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.).

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 ($1315 vs. $1137, P = 0.03) and pathology costs ($1195 vs $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 ($10,476 vs $11,219, P = 0.40) or hospital perspective ($5090 vs $5116, P = 0.37) between the "shave" and "no shave" groups. CONCLUSIONS: Overall costs were not significantly different between the "shave" and "no shave" groups due to significantly fewer reoperative surgeries in the former.

Characteristics of Multifocal and Multicentric Breast Cancers.

BACKGROUND: Multifocality and multicentricity are increasingly recognized in breast cancer. However, little is known about the characteristics and biology of these cancers and the clinical implications are controversial. METHODS: A retrospective, institutional database was used to compare characteristics of multifocal (MF) and multicentric (MC) breast cancers with unifocal (UF) cancers to study concordance of histology and receptor status among primary and secondary foci and to evaluate predictors of lymph node positivity using multivariate logistic regression. RESULTS: Of 1495 invasive cancers, 1231 (82.3 %) were UF, 169 (11.3 %) were MF, and 95 (6.4 %) were MC cancers. When MF and MC cancers were compared with UF cancers, MC but not MF cancers were associated with young age at diagnosis, larger tumor size, lymphovascular invasion, and node positivity. MF but not MC tumors were more likely to be ER/PR+Her2+ tumors and less likely to be triple-negative cancers compared with UF tumors. MF tumors were more likely to be infiltrating ductal carcinomas with an extensive intraductal component, and MC tumors were more likely to be infiltrating lobular carcinomas. Concordance of histology and receptor status between primary and secondary foci was high and was similar for both MF and MC cancers. Multicentricity remained an independent predictor of lymph node positivity on multivariate analysis. CONCLUSION: MF and MC tumors seem to be biologically different diseases. MC is clinicopathologically more aggressive than MF disease and is more frequently associated with younger age and larger tumor size and also is an independent predictor of node positivity.

The number of lymph nodes dissected in breast cancer patients influences the accuracy of prognosis.

BACKGROUND: Recent trials have suggested that axillary node dissection may not be warranted in some breast cancer patients with one to two positive nodes. Given that lymph node ratio (LNR; number of positive lymph nodes divided by the total examined) has been shown to be a significant prognostic factor, we sought to determine whether the number of nodes removed in this low risk population predicted survival. METHODS: The National Cancer Database is a comprehensive clinical surveillance resource capturing 70% of newly diagnosed malignancies in the United States; 309,216 breast cancer patients diagnosed between 1998 and 2005, with tumors ≤5 cm and one to two positive nodes, formed the cohort of interest. RESULTS: Median age at diagnosis was 57 (range 18-90) years. Median tumor size was 2 (range 0.1-5) cm; 215,382 patients (69.7%) had one positive node, and 93,834 (30.3%) had two. The median number of lymph nodes examined was 11 (range 1-84). Patients were categorized into low (≤0.2), medium (0.21-0.65), or high (>0.65) LNR groups, with 228,822 (74%), 55,797 (18%), and 24,597 (8%) patients in each of these categories, respectively. Median follow-up was 54.1 months. Median overall survival (OS) for low, intermediate, and high LNR was 66.1, 61.1, and 56.5 months, respectively (p < 0.001). In a Cox model controlling for clinicopathologic and therapy covariates, LNR category remained a significant predictor of OS (p < 0.001). CONCLUSIONS: LNR is an independent predictor of OS in a low-risk population with one to two positive nodes and tumors ≤5 cm. Therefore, the number of lymph nodes excised may influence prognostic stratification.

Factors associated with breast MRI use: a population-based analysis.

INTRODUCTION: Although controversial, the use of breast magnetic resonance imaging (MRI) is widespread. We sought to determine factors that influenced its use in a population-based sample. METHODS: The National Health Interview Survey is conducted annually by the Centers for Disease Control and is designed to be representative of the American population. Data from 2010 were queried for the use of breast MRI and associated sociodemographic and risk characteristics. RESULTS: Of the 11,222 women aged ≥30 years who were surveyed, 4.7 % reported ever having a breast MRI. Nearly a quarter were done as part of a "routine exam" and <5 % were done for "family history" or for "high risk." Factors correlating with MRI use on univariate analysis included age, race, personal and/or family history of breast cancer, history of benign breast biopsy, perceived risk, and insurance. On multivariate analysis, African-American race (p = 0.001), personal history (p < 0.001), history of benign biopsy (p < 0.001), and high perceived risk (p < 0.001) were significantly associated with increased MRI use. In a cohort without a personal history of breast cancer, race, history of benign biopsy, and perceived risk were independent correlates of breast MRI, whereas family history, age, and insurance were no longer significant. CONCLUSIONS: Personal history is the strongest factor associated with breast MRI use. However, whereas race, history of benign biopsy, and perceived risk were independently associated with MRI use, family history was not. These findings call into question whether current practice patterns follow evidence-based guidelines.

Is there a correlation between breast cancer molecular subtype using receptors as surrogates and mammographic appearance?

BACKGROUND: The identification of distinct molecular subtypes has changed breast cancer management. The correlation between mammographic appearance and molecular subtype for invasive breast cancer has not been extensively studied. METHODS: A retrospective review of our prospectively collected database was performed to evaluate the mammographic appearance and molecular subtypes of all cases of invasive breast cancers diagnosed between 2003 and 2010. RESULTS: There were 985 cases of invasive breast cancer with complete data on receptor status and mammographic appearance. The most common mammographic finding was a mass (61 %), and the most common molecular subtype was ER/PR positive, HER2 negative (71 %). On univariate analysis, race, stage, and histology were all significantly associated with molecular subtype. On multivariate analysis, the luminal molecular type was associated with architectural distortion [odds ratio (OR) 4.3, 95 % CI 1.3-14.1]; HER2 positive cancers, either with or without ER/PR expression, were more likely to be associated with mammographic calcifications (OR 2.8 and 3.1, respectively; 95 % CI 1.7-4.8 and 1.7-5.5); and triple negative cancers were most likely to be associated with a mammographic mass (OR 2.5; 95 % CI 1.4-4.4). CONCLUSIONS: We observed several characteristic associations between molecular subtype and mammographic appearance. Improved understanding of these associations may help guide clinical decision making and provide information about underlying tumor biology.

Characteristics and treatment of human epidermal growth factor receptor 2 positive breast cancer: 43,485 cases from the National Cancer Database treated in 2010 and 2011.

BACKGROUND: Although identification of human epidermal growth factor receptor 2 (Her2) positive breast cancer represents one of the greatest advances over the past 3 decades, it has not been studied extensively on a national level. METHODS: The National Cancer Database is a joint project of the American Cancer Society and the American College of Surgeons and contains data on about 70% of the cancer cases in the United States. Data on Her2 have been collected since 2010 and was used for this study. RESULTS: Of 298,937 cases of invasive breast cancer with known Her2 status diagnosed in 2010 and 2011, 43,485 (14.5%) were Her2 positive. Her2 positivity was greatest in Asian/Pacific Islanders and least in non-Hispanic Whites and was markedly more common in younger women. The incidence of Her2 positive tumors ranged from a low of 13.9% in the Mountain West region to a high of 16.0% in the West South Central region (P < .001). Compared with Her2 negative tumors, Her2 positive tumors were larger (2.6 vs 2.2 cm, P < .001), more likely to have positive nodes (39% vs 31% P < .001), have lymphovascular invasion (30% vs 20%, P < .001), and be high grade (56% vs 29%, P < .001). There were also differences by histology: invasive ductal 16.4%, invasive lobular 5.5%, tubular 2.3%, inflammatory 36%, and Paget's with invasion 59%. When adjusted for age, race, tumor size, and nodal status Her2 positive tumors were much more likely to receive chemotherapy (odds ratio = 5.5, confidence interval = 5.2 to 6.0) and somewhat less likely to undergo breast preservation (odds ratio = .78, confidence interval = .76 to .80). CONCLUSIONS: Her2 positive tumors have distinct epidemiologic, clinical, and treatment characteristics.

Intraoperative Injection of Technetium-99m Sulfur Colloid for Sentinel Lymph Node Biopsy in Breast Cancer Patients: A Single Institution Experience.

Background. Most institutions require a patient undergoing sentinel lymph node biopsy to go through nuclear medicine prior to surgery to be injected with radioisotope. This study describes the long-term results using intraoperative injection of radioisotope. Methods. Since late 2002, all patients undergoing a sentinel lymph node biopsy at the Yale-New Haven Breast Center underwent intraoperative injection of technetium-99m sulfur colloid. Endpoints included number of sentinel and nonsentinel lymph nodes obtained and number of positive sentinel and nonsentinel lymph nodes. Results. At least one sentinel lymph node was obtained in 2,333 out of 2,338 cases of sentinel node biopsy for an identification rate of 99.8%. The median number of sentinel nodes found was 2 and the mean was 2.33 (range: 1-15). There were 512 cases (21.9%) in which a sentinel node was positive for metastatic carcinoma. Of the patients with a positive sentinel lymph node who underwent axillary dissection, there were 242 cases (54.2%) with no additional positive nonsentinel lymph nodes. Advantages of intraoperative injection included increased comfort for the patient and simplification of scheduling. There were no radiation related complications. Conclusion. Intraoperative injection of technetium-99m sulfur colloid is convenient, effective, safe, and comfortable for the patient.

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

PURPOSE: The 21-gene recurrence score (RS) assay is used to help formulate adjuvant chemotherapy recommendations for patients with estrogen receptor-positive, early-stage breast cancer. Most frequently, medical oncologists order RS after surgery. Results take an additional 2 weeks to return, which can delay decision making. We conducted a prospective quality-improvement project to assess the impact of early guideline-directed RS ordering by surgeons before the first visit with a medical oncologist on adjuvant therapy decision making. MATERIALS AND METHODS: Surgical oncologists ordered RS testing following National Comprehensive Cancer Network guidelines at time of diagnosis or at time of surgery between July 1, 2015 and December 31, 2015. We measured the testing rate of patients eligible for RS, time to chemotherapy decisions, rates of chemotherapy use, accrual to RS-based clinical trials, cost, and physician acceptance of the policy and compared the results to patients who met eligibility criteria for early guideline-directed testing during the 6 months before the project. RESULTS: Ninety patients met eligibility criteria during the testing period. RS was ordered for 91% of patients in the early testing group compared with 76% of historical controls ( P < .001). Median time to chemotherapy decision was significantly shorter in the early testing group (20 days; 95% CI, 17 to 23 days) compared with historical controls (32 days; 95% CI, 29 to 35 days; P < .001). There were no significant differences in time to chemotherapy initiation, chemotherapy use, RS-based trial enrollment, or calculated costs between the groups. CONCLUSION: Early guideline-directed RS testing in selected patients is an effective way to shorten time to treatment decisions.

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

The 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.

Breast cancer biology varies by method of detection and may contribute to overdiagnosis.

BACKGROUND: Recently, it has been suggested that screening mammography may result in some degree of overdiagnosis (ie, detection of breast cancers that would never become clinically important within the lifespan of the patient). The extent and biology of these overdiagnosed cancers, however, is not well understood, and the effect of newer screening modalities on overdiagnosis is unknown. METHODS: We performed a retrospective review of a prospectively collected database of breast cancers diagnosed at the Yale Breast Center from 2004-2014. The mode of initial presentation was categorized into 5 groups: screening mammogram, screening magnetic resonance imaging, screening ultrasonography, self-detected masses, and physician-detected masses. RESULTS: Compared with cancers presenting with masses, cancers detected by image-based screening were more likely to present with ductal carcinoma-in-situ or T1 cancers (P < .001). In addition to a simple stage shift, however, cancers detected by image-based screening were also more likely to be luminal and low-grade cancers; symptomatic cancers were more likely high-grade and triple-negative (P < .001, respectively). On a multivariate analysis, adjusting for age, race, and tumor size, cancers detected by mammogram, US, and magnetic resonance imaging had greater odds of being luminal (odds ratio 1.8, 95% confidence interval, 1.5-2.3; odds ratio 2.2, 95% confidence interval, 1.1-4.7; and odds ratio 4.7, 95% confidence interval, 2.1-10.6, respectively), and low-grade (odds ratio 2.2, 95% confidence interval, 1.6-2.9; odds ratio 4.9, 95% confidence interval, 2.7-8.9; and odds ratio 4.6, 95% confidence interval, 2.6-8.1, respectively) compared with cancers presenting with self-detected masses. CONCLUSION: Screening detects cancers with more indolent biology, potentially contributing to the observed rate of overdiagnosis. With magnetic resonance imaging and US being used more commonly for screening, the rate of overdiagnosis may increase further.

Does three-dimensional intraoperative specimen imaging reduce the need for re-excision in breast cancer patients? A prospective cohort study.

BACKGROUND: Standard two-dimensional (2D) specimen radiography may guide intraoperative re-excision of margins in patients undergoing breast conserving surgery. We sought to determine the impact of three-dimensional (3D) specimen imaging in further reducing positive margin rates. METHODS: A prospective study of 100 patients in which both 2D and 3D specimen radiographies were performed. The impact of orthogonal view on intraoperative surgical management and final margins was assessed. RESULTS: Ten patients had no residual tumor; therefore, 90 patients formed the cohort of interest. Of them, 21 patients (23.3%) had ductal carcinoma in situ; 18 (20.0%) had invasive cancer; and 51 (56.7%) had both. Median tumor size was 1.7 cm (range, .2 to 8.1 cm). On the basis of 2D imaging, surgeons stated they would take more tissue in 26 patients (28.9%). Three-dimensional imaging changed management in 4 patients (6.3%). One of these patients would have had positive margins if the intraoperative resection done on the basis of the 3D imaging would have been omitted. CONCLUSIONS: Three-dimensional specimen imaging results in further intraoperative re-excision in 6.3% of patients and may reduce re-excision rates in 2.2%.

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 patient's 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.

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.

Systematic approach to providing breast cancer survivors with survivorship care plans: a feasibility study.

PURPOSE: This was a feasibility study with the primary purpose to identify women with a diagnosis of breast cancer for survivorship care plan (SCP) delivery at the postoperative visit and deliver an SCP after treatment. The secondary purpose was to determine if patients' knowledge about their diagnosis, treatment, and risk for future adverse events improved with the SCP. METHODS: Sixty-seven English-speaking women older than age 18 years with stage I-III breast cancer were enrolled at their postoperative appointment. The participants' treatment was tracked through the electronic medical record; SCPs were generated based on information abstracted from the records. After treatment completion, participants received an SCP during a routine follow-up appointment. Knowledge of tumor, treatments, adverse events, and screening recommendations were assessed before receiving the SCP and 2 months later. Accuracy at baseline and follow-up were compared using the McNemar test. RESULTS: One hundred twenty-nine visits were screened to identify 75 eligible participants. Seventy-five eligible participants (100%) agreed to enroll, and 71 (95%) were given an SCP. Participants were more accurate in reporting details about their history, screening recommendations, and potential adverse events at follow-up than they were at baseline for most measures, but the only statistically significant changes were found with stage (P = .0016) and increased risk of leukemia (P = .0348). CONCLUSION: It is feasible to identify and deliver SCPs to women with breast cancer who are approached during the postoperative visit in a surgical clinic. Additionally, SCPs seem to improve patient knowledge in several areas.

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.

A PHASE II TRIAL OF BALLOON-CATHETER PARTIAL BREAST BRACHYTHERAPY OPTIMIZATION IN THE TREATMENT OF STAGE 0, I AND IIA BREAST CARCINOMA.

OBJECTIVES: (a) To prospectively determine if multidwell position dose delivery can decrease skin dose and resultant toxicity over single dwell balloon-catheter partial breast irradiation, and (b) to evaluate whether specific skin parameters could be safely used instead of skin-balloon distance alone for predicting toxicity and treatment eligibility. METHODS: A single-arm phase II study using a Simon two-stage design was performed on 28 women with stage 0-II breast cancer. All patients were treated with multiple dwell position balloon-catheter brachytherapy. The primary endpoint was ≥ grade 2 skin toxicity. Initial entry required a balloon-skin distance ≥ 7 mm. Based on the toxicity in the first 16 patients, additional patients were treated irrespective of skin-balloon distance as long as the Dmax to 1 mm skin thickness was < 130%. RESULTS: Compared to the phantom single dwell plans, multidwell planning yielded superior PTV coverage as per median V90, V95 and V100, but had slightly worse V150, V200 and DHI. Dmax to skin was decreased by multidwell planning at multiple skin thicknesses. The most common acute toxicity was grade 1 erythema (57%), and only two patients (7%) developed acute grade 2 toxicity (erythema). Late grade 1 fibrosis was seen in 32%. No patients experienced grade 3, 4, or 5 toxicity. CONCLUSIONS: Multidwell position planning for balloon-catheter brachytherapy results in lower skin doses with equal to superior PTV coverage and an overall low rate of initial skin toxicity. Our data suggest that limiting the Dmax to < 130% to 1 mm thick skin is achievable and results in minimal toxicity.

Impact of financial burden of cancer on survivors' quality of life.

PURPOSE: Little is known about the relationship between the financial burden of cancer and the physical and emotional health of cancer survivors. We examined the association between financial problems caused by cancer and reported quality of life in a population-based sample of patients with cancer. METHODS: Data from the 2010 National Health Interview Survey (NHIS) were analyzed. A multivariable regression model was used to examine the relationship between the degree to which cancer caused financial problems and the patients' reported quality of life. RESULTS: Of 2,108 patients who answered the survey question, "To what degree has cancer caused financial problems for you and your family?," 8.6% reported "a lot," whereas 69.6% reported "not at all." Patients who reported "a lot" of financial problems as a result of cancer care costs were more likely to rate their physical health (18.6% v 4.3%, P < .001), mental health (8.3% v 1.8%, P < .001), and satisfaction with social activities and relationships (11.8% v 3.6%, P < .001) as poor compared to those with no financial hardship. On multivariable analysis controlling for all of the significant covariates on bivariate analysis, the degree to which cancer caused financial problems was the strongest independent predictor of quality of life. Patients who reported that cancer caused "a lot" of financial problems were four times less likely to rate their quality of life as "excellent," "very good," or "good" (odds ratio = 0.24; 95% CI, 0.14 to 0.40; P < .001). CONCLUSION: Increased financial burden asa result of cancer care costs is the strongest independent predictor of poor quality of life among cancer survivors.