The effect of referral for genetic counseling on genetic testing and surgical prevention in women at high risk for ovarian cancer: Results from a randomized controlled trial.

BACKGROUND: Guidelines recommend genetic counseling and testing for women who have a pedigree suggestive of an inherited susceptibility for ovarian cancer. The authors evaluated the effect of referral to genetic counseling on genetic testing and prophylactic oophorectomy in a randomized controlled trial. METHODS: Data from an electronic mammography reporting system identified 12,919 women with a pedigree that included breast cancer, of whom 625 were identified who had a high risk for inherited susceptibility to ovarian cancer using a risk-assessment questionnaire. Of these, 458 women provided informed consent and were randomized 1:1 to intervention consisting of a genetic counseling referral (n = 228) or standard clinical care (n = 230). RESULTS: Participants were predominantly aged 45 to 65 years, and 30% and 20% reported a personal history of breast cancer or a family history of ovarian cancer, respectively. Eighty-five percent of women in the intervention group participated in a genetic counseling session. Genetic testing was reported by 74 (33%) and 20 (9%) women in the intervention and control arms (P < .005), respectively. Five women in the intervention arm and 2 in the control arm were identified as germline mutation carriers. Ten women in the intervention arm and 3 in the control arm underwent prophylactic bilateral salpingo-oophorectomy (P < .05). CONCLUSIONS: Routine referral of women at high risk for ovarian cancer to genetic counseling promotes genetic testing and prophylactic surgery. The findings from the current randomized controlled trial demonstrate the value of implementing strategies that target women at high risk for ovarian cancer to ensure they are offered access to recommended care. CA Cancer J Clin 2016. © 2016 American Cancer Society, Inc. Cancer 2016;122:3509-3518. © 2016 American Cancer Society.

Cancer Risk Awareness and Concern among Women with a Family History of Breast or Ovarian Cancer.

Women with a documented deleterious mutation in BRCA1 or BRCA2 are at substantially elevated risk for ovarian cancer. To understand what percentage of women with high-risk family histories know their risk is elevated we surveyed 1,885 women with a high- or moderate-risk family history and no personal history of breast or ovarian cancer, and asked about their perceived risk of breast and ovarian cancer. Among high-risk women, fewer than 20% reported use of genetic counseling, and knowledge of elevated risk of ovarian cancer was low. Prior genetic counseling was associated with greater perceived risk for ovarian cancer. Results suggest that most high-risk women (>75%) do not know their risk for ovarian cancer. Identification of potentially high-risk women for referral to genetic counseling may improve informed ovarian cancer risk management.

(18)F-FDG PET/CT-positive internal mammary lymph nodes: pathologic correlation by ultrasound-guided fine-needle aspiration and assessment of associated risk factors.

OBJECTIVE: Metastatic breast cancer in internal mammary (IM) lymph nodes is associated with a poor prognosis. This study correlates (18)F-FDG PET/CT-positive IM lymph nodes with ultrasound-guided fine-needle aspiration (FNA) cytopathologic results and determines risk factors for IM node positivity on PET/CT. MATERIALS AND METHODS: For this retrospective study, a database search was performed to identify patients referred for whole-body (18)F-FDG PET/CT for initial staging or restaging of breast cancer from January 1, 2005, through December 31, 2010. The radiology reports and images were reviewed for patients with (18)F-FDG-avid IM lymph nodes on PET/ CT and correlated with the cytopathologic results from FNA of selected PET/CT-positive IM lymph nodes. The patients with positive IM nodes on PET/CT who underwent PET/CT for initial staging were compared against age-matched and tumor size-matched patients to identify risk factors for IM node positivity on PET/CT. RESULTS: One hundred ten of 1259 patients (9%) had an (18)F-FDG-avid IM lymph node on PET/CT. Twenty-five patients underwent ultrasound-guided FNA of a suspicious IM node, and 20 IM lymph nodes (80%) were cytologically proven metastases from the primary breast malignancy. High tumor grade, the presence of lymphovascular invasion (LVI), and triple receptor-negative hormonal receptor status were found to be significant risk factors for IM node positivity on PET/CT (p < 0.05). CONCLUSION: Although fewer than 10% of breast cancer patients have positive IM nodes on (18)F-FDG PET/CT performed for initial staging or restaging, a positive IM node indicates a very high likelihood of malignant involvement on ultrasound-guided FNA. The presences of high tumor grade, LVI, or triple receptor-negative status are risk factors for IM node positivity on (18)F-FDG PET/CT.

Positron emission mammography (PEM): effect of activity concentration, object size, and object contrast on phantom lesion detection.

PURPOSE: To characterize the relationship between lesion detection sensitivity and injected activity as a function of lesion size and contrast on the PEM (positron emission mammography) Flex Solo II scanner using phantom experiments. METHODS: Phantom lesions (spheres 4, 8, 12, 16, and 20 mm diameter) were randomly located in uniform background. Sphere activity concentrations were 3 to 21 times the background activity concentration (BGc). BGc was a surrogate for injected activity; BGc ranged from 0.44-4.1 kBq∕mL, corresponding to 46-400 MBq injections. Seven radiologists read 108 images containing zero, one, or two spheres. Readers used a 5-point confidence scale to score the presence of spheres. RESULTS: Sensitivity was 100% for lesions ≥12 mm under all conditions except for one 12 mm sphere with the lowest contrast and lowest BGc (60% sensitivity). Sensitivity was 100% for 8 mm spheres when either contrast or BGc was high, and 100% for 4 mm spheres only when both contrast and BGc were highest. Sphere contrast recovery coefficients (CRC) were 49%, 34%, 26%, 14%, and 2.8% for the largest to smallest spheres. Cumulative specificity was 98%. CONCLUSIONS: Phantom lesion detection sensitivity depends more on sphere size and contrast than on BGc. Detection sensitivity remained ≥90% for injected activities as low as 100 MBq, for lesions ≥8 mm. Low CRC in 4 mm objects results in moderate detection sensitivity even for 400 MBq injected activity, making it impractical to optimize injected activity for such lesions. Low CRC indicates that when lesions <8 mm are observed on PEM images they are highly tracer avid with greater potential of clinical significance. High specificity (98%) suggests that image statistical noise does not lead to false positive findings. These results apply to the 85 mm thick object used to obtain them; lesion detectability should be better (worse) for thinner (thicker) objects based on the reduced (increased) influence of photon attenuation.

Identifying breast cancer recurrence histories via patient-reported outcomes.

PURPOSE: To test accuracy of patient self-report of breast cancer recurrence for enhancing standard population-based cancer registries that do not routinely collect cancer recurrence data despite the importance of this outcome. METHODS: Potential research subjects were identified in the Breast Cancer Research Database (BCRD) of the Swedish Cancer Institute (SCI). The BCRD has collected data within 45 days of each medical encounter on new primary breast cancer patients receiving all or part of their initial care at SCI. Females diagnosed with a new primary breast cancer 2004-2016, Stages I-III, and alive at the time of study initiation (2018) were identified. Recurrent breast cancer patients were matched 1:1 to surviving non-recurrent patients by patient age, date of diagnosis, and single or multiple primary tumors. Consented research subjects were surveyed about their initial and subsequent diagnostic, therapeutic, and recurrent events. PRO survey responses were compared with BCRD information for each individual participant. Discrepancies were reviewed in medical records. RESULTS: A matched sample of 88 recurrent and 88 non-recurrent patients were used in analyses. Respondents correctly identified the date of diagnosis of first primary breast cancer within 1 year 94% (165/176). Recurrence was reported by 97% (85/88) of recurrent patients. No recurrence was reported by 100% (88/88) of non-recurrent patients. Recurrence date within 1 year was correctly identified in 79% (67/85). Recurrence site was correctly identified in 82% (70/85). Medical record review of survey-registry discrepancies led to BCRD corrections in 4.5% (8/176) of cases. IMPLICATIONS FOR CANCER SURVIVORS: Breast cancer patients can accurately report their disease characteristics, treatments, and recurrence history. Patient-reported information would enhance cancer registry data.

Positron emission mammography: correlation of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 status and 18F-FDG.

OBJECTIVE: The study objective was to assess the correlation between (18)F-FDG uptake values on positron emission mammography (PEM), expressed as maximum uptake value and lesion-to-background ratio, and receptor status (i.e., estrogen receptor [ER], progesterone receptor [PR], and human epidermal growth factor receptor 2 [HER2]), tumor histology, and tumor grade. We also evaluated for the correlation between maximum uptake value on PEM and maximum uptake value on a whole-body PET/CT. MATERIALS AND METHODS: We retrospectively reviewed our database for patients with newly diagnosed breast cancer who were referred for PEM between June 2007 and September 2009. A subset of patients also underwent a whole-body PET/CT scan. The original pathology reports were reviewed to establish the histologic type, grade, and receptor status. RESULTS: The study involved 98 patients with 100 lesions. ER-negative tumors and PR-negative tumors had significantly higher mean lesion-to-background ratio than did their respective receptor-positive tumors (p = 0.02). Triple-negative tumors (i.e., ER-negative, PR-negative, and HER2-negative tumors) had statistically higher mean lesion-to-background ratio than did ER-positive PR-positive HER2-negative tumors (p = 0.04). Infiltrating ductal carcinomas had significantly higher PEM FDG uptake values than did infiltrating lobular carcinomas (p = 0.02-0.04). Breast tumors with higher histologic grade also had significantly higher PEM FDG uptake values than did those with lower grade (p = 0.03 and p < 0.001). A moderately high correlation (0.76-0.79) was seen between whole-body PET/CT and PEM uptake values. CONCLUSION: This study shows a correlation between PEM FDG uptake values and the prognostic factors that have been shown to predict breast cancer survival.

Surgical perspectives from a prospective, nonrandomized, multicenter study of breast conserving surgery and adjuvant electronic brachytherapy for the treatment of breast cancer.

BACKGROUND: Accelerated partial breast irradiation (APBI) may be used to deliver radiation to the tumor bed post-lumpectomy in eligible patients with breast cancer. Patient and tumor characteristics as well as the lumpectomy technique can influence patient eligibility for APBI. This report describes a lumpectomy procedure and examines patient, tumor, and surgical characteristics from a prospective, multicenter study of electronic brachytherapy. METHODS: The study enrolled 65 patients of age 45-84 years with ductal carcinoma or ductal carcinoma in situ, and 44 patients, who met the inclusion and exclusion criteria, were treated with APBI using the Axxent® electronic brachytherapy system following lumpectomy. The prescription dose was 34 Gy in 10 fractions over 5 days. RESULTS: The lumpectomy technique as described herein varied by site and patient characteristics. The balloon applicator was implanted by the surgeon (91%) or a radiation oncologist (9%) during or up to 61 days post-lumpectomy (mean 22 days). A lateral approach was most commonly used (59%) for insertion of the applicator followed by an incision site approach in 27% of cases, a medial approach in 5%, and an inferior approach in 7%. A trocar was used during applicator insertion in 27% of cases. Local anesthetic, sedation, both or neither were administered in 45%, 2%, 41% and 11% of cases, respectively, during applicator placement. The prescription dose was delivered in 42 of 44 treated patients. CONCLUSIONS: Early stage breast cancer can be treated with breast conserving surgery and APBI using electronic brachytherapy. Treatment was well tolerated, and these early outcomes were similar to the early outcomes with iridium-based balloon brachytherapy.

Neoadjuvant chemotherapy of breast cancer: tumor markers as predictors of pathologic response, recurrence, and survival.

This study reports the value of the tumor markers estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) in predicting the response of breast cancer to neoadjuvant chemotherapy. A community cancer center prospectively maintained breast cancer database containing over 8,000 patient records was used. Since 1989, 464 patients were treated with neoadjuvant chemotherapy followed by surgical resection and were tested for ER and PR. Estrogen receptor and/or PR positive patients were considered hormone receptor (HR) positive. Human epidermal growth factor receptor 2 status was available on 368 patients. Total, breast, and nodal pathologic complete response (pCR) rates, recurrence, and overall survival were assessed. Total and breast pCR rates were higher in HR negative (HR-) patients (26% and 32%, respectively) than in HR positive (HR+) patients (4% and 7%, respectively; p < 0.001). Compared to HR+ patients, HR- patients had higher recurrence rates (38% versus 22%; p < 0.001), a shorter time to recurrence (1.28 versus 2.14 years; p < 0.001), and decreased overall survival (67% versus 81%; p < 0.001). Human epidermal growth factor receptor 2 positive patients treated with neoadjuvant trastuzumab (NAT) demonstrated higher total pCR (34% versus 13%; p = 0.008), breast pCR (37% versus 17%; p = 0.02), and nodal pCR rates (47% versus 23%; p = 0.05) compared to HER2+ patients not treated with NAT. Furthermore, HER2+ patients who received NAT had lower recurrence rates (5% versus 42%; p < 0.001) and increased overall survival (97% versus 68%; p < 0.001). In conclusion, breast cancer HR status is predictive of total and breast pCR rates after neoadjuvant chemotherapy. Although HR- patients derive greater benefit from neoadjuvant chemotherapy in terms of pathologic response, they have worse outcomes in terms of recurrence and survival. Hormone receptor positive patients demonstrate significantly less response to neoadjuvant chemotherapy, but significantly better overall outcome. For both HR- and HR+, addition of NAT for HER2+ tumors results in both a superior response and outcome.

Correction: Incorporating Breast Cancer Recurrence Events Into Population-Based Cancer Registries Using Medical Claims: Cohort Study.

[This corrects the article DOI: 10.2196/18143.].

Incorporating Breast Cancer Recurrence Events Into Population-Based Cancer Registries Using Medical Claims: Cohort Study.

BACKGROUND: There is a need for automated approaches to incorporate information on cancer recurrence events into population-based cancer registries. OBJECTIVE: The aim of this study is to determine the accuracy of a novel data mining algorithm to extract information from linked registry and medical claims data on the occurrence and timing of second breast cancer events (SBCE). METHODS: We used supervised data from 3092 stage I and II breast cancer cases (with 394 recurrences), diagnosed between 1993 and 2006 inclusive, of patients at Kaiser Permanente Washington and cases in the Puget Sound Cancer Surveillance System. Our goal was to classify each month after primary treatment as pre- versus post-SBCE. The prediction feature set for a given month consisted of registry variables on disease and patient characteristics related to the primary breast cancer event, as well as features based on monthly counts of diagnosis and procedure codes for the current, prior, and future months. A month was classified as post-SBCE if the predicted probability exceeded a probability threshold (PT); the predicted time of the SBCE was taken to be the month of maximum increase in the predicted probability between adjacent months. RESULTS: The Kaplan-Meier net probability of SBCE was 0.25 at 14 years. The month-level receiver operating characteristic curve on test data (20% of the data set) had an area under the curve of 0.986. The person-level predictions (at a monthly PT of 0.5) had a sensitivity of 0.89, a specificity of 0.98, a positive predictive value of 0.85, and a negative predictive value of 0.98. The corresponding median difference between the observed and predicted months of recurrence was 0 and the mean difference was 0.04 months. CONCLUSIONS: Data mining of medical claims holds promise for the streamlining of cancer registry operations to feasibly collect information about second breast cancer events.

Impact and outcomes of routine microstaging of sentinel lymph nodes in breast cancer: significance of the pN0(i+) and pN1mi categories.

BACKGROUND: In 2003, the American Joint Committee on Cancer (AJCC) initiated the 6th edition staging criteria, including pN0(i+) and pN1mi categories for breast cancer. However, the clinical significance of these categories is debated in the literature. METHODS: A prospective registry was used to identify patients staged with sentinel lymph node (SLN) biopsy. SLN evaluation included routine serial sectioning and immunohistochemical stains. SLN biopsies performed before January 2003 were restaged according to the AJCC's 6th edition criteria. RESULTS: Of 954 SLN biopsies identified, on review, 491 N0i-, 86 N0i+, 73 N1mi, 146 N1a, 29 N2a, and 11 N3a patients were available for analysis with a median follow-up of 45.4 months. Significant prognostic and therapeutic differences existed between the groups. Differences in overall survival (OS) and recurrence-free survival (RFS) were only noted when the size of the metastases reached the N1a level. There were no statistically significant differences in OS or RFS between N0(i-) and N0(i+) or N1mi disease. Cases that were N0(i+) or N1mi were more likely to have other poor prognostic factors and to receive more aggressive therapy. CONCLUSION: SLN biopsy allows a more sensitive evaluation of lymph nodes for metastatic cells. This has led to the increased identification of very small axillary metastases. While the new microstaging categories are not yet clearly associated with a significantly decreased OS or DFS in this series, they are associated with other poor prognostic factors and more local/regional and systemic therapy. Further analysis of the microstaging categories is needed.

Metaplastic breast cancer: clinical significance.

BACKGROUND: Metaplastic breast carcinoma (MBC) is a rare poorly differentiated breast cancer characterized by coexistence of ductal carcinoma with areas of matrix producing, spindle-cell, sarcomatous, or squamous differentiation; ER/PR/HER2 negativity; and a reputation for poor outcome. METHODS: The Swedish Cancer Institute prospective breast cancer database (> 6500 patients; 1990-2005) has 24 MBC cases that were compared with typical breast cancer cases matched for age, date of diagnosis, stage, and ER/PR/HER2 status. RESULTS: The mean metaplastic primary tumor diameter was 2.5 cm. The histological/nuclear grade was high in 21 of 24 cases. No patient had distant metastasis. ER and/or PR receptor status was negative in all cases. HER2 was negative in 10 of 11 cases tested. EGFR (HER1) was positive in 7 of 7 cases tested. All patients had sentinel and/or axillary lymph node dissection and surgical resection; 18 received chemotherapy and 22 had radiation therapy. Four patients had distant recurrences 5 to 88 months from diagnosis. Five-year survival was 83% (95% confidence interval, 66-100%). Comparison with matched typical breast cancer cases revealed no major significant difference in multidisciplinary treatment patterns, recurrence, or survival. CONCLUSION: MBC is associated with poor prognostic indicators, but outcomes comparable with matched typical breast cancer cases can be achieved with routine aggressive multidisciplinary care. Increased, expression of EGFR (HER1) provides an opportunity for targeted tumor therapy.

Accuracy of intraoperative imprint cytology of sentinel lymph nodes in breast cancer.

BACKGROUND: In breast cancer treatment, immediate completion of axillary lymph node dissection (ALND) can be performed if the intraoperative sentinel lymph node (SLN) examination is positive. This study evaluates the accuracy of intraoperative imprint cytology (IC) for detecting SLN metastases. METHODS: Pathology reports from 385 SLN biopsy examinations were reviewed retrospectively. The SLNs were serially sectioned perpendicular to the long axis and IC was performed intraoperatively. The SLNs then were formalin-fixed for permanent sections. Final pathology was compared with the intraoperative IC results. RESULTS: The sensitivities for IC detection of N0(i+) (n = 36), N1mi (n = 24), and N1a-3a (n = 65) metastases were 0%, 4%, and 74%, respectively. The specificity was 100%. CONCLUSIONS: Final pathology identified 89 (23%) patients with N1 or greater disease. IC allowed 49 (55%) of these patients to undergo synchronous completion of ALND. No unnecessary completion ALNDs were performed. The sensitivity of IC decreased with decreasing size of the metastasis.

Positron Emission Mammography Image Interpretation for Reduced Image Count Levels.

UNLABELLED: We studied the effects of reduced (18)F-FDG injection activity on interpretation of positron emission mammography (PEM) images and compared image interpretation between 2 postinjection imaging times. METHODS: We performed a receiver-operating-characteristic (ROC) study using PEM images reconstructed with different count levels expected from injected activities between 23 and 185 MBq. Thirty patients received 2 PEM scans at postinjection times of 60 and 120 min. Half of the patients were scanned with a standard protocol; the others received one-half of the standard activity. Images were reconstructed using 100%, 50%, and 25% of the total counts acquired. Eight radiologists used a 5-point confidence scale to score 232 PEM images for the presence of up to 3 malignant lesions. Paired images were analyzed with conditional logistic regression and ROC analysis to investigate changes in interpretation. RESULTS: There was a trend for increasing lesion detection sensitivity with increased image counts: odds ratios were 2.2 (P = 0.01) and 1.9 (P = 0.04) per doubling of image counts for 60- and 120-min uptake images, respectively, without significant difference between time points (P = 0.7). The area under the ROC curve (AUC) was highest for the 100%-count, 60-min images (0.83 vs. 0.75 for 50%-counts, P = 0.02). The 120-min images had a similar trend but did not reach statistical significance (AUC = 0.79 vs. 0.73, P = 0.1). Our data did not yield significant trends between specificity and image counts. Lesion-to-background ratios increased between 60- and 120-min scans (P < 0.001). CONCLUSION: Reducing the image counts relative to the standard protocol decreased diagnostic accuracy. The increase in lesion-to-background ratio between 60- and 120-min uptake times was not enough to improve detection sensitivity in this study, perhaps in part due to fewer counts in the later scan.

JAK2 expression is associated with tumor-infiltrating lymphocytes and improved breast cancer outcomes: implications for evaluating JAK2 inhibitors.

Janus kinase-2 (JAK2) supports breast cancer growth, and clinical trials testing JAK2 inhibitors are under way. In addition to the tumor epithelium, JAK2 is also expressed in other tissues including immune cells; whether the JAK2 mRNA levels in breast tumors correlate with outcomes has not been evaluated. Using a case-control design, JAK2 mRNA was measured in 223 archived breast tumors and associations with distant recurrence were evaluated by logistic regression. The frequency of correct pairwise comparisons of patient rankings based on JAK2 levels versus survival outcomes, the concordance index (CI), was evaluated using data from 2,460 patients in three cohorts. In the case-control study, increased JAK2 was associated with a decreasing risk of recurrence (multivariate P = 0.003, n = 223). Similarly, JAK2 was associated with a protective CI (<0.5) in the public cohorts: NETHERLANDS CI = 0.376, n = 295; METABRIC CI = 0.462, n = 1,981; OSLOVAL CI = 0.452, n = 184. Furthermore, JAK2 was strongly correlated with the favorable prognosis LYM metagene signature for infiltrating T cells (r = 0.5; P < 2 × 10(-16); n = 1,981) and with severe lymphocyte infiltration (P = 0.00003, n = 156). Moreover, the JAK1/2 inhibitor ruxolitinib potently inhibited the anti-CD3-dependent production of IFN-γ, a marker of the differentiation of Th cells along the tumor-inhibitory Th1 pathway. The potential for JAK2 inhibitors to interfere with the antitumor capacities of T cells should be evaluated.

Rapid point-of-care breath test for biomarkers of breast cancer and abnormal mammograms.

BACKGROUND: Previous studies have reported volatile organic compounds (VOCs) in breath as biomarkers of breast cancer and abnormal mammograms, apparently resulting from increased oxidative stress and cytochrome p450 induction. We evaluated a six-minute point-of-care breath test for VOC biomarkers in women screened for breast cancer at centers in the USA and the Netherlands. METHODS: 244 women had a screening mammogram (93/37 normal/abnormal) or a breast biopsy (cancer/no cancer 35/79). A mobile point-of-care system collected and concentrated breath and air VOCs for analysis with gas chromatography and surface acoustic wave detection. Chromatograms were segmented into a time series of alveolar gradients (breath minus room air). Segmental alveolar gradients were ranked as candidate biomarkers by C-statistic value (area under curve [AUC] of receiver operating characteristic [ROC] curve). Multivariate predictive algorithms were constructed employing significant biomarkers identified with multiple Monte Carlo simulations and cross validated with a leave-one-out (LOO) procedure. RESULTS: Performance of breath biomarker algorithms was determined in three groups: breast cancer on biopsy versus normal screening mammograms (81.8% sensitivity, 70.0% specificity, accuracy 79% (73% on LOO) [C-statistic value], negative predictive value 99.9%); normal versus abnormal screening mammograms (86.5% sensitivity, 66.7% specificity, accuracy 83%, 62% on LOO); and cancer versus no cancer on breast biopsy (75.8% sensitivity, 74.0% specificity, accuracy 78%, 67% on LOO). CONCLUSIONS: A pilot study of a six-minute point-of-care breath test for volatile biomarkers accurately identified women with breast cancer and with abnormal mammograms. Breath testing could potentially reduce the number of needless mammograms without loss of diagnostic sensitivity.

Irradiation effect after mastectomy on breast cancer recurrence in patients presenting with locally advanced disease.

BACKGROUND: Current guidelines recommend postmastectomy irradiation (PMI) for patients with tumors >5 cm and/or ≥4 positive lymph nodes. This study evaluates the effect of PMI on recurrence and survival within tumor size and node status groups. METHODS: Locoregional and distant recurrences and survival for different tumor and treatment characteristics were analyzed in 2,797 patients with invasive breast cancer treated with mastectomy. RESULTS: Tumor size, positive nodes, extranodal extension, lymphatic/vascular invasion, estrogen receptor/progesterone negative, HER-2 positive, and high grade were associated with significantly increased recurrence. In patients with ≥4 positive nodes and patients with tumors >5 cm and positive nodes, PMI decreased local and distant recurrence (overall 53% vs 24%, P < .001) and increased disease-free survival (P < .001) but not overall survival. In patients with less disease, a benefit from PMI irradiation could not be identified. CONCLUSIONS: PMI is indicated for patients with ≥4 positive nodes or patients with tumors >5 cm and positive nodes.

Utilization of cancer registry data for monitoring quality of care.

BACKGROUND: Cancer Program Practice Profile Reports (CP(3)R), established by the Commission on Cancer, are based on 6 guidelines for breast and colorectal cancer care using cancer registry data. The long-term goal is the use of cancer registry data for real-time interventions to optimize the process of individual patient multidisciplinary care. METHODS: CP(3)R results using 593 analytic breast cancer cases in 2008 were compared in 3 databases: an institutional breast cancer research database, an institutional cancer registry, and a regional Cancer Surveillance System. RESULTS: Compliance with the CP(3)R guidelines calculated using the 3 databases was 80% to 98% for radiation therapy following breast-conserving surgery, 78% to 88% for combination chemotherapy of hormone receptor-negative stage T1c, II, or III disease, and 53% to 85% for hormone therapy of hormone receptor-positive stage T1c, II, or III disease. There was a high rate of discrepancy of tumor characteristics, treatment, and CP(3)R resulting from inaccurate and incomplete data. CONCLUSIONS: Using national cancer databases prospectively to monitor and ensure optimal multidisciplinary cancer care will require dramatic changes in cancer registry processes.