Cost-effectiveness of different surgical treatment approaches for early breast cancer: a retrospective matched cohort study from China.

BACKGROUND: Both breast-conserving surgery and breast reconstruction surgery are less popular in China, although they can improve patients' quality of life. The main reason comes from the economy. There is currently no economic evaluation of different surgical treatment options for early breast cancer. Our study aims to assess the economic impact and long-term cost-effectiveness of different surgical treatments for early breast cancer. The surgical approaches are including mastectomy (MAST), breast-conserving therapy (BCT), and mastectomy with reconstruction (MAST+RECON). METHODS: Based on demographic data, disease-related information and other treatments, we applied propensity score matching (PSM) to perform 1: 1 matching among patients who underwent these three types of surgery in the tertiary academic medical center from 2011 to 2017 to obtain a balanced sample of covariates between groups. A Markov model was established. Clinical data and cost data were obtained from the medical records. Health utility values were derived from clinical investigations. Strategies were compared using an incremental cost-effectiveness ratio (ICER). RESULTS: After PSM, there were 205 cases in each group. In the matched data set, the distribution of covariates was fully balanced. The total cost of MAST, MAST+RECON and BCT was $37,392.84, $70,556.03 and $82,330.97, respectively. The quality-adjusted life year (QALYs) were 17.11, 18.40 and 20.20, respectively. Compared with MAST, MAST+RECON and BCT have an ICER of $25,707.90/QALY and $14,543.08/QALY, respectively. The ICER of BCT vs. MAST was less than the threshold of $27,931.04. The reliability and stability of the results were confirmed by Monte Carlo simulation and sensitivity analysis. CONCLUSIONS: We believe that in the context of the limited resources in China, after comparing the three surgical approaches, BCT is the more cost-effective and preferred solution.

Burden of early, advanced and metastatic breast cancer in The Netherlands.

BACKGROUND: The aim of this study was to estimate the total economic and health related burden of breast cancer in the Netherlands. METHODS: Data on incidence, prevalence, mortality and survival were extracted from the Dutch National Cancer Registry and were used to calculate the economic and health related burden of breast cancer for overall, DCIS (stage 0), early- (stage I), locally advanced- (stage II-III) and metastatic- (stage IV) breast cancer by age groups and by year (if applicable). RESULTS: The overall incidence of breast cancer increased from 103.4 up to 153.2 per 100,000 women between 1990 and 2014. The increase was driven by DCIS and early breast cancer as the incidence of locally advanced and metastatic breast cancer remained stable. Between 1990 and 2014, ten-year overall survival rates increased from 87% to 93% for early breast cancer, 41% to 62% for locally advanced- and from 6% to 9% for metastatic disease. Annually, breast cancer in the Netherlands is responsible for approximately 3100 deaths, 26,000 life years lost, 65,000 Disability Adjusted Life Years (DALYs) and an economic burden of €1.27 billion. CONCLUSIONS: This study provides a comprehensive assessment of the burden of breast cancer and subsequent trends over time in the Netherlands.

Cost-effectiveness of surgeon performed intraoperative specimen ink in breast conservation surgery.

BACKGROUND: Re-excision rates after breast conservation surgery are reported to be 20%-40%. Inaccuracies with specimen orientation may affect margin assessment. This study examined whether the addition of surgeon performed intraoperative inking of the lumpectomy specimen after adoption of margin guidelines would be cost-effective. METHODS: A retrospective review of a prospective surgical database was performed from 2009 to 2017. Patients with initial lumpectomy and a preoperative diagnosis of invasive breast carcinoma or ductal carcinoma in situ (DCIS) were included. Re-excision rates and the surgical costs per 100 initial lumpectomies were compared across three periods: before margin guideline publication, after guideline adoption, and after the addition of intraoperative surgeon performed specimen inking. RESULTS: Four hundred initial lumpectomies were evaluated. Overall re-excision rate was 21% (n = 84). There was a nonsignificant reduction in re-excision rates after margin guidelines from 24% (n = 36) to 20% (n = 23) and to 19% (n = 25) after addition of intraoperative specimen ink. Re-excision rates were significantly lower for invasive cancer than for DCIS across three periods (20%, 15%, and 12% versus 37%, 33%, and 31%) (odds ratio 3.31, P = 0.007). The estimated cost of re-excision per 100 initial lumpectomies decreased after guidelines by 25% ($128,270) for invasive breast cancer and by 11% ($102,616) for DCIS. The addition of intraoperative specimen inking after margin guideline adoption resulted in further 17% cost savings ($66,692) for invasive breast cancer and 5% ($41,308) for DCIS. CONCLUSIONS: Surgeon performed intraoperative inking of the lumpectomy specimen after adoption of margin guidelines is a cost-effective technique in breast conservation surgery.

Economic Impact of Routine Cavity Margins Versus Standard Partial Mastectomy in Breast Cancer Patients: Results of a Randomized Controlled Trial.

OBJECTIVE: The aim of the study was to compare costs associated with excision of routine cavity shave margins (CSM) versus standard partial mastectomy (PM) in patients with breast cancer. BACKGROUND: Excision of CSM reduces re-excision rates by more than 50%. The economic implications of this is, however, unclear. METHODS: Between October 21, 2011 and November 25, 2013, 235 women undergoing PM for Stage 0-III breast cancer were randomized to undergo either standard PM ("no shave", n = 116) or have additional CSM taken ("shave", n = 119). Costs from both a payer and a hospital perspective were measured for index surgery and breast cancer surgery-related care through subsequent 90 days. RESULTS: The 2 groups were well-matched in terms of baseline characteristics. Those in the "shave" group had a longer operative time at the initial surgery (median 76 vs 66 min, P < 0.01), but a lower re-excision rate for positive margins (13/119 = 10.9% vs 32/116 = 27.6%, P < 0.01). Actual direct hospital costs associated with operating room time ($1315 vs. $1137, P = 0.03) and pathology costs ($1195 vs $795, P < 0.01) were greater for the initial surgery in patients in the "shave" group. Taking into account the index surgery and the subsequent 90 days, there was no significant difference in cost from either the payer ($10,476 vs $11,219, P = 0.40) or hospital perspective ($5090 vs $5116, P = 0.37) between the "shave" and "no shave" groups. CONCLUSIONS: Overall costs were not significantly different between the "shave" and "no shave" groups due to significantly fewer reoperative surgeries in the former.

Influence of Distance to Hospital and Insurance Status on the Rates of Contralateral Prophylactic Mastectomy, a National Cancer Data Base study.

INTRODUCTION: We evaluated the impact of travel distance and insurance status on contralateral prophylactic mastectomy (CPM) rates in breast cancer. METHODS: We queried the National Cancer Data Base (NCDB) for women >18 years of age with a nonmetastatic primary breast cancer of ductal, lobular, or mixed histology. Patient- and facility-specific CPM rates were calculated based on insurance, race, and distance to treatment center. Standard univariable and multivariable regression analysis was performed. RESULTS: Overall, the CPM rate was 6.5% for the 864,105 patients identified. Most patients traveled <20 miles to a treatment center (79.5%) and had private insurance or Medicare (58.3 and 33.4%, respectively). In general, younger, White, non-Hispanic, and privately insured patients residing further from a treatment center was associated with increased rates of CPM. However, distance to the treatment center and insurance type had a greater absolute impact on rates of CPM for Black and Hispanic patients. Absolute CPM rate increases for patients >100 miles from a treatment center compared with those <20 miles from a treatment center were observed to be greater for Black and Hispanic patients (3.5 and 3.9%, respectively) compared with White and non-Hispanic patients (2.5 and 2.6%). Additionally, further patient travel distance was associated with higher treatment center-specific CPM rates. CONCLUSION: Increased travel distance is independently associated with increased rates of CPM for all patients and increased facility-specific rates of CPM. Black and Hispanic patients were found to be more vulnerable to the impact of travel distance and insurance status on rates of CPM.

Cavity Shaving Reduces Involved Margins and Reinterventions Without Increasing Costs in Breast-Conserving Surgery: A Propensity Score-Matched Study.

BACKGROUND: Currently, reinterventions for involved margins after breast-conserving surgery remain common. The aim of this study was to assess the capability of the cavity shave margins (CSM) technique to reduce positive margin rates and reoperations compared with simple lumpectomy (SL). The impact of CSM on the various biological portraits of breast cancer and costs were also investigated. METHODS: A retrospective review of 976 consecutive patients from a single center was performed; 164 patients underwent SL and 812 received CSM. All patients were treated with an oncoplastic approach. and involved margins and reoperations were compared for each group. To avoid selection bias, propensity score-matched analysis was performed before applying a logistic regression model. Main outcomes were reanalyzed for each biological portrait, and surgery and hospitalization costs for SL and CSM were compared. RESULTS: Clear margins were found in 98.3% of patients in the CSM group versus 74.4% of patients in the SL group (p < 0.001). The reoperation rate was 18.9% in the SL group and 1.9% in the CSM group (p < 0.001). After propensity score-matched logistic regression, odds ratio (OR) for positive final margin status was 6.2 (95% confidence interval [CI] 2.85-13.46; p < 0.001) without CSM, while OR for reintervention was 5.46 (95% CI 2.21-13.46; p < 0.001). CSM significantly reduced positive margins and reexcisions for Luminal A, Luminal B, and triple-negative breast cancers (p < 0.001, p < 0.001, and p = 0.0137, respectively). SL had higher global costs compared with CSM: €193,630.6 versus €177,830 for 100 treated patients (p = 0.009). CONCLUSIONS: CSM reduces reexcisions, mainly in luminal breast cancers, without increasing costs.

A cost-effective handheld breast scanner for use in low-resource environments: a validation study.

BACKGROUND: With the incidence of breast cancer rising worldwide, we are evaluating the iBreastExam (iBE) (UE LifeSciences Inc.), a handheld breast scanning device that can be utilized by community health workers to screen for breast abnormalities. The purpose of this study is to determine the sensitivity of the iBE in a population undergoing diagnostic breast imaging. METHODS: Adult patients presenting to a breast imaging center for a diagnostic workup were eligible. Patients underwent an iBE exam performed by a trained ultrasound technician followed by their indicated imaging. Demographic, imaging, and biopsy data were recorded. RESULTS: Seventy-eight iBE exams were completed, 77 females and one male with a mean age of 42 (21-79). All patients were evaluated by ultrasound, 52 had diagnostic mammography and 39 had biopsies. Imaging and/or biopsy confirmed a mass (fibroadenoma, cyst, papilloma, myofibroblastoma, fat necrosis, DCIS, or cancer) in 60 patients. Twelve patients had a cancer diagnosed. In total, 342 quadrants were scanned, 77 quadrants had lesions confirmed on imaging, and iBE correctly identified 66 lesions for a sensitivity of 86 % and specificity of 89 %. CONCLUSIONS: This validation study demonstrated excellent sensitivity of iBE for the identification of clinically significant lesions in patients presenting for diagnostic imaging. TRIAL REGISTRATION: A Cost-Effective Handheld Breast Scanner for Use in Low Resource Environments: A Validation Study: NCT02814292 .

Margin re-excision and local recurrence in invasive breast cancer: A cost analysis using a decision tree model.

BACKGROUND: SSO-ASTRO recently published guidelines defining adequate margins in breast conservation therapy (BCT) as no tumor on ink based on studies demonstrating little difference in local recurrence (LR) with wider margins. We hypothesize that not routinely re-excising close margins results in decreased costs without compromising care. METHODS: A decision tree model was developed for the management of margins after BCT for invasive cancer. Patients were compared among three margin status groups: positive, close (≤2 mm) and negative (>2 mm). Ten publications provided re-excision rates (RER) and LR rates. The model assumed 140,000 BCT/year. Sensitivity analyses determined the most cost-effective strategy. Surgical costs were estimated using 2013 Medicare reimbursement rates. RESULTS: Re-excising close margins was significantly more costly than the alternative, $233.1 million versus $214.3 million, per year in the United States. Total surgical cost was most sensitive to re-excision of close margins-increasing the RER from 0% to 100% resulted in an $18.8 million cost difference. CONCLUSIONS: The strategy of re-excising close margins resulted in a predicted cost of $18.8 million per year. This does not include hospital costs, the cost of surgical complications after re-excision, and underestimates the potential savings by using Medicare reimbursement rates.

Cost comparison of radiation treatment options after lumpectomy for breast cancer.

BACKGROUND: Radiation therapy (RT) after lumpectomy for breast cancer can be delivered with several different regimens. We evaluated a cost-minimization strategy to select among RT options. METHODS: An institutional review board (IRB)-approved retrospective review identified a sample of 100 women who underwent lumpectomy for invasive or in situ breast cancer during 2009. Post lumpectomy RT options included: no radiation in women ≥70 years [T1N0, estrogen receptor (ER)+] per Cancer and Leukemia Group B (CALGB) 9343 (no-RT), accelerated external-beam partial-breast irradiation (APBI), and Canadian fractionation (C-RT), as alternatives to standard whole-breast radiation therapy (WBRT). Eligibility for RT regimens was based on published criteria. RT costs were estimated using the 2011 US Medicare Physician Fee Schedule and average Current Procedural Terminology (CPT) codes billed per regimen at our institution. Costs were modeled in a 1,000-patient theoretical cohort. RESULTS: Median patient age was 56.5 years (range 32-93 years). Tumor histology included invasive ductal cancer (78 %), ductal carcinoma in situ (DCIS) (15 %), invasive lobular cancer (6 %), and mixed histology (1 %). Median tumor size was 1 cm (range 0.2-5 cm). Estimated per-patient cost of radiation was US$5,341.81 for APBI, US$9,121.98 for C-RT, and US$13,358.37 for WBRT. When patients received the least expensive radiation regimen for which they were eligible, 14 % received no-RT, 44 % received APBI, 7 % received C-RT, and 35 % defaulted to WBRT. Using a cost-minimization strategy, estimated RT costs were US$7.67 million, versus US$13.36 million had all patients received WBRT, representing cost savings of US$5.69 million per 1,000 patients treated. CONCLUSIONS: A cost-minimization strategy results in a 43 % reduction in estimated radiation costs among women undergoing breast conservation.

[10-year changes and development of surgical treatment for breast cancer in China].

OBJECTIVE: To investigate the changes and development of surgical treatment for breast cancer from 1999 to 2008 in China, and compare the differences between the surgical methods used in high-resource and low-resource areas. METHODS: Clinicopathological data of surgical treatment for female primary breast cancer was collected via medical chart review at hospitals in seven geographic areas in China. Chi-square test and chisqure test for linear trends were used to analyze the changes and development of the surgical methods used for breast cancer in the 10 years. RESULTS: A total of 4211 primary breast cancer patients were selected from the 10-year database, including 4078 women (97.5%) treated by surgical operation. Among 3271 women (80.21%) treated with modified radical mastectomy, the surgical rate was rising from 68.89% in 1999 to 80.17% in 2008, ascending by 11.28% (χ(2) = 31.143, P < 0.001). In high-resource areas, the surgical rate of modified radical mastectomy was rising from 45.64% in 1999 to 76.13% in 2008, ascending by 30.49% (χ(2) = 89.393, P < 0.001), while in low-resource areas it kept a steady rate at 80% in the ten years (χ(2) = 2.113,P = 0.146). Among 231 women (5.66%) treated with breast-conserving surgery, the surgical rate was rising from 1.29% in 1999 to 11.57% in 2008, ascending by 10.28% (χ(2) = 102.835, P < 0.001). In high-resource areas, the surgical rate of breast-conserving surgery was rising from 2.68% in 1999 to 16.87% in 2008, ascending by 14.19% (χ(2) = 69.544, P < 0.001), while in low-resource areas it was rising from 0.42% in 1999 to 6.22% in 2008, ascending by 5.80% (χ(2) = 30.003, P < 0.001). Among 469 women (11.50%) treated with Halsted radical mastectomy, the surgical rate was declining from 28.28% in 1999 to 4.96% in 2008, descending by 23.32% (χ(2) = 206.202, P < 0.001). In high-resource areas, the surgical rate of Halsted radical mastectomy was declining from 50.34% in 1999 to 3.29% in 2008, descending by 47.05% (χ(2) = 274.830, P < 0.001), while in low-resource areas it was declining from 14.58% in 1999 to 6.64% in 2008, descending by 7.94% (χ(2) = 8.166, P = 0.004). Among 3786 women treated with breast mastectomy (including modified radical mastectomy and Halsted radical mastectomy), the surgical rate was declining from 98.46% in 1999 to 86.36% in 2008, descending by 12.10% (χ(2) = 95.744, P < 0.001). In high-resource areas, the surgical rate of breast mastectomy was declining from 96.64% in 1999 to 80.66% in 2008, descending by 15.98% (χ(2) = 53.446, P < 0.001), while in low-resource areas it was declining from 99.58% in 1999 to 92.12% in 2008, descending by 7.46% (χ(2) = 36.758,P < 0.001). CONCLUSIONS: The main primary surgical treatment for breast cancer is modified radical mastectomy during the period 1999 - 2008. Halsted radical mastectomy is gradually replaced by modified radical mastectomy and breast-conserving surgery. The rate of changes for breast-conserving surgery and mastectomy is higher in high-resource areas than that in low-resource areas. Breast-conserving surgery will become the main treatment for early-stage breast cancer.

Gene expression profile testing for breast cancer and the use of chemotherapy, serious adverse effects, and costs of care.

As gene expression profile (GEP) testing for breast cancer may provide additional prognostic information to guide the use of adjuvant chemotherapy, we examined the association between GEP testing and use of chemotherapy, serious chemotherapy-related adverse effects, and total charges during the 12 months following diagnosis. Medical record review was conducted for women age 30-64 years, with incident, non-metastatic, invasive breast cancer diagnosed 2006-2008 in a large, national health plan. Of 534 patients, 25.8% received GEP testing, 68.2% received chemotherapy, and 10.5% experienced a serious chemotherapy-related adverse effect. GEP testing was most commonly used in women at moderate clinical risk of recurrence (52.0 vs. 25.0% of low-risk women and 5.5% of high-risk). Controlling for the propensity to receive GEP testing, women who had GEP were less likely to receive chemotherapy (propensity adjusted odds ratio, 95% confidence interval 0.62, 0.39-0.99). Use of GEP was associated with more chemotherapy use among women at low risk based on clinical characteristics (OR = 42.19; CI 2.50-711.82), but less use among women with a high risk based on clinical characteristics (OR = 0.12; CI 0.03-0.47). Use of GEP was not associated with chemotherapy for the moderate risk group. There was no significant relationship between GEP use and either serious chemotherapy-associated adverse effects or total charges. While GEP testing was associated with an overall decrease in adjuvant chemotherapy, we did not find differences in serious chemotherapy-associated adverse events or charges during the 12 months following diagnosis.

Evaluation of trastuzumab without chemotherapy as a post-operative adjuvant therapy in HER2-positive elderly breast cancer patients: randomized controlled trial [RESPECT (N-SAS BC07)].

OBJECTIVE: This trial is conducted to investigate the benefit of trastuzumab monotherapy compared with a combination therapy of trastuzumab and chemotherapy in women over 70 years with human epidermal growth factor receptor type-2-positive primary breast cancer. METHODS: Inclusion criteria are the following: histologically diagnosed as invasive breast cancer and received curative operation for primary breast cancer; Stage I, IIA, IIB or IIIA/M0; and baseline left ventricular ejection fraction is ≥55%. Patients are randomized to receive either trastuzumab (8 mg/kg loading dose, 6 mg/kg every 3 weeks for 1 year) plus chemotherapy selected from regimens specified on the protocol or trastuzumab monotherapy. The primary endpoint is disease-free survival. Secondary endpoints are overall survival, relapse-free survival, safety, health-related quality of life, comprehensive geriatric assessment and cost effectiveness. RESULTS: Patients recruitment has been commenced in October 2009. Enrollment of 300 patients is planned during the 4-year recruitment period. CONCLUSIONS: We hereby report the study concept.

Breast-Conserving Surgeries With and Without Cavity Shave Margins Have Different Re-excision Rates and Associated Overall Cost: Institutional and Patient-Driven Decisions for Its Utilization.

BACKGROUND: Reducing the rate of margin positivity and reoperations remains a paramount goal in breast-conserving surgery (BCS). This study assesses the effectiveness of standard partial mastectomy with cavity shave margins (CSM) compared with partial mastectomy with selective margin resection (SPM), with regard to outcomes of the initial surgeries, re-excisions, and overall costs. PATIENTS AND METHODS: This is a retrospective review of 122 eligible breast cancer patients who underwent BCS at one institution. The CSM and SPM groups each included 61 patients, matched for presurgical diagnoses and clinical stage. Data including margin status, rates and reason for re-excision, associated operation times, and costs were analyzed. RESULTS: Patients undergoing CSM had less than half the rate of positive margins (PMs) (10% vs. 23%; P = .03) and re-excisions (8% vs. 23%; P = .02) compared with SPM. In the former group, the margin involvement was focal, and re-excisions were performed almost exclusively for PMs. For SPM, the majority (92%) of PMs were on the main lumpectomy specimen rather than the selective margins, and re-excisions included, in addition to PMs, extensive or multifocal negative but close margins. Reduced breast tissue volumes were removed with CSM, particularly for patients undergoing a single surgery (47 vs. 165 cm3; P < .001). The initial surgery with CSM is on average 27% more costly than that for SPM (P < .001), due to the increased pathology costs which are partially offset by the increased re-excision rates in SPM. CONCLUSION: Circumferential cavity shaving, associated with consistent lower PMs, tissue volumes excised, and re-excision rates, is appropriate for routine implementation as a method offering superior surgical outcomes.

Cost modeling of preoperative axillary ultrasound and fine-needle aspiration to guide surgery for invasive breast cancer.

PURPOSE: Preoperative axillary lymph node ultrasound (US) and fine-needle aspiration (FNA) biopsy can identify a proportion of node-positive patients and avoid sentinel lymph node (SLN) surgery and direct surgical treatment. We compared the costs with preoperative US/FNA to without US/FNA (standard of care) for invasive breast cancer. METHODS: Using decision-analytic software we constructed a model to assess the costs associated with the two preoperative strategies. Diagnostic test sensitivities and specificities were obtained from literature review. Costs were derived from Medicare payment rates and actual resource utilization. Base-case results were fully probabilistic to capture parameter uncertainty in economic results. RESULTS: Base-case results estimate total mean costs per patient of $10,947 ("$" indicates US dollars throughout) with the US/FNA strategy and $10,983 with standard of care, an incremental cost savings of $36, on average, per patient [95% confidence interval (CI) of cost difference: -$248 to $179]. Most (63%) of the simulations resulted in cost saving with axillary US/FNA. One-way sensitivity analyses suggest that results are sensitive to assumed diagnostic and surgical costs and selected diagnostic test parameters. US/FNA approach was similar in costs or cost saving relative to the standard of care for all tumor stages. CONCLUSIONS: The additional cost of performing axillary US with possible FNA in every patient is balanced, on average, by the savings from avoiding SLN in cases where metastasis can be documented preoperatively. Routine use of preoperative axillary US with FNA to guide surgical planning can decrease the overall cost of patient care for invasive breast cancer.

Development of a method to determine the cost of breast cancer treatment with chemotherapy at Groote Schuur Hospital, Cape Town, South Africa.

BACKGROUND: There has been no comprehensive study determining the financial burden of breast cancer in the South African (SA) public sector. OBJECTIVES: To develop a method to determine the cost of breast cancer treatment with chemotherapy per episode of care and to quantify the associated costs relating to chemotherapy at Groote Schuur Hospital (GSH), a government hospital in SA. These costs included costs associated with the management of adverse events arising from chemotherapy. METHODS: Retrospective patient-level data were collected for 200 patients from electronic databases and patient folders between 2013 and 2015. Direct medical costs were determined from the health funder's perspective. The information collected was categorised into the following cost components: chemotherapy medicines, support medicines, administration of chemotherapy, laboratory tests, radiology scans and imaging, doctor consultations and adverse events. Time-and-motion studies were conducted on a set of new patients and the data obtained were used for the study sample of 200 patients. All the above costs were used to determine the cost of chemotherapy per episode of care. The episode of care was defined as the care provided from 2 months prior to the date of commencing chemotherapy (pre-chemotherapy phase), during chemotherapy (treatment phase) and until 6 months after the date when the last cycle of chemotherapy was administered (follow-up phase). RESULTS: A method was developed to determine the episode-of-care costs for breast cancer at GSH. The total direct medical cost for treatment of breast cancer at GSH for 200 patients was ZAR3 154 877, and the average episode-of-care cost per patient was ZAR15 774. The average cost of management of adverse events arising from the various treatment modalities was ZAR13 133 per patient. It was found that the cost of treating a patient with adverse events was 1.8 times higher than the cost of treating a patient without adverse events. Of the patients, 86.5% managed to complete their prescribed chemotherapy treatment cycles, and the average cost of treatment of these patients was 1.3 times more than the average cost for patients who could not complete their treatment, based on the number of treatment cycles received. CONCLUSION: A comprehensive method to determine the costs associated with breast cancer management per episode of care was developed, and costs were quantified at GSH according to the treatment protocol used at the hospital.

Treatment patterns, clinical outcomes, health resource utilization, and cost in patients with BRCA-mutated metastatic breast cancer treated in community oncology settings.

PURPOSE: This retrospective study of community oncology patients with breast cancer gene (BRCA)-mutated metastatic breast cancer (MBC) examined treatment outcomes and health resource utilization (HRU) and costs for a sample of patients with human epidermal growth factor receptor 2 (HER2)-negative disease who were either hormone receptor positive (HR+) or triple negative breast cancer (TNBC). METHODS: Evidence from the Vector Oncology Data Warehouse, a repository of electronic medical records/billing data and provider notes, was analyzed. Treatment outcomes were progression-free survival (PFS) and overall survival (OS) from start of first-line therapy in the metastatic setting. HRU and cost measures were collected from the time of MBC diagnosis to end of the record. HRU included hospitalizations, emergency room visits, infused/parenteral supportive care drugs, and outpatient visits. Costs were computed both as total and monthly costs. RESULTS: 57 HR+ and 57 TNBC patients (2013-2015) met inclusion criteria. Eight TNBC patients did not get treatment. HR+ patients had median first line PFS of 12.1 months and TNBC patients had 6.1 months. HR+ patients had median OS from start of first line of 38.4 months, and TNBC patients had 23.4 months. Rate of use of infused/parenteral supportive care drugs was 25.5% overall and 36.7% among TNBC patients with 15.8% among HR+ patients. CONCLUSION: There is an unmet need in BRCA-mutated patients with MBC, including those with HR+ and TNBC disease. The unmet need among TNBC patients was most evident in that 12% were not treated and TNBC patients appeared to have poor treatment outcomes. MICRO ABSTRACT: Reviewed medical records for outcomes, resource utilization, and costs in 114 community patients with BRCA mutated metastatic breast cancer. 57 hormone positive (HP); 57 triple negative (TN). RESULTS: median PFS: 12.1 months HP; 6.1 TN. HP OS was 38.4; TN 23.4. Rate of infused supportive care drugs: 25.5% HP; 36.7% TN. Patients with TN disease need better therapeutic options.

Introduction of additional double reading of mammograms by radiographers: effects on a biennial screening programme outcome.

PURPOSE: To determine the effect of introducing radiographer double reading, in addition to standard radiologist double reading, on screening mammography outcome. METHODS: In period A, 66,225 mammograms were read by two screening radiologists. In period B, 78,325 mammograms were read by two radiographers in addition and radiologists were blinded to the referral opinion of the radiographers. Mammograms, for which only radiographers had suggested referral, (i.e. cases that would only be referred by technologists) were re-evaluated by the screening radiologists. Women were referred if at least one radiologist considered this necessary, and diagnostic costs of these additional referrals were estimated. RESULTS: In period A, 322 cancers were diagnosed after referral of 678 women. During period B, radiologists initially referred 1122 patients and 411 cancers were detected. Radiologists' referral rate was higher in period B than in period A (1.43% versus 1.02%, p<0.001), as well as the cancer detection rate per 1000 women screened (CDR) (5.25 versus 4.86, p=0.3). The positive predictive value of referral (PPV) was 36.6% versus 47.5% (p<0.001). In period B, radiologist review of 544 additional positive radiographer readings led to 102 extra referrals, with 29 additional cancers detected, resulting in an overall referral rate of 1.56% (compared to period A, p<0.001), an overall CDR of 5.62 (p=0.048) and an overall PPV of 35.9% (p<0.001). Workup expenses of the 102 additional referrals were euro60,274. CONCLUSION: Additional radiographer double reading detected cancers that would have been missed by radiologists. Mean expenses for diagnostic confirmation of these extra cancers was euro2078 per cancer.

Unsuccessful preoperative biopsies, fine needle aspiration cytology or core needle biopsy, lead to increased costs in the diagnostic workup in breast cancer.

Correct preoperative diagnosis of a breast lesion is essential for optimal treatment planning. Our aim was to compare feasibility of fine needle aspiration cytology (FNAC) and core needle biopsy (CNB) in diagnosis of breast lesions. The special aim was to evaluate the extra costs and delay in surgical treatment due to unsuccessful preoperative biopsies. Diagnostic work-ups in 572 patients with 580 breast lesions were retrospectively evaluated. FNAC was the first biopsy method for 339 lesions, CNB for 241 lesions. The postoperative diagnosis was malignant for 503 lesions. The preoperative rate of definitely malignant diagnosis was 67% (194/289) for FNAC and 96% (206/214) for CNB (p < 0.0001), and 95% and 99%, respectively (p = 0.0173), when also suspicious findings were included. In patients with FNAC, an additional needle biopsy was performed for 93 and a surgical biopsy for 62 lesions. In the CNB group, a subsequent CNB was performed for 2 and a surgical biopsy for 33. The frequent need for additional biopsies raised the total expenses of FNAC over those of CNB. Multiple biopsies may also delay cancer surgery. It is therefore recommended to use CNB as the initial needle biopsy method.

The impact and indications for Oncotype DX on adjuvant treatment recommendations when third-party funding is unavailable.

OBJECTIVES: Industry-supported decision impact studies demonstrate that Oncotype Dx (ODX) changes treatment recommendations (TR) in 24-40% of hormone receptor+/HER2- patients. ODX is not reimbursed by third-party payers in Australia, potentially resulting in more selective use. We sought to evaluate the impact of self-funded ODX on TRs. METHODS: Data collected included demographics, tumor characteristics, indication for ODX and pre- and post-recurrence score (RS) TR. Primary endpoint was frequency of TR change and associations with TR change were sought. RESULTS: Eighteen physicians contributed 382 patients (median age 54). A total of 232 (61%) of tumors were T1 and were grade 1, 2 and 3 in 49 (13%), 252 (66%) and 79 (21%). A total of 257 (67%) were node negative. Assay indications were: confirm need for chemotherapy (CT) (36%), confirm omission of CT (40%) and genuine equipoise (24%). RS was low (≤17) in 55%, intermediate (18-31) in 36% and high (≥32) in 9%. Thirty-eight percent of patients had TR change post-ODX. Sixty-five percent of patients recommended CT pre-ODX changed to hormone therapy alone (HT)-more likely if lower grade and if ER and/or PR > 10%. Fourteen percent of patients with pre-ODX TR for HT added CT-more likely if ER and/or PR ≤10% and if Ki67 > 15% Overall, TR for CT decreased from 47% to 24%. CONCLUSION: Patient-funded ODX changed TRs in 38% of patients, de-escalating 65% from CT to HT and adding CT to 14% of those recommended HT. These changes were greater than an industry-funded study suggesting that physicians can identify situations where the assay may influence decisions.

The Association Between Out-of-Pocket Costs and Adherence to Adjuvant Endocrine Therapy Among Newly Diagnosed Breast Cancer Patients.

OBJECTIVE: To determine how out-of-pocket costs for adjuvant endocrine therapy (AET) medication affects adherence among newly diagnosed breast cancer survivors with private health insurance who initiate therapy. MATERIALS AND METHODS: We examined medical and pharmacy claims for the 1-year period after initiating AET using the Truven Health Analytics MarketScan database. Adherence was defined as ≥80% proportion of days covered. Mean out-of-pocket costs for AET fill were measured as the sum of copayments, coinsurance, and deductibles and adjusted to 30-day amounts. Using a multivariable logistic regression model we calculated adjusted risk ratios controlling for age, comorbidities, type of surgery, use of chemotherapy and/or radiation therapy, average out-of-pocket costs for other services, and pharmacy use characteristics. RESULTS: Of the 6863 women 64 years and younger who were diagnosed with breast cancer and initiated AET, 73.9% were adherent (proportion of days covered≥80%). A total of 19% of patients had <$5 monthly out-of-pocket costs for AET, 30% had $5 to $9.99, 17% had $10 to $14.99, 10% had $15 to $19.99, and 25% had $20 or greater. Patients with out-of-pocket costs for AET between $10 and $14.99, $15 and $19.99, and >$20 were 6% to 8% less likely to be adherent compared with patients paying <$5.00, after controlling for covariates (P<0.05). Out-of-pocket costs for inpatient, outpatient, and other pharmacy services were not associated with adherence. CONCLUSIONS: A substantial proportion of privately insured patients are nonadherent to AET and out-of-pocket costs for AET medication are significantly associated with a greater likelihood of nonadherence.