Impact of body mass index on clinical outcomes in triple-negative breast cancer.

BACKGROUND: Obesity is associated with poorer outcomes in patients with hormone receptor-positive breast cancers. This association is not well established for women with triple-negative breast cancers (TNBC). In this study, the prognostic effects of body mass index on clinical outcome were evaluated in patients with TNBC. METHODS: A retrospective study was conducted on 418 patients who were treated between July 1996 and July 2010 for TNBC. Recurrence-free survival (RFS) and overall survival (OS) were evaluated in relation to body mass index (BMI) after controlling for clinically significant variables. RESULTS: One hundred twenty-four patients (29.7%) were normal/underweight (BMI ≤24.9 kg/m(2) ), 130 patients (31.1%) were overweight (BMI from 25 to 29.9 kg/m(2) ), and 164 patients (39.2%) were obese (BMI ≥30 kg/m(2) ). At a median follow-up of 37.2 months, there were 105 recurrences (25.1%) and 87 deaths (20.8%). Compared with normal/underweight patients, the multivariate hazard ratio (HR) for RFS was 0.81 (95% confidence interval [CI], 0.49-1.34) for obese patients. Similarly, OS was not associated with BMI category; obese patients had an HR of death of 0.94 (95% CI, 0.54-1.64) compared with normal/underweight patients. A Cox regression analysis identified the receipt of chemotherapy (HR, 0.25; 95% CI, 0.12-0.52), ductal histology (HR, 0.49; 95% CI, 0.25-0.97), stage III disease (HR, 3.5; 95% CI, 1.35-9.06), and increasing tumor size (HR, 1.19; 95% CI, 1.09-1.3) as independent prognostic factors for OS. CONCLUSIONS: No significant relation between obesity and RFS or OS emerged in patients with TNBC after controlling for clinically significant factors.

Claims data linked to hospital registry data enhance evaluation of the quality of care of breast cancer.

BACKGROUND: Complete treatment data is central to evaluation and improvement of cancer care quality. Cancer registries vary in completeness of radiation (RT), chemotherapy (CT), and hormone therapy (HT) data. Administrative claims from health payers may supplement these registries. This study assesses the ability to link private payer claims to the National Cancer Data Base (NCDB) and the extent of additional treatment data identified in claims. METHODS: Claims for patients with breast cancer surgery from one payer in Western New York (WNY) were matched with NCDB for participating hospitals for 2001-2003 using available identifiers (reporting hospital, gender, birth date, ZIP code). Claims were analyzed for breast and axillary surgery, RT, CT, and HT, and compared with treatment recorded in the NCDB. RESULTS: Four hundred seventy women had claims for breast cancer surgery and 439 (91%) matched to the NCDB. Seventeen had duplicate/incomplete records. Non-matches included cases with surgery for cancer recurrence. Among 422 evaluable cases, stage was 0: 9%; I: 49%; II: 33%; III: 7%; and IV: 2%. Claims and registry were highly concordant for surgery. Registry identified RT, CT, and HT in 38%, 47%, 18%, respectively, of treatment reported in claims. Claims also provided information on drugs used and treatment duration. CONCLUSIONS: The NCDB can be matched with private payer claims using available identifiers. Registry data in this convenience sample of hospitals did not include a substantial fraction of outpatient data identified by claims. Private payer claims may help enhance the completeness of NCDB treatment information.

TLE3 as a candidate biomarker of response to taxane therapy.

INTRODUCTION: The addition of taxanes (Ts) to chemotherapeutic regimens has not demonstrated a consistent benefit in early-stage breast cancer. To date, no clinically relevant biomarkers that predict T response have been identified. METHODS: A dataset of immunohistochemistry stains in 411 patients was mined to identify potential markers of response. TLE3 emerged as a candidate marker for T response. To test the association with T sensitivity, an independent 'triple-negative' (TN) validation cohort was stained with anti-TLE3 antibody. RESULTS: TLE3 staining was associated with improved 5-year disease-free interval (DFI) in the overall cohort (n = 441, P < 0.004), in patients treated with cyclophosphamide (C), methotrexate, and 5-fluorouracil (n = 72, P < 0.02), and in those treated with regimens containing doxorubicin (A) and a T (n = 65, P < 0.04). However, no association was shown with outcome in untreated patients (n = 203, P = 0.49) or those treated with a regimen containing A only (n = 66, P = 0.97). In the TN cohort, TLE3 staining was significantly associated with improved 5-year DFI in all patients (n = 81, P < 0.015), in patients treated with AC + T (n = 45, P < 0.02), but not in patients treated with AC (n = 17, P = 0.81). TLE3 was independent of tumor size, nodal status, and grade by bivariable analysis in both cohorts. CONCLUSION: TLE3 staining is associated with improved DFI in T-treated patients in two independent cohorts. Since the validation study was performed in a TN cohort, TLE3 is not serving as a surrogate for estrogen receptor or HER2 expression. TLE3 should be studied in large clinical trial cohorts to establish its role in T chemotherapy selection.

Prognosis of occult breast carcinoma presenting as isolated axillary nodal metastasis.

Axillary metastasis from an occult breast carcinoma is an uncommon presentation and presents a therapeutic dilemma. The objective of this study is to describe the presenting clinical features, management approach and treatment outcomes for occult breast carcinoma. We conducted a retrospective review of patients who presented with axillary nodal metastases from an occult breast carcinoma between 1997 and 2004 at the Roswell Park Cancer Institute; 2,150 patients were diagnosed and treated for breast cancer during this period. After excluding stage I and IV patients, we identified 642 who had disease metastatic to lymph nodes, 10 of these had no primary tumor in the breast despite a thorough evaluation including bilateral mammography and breast ultrasound. Of these, 7 had undergone breast magnetic resonance imaging as well. All patients underwent axillary nodal dissection. The breast was managed with radiotherapy alone in 8 patients, wide local excision with radiation therapy in 1 patient and 1 patient underwent mastectomy. No patient had a recurrence with a median 57 months of follow-up. Breast conservation with radiation therapy alone can be considered as a management option for women with occult breast cancer presenting with axillary nodal metastasis.

Concordance with breast cancer pathology reporting practice guidelines.

BACKGROUND: Accurate pathology reporting is important for treatment of breast cancer. The College of American Pathologists (CAP) distributed guidelines for reporting cancer specimens in 1998. The aim of this study was to determine community-wide concordance with CAP breast cancer reporting guidelines. STUDY DESIGN: Pathology reporting of stage I and II breast cancers was examined for adherence to CAP guidelines. Pathology reports were reviewed from 100 consecutive cases of invasive breast cancers referred to Roswell Park Cancer Institute in 1998 to 1999 from community hospitals after excisional breast biopsy and 20 consecutive cases with excisional biopsy at RPCI. Adherence to CAP guidelines for clinically relevant items was determined from the original pathology report in each case. RESULTS: One hundred one cases met the inclusion criteria. Most reports did not include at least one of the guideline required elements. Surgical margins were inked in only 77%, and the margins oriented in only 25% of patients. Many specimens were not oriented by the surgeon. Grade was reported in most cases, but the Bloom Scarf Richardson grade was reported in only 6%. The presence or absence of lymphovascular invasion, and of coexisting in situ disease, was reported in 57% and 71%, respectively. The extent and type of in situ disease was reported in 47% and 49%, respectively. CONCLUSIONS: Breast cancer pathology reporting varies widely. Key elements that affect treatment are often omitted. These include gross description and size, orientation and involvement of surgical margins, and description of histologic features, including Bloom Scarf Richardson reporting of grade and the extent of an in situ component. Passive distribution of CAP practice guidelines might be insufficient to accomplish community-wide quality improvement in breast pathology reporting.

Fostering coordinated survivorship care in breast cancer: who is lost to follow-up?

INTRODUCTION: Increasing numbers of cancer survivors and the recognition of their needs beyond recurrence surveillance are stretching resources at many cancer centers. Sometimes, patients solely follow up with providers other than the oncologist without coordinated care transfer plans. This study examines factors associated with transfer of breast cancer survivorship care outside one large cancer center. METHODS: Records on women with breast cancer diagnosed between July 1, 1997 and March 31, 2010 were linked to billing data through March 31, 2012 to identify the details of last oncology follow-up. A patient was classified as having transferred care outside the center if there was no oncology visit for more than 2 years. Clinical and pathologic characteristics were examined in a multivariate proportional hazards model to identify factors associated with transfer of care. RESULTS: Of 3,924 women with breast cancer, 858 (21.9%) transferred care outside of our institution, 18 and 36% at 5 and 10 years, respectively. Factors independently associated with transfer of care were age at diagnosis (unit increase 1.01/year age), stage IIA (HR 1.30, p = 0.02), longer driving distance to the cancer center (HR 1.65, p < 0.01), having had a cancer recurrence (HR 0.15 p < 0.01), and last visit in a medical oncology versus surgical oncology clinic (HR 0.32 p < 0.01). CONCLUSIONS: Many patients with breast cancer do not continue oncology follow-up after treatment. Cancer programs should develop mechanisms to assist patients with care transfer and assure coordinated transfer to other providers to improve continuity of care. IMPLICATIONS FOR CANCER SURVIVORS: The results of this study will help the cancer centers identify the population of patients that are most likely to transfer care or become lost to follow up. Prospectively, identifying patients who may be more likely to transfer care will offer opportunities to effectively coordinate posttreatment surveillance with primary care.

Completeness of American Cancer Registry Treatment Data: implications for quality of care research.

BACKGROUND: Evaluating and improving the quality of cancer care requires complete information on cancer stage and treatment. Hospital-based registries are a key tool in this effort, but reports in the 1990s showed that they fail to identify a major fraction of outpatient-administered treatment, including chemotherapy, endocrine therapy, and radiation. This can limit their value for evaluating patterns and quality of care. To determine the completeness of registry data in more recent years, we linked administrative claims from 2 private payers in Ohio to the National Cancer Data Base and Ohio Cancer Incidence and Surveillance System. METHODS: Incident breast and colorectal cancers among Ohio residents diagnosed in 2004-2006 were identified from linkage of the National Cancer Data Base, Ohio Cancer Incidence and Surveillance System, and payer insurance claims using ICD-9 and CPT procedure codes, and ICD-9 diagnosis codes. Linkage was accomplished using patient demographics, surgery dates, and hospital facility. Treatment found in claims and registry data were compared and assessed using the κ statistic. RESULTS: The analytic cohort included 2,552 breast and 822 colorectal cases. Results showed high agreement for breast surgery type, and moderately high agreement for colorectal surgery type. For breast cases, the registries captured 87% of chemotherapy, 86% of radiation, and 64% of endocrine treatment in claims. For colorectal cases, the registry captured 83% of chemotherapy and 84% of radiation in claims. CONCLUSIONS: Hospital-based registries for breast and colon cancer diagnosed in 2004-2006 captured about 85% of radiation and chemotherapy data compared with claims data, a higher percentage than earlier reports. These findings provide direction and a cautionary note to those using registry data for study of patterns and quality of systemic and radiation therapy care.

Linked claims and medical records for cancer case management : evaluation of mammography abnormalities.

BACKGROUND: Failure to obtain the requisite follow-up of patients with abnormal mammograms may delay cancer diagnosis and impact outcome. Up to 20% of women do not receive timely recommended follow-up. The current study tested the accuracy of the linkage of payer claims and clinical data to identify the appropriate treatment for patients with abnormal mammograms. METHODS: Electronic medical records in a staff model practice that was affiliated with a single health payer were scanned to identify the Breast Imaging Reporting and Data System (BI-RADS(R)) code for all mammograms. For each woman with a BI-RADS code 0, 3, 4, or 5 mammogram, the payer claims were searched for follow-up breast procedures (imaging, biopsy, and surgery) occurring within 2 months for BI-RADS code 0, 4, and 5 mammograms and within 8 months for BI-RADS code 3 mammograms. For women with >1 abnormal mammogram during the study period, only follow-up for the first abnormal mammogram was examined. The medical records of cases defined by claims as not having recommended follow-up care were reviewed to determine the accuracy of claims analyses. RESULTS: A total of 17,329 women underwent 23,721 mammograms between January 1, 2001 and December 31, 2003. BI-RADS codes 0, 3, 4, or 5 occurred in 1,490 mammograms (6.3%). Among 1,206 women with a first abnormal mammogram who were eligible for claims follow-up, 16% did not receive recommended follow-up care. Medical record review demonstrated that the claims search accurately identified follow-up care in 97% of these cases. CONCLUSIONS: Administrative claims supplemented with BI-RADS data were found to accurately identify the follow-up care of patients with abnormal mammograms. Case management using this method may assist physicians in ensuring that all patients receive appropriate care.

Axillary recurrence in women with a negative sentinel lymph node and no axillary dissection in breast cancer.

OBJECTIVES: Sentinel lymph node biopsy (SLNB) is widely used for staging breast cancer. SLNB accurately determines axillary lymph node status with a low false negative rate. There remains concern that omitting axillary dissection may lead to recurrence in the axilla, and impact long term survival. The purpose of this study was to determine the frequency of axillary lymph node recurrence in patients who had a negative sentinel lymph node and did not undergo axillary node dissection. METHODS: Data was collected on all patients who had negative SLNB at Roswell Park Cancer Institute between July 1997 and June 2002. Demographics, type of operation, postoperative systemic, and radiation therapy, co-morbidity score, hormone receptor status, and the pathologic features of the tumor were abstracted for each patient. For each woman with recurrence, the dates of recurrence, the site(s) of recurrence, and the treatment for recurrence were recorded. RESULTS: With a median follow-up of 33 months, 15 of 335 (4.5%) women who had negative SLNBs and who did not undergo completion axillary dissection developed a cancer recurrence. Only two patients (0.6%) had an axillary recurrence. CONCLUSIONS: The rate of axillary recurrence following a negative sentinel node biopsy is the same or less than axillary lymph node dissection (ALND) alone. Concerns that omitting completion axillary dissection following a negative SLNB will increase the rate of axillary recurrence appear unfounded.

Provider case volume and outcome in the evaluation and treatment of patients with mammogram-detected breast carcinoma.

BACKGROUND: Practice volume may affect the outcome of patients with breast carcinoma. Defining factors that influence the relation of volume and outcome for the diagnosis and treatment of breast carcinoma is important, because breast carcinoma is common, and care is decentralized. METHODS: Community-wide diagnosis and treatment of mammogram-detected breast carcinoma was examined using claims data from a single insurer representing 25% of the regional population. Among 1001 mammogram-directed breast biopsies, the rate of breast carcinoma diagnosed by stereotactic core needle biopsy (SCNB) or excisional biopsy with needle localization (EBNL) and the rate at which breast-conserving surgery (BCS) was used were analyzed. Outcome and practice volume were examined for surgeons, radiologists, and medical centers. RESULTS: Two hundred twenty-four tumors were diagnosed by EBNL (604 diagnoses) and SCNB (397 tumors), for a 22.4% positive biopsy rate. The median number of procedures per physician was one. Positive biopsy rates for radiologists, surgeons, and medical centers did not correlate with practice volume. Positive biopsy rates for high-volume physician providers and medical centers ranged from 9% to 46%. The BCS rate was 45% and 64% for surgeons treating one or more than one claim, respectively. Tumor stage and surgeon case volume were the only independent predictors of BCS (P < 0.05). CONCLUSIONS: There is wide variation in diagnosis and treatment outcomes for patients with mammogram-detected breast carcinoma. Overall, practice volume was correlated with the use of BCS but not with the rate of positive biopsy. A wide variation in the positive biopsy rate among high-volume providers and medical centers suggests that volume of practice is not a surrogate for quality in the diagnosis of breast carcinoma.

Lymphedema secondary to postmastectomy radiation: incidence and risk factors.

BACKGROUND: Postmastectomy radiotherapy (PMRT) has proven benefits for certain patients with breast cancer; however, one of its complications is lymphedema. This study examines the incidence of and risk factors associated with lymphedema secondary to PMRT. METHODS: The charts of patients treated with mastectomy at Roswell Park Cancer Institute between January 1, 1995, and April 20, 2001, who received PMRT were reviewed. Univariate analysis of patient, disease, and treatment variables was conducted. Multivariate analysis was performed on variables found to be significant in univariate analysis. RESULTS: One hundred five patients received PMRT. The incidence of lymphedema was 27%. Patient age, body mass index, disease stage, positive lymph nodes, nodes resected, postoperative infection, duration of drainage, chemotherapy, and hormonal therapy were not associated with lymphedema. Total dose (P =.032), posterior axillary boost (P =.047), overlap technique (P =.037), radiotherapy before 1999 (P =.028), and radiotherapy at Roswell Park Cancer Institute (P =.028) were significantly associated with lymphedema. Increased lymphedema was noted with supraclavicular, internal mammary, mastectomy scar boost, and chest wall tangential photon beam radiation, but the associations were not statistically significant. CONCLUSIONS: The high incidence and debilitating effects of lymphedema must be weighed against the benefits of PMRT. Efforts to prevent lymphedema should be emphasized.