient characteristics. Results: 598 patients, followed for a mean of 653 days after becoming metastatic, were included. Mean unadjusted length of follow-up was lowest among patients who received no chemotherapy (516 days) or only 1 line (511 days), and increased to 627 days for those with 2 lines and 930 days for those with 3+ lines. However, multivariate analysis indicated that patients with 3+ lines had comparable survival vs. those with 0 (HR=0.79), 1 (HR=1.59), or 2 (HR=1.15) lines of therapy (p>0.05 for all comparisons). Compared to patients who presented with stage 4 CRC, those who progressed from stage 0-2 (HR=1.22), stage 3 (HR=0.83), or unknown stage (HR=1.18) had similar survival after metastases (p>0.05 for all comparisons). After excluding 94 patients who didn’t receive chemotherapy, patients treated with an oxaliplatin-based regimen (HR=1.28; p=0.24) in first line had similar survival compared to patients treated with an irinotecan-based or anti-EGFR regimen in first line. Conclusions: Lines of therapy received and initial stage were not associated with survival after development of metastases.


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