Faculty Bibliography

PURPOSE: Patients with breast cancer who need adjuvant treatments often fail to receive them. High-quality, community-based patient-assistance programs are an underused, inexpensive resource to help patients with cancer obtain needed therapy. We sought to determine whether connecting women to patient-assistance programs would reduce underuse of adjuvant therapies. METHODS: We conducted a randomized trial of 374 women (190 assigned intervention [INT], 184 to usual care [UC]) with early-stage breast cancer who underwent surgery between October 2006 and August 2009. After initial needs assessment, individualized action plans were created to connect INT patients with targeted patient-assistance programs; UC patients received an informational pamphlet. Main outcome measures were receiving adjuvant treatment and obtaining help. RESULTS: High rates of INT and UC patients received treatment: 87% INT versus 91% UC women who underwent lumpectomy received radiotherapy (P = .39); 93% INT versus 86% UC women with estrogen receptor (ER) -negative tumors >/= 1 cm received chemotherapy (P = .42); 92% INT versus 93% UC women with ER-positive tumors >/= 1 cm received hormonal therapy (P = .80). Many women reported needs: 63% had informational; 55%, psychosocial; and 53%, practical needs. High rates of INT patients with needs connected with a program within 2 weeks (92%). At 6 months, INT and UC women used patient-assistance programs at similar rates (75% v 76%; P = .54). Women with informational or psychosocial needs were more likely to receive help (relative risk [RR], 1.77; 95% CI, 1.51 to 1.90 and RR, 1.37; 95% CI, 1.06 to 1.61, respectively). CONCLUSION: INT and UC patients received high rates of adjuvant treatment regardless of trial assignment. Patients with breast cancer who connect to relevant patient assistance programs receive useful informational and psychosocial but not practical help.

PURPOSE: Because insurers use performance and quality metrics to inform reimbursement, identifying remediable causes of poor-quality cancer care is imperative. We undertook this descriptive cohort study to assess key predictors of women's perceived quality of their breast cancer care and actual guideline-concordant quality of care received. PATIENTS AND METHODS: We surveyed inner-city women with newly diagnosed and surgically treated early-stage breast cancer requiring adjuvant treatment who were enrolled onto a randomized controlled trial (RCT) of patient assistance to reduce disparities in care. We assessed women's perceived quality of care and perceived quality of the process of getting care, such as getting referrals, test results, and treatments; we abstracted records to determine the actual quality of care. RESULTS: Of the 374 new patients with early-stage breast cancer enrolled onto the RCT, only a slight majority of women (55%) perceived their quality of care as excellent; 88% actually received good-quality, guideline-concordant care. Excellent perceived quality (P < .001) was significantly associated with patients' perception of the quality of the process of getting care (adjusted relative risk [RR], 1.78; 95% CI, 1.65 to 1.87). Also associated with perceived quality-and mediated by race-were trust in one's physician (adjusted RR, 1.43; 95% CI, 1.16 to 1.64) and perceived racism, which affected black women more than women of other races/ethnicities (black race-adjusted RR for perceived racism, 0.33 [95% CI, 0.10 to 0.87]; black race-adjusted RR for trust, 1.61 [95% CI, 0.97 to 1.90]; c = 0.82 for the model; P < .001). Actual quality of care provided did not affect perceived quality of care received. CONCLUSION: Patients' perceived quality of care differs from their receipt of high-quality care. Mutable targets to improve perceived quality of care include the processes of getting care and trusting their physician.

Background. The MammaPrint (MP) diagnostic assay stratifies breast cancer patients into high- and low-risk groups using mRNA analysis of a 70-gene profile. The assay is validated for assessment of patients with estrogen receptor positive or negative tumors less than 5 cm with 3 or fewer malignant lymph nodes. TargetPrint (TP) is an assay for assessing estrogen, progesterone, and HER2-neu receptor status based on mRNA expression. A potential limitation of these assays is that they require an evaluation of fresh tissue samples. There is limited published experience describing MP or TP implementation. Methods. Over 10 months, 4 breast surgeons obtained samples from 54 patients for MP/TP analysis. The samples were analyzed by Agendia Labs. The tumors were independently evaluated for receptor status using immunohistochemistry (IHC). Retrospectively, we identified patients who were assessed by MP/TP during this period. Patients who underwent OncotypeDx evaluation were also identified. Results. Of the 54 patients receiving MP, 4 were found ineligible for MP risk assessment because >3 lymph nodes were found to be malignant. Out of all eligible patients, 14/50 (28%) had samples whose quantity of tumor was not sufficient for analysis (QNS). Out of eligible patients with tumors <1 cm, 7/8 (88%) had QNS samples. 7/42 with tumors >/=1 cm (17%) had QNS samples. Nine patients had discordant receptor results when evaluated by IHC versus. TP. Of patients who also underwent OncotypeDx testing, 6/14 (43%) had discordant results with MP. Conclusions. This study indicates that using MP/TP assay is feasible in a tertiary care center but there may be utility in limiting MP testing to patients with tumors between 1 and 5 cm due to high likelihood of uninformative results in subcentimeter tumors. Further study is needed to explore the discordance between oncotype and MP results.

BACKGROUND: Atypical ductal hyperplasia and atypical lobular neoplasia are common benign breast diseases that increase breast cancer risk. We performed a cohort analysis that compared atypia patients for additional risk factors to asses the effect on breast cancer risk by atypia status. METHODS: This longitudinal cohort study used data from the Women At Risk High-Risk Registry at Columbia University Medical Center, New York. Women with atypia were compared to women without atypia across known risk factors to determine the combined effect on breast cancer development. Odds ratios (ORs) stratified by atypia status were calculated for each risk factor of interest with 95% confidence intervals (95% CIs). P values were calculated to determine statistical significance. RESULTS: The study population included 1598 high-risk women, 921 (57.6%) of whom had a history of biopsy-proven atypia. The remaining 677 high-risk women (42.4%) did not have atypia. Fifty women (3.1%) developed breast cancer. Alcohol was significantly associated with the development of breast cancer (P = 0.02) and increased breast cancer risk among women with atypia (OR, 2.13; 95% CI, 0.95-4.81) compared to women without atypia (OR, 1.71). The odds of breast cancer were higher for atypia patients with first-degree relatives (OR, 1.48; 95% CI, 0.64-3.35) compared to women with a relative and no atypia diagnosis (OR, 0.98; 95% CI, 0.41-2.63). The other risk factors of interest did not differ significantly by atypia status. CONCLUSIONS: Atypia patients who drank alcohol and had a first-degree relative with breast cancer have an increased risk of breast cancer compared to those without atypia. Continued understanding of the high-risk population will lead to more individualized protocols for risk reduction and prevention

Preoperative needle diagnosis (PND) is being considered as a quality measure in breast cancer surgery. This criterion has not been thoroughly evaluated in the literature. The purpose of this study is to assess ease of access to these data and rate of compliance in a tertiary care center. We retrospectively reviewed all our breast cancer cases between July 2006 and July 2007. The data were queried for preoperative needle diagnosis. Charts of patients who did not meet this criterion were reviewed to determine the cause for noncompliance. In the year 2006-2007, 396 breast cancer operations were performed (age range 19-96 years). Of 396 cases, 43 (11%) underwent a surgical procedure without diagnosis of cancer. In 19/396 (5%) cases PND was not feasible due to technical reasons. In 22/396 (5.5%) cases, preoperative needle biopsy did not render a malignant diagnosis: the pathology report was discordant with the radiological or clinical findings, or the needle biopsy result necessitated surgical resection. In only 2 of 396 cases (0.5%) was PND not attempted: an 80-year-old woman with a radiologically and clinically malignant mass, and a 43-year-old woman with a clinical and ultrasonographic suggestion of fibroadenoma. We conclude that data for preoperative needle diagnosis were easily accessible in our center. If this criterion is used as a quality measure in breast cancer surgery, 100% compliance may not be an achievable goal

BACKGROUND: Most women with localized breast cancer have a choice between mastectomy and breast conserving surgery (BCS). Aside from clinical factors, this decision may be associated with surgeon and patient characteristics. We investigated the effect of surgeon characteristics on the BCS rate. METHODS: We used the Surveillance, Epidemiology, and End Results-Medicare database to identify women >65 years, diagnosed with stages I-II BC, between 1991 and 2002, and used the Physician Unique Identification Number linked to the American Medical Association Masterfile to obtain information on surgeons. We investigated the association of patient demographic, tumor, and surgeon-related factors with receipt of BCS, using Generalized Estimating Equations to control for clustering. RESULTS: Of 56,768 women with breast cancer, 30,006 (53%) underwent BCS, whereas 26,762 (47%) underwent mastectomy. Between 1991 and 2002, the proportion of patients undergoing BCS increased from 35% to 60%. In a multivariate analysis, patients who received BCS were younger, of higher SES, and had more favorable tumor characteristics. They were also more likely to be black and live in metropolitan areas. Women who underwent BCS were more likely to have surgeons who were female (OR = 1.40; 95% CI: 1.25-1.55), US-trained (OR = 1.12; 95% CI: 1.02-1.22), with a larger patient panel (OR = 1.29; 95% CI: 1.21-1.39), and completed training after 1975 (OR = 1.16; 95% CI: 1.08-1.25), than surgeons of patients who underwent mastectomy. CONCLUSIONS: Surgeon characteristics, such as gender, training, year of graduation, and volume, are small but significant independent predictor of BCS. Efforts to differentiate whether these associations reflect patients' preferences, quality of physician training, surgeon attitudes, physician-patient communication, or other effects on decision-making are warranted

Information is lacking regarding the interaction of established breast cancer risk factors and patient age. We attempted to study this interaction in high-risk women at the extremes of age in our population. The Women-At-Risk Registry was queried for women who were < or =35 and > or =70 years of age. Enrollment criteria included: strong family history of breast cancer (FHBC), and/or biopsy-proven history of atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), or lobular carcinoma in situ (LCIS). Descriptive analyses and Fisher's exact tests were used to analyze these factors and to assess their influence on breast cancer development. Our population included 1,412 high-risk women with median follow-up of 4 years. Of 195 women < or =35 years, 3 (1.5%) developed breast cancer. All three had strong FHBC and none had a prior high-risk lesion. Of 82 women > or =70 years, 6 (7.3%) developed breast cancer. Mean Gail score for women > or =70 years was 4.3, as compared with 4.7 in the subset of older women diagnosed with cancer. Fisher's tests demonstrated that ADH (p = 0.15), ALH (p = 1.0), LCIS (p = 1.0), and FHBC (p = 1.0) were not associated with breast cancer development in older women. We conclude that, for women < or =35 years, a significant FHBC may be a stronger predictor for breast cancer development than high-risk lesions. For women > or =70 years, FHBC and history of ADH, ALH, and LCIS were not predictors of breast cancer. This study emphasizes the importance of defining age-appropriate recommendations for breast cancer risk management, including surveillance and chemoprevention