Treatment Patterns and Clinical Characteristics of Patients with Advanced Basal Cell Carcinoma in the Community Oncology Setting

Advanced basal cell carcinoma (aBCC) includes metastatic and locally advanced BCC that is inoperable (or with surgery contraindicated). We describe patient characteristics and treatment history for aBCC cases from community oncology. Nine cases of aBCC were found within the ACORN Data Warehouse, a community oncology database of >180,000 cancer patients. Data were summarized descriptively. Three illustrative case histories are presented. Patients were predominantly Caucasian (8/9), male (6/9), and over 60 (6/9). Four had metastatic disease;five had aBCC without metastasis. Five had a history of treatment for early stage BCC, including surgery (5/5), radiation (1/5), and none had chemotherapy. Those with history of early stage BCC had periods of apparent lack of follow-up and treatment. One had chemotherapy for aBCC (platinum based with radiation) and eight had radiation without chemotherapy. Patients had multiple comorbid serious medical conditions. Six were deceased, but only one was documented to have aBCC as cause of death. Advanced BCC is rare in community oncology settings. There appear to be gaps in the care and follow-up of patients with initial early stage BCC. More data and larger samples are needed from multi-specialty databases such as dermatology and head and neck surgery.

Overall Survival and Health Care Costs of Medicare Patients with Previously Treated Chronic Lymphocytic Leukemia

Background: Bendamustine-based regimens are often used in the management of patients with chronic lymphocytic leukemia (CLL) but few studies have analyzed the comorbidity- and/or adverse event (CAE)-related healthcare costs in patients receiving these regimens in a real-world setting. Aims: To describe all-cause and CAE-related healthcare costs in relapse/refractory (R/R) elderly patients with CLL treated with bendamustine-based regimens in a real-world setting. Methods: Adult patients with R/R CLL who received bendamustine-based regimens on/after January 2010 were selected from the Medicare Limited Data Set (LDS) 5% Standard Analytic Files. Selected patients were classified into cohorts based on the two most prevalent bendamustine-based regimens observed (index treatment): 1) bendamustine + rituximab (BR cohort) and 2) bendamustine monotherapy (B-mono cohort). For each cohort, all-cause and CAE-related healthcare costs, while on treatment, were reported per-patient-per-month (PPPM). Overall survival (OS) rates following initiation of the index treatment were described using age- and gender-adjusted Kaplan-Meier curves. Results: A total of 275 patients were included in the BR cohort and 100 patients in the B-mono cohort. Most patients were male and the mean age was approximately 75 years old. During treatment, total all-cause healthcare costs were $14,520 PPPM for the BR cohort and $13,125 PPPM for the B-mono cohort—outpatient costs (mainly driven by CLL-drug costs) represented 86.1% of the total all-cause healthcare costs for the BR cohort and 69.8% for the B-mono cohort. CAE costs accounted for 58.3% of the total all-cause healthcare costs for the BR cohort and 66.9% for the B-mono cohort. Median OS was 35 months in the BR cohort and 21 months in the B-mono cohort. Conclusion: In this population of elderly patients with R/R CLL treated with bendamustine-based regimens, CAEs were common and translated into important medical costs. Median OS was also relatively short suggesting an unmet medical need.

Increased Mortality Risk among Early Stage Hormone Receptor Positive Breast Cancer Patients Who Did Not Receive Adjuvant or Neoadjuvant Therapy

Background: Hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) is the most common biologic subtype of breast cancer. Although adjuvant therapy has demonstrated a survival benefit in clinical trials, its use is poorly understood in the real-world among elderly breast cancer patients since age is a barrier to receiving adjuvant therapy. An examination of treatment patterns and outcomes associated with receipt of adjuvant/neoadjuvant therapy among elderly HR + HER2-breast cancer patients was undertaken. Methods: There were 18,470 HR + HER2-breast cancer patients from the linked SEER-Medicare database. Patients were diagnosed with stage I-III disease between 1/1/2007-12/31/2011, ≥66 years, enrolled in Medicare Parts A, B and D, and underwent breast cancer surgery after diagnosis. Time-varying Cox proportional hazards regression assessed overall survival. Results: There were 13,670 (74%) patients treated with adjuvant/neoadjuvant therapy and 4800 (26%) untreated. Compared to treated patients, untreated patients were older, had earlier stage, lower grade, smaller tumors, poorer performance, higher comorbidity score, and less use of a 21-gene recurrence score (RS) assay (p < 0.0001). In the survival model, increasing age, stage, tumor size, tumor grade, comorbidity score and poor performance were significantly associated with higher mortality risks, while use of an RS assay was associated with lower risks. The Cox model showed a 48% higher risk of death in untreated compared to treated patients. In a subset of 8967 patients with stage I disease, tumor size < 2.0 cm and grade 1/2;untreated patients had a 22% higher risk of death compared to treated patients. Conclusions: Older patients with favorable clinical characteristics (earlier stage, smaller tumor, lower grade) are less likely to be treated and have a higher risk of death compared to adjuvant/neoadjuvant treated patients. An unmet need among older breast cancer patients persists.

Treatment Patterns and Mortality Risk among Elderly Patients with Metastatic Triple Negative Breast Cancer in the United States: An Observational Cohort Study Using SEER-Medicare Data

Purpose: Triple negative breast cancer is more aggressive than other breast cancer subtypes and accounts for up to 20% of all breast cancers. Despite the poorer prognosis, there are no approved targeted treatments available and chemotherapy remains the only choice. We examined treatment patterns and outcomes among elderly metastatic triple-negative breast cancer (mTNBC) patients in routine clinical practice. Methods: Patients were identified from the linked SEER-Medicare database between 1/1/2001 and 12/31/2013 and included de novo Stage IV (n = 776) and patients with distant metastasis followed an initial diagnosis of Stage I - III disease (n = 1851). Kaplan-Meier analyses and time-varying Cox proportional hazards regression were used to assess overall survival (OS). Results: The mean age at metastatic diagnosis was 77.6 years and 1259 (48%) patients received chemotherapy. Compared to <70 year olds, ≥70 year olds had worse performance status, higher comorbidity burden, and were less likely to receive chemotherapy (45% vs. 66%). Patients treated with chemotherapy had increased OS compared to untreated patients, and the survival advantage was more pronounced in the -month longer unadjusted OS compared to the ≥70 cohort (log rank p < 0.0001). This finding was supported in the adjusted multivariate model which showed a 46% increased risk of death for untreated patients in the <70 year olds and a 17% increased risk of death for untreated patients in the ≥70 year olds (vs. treated). Conclusions: In this real-world analysis, 48% of elderly mTNBC patients did not receive chemotherapy and a greater proportion were untreated in the ≥70 year old cohort (55%). Although the survival benefits of chemotherapy were greater in the younger cohort, the benefits of treatment persisted in ≥70 year olds. These findings suggest opportunities exist to improve the clinical treatment of elderly mTNBC patients.

The Unmet Need in Chronic Lymphocytic Leukemia: Impact of Comorbidity Burden on Treatment Patterns and Outcomes in Elderly Patients

Introduction: Chronic lymphocytic leukemia (CLL) is a disease of the elderly. Elderly patients often have increased comorbidity burden and loss of organ reserve that may impact their ability to tolerate cancer therapy. We described realworld characteristics of typical CLL patients and identified factors predictive of receiving treatment. Methods: A retrospective cohort analysis of 8343 first primary CLL patients was performed using the linked Surveillance, Epidemiology, and End Results-Medicare database. Patients were diagnosed from 1/1/1998 to 12/31/2007, >66 years, and continuously enrolled in Medicare Parts A and B in the year prior to diagnosis. Comorbidity was examined using the National Cancer Institute comorbidity index and the Cumulative Illness Rating Scale. Cox and Logistic regression modeling assessed patient characteristics predictive of receiving treatment within the first year after diagnosis. Results: Median follow-up time from diagnosis was 782 days. During the study time period, there were 3366 (40%) treated patients and 4977 (60%) untreated. Even among those diagnosed with advanced stage (n = 4213), 57% were not treated. Treated patients were younger at diagnosis compared to untreated (76 vs. 79;p < 0.0001). In general, as age increased, the incidence and severity of comorbidities increased. In multivariate regression analyses, the treatment rate was significantly lower among patients >80 years, females, and with early stage disease;and significantly decreased with increasing comorbidity burden. Conclusions: Age, gender, comorbidity and stage were predictive of receiving treatment. Among patients with advanced stage, 57% were not being treated possibly due to older age and/or higher comorbidity burden.