Monica Rizzo

Randomized Study of Basal-Bolus Insulin Therapy in the Inpatient Management of Patients With Type 2 Diabetes Undergoing General Surgery (RABBIT 2 Surgery)

OBJECTIVE The optimal treatment of hyperglycemia in general surgical patients with type 2 diabetes mellitus is not known. RESEARCH DESIGN AND METHODS This randomized multicenter trial compared the safety and efficacy of a basal-bolus insulin regimen with glargine once daily and glulisine before meals (n = 104) to sliding scale regular insulin (SSI) four times daily (n = 107) in patients with type 2 diabetes mellitus undergoing general surgery. Outcomes included differences in daily blood glucose (BG) and a composite of postoperative complications including wound infection, pneumonia, bacteremia, and respiratory and acute renal failure. RESULTS The mean daily glucose concentration after the 1st day of basal-bolus insulin and SSI was 145 ± 32 mg/dL and 172 ± 47 mg/dL, respectively (P < 0.01). Glucose readings <140 mg/dL were recorded in 55% of patients in basal-bolus and 31% in the SSI group (P < 0.001). There were reductions with basal-bolus as compared with SSI in the composite outcome [24.3 and 8.6%; odds ratio 3.39 (95% CI 1.50–7.65); P = 0.003]. Glucose <70 mg/dL was reported in 23.1% of patients in the basal-bolus group and 4.7% in the SSI group (P < 0.001), but there were no significant differences in the frequency of BG <40 mg/dL between groups (P = 0.057). CONCLUSIONS Basal-bolus treatment with glargine once daily plus glulisine before meals improved glycemic control and reduced hospital complications compared with SSI in general surgery patients. Our study indicates that a basal-bolus insulin regimen is preferred over SSI in the hospital management of general surgery patients with type 2 diabetes.

Prevalence and clinical outcome of hyperglycemia in the perioperative period in noncardiac surgery.

OBJECTIVE Hospital hyperglycemia, in individuals with and without diabetes, has been identified as a marker of poor clinical outcome in cardiac surgery patients. However, the impact of perioperative hyperglycemia on clinical outcome in general and noncardiac surgery patients is not known. RESEARCH DESIGN AND METHODS This was an observational study with the aim of determining the relationship between pre- and postsurgery blood glucose levels and hospital length of stay (LOS), complications, and mortality in 3,184 noncardiac surgery patients consecutively admitted to Emory University Hospital (Atlanta, GA) between 1 January 2007 and 30 June 2007. RESULTS The overall 30-day mortality was 2.3%, with nonsurvivors having significantly higher blood glucose levels before and after surgery (both P < 0.01) than survivors. Perioperative hyperglycemia was associated with increased hospital and intensive care unit LOS (P < 0.001) as well as higher numbers of postoperative cases of pneumonia (P < 0.001), systemic blood infection (P < 0.001), urinary tract infection (P < 0.001), acute renal failure (P = 0.005), and acute myocardial infarction (P = 0.005). In multivariate analysis (adjusted for age, sex, race, and surgery severity), the risk of death increased in proportion to perioperative glucose levels; however, this association was significant only for patients without a history of diabetes (P = 0.008) compared with patients with known diabetes (P = 0.748). CONCLUSIONS Perioperative hyperglycemia is associated with increased LOS, hospital complications, and mortality after noncardiac general surgery. Randomized controlled trials are needed to determine whether perioperative diabetes management improves clinical outcome in noncardiac surgery patients.

Overexpression and activation of hepatocyte growth factor/scatter factor in human non-small-cell lung carcinomas

Hepatocyte growth factor/scatter factor (HGF/SF) stimulates the invasive growth of epithelial cells via the c-MET oncogene-encoded receptor. In normal lung, both the receptor and the ligand are detected, and the latter is known to be a mitogenic and a motogenic factor for both cultured bronchial epithelial cells and non-small-cell carcinoma lines. Here, ligand and receptor expression was examined in 42 samples of primary human non-small-cell lung carcinoma of different histotype. Each carcinoma sample was compared with adjacent normal lung tissue. The Met/HGF receptor was found to be 2 to 10-fold increased in 25% of carcinoma samples (P = 0.0113). The ligand, HGF/SF, was found to be 10 to 100-fold overexpressed in carcinoma samples (P < 0.0001). Notably, while HGF/SF was occasionally detectable and found exclusively as a single-chain inactive precursor in normal tissues, it was constantly in the biologically-active heterodimeric form in carcinomas. Immunohistochemical staining showed homogeneous expression of both the receptor and the ligand in carcinoma samples, whereas staining was barely detectable in their normal counterparts. These data show that HGF/SF is overexpressed and consistently activated in non-small-cell lung carcinomas and may contribute to the invasive growth of lung cancer.

Randomized Study Comparing a Basal Bolus With a Basal Plus Correction Insulin Regimen for the Hospital Management of Medical and Surgical patients With Type 2 Diabetes: Basal Plus Trial

OBJECTIVE Effective and easily implemented insulin regimens are needed to facilitate hospital glycemic control in general medical and surgical patients with type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS This multicenter trial randomized 375 patients with T2D treated with diet, oral antidiabetic agents, or low-dose insulin (≤0.4 units/kg/day) to receive a basal-bolus regimen with glargine once daily and glulisine before meals, a basal plus regimen with glargine once daily and supplemental doses of glulisine, and sliding scale regular insulin (SSI). RESULTS Improvement in mean daily blood glucose (BG) after the first day of therapy was similar between basal-bolus and basal plus groups (P = 0.16), and both regimens resulted in a lower mean daily BG than did SSI (P = 0.04). In addition, treatment with basal-bolus and basal plus regimens resulted in less treatment failure (defined as >2 consecutive BG >240 mg/dL or a mean daily BG >240 mg/dL) than did treatment with SSI (0 vs. 2 vs. 19%, respectively; P < 0.001). A BG <70 mg/dL occurred in 16% of patients in the basal-bolus group, 13% in the basal plus group, and 3% in the SSI group (P = 0.02). There was no difference among the groups in the frequency of severe hypoglycemia (<40 mg/dL; P = 0.76). CONCLUSIONS The use of a basal plus regimen with glargine once daily plus corrective doses with glulisine insulin before meals resulted in glycemic control similar to a standard basal-bolus regimen. The basal plus approach is an effective alternative to the use of a basal-bolus regimen in general medical and surgical patients with T2D.

High prevalence of triple-negative tumors in an urban cancer center†

A disparate proportion of breast cancer deaths occur among young women, those of African‐American (AA) ancestry, and particularly young AA women. Estrogen receptors (ER), progesterone receptors (PR), and human epidermal growth factor receptor‐2 (HER‐2) are key clinically informative biomarkers. The triple‐negative (ER‐/PR‐/HER‐2‐) tumor subgroup is intrinsically resistant to treatment and portends a poor prognosis. Age, race, and socioeconomic status have been associated with triple‐negative tumors (TNT). In the current study, the authors investigated breast cancer subgroups among patients in an urban cancer center serving a multiracial, low socioeconomic population.

Effects of an outreach and internal navigation program on breast cancer diagnosis in an urban cancer center with a large African-American population

Compared with white women, African‐American (AA) women who are diagnosed with breast cancer experience an excess in mortality. To improve outcomes, the authors implemented community education and outreach initiatives in their cancer center, at affiliated primary care sites, and in the surrounding communities. They then assessed the effectiveness of these outreach initiatives and internal patient navigation on stage of diagnosis.

Management of Papillary Breast Lesions Diagnosed on Core-Needle Biopsy: Clinical Pathologic and Radiologic Analysis of 276 Cases with Surgical Follow-Up

BACKGROUND Clinical management of papillary breast lesions (PBLs) remains controversial. The objective of this study was to identify pathologic and radiologic predictors of malignancy from a large cohort of PBLs diagnosed on core-needle biopsy (CNB). STUDY DESIGN Retrospective review of the institutional pathology database identified all PBLs diagnosed from 2001 to 2009 and surgically excised within 6 months of diagnosis. PBLs were divided into intraductal papilloma (IDP) and IDP associated with atypical ductal or lobular hyperplasia (ADH/ALH). Surgical pathology of all lesions was reviewed and upgrade was defined as a change to a lesion of greater clinical significance, including ALH, ADH, lobular, or ductal carcinoma in situ (LCIS or DCIS), and invasive ducal carcinoma (IDC). RESULTS We identified 276 patients (mean age 56 years; range 23 to 88 years) with PBLs on CNB. Seventy-nine patients (28.6%) upgraded to a lesion of greater clinical significance. Of the 234 (84.7%) had IDP only, 42 (17.9%) upgraded to ADH, and 21 (8.9%) to DCIS or IDC. Of the 42 (15.3%) patients with associated ADH or ALH on CNB, 16 (38.0%) upgraded to DCIS or IDC. The majority of patients (n = 173, 62.6%) had no breast symptoms. All patients had an abnormal mammogram and/or ultrasound that prompted the CNB. Among all clinical and radiographic variables analyzed, older age alone was predictive of upgrade. CONCLUSIONS Frequent upgrade to a high-risk lesion or cancer is observed with IDPs diagnosed on CNB without adequate identifiable clinical and radiographic risk factors. Surgical excision should be performed for all IDPs to delineate subsequent clinical management.

21-Gene recurrence scores: Racial differences in testing, scores, treatment, and outcome

African American (AA) women experience higher breast cancer mortality than white (W) women. These differences persist even among estrogen receptor (ER)‐positive breast cancers. The 21‐gene recurrence score (RS) predicts recurrence in patients with ER‐positive/lymph node‐negative breast cancer according to RS score—low risk (RS, 0‐18), intermediate risk (RS, 19‐31), and high risk (RS, >31). The high‐risk group is most likely to benefit from chemotherapy, to achieve minimal benefit from hormonal therapy, and to exhibit lower ER levels (intrinsically luminal B cancers). In the current study, the authors investigated racial differences in RS testing, scores, treatment, and outcome.

Characteristics and treatment modalities for African American women diagnosed with stage III breast cancer.

Stage III breast cancers account for about 6% to 7% of all invasive breast cancers diagnosed annually in the United States. In African American (AA) women, the incidence of stage III breast cancers is almost double that in Caucasian women. The aim of this study was to correlate age, receptor status, nuclear grade, and differences in treatment modalities for stage III breast cancer in an inner‐city hospital serving a large AA population.

National Surgical Patterns of Care for Primary Surgery and Axillary Staging of Phyllodes Tumors

Abstract:  Phyllodes tumors (PT) are rare and unique in their suspected stromal and epithelial origin, and their propensity to recur despite surgical resection. Current surgical treatment of PT does not include sampling of regional lymph nodes (LNs) as malignant PT infrequently spread to LNs. We hypothesize that, because of substantial experience with common epithelial lesions of the breast, surgeons are more prone to sample LNs in PT patients. We reviewed national surgical patterns of care of axillary LN sampling for PT using the Surveillance Epidemiology & End Results (SEER) registry. SEER data for LN evaluation are available from 1988. The public‐access SEER data‐base was queried for patients presenting over all 17 registries between 1988 and 2003 with PT of the breast. Data were collated by type of surgery and number of LNs examined, and further analyzed by tumor size of the primary lesion where available; 1,035 cases of PT were identified for the 16‐year period. Patients had a median age of 50 (range 12–96). Of the specimens with SEER grade listed, 117 were well‐differentiated, 186 moderately differentiated, 79 poorly differentiated, and 132 undifferentiated; 612 (59.1%) cases had specific surgical procedures reported: 191 partial, 251 simple, 5 subcutaneous, 154 modified radical, and 6 radical mastectomies, with 5 mastectomies (NOS) documented. The remainder of cases had surgery that was coded as “undocumented” or unknown. When surveyed by LNs examined, 25.5% of patients (n = 264) underwent some degree of regional lymphadenectomy; the median number of LNs examined in these patients was 7 (range 1–37). Of all PT patients, 9.0% of patients underwent axillary sampling of 10 LN or more. Only nine patients (3.4%) had positive LNs. When assessing axillary sampling rate by tumor size, smaller lesions were less likely to undergo sampling than larger lesions (19.3% for lesions <2 cm, 20.5% for lesions 2–4.9 cm, 27.9% for 5–9.9 cm); although this was nonsignificant. In spite of the lack of supporting data for LN examination axillary staging continues to be performed for many cases of PT.