Evaluation and Comparison of Real-World Databases for Conducting Research in Patients With Colorectal Cancer.

PURPOSE: Evaluating whether patient populations in clinico-genomic oncology databases are comparable with whom in other databases without genomic component is important. METHODS: Four databases were compared for colorectal cancer (CRC) cases and stage IV CRC cases: American Association for Cancer Research Project Genomics Evidence Neoplasia Information Exchange Biopharma Collaborative (GENIE-BPC), The Cancer Genome Atlas (TCGA), SEER-Medicare, and MarketScan Commercial and Medicare Supplemental claims databases. These databases were also compared with the SEER registry database which serves as national benchmarks. Demographics, clinical characteristics, and overall survival were compared in patients with newly diagnosed CRC and patients with stage IV CRC across databases. Treatment patterns were further compared in patients with stage IV CRC. RESULTS: A total of 65,976 patients with CRC and 13,985 patients with stage IV CRC were identified. GENIE-BPC had the youngest patient population (mean age [years]: CRC, 54.1; stage IV CRC, 52.7). SEER-Medicare had the oldest patient population (CRC, 77.7; stage IV CRC, 77.3). Most patients were male and of White race across databases. GENIE-BPC had the highest proportion of patients with stage IV CRC (48.4% v other databases 13.8%-25.4%) and patients receiving treatments (95.7% v 37.6%-59.1%). Infusional fluorouracil, leucovorin, and oxaliplatin with or without bevacizumab was the most common regimen across databases accounting for 47.3%-78.5% of patients receiving first line of therapy. The median survival from diagnosis was 36, 94, 44 months (CRC) and 23, 36, 15 months (stage IV CRC) for patients in GENIE-BPC after left truncation, TCGA, and SEER-Medicare databases, respectively. CONCLUSION: Compared with other databases, GENIE-BPC had the youngest patients with CRC with the most advanced disease and the largest proportion of patients receiving treatment. Investigators should consider adjustments when extrapolating results from clinico-genomic databases to the general CRC population.

Mismatch Repair/Microsatellite Instability Testing Practices among US Physicians Treating Patients with Advanced/Metastatic Colorectal Cancer.

The study objective was to assess US physicians' Mismatch Repair/Microsatellite Instability (MMR/MSI) testing practices for metastatic colorectal cancer (mCRC) patients. A non-interventional, cross-sectional online survey was conducted among 151 physicians (91 oncologists, 15 surgeons and 45 pathologists) treating mCRC patients in the US. Eligible physicians were US-based with at least 5 years of experience treating CRC patients, had at least one mCRC patient in their routine care in the past 6 months, and had ordered at least one MMR/MSI test for CRC in the past 6 months. Descriptive and logistic regression analyses were performed. Awareness of specific MMR/MSI testing guidelines was high (n = 127, 84.1%). Of those, 93.7% (119/127) physicians had awareness of specific published guidelines with majority 67.2% (80/119) being aware of National Comprehensive Cancer Network (NCCN) guidelines. Universal testing for all CRC patients was performed by 68.9% (104/151) physicians, while 29.8% (45/151) selectively order the test for some CRC patients. Key barriers for testing included insufficient tissue sample (48.3%, 73/151), patient declined to have the test done (35.8%, 54/151) and insurance cost concerns for patients (31.1%, 47/151), while 27.2% (41/151) reported no barriers. The survey demonstrated high awareness and compliance with MMR/MSI testing guidelines although universal testing rates seem to be suboptimal.

Analysis of costs associated with administration of intravenous single-drug therapies in metastatic breast cancer in a U.S. population.

BACKGROUND: An estimated $8.1 billion (in 2004 dollars) is spent annually on total health care costs for the treatment of breast cancer in the United States. Breast cancer has traditionally been treated with intravenous (IV) cancer therapies that entail not only the drug acquisition cost, but additional costs of personnel time, supplies, and equipment used in the preparation and administration of the IV drug. A systematic study of the costs of IV administration in the metastatic breast cancer (MBC) population has not been performed. OBJECTIVE: To assess the cost components, overall and by payer type and patient age group, for administering a single-agent IV breast cancer drug to women with MBC in the United States. METHODS: Women diagnosed with MBC (ICD-9-CM codes 174.XX and 196.XX-198.XX) reported any time between January 1, 2003, and May 31, 2006, and receiving single-agent IV breast cancer therapy (including intramuscular fulvestrant) during a visit were identified (using HCPCS and CPT codes) from an administrative claims database supporting 46 general/oncology clinics in the United States. Study drugs were either FDA-approved for breast cancer or recommended for use as preferred single agents per National Comprehensive Cancer Network (NCCN) clinical practice guidelines for breast cancer. Costs were estimated using the contracted allowed payment, which is the amount that the provider is eligible to receive from all parties, including payers and patients. Costs were measured using 2 approaches-average cost per IV-administration visit and average cost per patient per month (PPPM). RESULTS: Over the 41-month study period (through May 31, 2006), 46,273 patients had a breast cancer diagnosis, of which 8,533 (18.4%) were metastatic; 828 (9.7%) of these patients received 1 of 11 single-agent IV breast cancer drugs over 7,406 visits. Mean (SD) total payments across all drugs and cost components were $2,477 ($1,842) per visit and $4,966 ($3,841) PPPM, of which IV administration costs were 10.2% of per-visit and 11.4% of PPPM costs, and other drugs and services provided during IV administration were 30.8% of per-visit and 32.2% of PPPM costs. In both the per-visit and PPPM analyses, approximately 80% of costs for other drugs and services (approximately 25% of total treatment costs) were attributed to (a) antihypercalcemic agents (e.g., zoledronic acid: 6%-8% of total treatment cost), (b) colony-stimulating factors (CSFs) (e.g., pegfilgrastim, epoetin: 6%-7%), or (c) other anticancer agents being used off-label or for other conditions (e.g., bevacizumab, irinotecan, carboplatin, vincristine: 11%-12%). The remaining 20% of costs for other drugs and services (about 6% of total costs) were attributable primarily to antiemetic agents (e.g., palonosetron, granisetron) and miscellaneous or unclassified products. Non-protein-bound paclitaxel was the most commonly used IV therapy at a mean cost of $2,804 per visit, with IV administration accounting for $353 (12.6%) and other services accounting for $1,237 (44.1%) of total costs per visit. The second most commonly used IV therapy was trastuzumab at a mean cost of $2,526 per visit, with IV administration accounting for $214 (8.5%) and other services accounting for $336 (13.3%) of total costs per visit. CONCLUSIONS: For patients being administered a single FDA-approved or NCCN-recommended IV drug for treatment of MBC, IV administration costs accounted for approximately 10%-11% of total cost, and the study drugs accounted for 56%-59%. Other drugs and services accounted for 31%-32%, most of which was attributable to antihypercalcemic agents, CSFs, anticancer drugs being used off-label for breast cancer or for other conditions, and antiemetic agents. Although costs of IV administration are 10%-11% of total IV chemotherapy costs for MBC and would clearly be avoided with the use of oral agents, the extent to which other costs would be avoided or incurred with use of oral agents is unknown and requires further research.

Prescription, over-the-counter, and herbal medicine use in a rural, obstetric population.

OBJECTIVE: The purpose of this study was to identify the medications that are consumed by a rural obstetric population during pregnancy. STUDY DESIGN: Over a period of 26 months, pregnant women were interviewed about medication use. Interviews on subsequent visits provided a longitudinal study of medication usage and discontinuation. Trend differences were analyzed according to the number of medications, the trimester of use, and insurance status. RESULTS: Five hundred seventy-eight participants had 2086 interviews. The compilation of the interviews showed that 95.8% of the participants took prescription medications, 92.6% of the participants self-medicated with over-the-counter medications, and 45.2% of the participants used herbal medications. Over time, consumption of over-the-counter medications exceeded prescription medication use. Fifteen percent of the pregnant women took ibuprofen at some point during the pregnancy (5.7% in the third trimester). Eight percent of the women were noncompliant and 20% incompletely compliant with prenatal vitamin and mineral formulations. CONCLUSION: Medication use was substantial in this population. Medications (eg, ibuprofen) that are contraindicated in pregnancy were used at unexpectedly high rates. Of the three medication classes, over-the-counter medications were used most frequently.