Patterns of Biologics Use Across Treatment Lines in Elderly (Age >65) Medicare Patients With Metastatic Colon Cancer.

BACKGROUND: We explored biologics receipt in metastatic colon cancer. METHODS: We used Surveillance, Epidemiology, and End Results-Medicare data of 4,545 elderly patients diagnosed with incident metastatic colon cancer from 2003 to 2009, treated with chemotherapy and/or biologics, and followed up through 2010. RESULTS: A total of 2,504 (55%) patients received a biologics-containing regimen. Treatment with biologics fluctuated between 46% and 63% of first-line regimens and 67% and 73% of second-line regimens. Bevacizumab accounted for 95% of first-line and 68% of second-line biologics use. Cetuximab accounted for 33% of second-line and 48% of third-line use. Panitumumab accounted for 5% of second-line and 27% of third-line use. The adjusted odds of biologics receipt decreased rapidly with age, resulting in a threefold difference between the youngest and the oldest study participants in the sample (odds ratio [OR] 0.35, p < .01). African Americans (OR 0.77, p = .03) and patients with Charlson Comorbidity Index of 1 (OR 0.83, p = .02) or >1 (OR 0.75, p < .01) were considerably less likely to receive biologics therapy. Medicare state buy-in was associated with 2% lower odds of receiving biologics (OR 0.98, p = .04). CONCLUSION: After controlling for sociodemographic and clinical differences, age, race, comorbidities, and low income had a statistically significantly negative effect on the likelihood of receiving biologics among treated patients. Use of biologics varied over time, across the treatment continuum, and by chemotherapy regimen. Bevacizumab was most frequently used in both first- and second-line treatment. Cetuximab was the second most prescribed biologic. Panitumumab use was mostly limited to third-line treatment. IMPLICATIONS FOR PRACTICE: It is well-known that patients in the "real world" receive cancer treatments that do not reflect the strict treatment protocols of clinical trials. This is particularly true for complex and elderly patients with metastatic disease, who are frequently underrepresented in clinical trials. Although this article does not provide any additional evidence about the effectiveness of one treatment regimen or treatment sequence over another, it enhances our understanding of oncology practice outside of the clinical trial setting and provides useful information for future health services and health economics research in metastatic colon cancer.

Racial variation in the clinical and economic burden of skeletal-related events among elderly men with stage IV metastatic prostate cancer.

Prostate cancer (PCa) outcomes vary widely among African American (AA) and non-Hispanic White (NHW) men. The authors investigated racial variation in the incidence of skeletal-related events (SREs) and SRE-related healthcare costs among AA and NHW men, a topic that has received limited attention in the literature. AA and NHW men diagnosed with metastatic PCa were identified from the linked Surveillance, Epidemiology and End Results-Medicare dataset. The sample included 6455 men with metastatic PCa, including 5420 NHW men and 1035 AA men. Approximately 16% experienced SREs during follow-up. AA men were less likely to experience SREs compared with NHW men, controlling for individual characteristics (adjusted odds ratio: 0.79; 95% CI: 0.66- 0.94). The SRE-specific costs were US$35,725 (US$22,190-US$49,260) among AA men and US$25,896 (US$21,669-US$30,123) among NHW men. Although AA men were less likely to experience SREs, there were substantial costs attributable to the treatment of SREs among AA men.

Algorithm for identifying chemotherapy/biological regimens for metastatic colon cancer in SEER-Medicare.

BACKGROUND: Metastatic colon cancer (mCC) patients often receive multiple lines of chemotherapy/biological treatment (TX), yet subsequent TX lines have not been sufficiently examined using SEER-Medicare data. We developed an algorithm that identifies the number and type of TX lines received by mCC patients. METHODS: The algorithm rules for detecting TX lines were developed a priori and applied to SEER-Medicare data for 7951 elderly mCC patients, diagnosed in 2003-2007 and followed through 2009. Statistical analysis estimated the relationship between the number of treatments received and patient characteristics. Sensitivity analyses examined how results changed when different algorithm rules were used. RESULTS: Only 41% (3266) of mCC patients received any chemotherapy/biologics treatment; 1440 (18% of all, 44% of treated) and 274 (3% of all, 8% of treated) received second-line and third-line treatment, respectively. Initial and subsequent treatment regimens varied widely. Results were robust to alterations in the algorithm. CONCLUSIONS: The number of drugs used to treat cancer patients has increased during the past decade. Patients may have several TX lines with complex regimens. More guidance is needed with regard to identifying and studying these interventions using SEER-Medicare data. By proposing 1 approach to categorizing TX lines for mCC patients, we hope to empower the scientific community and to advance the use of SEER-Medicare data for health outcomes research.

Cost-effectiveness of second-line chemotherapy/biologics among elderly metastatic colon cancer patients.

INTRODUCTION: Advancements in chemotherapy treatment have improved the clinical management of metastatic colon cancer (mCC) patients. An increasing number of elderly mCC patients receive various combinations of regimens in second-line chemotherapy/biologics treatment (Tx2) after first-line treatment (Tx1) to prolong survival and/or palliate symptoms, but these regimens have higher costs. This analysis investigated the survival benefit and incremental cost associated with Tx2 among elderly mCC patients. METHODS: Elderly (aged ≥66 years) SEER-Medicare patients diagnosed with mCC in 2003-2007 were identified and followed until death or the end of 2009. Cox regression and partitioned least squares regression were utilized to obtain the survival benefit and incremental cost associated with Tx2 within a 5-year study period. A time-varying model was used to reduce bias due to sequential ordering of Tx1 and Tx2. The regressions controlled for patient demographic characteristics, clinical variables, and a proxy for poor performance. Bootstrapping was used to generate 95% confidence intervals (CI). RESULTS: Of the 3,266 elderly mCC patients who received Tx1, 2,744 (84%) died within the observation period; 1,440 (44%) received Tx2. The survival benefit associated with receipt of Tx2 was 0.33 years (95% CI 0.19-0.43), and the associated incremental cost was $40,888 (95% CI 3,044-44,324). The incremental cost-effectiveness ratio (ICER) for Tx2 was $123,903 per life year gained (95% CI 9,600-216,082). CONCLUSION: The estimated survival benefit of receiving second-line chemotherapy/biologics was about 4 months, which is consistent with evidence from clinical trials. This improved survival was associated with an ICER that exceeds the traditional threshold.

Benefits Improvement and Protection Act's impact on transplantation rates among elderly MEDICARE beneficiaries with end-stage renal disease.

BACKGROUND: The Benefits Improvement and Protection Act (BIPA) expanded Medicare coverage for posttransplantation immunosuppresants for elderly patients and others eligible for Medicare beyond their end-stage renal disease (ESRD) status yet retained the 3-year limit for patients eligible solely because of ESRD status. Our objective was to determine BIPA's impact on renal transplantation among elderly patients (age ≥65 years) affected by BIPA. METHODS: Medicare claims and the U.S. Renal Data System Standard Analysis Files were used to analyze the likelihood of transplantation among elderly patients, all of whom were affected by BIPA, versus the nonelderly, many of whom were unaffected by BIPA. A difference-in-differences approach and generalized logistic regressions were used to estimate BIPA's impact. RESULTS: Analysis of data for 632,904 ESRD Medicare beneficiaries who met inclusion/exclusion criteria suggests that BIPA made elderly patients more likely (relative likelihood, 1.36; 95% confidence interval, 1.32-1.41) to have a transplant. The likelihood for nonelderly patients decreased following BIPA (relative likelihood, 0.93; 95% confidence interval, 0.92-0.94). CONCLUSION: Transplantation rates increased among those elderly patients, all of whom were affected by BIPA by extending immunosuppressant coverage under BIPA. These results suggest that removing financial barriers to posttransplantation care may positively impact transplantation rates yet raise questions regarding whether the law shifted transplants from younger to older patients.

Impact of venous thromboembolism on mortality of elderly Medicare patients with stage III colon cancer.

BACKGROUND: The improvement in survival rates for patients with colon cancer has shifted the focus from examining cancer-specific mortality to exploring all-cause mortality. Adverse events such as venous thromboembolism (VTE) affect overall survival times and the net clinical benefit of cancer management strategies. METHODS: This retrospective study used Surveillance, Epidemiology and End Results (SEER) Medicare data to examine VTE incidence and mortality rates for elderly patients with stage III colon cancer who were diagnosed in 2004 or 2005 and followed through 2007. The impact of VTE on mortality was estimated using multivariable Cox proportional hazards regression. RESULTS: In all, 20.7% of 4,985 elderly patients with stage III colon cancer had clinically diagnosed VTE following diagnosis. All-cause mortality risk was higher for patients with a VTE diagnosis (hazard ratio [HR]: 1.15, 95% confidence interval [CI]: 1.04-1.27), greater comorbidity burden, more advanced tumor depth and nodal involvement within stage III, advanced age, and male sex; the risk was lower for patients treated with chemotherapy. VTE was associated with higher mortality hazards (HR: 1.41, 95% CI: 1.21-1.64) for patients treated with adjuvant chemotherapy but not for untreated patients. CONCLUSIONS: A new diagnosis of VTE significantly reduced survival rates for elderly patients with stage III colon cancer and further reduced survival rates for patients treated with chemotherapy. Improved prevention and management of VTE for elderly patients with stage III colon cancer who are at risk for VTE is warranted, particularly for patients treated with chemotherapy.

Health disparities in staging of SEER-medicare prostate cancer patients in the United States.

OBJECTIVES: To examine whether race or age disparities affected the odds of being staged among prostate cancer (PC) patients. Accurate staging is critical for determining treatment for PC. METHODS: Multivariable logistic regression models examined race and age disparities with respect to the odds of being staged among PC patients using Surveillance, Epidemiology, and End Results-Medicare data. Similar analyses were performed to estimate the adjusted odds of being staged with distant metastatic vs in situ or local/regional disease. RESULTS: The proportion of patients without staging ranged between 3% and 16% by age and between 6% and 8% by race. Adjusted results demonstrated statistically significant lower odds ratios (P <.05) for 70-74, 75-79, and 80+-year-olds of 0.76, 0.52, and 0.23, respectively, relative to PC patients aged 65-69. The odds of being staged for African Americans are 0.78 times that of non-Hispanic Whites (95% confidence interval = 0.72-0.86). The adjusted probability of distant metastatic disease at initial diagnosis is higher for African Americans (odds ratio = 1.61; 95% confidence interval = 1.47-1.76) and older men with odds ratios of 1.25, 1.85, and 4.33 for ages 70-74, 75-79, and 80+, respectively, compared with 65-69-year-olds (all P <.05). CONCLUSIONS: Even though the overall odds of being staged increased over time, race and age disparities persisted. When staging did occur, the probability of distant metastatic disease was high for African Americans, and there were increasing odds of metastatic disease for all men with advanced age.