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Background: Phase 1 clinical trials introduce new therapies to humans with the goal of establishing their safety. A prior Children's Oncology Group (COG) study analyzed the proportional enrollment of patients by race, ethnicity, sex, and age for all trial phases. The current study evaluated the representation of patients by race, ethnicity, sex, and age in phase 1 clinical trials.Methods: This study evaluated 1348 children with 128 diagnoses enrolled in COG and Pediatric Brain Tumor Consortium phase 1 clinical trials in the United States from February 28, 2000 to December 29, 2008. Observed and expected proportions were calculated according to an established methodology with a representative population from Surveillance, Epidemiology, and End Results data, which included 27,766 children with the same International Classification of Diseases for Oncology (third edition) diagnostic codes.Results: Underrepresentation in phase 1 trials was seen for lymphohematopoietic (LH) tumors (9.3% observed vs 37% expected) versus solid tumors (90.6% observed vs 63% expected). Although representation was fairly proportional, Hispanics (12.6% observed vs 27% expected), particularly Hispanic females (6% observed vs 18% expected), were significantly underrepresented. The 0- to 4-year age group was underrepresented (11.7% observed vs 36.5% expected). By tumor type, the most significantly underrepresented groups were 0- to 4-year-old children and Hispanics for both solid cancers (11% observed vs 34.4% expected for 0- to 4-year-old children and 12% observed vs 24% expected for Hispanics) and LH cancers (16% observed vs 40% expected for 0- to 4-year-old children and 19.4% observed vs 33% expected for Hispanics).Conclusions: Although sex and racial/ethnic groups are mostly proportionally represented in phase 1 trials, some specific subgroups such as Hispanic children are underrepresented and may benefit from focused accrual. Cancer 2016;122:3207-14. © 2016 American Cancer Society. [ABSTRACT FROM AUTHOR]

Background: The last 3 decades have witnessed limited therapeutic advances in small cell lung cancer (SCLC) management. This study evaluated real-world trends in the use of systemic therapies and the impact on patient outcomes in the United States.Methods: The Surveillance, Epidemiology, and End Results-Medicare database was used to find patients diagnosed with SCLC between 1985 and 2005. The 1985-1990 period served as the baseline for a temporal analysis conducted at 5-year intervals (1985-1990, 1991-1995, 1996-2000, and 2001-2005). Cox proportional models were used to estimate the effect of chemotherapy on survival. Results were validated with a propensity-matched analysis.Results: There were 47,351 eligible patients: 52% were male; the median age was 71 years; and 87% were white, 7% were black, and 1.4% were Asian. The proportion of patients treated with chemotherapy was low but increased over time (38%, 55%, 50%, and 53%; P < .001). Race, diagnosis period, age, stage, and location of residence significantly predicted chemotherapy use. Females (51%), Asians (53%), and rural residents (60%) were more likely to receive chemotherapy. The median overall survival with and without chemotherapy was 9.6 and 3.6 months, respectively. Linear trend analyses showed a modest reduction in the impact of chemotherapy on survival for patients treated with chemotherapy versus untreated patients (hazard ratios [HRs], 0.59, 0.61, 0.64, and 0.62; P < .001) but an overall trend of improved survival for treated (HRs, 1.0, 1.03, 1.00, and 0.96; P = .005) and untreated patients (HRs, 1.0, 0.99, 0.94, and 0.92; P < .001). There was no survival difference between patients treated with carboplatin and patients treated with cisplatin (HR, 0.99; confidence interval [CI], 0.81-1.19; P = .875). Additional therapy beyond platinum-based chemotherapy was associated with a survival benefit (HR, 0.78; CI, 0.75-0.81; P < .001).Conclusions: Chemotherapy use was associated with a survival benefit in Medicare patients with SCLC treated in a real-world setting. [ABSTRACT FROM AUTHOR]

Objectives. Disparity exists between patients with lung cancer enrolled in clinical trials and patients treated in the community setting. This study assessed the real-world effectiveness of cytotoxic agents that became available for the treatment of non-small cell lung cancer (NSCLC) in the last 2 decades. Methods. We employed the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database for patients diagnosed with stage IIIB/IV NSCLC between 1988 and 2005 to assess the effectiveness of newly approved agents. Effectiveness of specific agents was assessed at time periods immediately following the approval of the agent for NSCLC: baseline, 1988 -1994; platinum, 1995-1999; docetaxel, 1999 -2003; pemetrexed and bevacizumab, 2004-2005. Significant associations between specific drug treatment and survival improvement were determined using the Kaplan-Meier method, Cox proportional hazard model, and propensity score analyses. Significant differences were established by log-rank test. Results. This analysis employed data from 143,548 patients by sex (58% male,42%female), cancer stage (35% stage IIIB,65% stage IV), and age (12% 20-64 years, 22% 65-69 years, 45% 70 -79 years, 22% 80 years and older). There was temporal improvement in survival for patients treated with newly approved chemotherapy (1-year survival rates: 32.41% in 1988- 1994, 32.95% in 1995-1998, 37.40% in 1999 -2003, and 39.55% in 2004 -2005). Patients treated with a newly approved drug during the relevant treatment era had a significant reduction in the risk of death when compared with patients treated with chemotherapy other than the newly approved agent (hazard ratios [95% confidence interval] were 0.76 [0.71- 0.81] for platinum, 0.73 [0.70-0.75] for docetaxel, 0.40 [0.37- 0.44] for pemetrexed,and0.33 [0.27- 0.40] for bevacizumab; p < .001). Propensity score adjustment did not significantly alter these results. Conclusions. Currently approved drugs for the treatment of advanced NSCLC are associated with improved survival in the U.S. Medicare patient population. Our findings support the effectiveness of these agents in the real-world oncology practice. [ABSTRACT FROM AUTHOR]

Objective: Develop the WVCR-Linked dataset by combining the West Virginia Cancer Registry (WVCR) with Medicare, Medicaid, and other data sources. Determine health care utilization, costs, and overall burden of four major cancers among the elderly in a rural and medically underserved state population, and to compare them with national estimates. Method: We extracted personal identifiers from the West Virginia Cancer Registry (WVCR) data file for individuals ≥ 65 years of age with an incident diagnosis of any cancer between January 1, 2002 and December 31, 2007. We linked the extracted data with Medicare and Medicaid administrative data using deterministic record linkage procedures. We updated missing vital status information by linking the National Death Index (NDI) data file. The updated WVCR-Linked dataset was enriched by links to the U.S. decennial census (2000) file and the Area Resource File. Results: We identified 42,333 individuals, of which 41,574 (98.2%) and 6,031 (14.3%) individuals were matched with Medicare and Medicaid administrative data files, respectively. The NDI data added or updated vital status information for 3,295 (7.8%) individuals in the WVCR-Linked dataset. Conclusion: The WVCR-Linked dataset is a comprehensive dataset offering many opportunities to understand factors related to cancer treatment patterns, costs, and outcomes in a rural and medically underserved elderly Appalachian population. Following our example, non-participant states in the Surveillance, Epidemiology and End Results (SEER) program can build a powerful dataset to identify and target cancer disparities, and to improve cancer-related outcomes for their elderly and dual-eligible citizens. [ABSTRACT FROM AUTHOR]

Purpose: Cardiac radiation dose was a predictor of inferior overall survival in the Radiation Therapy Oncology Group 0617 non-small cell lung cancer trial. We examined the association between radiation therapy (RT) and cardiac events (CE) for patients with small cell lung cancer (SCLC).Methods and Materials: The US population-based Surveillance, Epidemiology, and End Results Program and Medicare claims databases were queried for rates of CE among patients with SCLC treated with chemotherapy (CTX) ± RT. Propensity score matching (PSM) and multivariate analysis were conducted. Patients were matched for actual/theoretical RT start date (to prevent immortal time bias) and then full PSM balanced clinical characteristics. Cumulative incidence function curves were generated.Results: From 2000 to 2011, 7060 patients were included: 2892 limited-stage SCLC (LS-SCLC) and 4168 extensive-stage SCLC. Grouping LS-SCLC and extensive-stage SCLC together, the incidence of CE for the CTX + RT and CTX-only groups was 44.1% versus 39% at 60 months (P = .008). After PSM (5286 patients), the incidence of CE for the CTX + RT and CTX-only groups was 43% versus 38.6% at 60 months (P = .033). Analysis of only LS-SCLC (2016 patients) demonstrated that the incidence of CE for CTX + RT versus CTX-only groups was 50.3% versus 42% at 60 months (P = .0231). Multivariate analysis again demonstrated an association between CE and RT (hazard ratio 1.20; 95% confidence interval 1.06-1.37; P = .005). After PSM (1614 patients), the incidence of CE for CTX + RT versus CTX-only groups was 51.7% versus 41.6% at 60 months (P = .0042).Conclusions: Patients with SCLC are at significant risk of developing CE posttreatment; RT is associated with an absolute increase in the rate of CE at 5 years of approximately 5% for all patients with SCLC and up to 10% for patients with LS-SCLC. Cardiac risk management and cardiac-sparing RT techniques should be further evaluated for patients with SCLC. [ABSTRACT FROM AUTHOR]