Nina R. Horowitz

A Randomized, Controlled Trial of Cavity Shave Margins in Breast Cancer

BACKGROUND Routine resection of cavity shave margins (additional tissue circumferentially around the cavity left by partial mastectomy) may reduce the rates of positive margins (margins positive for tumor) and reexcision among patients undergoing partial mastectomy for breast cancer. METHODS In this randomized, controlled trial, we assigned, in a 1:1 ratio, 235 patients with breast cancer of stage 0 to III who were undergoing partial mastectomy, with or without resection of selective margins, to have further cavity shave margins resected (shave group) or not to have further cavity shave margins resected (no-shave group). Randomization occurred intraoperatively after surgeons had completed standard partial mastectomy. Positive margins were defined as tumor touching the edge of the specimen that was removed in the case of invasive cancer and tumor that was within 1 mm of the edge of the specimen removed in the case of ductal carcinoma in situ. The rate of positive margins was the primary outcome measure; secondary outcome measures included cosmesis and the volume of tissue resected. RESULTS The median age of the patients was 61 years (range, 33 to 94). On final pathological testing, 54 patients (23%) had invasive cancer, 45 (19%) had ductal carcinoma in situ, and 125 (53%) had both; 11 patients had no further disease. The median size of the tumor in the greatest diameter was 1.1 cm (range, 0 to 6.5) in patients with invasive carcinoma and 1.0 cm (range, 0 to 9.3) in patients with ductal carcinoma in situ. Groups were well matched at baseline with respect to demographic and clinicopathological characteristics. The rate of positive margins after partial mastectomy (before randomization) was similar in the shave group and the no-shave group (36% and 34%, respectively; P=0.69). After randomization, patients in the shave group had a significantly lower rate of positive margins than did those in the no-shave group (19% vs. 34%, P=0.01), as well as a lower rate of second surgery for margin clearance (10% vs. 21%, P=0.02). There was no significant difference in complications between the two groups. CONCLUSIONS Cavity shaving halved the rates of positive margins and reexcision among patients with partial mastectomy. (Funded by the Yale Cancer Center; ClinicalTrials.gov number, NCT01452399.).

Neoadjuvant Chemotherapy for Breast Cancer Increases the Rate of Breast Conservation: Results from the National Cancer Database

BACKGROUND Neoadjuvant chemotherapy has been shown to increase the rate of breast conservation in clinical trials and small institutional series, but it has never been studied on a national level. STUDY DESIGN We performed a retrospective review of the National Cancer Database (NCDB). The NCDB is a joint project of the Commission on Cancer of the American College of Surgeons and the American Cancer Society and contains about 80% of the cancer cases in the United States. All women in the NCDB diagnosed with invasive breast cancer from 2006 through 2011, who underwent definitive breast surgery and received either neoadjuvant or adjuvant chemotherapy, excluding patients with distant metastases or T4 tumors, were included and rates of breast preservation were determined. RESULTS Of 354,204 patients who met the inclusion criteria, 59,063 (16.7%) underwent neoadjuvant chemotherapy. This proportion steadily increased from 13.9% in 2006 to 20.5% in 2011 (p<0.001). Receipt of neoadjuvant chemotherapy was associated with larger tumor size (7% cT1, 25% cT2, and 58% cT3; p<0.001), more advanced nodal disease (11% cN0, 39% cN1-3; p<0.001), younger patient age (21%<50 years vs 14%>50 years; p<0.001), higher tumor grade (18% grade 3, 15% grade 2, vs 12% grade 1; p<0.001), and estrogen receptor (ER)-negative tumors (21% ER negative vs 15% ER postive; p<0.001). Multivariate logistic regression showed that when adjusted for the above variables, patients with tumors larger than 3 cm undergoing neoadjuvant chemotherapy were more likely to receive breast preservation than those who opted for primary surgery (odds ratio 1.7, 95% CI 1.6 to 1.8). CONCLUSIONS Neoadjuvant chemotherapy increases breast preservation for patients with breast tumor size larger than 3 cm.

Racial Differences in the Use and Outcome of Neoadjuvant Chemotherapy for Breast Cancer: Results From the National Cancer Data Base

PURPOSE To explore racial differences in the use and outcome of neoadjuvant chemotherapy for breast cancer. METHODS The National Cancer Data Base was queried to identify women with stage 1 to 3 breast cancer diagnosed in 2010 and 2011. Chemotherapy use and rate of pathologic complete response (pCR) was determined for various racial/ethnic groups. RESULTS Of 278,815 patients with known race and ethnicity, 127,417 (46%) received chemotherapy, and of 121,446 where the timing of chemotherapy was known, 27,300 (23%) received neoadjuvant chemotherapy. Chemotherapy, and neoadjuvant chemotherapy in particular, was given more frequently to black, Hispanic, and Asian women than to white women (P < 0.001). This difference was largely explained by more advanced stage, higher grade tumors, and a greater proportion of triple-negative and human epidermal growth factor receptor 2 (HER2)-positive tumors in these women. Of 17,970 patients with known outcome, 5,944 (33%) had a pCR. No differences in response rate for estrogen receptor (ER)/progesterone receptor (PR)-positive tumors were found, but compared with white women, black but not Hispanic or Asian women had a lower rate of pCR for ER/PR-negative, HER2-positive (43% v 54%, P = 0.001) and triple-negative tumors (37% v 43%, P < 0.001). This difference persisted when adjusted for age, clinical T stage, clinical N stage, histology, grade, comorbidity index, facility type, geographic region, insurance status, and census-derived median income and education for the patients zip code (odds ratio, 0.84; 95% CI, 0.77 to 0.93). CONCLUSION Neoadjuvant chemotherapy is given more frequently to black, Hispanic, and Asian women than to white women. Black women have a lower likelihood of pCR for triple-negative and HER2-positive breast cancer. Whether this is due to biologic differences in chemosensitivity or to treatment or socioeconomic differences that could not be adjusted for is unknown.

Features of triple-negative breast cancer: Analysis of 38,813 cases from the national cancer database

AbstractThe aim of this study was to determine the features of triple-negative breast cancer (TNBC) using a large national database. TNBC is known to be an aggressive subtype, but national epidemiologic data are sparse. All patients with invasive breast cancer and known molecular subtype diagnosed in 2010 to 2011 were identified from the National Cancer Data Base (NCDB). Patients with and without TNBC were compared with respect to their sociodemographic and clinicopathologic features. TNBC was present in 38,628 of 295,801 (13%) female patients compared to 185 of 3136 (6%) male patients (P < 0.001). The incidence of TNBC varied by region from 10.8% in New England to 15.8% in the east south central US (P < 0.001), as well as by race with the highest rates in African-Americans (23.7%), and lowest in Filipino patients (8.9%). The incidence of TNBC also varied by histology, accounting for 76% of metaplastic cancers, but only 2% of infiltrating lobular carcinomas. TNBCs were significantly larger than non-TNBC (mean 2.8 cm vs 2.1 cm, P < 0.001), and more TNBC were poorly differentiated compared to other subtypes (79.7% vs 25.8%, P < 0.001). On univariate analysis, TNBC was no more likely than non-TNBC to have node-positive disease (32.0% vs 31.7%, respectively, P = 0.218) but in a multivariable analysis controlling for tumor size and grade, TNBC was associated with significantly less node-positivity (OR = 0.59; 95% confidence interval [CI]: 0.57–0.60). TNBC has distinct features regarding age, gender, geographic, and racial distribution. Compared to non-TNBC, TNBC is larger and higher grade, but less likely to have lymph node metastases.

Smoking and Breast Cancer Recurrence after Breast Conservation Therapy

Background. Prior studies have shown earlier recurrence and decreased survival in patients with head and neck cancer who smoked while undergoing radiation therapy. The purpose of the current study was to determine whether smoking status at the time of partial mastectomy and radiation therapy for breast cancer affected recurrence or survival. Method. A single institution retrospective chart review was performed to correlate smoking status with patient demographics, tumor characteristics, and outcomes for patients undergoing partial mastectomy and radiation therapy. Results. There were 624 patients who underwent breast conservation surgery between 2002 and 2010 for whom smoking history and follow-up data were available. Smoking status was associated with race, patient age, and tumor stage, but not with grade, histology, or receptor status. African American women were more likely to be current smokers (22% versus 7%, P < 0.001). With a mean follow-up of 45 months, recurrence was significantly higher in current smokers compared to former or never smokers (P = 0.039). In a multivariate model adjusted for race and tumor stage, recurrence among current smokers was 6.7 times that of never smokers (CI 2.0–22.4). Conclusions. Although the numbers are small, this study suggests that smoking may negatively influence recurrence rates after partial mastectomy and radiation therapy. A larger study is needed to confirm these observations.

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 (

P3-07-26: How Generalizable Is the Patient Population Enrolled in ACOSOG Z11?

1315 vs.

Impacts of Early Guideline-Directed 21-Gene Recurrence Score Testing on Adjuvant Therapy Decision Making

1137, P = 0.03) and pathology costs (

Does removal of DCIS decrease the incidence of invasive breast cancer

1195 vs

Long‐Term Survival of De Novo Stage IV Human Epidermal Growth Receptor 2 (HER2) Positive Breast Cancers Treated with HER2‐Targeted Therapy

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 (