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Beitsch P.D.,Dallas Breast Center | Wilkinson J.B.,Oakland University | Vicini F.A.,Michigan Healthcare Professionals | Haffty B.,Johnson University | And 4 more authors.
Annals of Surgical Oncology | Year: 2012

Background. Randomized trials demonstrate that lumpectomy plus whole-breast irradiation (WBI) yields survival equivalent to mastectomy. Studies that use WBI, however, typically report higher tumor bed recurrence rates than elsewhere failures (EF) (historically considered new primary lesions). The rate of true recurrence (TR) versus EF was queried for a large patient cohort treated with accelerated partial breast irradiation (APBI). Methods. A total of 1,449 cases of early-stage breast cancer were treated on the American Society of Breast Surgeons MammoSite® Registry Trial with lumpectomy plus balloon-based APBI (34 Gy, 10 BID fractions). A total of 1,255 cases (87 %) had invasive breast cancer, and 194 patients (13 %) had ductal carcinoma in situ. Rates of TR versus EF were calculated and compared to historical WBI controls. Results. Median follow-up was 60 (range 0-109) months. Fifty patients (3.5 %) developed an ipsilateral breast tumor recurrence (IBTR). The 5-year actuarial rate of IBTR was 3.6 % (invasive breast cancer 3.6 %, ductal carcinoma in situ 3.4 %). Fourteen IBTR (1.1 %) were TR, while 36 (2.6 %) were EF. Estrogen receptor-negative status was associated with IBTR for invasive malignancies as well as for EF only (p<0.001). Trends for increased rates of EF were noted for increased tumor size (p = 0.067) and extensive intraductal component (p = 0.087). No pathologic factors were explicitly associated with TR. Conclusions. IBTR after balloon-based APBI is low and similar to rates reported for WBI. In this data set, APBI had fewer tumor bed recurrences (presumably initial cancer recurrences) than EF (presumably new primary lesions). This suggests that balloon-based APBI has a tumor bed control rate that is at least equal to (and potentially higher than) WBI. © Society of Surgical Oncology 2012.

Schnell O.,Helmholtz Center Munich | Amann-Zalan I.,Roche Holding AG | Jelsovsky Z.,Biostat International Inc. | Moritz A.,Roche Holding AG | And 5 more authors.
Diabetes Care | Year: 2013

OBJECTIVE-The effect of therapeutic strategies on cardiovascular (CV) disease can be evaluated by monitoring changes in CV risk biomarkers. This study investigated the effect of a structured self-monitoring of blood glucose (SMBG) protocol and the resulting improvements in glycemic control on changes in high-sensitivity C-reactive protein (hs-CRP) in insulin-naïve patients with type 2 diabetes. RESEARCH DESIGN ANDMETHODS-The Structured Testing Program (STeP) study was a prospective, cluster-randomized, multicenter trial in which 483 poorly controlled, insulinnaïve patientswith type 2 diabetes were randomized to active control (ACG) or structured testing (STG) that included quarterly structured SMBG. Changes in A1C, hs-CRP, and glycemic variability (STG subjects only) were measured at baseline and quarterly. RESULTS-Reductions in geometric mean hs-CRP values were significantly greater in the STG group at months 3 (P = 0.005), 6 (P = 0.0003), and 12 (P = 0.04) than in the ACG group. STG patients at high CV risk (>3mg/L) showed significantly greater reductions in hs-CRP levels than ACG patients at high CV risk: 23.64 mg/dL (95% CI 24.21 to 23.06) versus 22.18 mg/dL (22.93 to21.43), respectively (P = 0.002). There was a strong correlation between reductions in hs-CRP and A1C in both groups: standardized coefficient (β) was 0.25 for the entire cohort (P< 0.0001), 0.31 for STG (P < 0.0001), and 0.16 for ACG (P = 0.02). CONCLUSIONS- Reductions in hs-CRP level are associated with reductions in A1C but not reductions in lipids or glycemic variability. Comprehensive structured SMBG-based interventions that lower A1C may translate into improvements in CV risk, as evidenced by levels of the biomarker hs-CRP. © 2013 by the American Diabetes Association.

Fisher L.,University of California at San Francisco | Polonsky W.H.,University of California at San Diego | Parkin C.G.,CGParkin Communications Inc. | Jelsovsky Z.,Biostat International Inc. | And 2 more authors.
Diabetes Research and Clinical Practice | Year: 2012

Introduction: Patients with T2DM often view self-monitoring of blood glucose (SMBG) as burdensome and pointless, which may affect their broader attitudes toward diabetes management. We examined how a structured SMBG protocol influenced diabetes self-efficacy and autonomous motivation over time, and linked these to changes in glycemic control. Materials and methods: The Structured Testing Program (STeP) is a 12-month, two-arm, cluster-randomized trial that assessed the efficacy of structured SMBG in 483 insulin-naïve T2DM patients. Measures included: Confidence in Diabetes Self-Care for Type 2 patients (CIDS-T2), Diabetes-related Autonomous Motivation (DRAM), self-management behaviors and HbA1c. Results: Intent-to-treat (ITT) and per-protocol (PP) analyses showed significant increases in CIDS-T2 scores over time (main effects p< 0.0001). PP analysis showed significant between-group differences (p< 0.05), with adherent STG patients displaying greater CIDS-T2 improvement than ACG patients. PP analyses showed main and between-group effects in DRAM with similar findings. Changes in CIDS-T2 were related to HbA1c changes over time; no self-management variable mediated this relationship. CIDS-T2 and HbA1c displayed a significant time-concordant relationship. Discussion: Structured SMBG leads to significant increases in self-confidence and autonomous motivation associated with diabetes self-management. Changes in self-confidence are linked to changes in glycemic control and share a time-concordant relationship. © 2011 Elsevier Ireland Ltd.

Wilkinson J.B.,Oakland University | Beitsch P.D.,Dallas Surgical Group | Shah C.,University of Washington | Arthur D.,Virginia Commonwealth University | And 8 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2013

Purpose: To determine whether the American Society for Radiation Oncology (ASTRO) Consensus Statement (CS) recommendations for accelerated partial breast irradiation (APBI) are associated with significantly different outcomes in a pooled analysis from William Beaumont Hospital (WBH) and the American Society of Breast Surgeons (ASBrS) MammoSite® Registry Trial. Methods and Materials: APBI was used to treat 2127 cases of early-stage breast cancer (WBH, n=678; ASBrS, n=1449). Three forms of APBI were used at WBH (interstitial, n=221; balloon-based, n=255; or 3-dimensional conformal radiation therapy, n=206), whereas all Registry Trial patients received balloon-based brachytherapy. Patients were divided according to the ASTRO CS into suitable (n=661, 36.5%), cautionary (n=850, 46.9%), and unsuitable (n=302, 16.7%) categories. Tumor characteristics and clinical outcomes were analyzed according to CS group. Results: The median age was 65 years (range, 32-94 years), and the median tumor size was 10.0 mm (range, 0-45 mm). The median follow-up time was 60.6 months. The WBH cohort had more node-positive disease (6.9% vs 2.6%, P<.01) and cautionary patients (49.5% vs 41.8%, P=.06). The 5-year actuarial ipsilateral breast tumor recurrence (IBTR), regional nodal failure (RNF), and distant metastasis (DM) for the whole cohort were 2.8%, 0.6%, 1.6%. The rate of IBTR was not statistically higher between suitable (2.5%), cautionary (3.3%), or unsuitable (4.6%) patients (P=.20). The nonsignificant increase in IBTR for the cautionary and unsuitable categories was due to increased elsewhere failures and new primaries (P=.04), not tumor bed recurrence (P=.93). Conclusions: Excellent outcomes after breast-conserving surgery and APBI were seen in our pooled analysis. The current ASTRO CS guidelines did not adequately differentiate patients at an increased risk of IBTR or tumor bed failure in this large patient cohort. © 2013 Elsevier Inc.

Shah C.,Summa Health System | Badiyan S.,Summa Health System | Ben Wilkinson J.,Oakland University | Vicini F.,Michigan Healthcare Professionals 21st Century Oncology | And 4 more authors.
Annals of Surgical Oncology | Year: 2013

Background: The purpose of this study was to examine data on treatment efficacy, cosmesis and toxicities for the final analysis of the American Society of Breast Surgeons MammoSite® breast brachytherapy registry trial. Methods: A total of 1,449 cases of early-stage breast cancer underwent breast conserving therapy. The single-lumen MammoSite® device was used to deliver accelerated partial breast irradiation (APBI) (34 Gy in 3.4 Gy fractions). Of these, 1,255 cases (87 %) had invasive breast cancer (IBC) and 194 cases had DCIS. Median follow-up was 63.1 months with 45 % of all patients having follow-up of 6 years or longer. Results: There were 41 cases (2.8 %) that developed an ipsilateral breast tumor recurrence (IBTR) for a 5-year actuarial rate of 3.8 % (3.7 % for IBC and 4.1 % for DCIS). Tumor size (odds ratio [OR] = 1.1, p = 0.03) and estrogen receptor negativity (OR = 3.0, p = 0.0009) were associated with IBTR, while a trend was noted for positive margins (OR = 2.0, p = 0.06) and cautionary/unsuitable status compared with suitable status (OR = 1.8, p = 0.07). The percentage of patients with excellent/good cosmetic results at 60, 72, and 84 months was 91.3, 90.5, and 90.6 %, respectively. The overall rates of fat necrosis and infections remained low at 2.5 and 9.6 % with few late toxicity events beyond 2 years. The overall symptomatic seroma rate was 13.4 and 0.6 % beyond 2 years. Conclusions: The final analysis of treatment efficacy, cosmesis, and toxicity from the American Society of Breast Surgeons MammoSite® breast brachytherapy registry trial confirms previously noted excellent results and compares favorably with other forms of APBI with similar follow-up and to outcomes seen in selected patients treated with whole breast irradiation. © 2013 Society of Surgical Oncology.

Rodbard H.W.,Endocrine and Metabolic Consultants | Schnell O.,Helmholtz Center Munich | Unger J.,Catalina Research Institute | Rees C.,Roche Holding AG | And 6 more authors.
Diabetes Care | Year: 2012

OBJECTIVE - We evaluated the impact of an automated decision support tool (DST) on clinicians' ability to identify glycemic abnormalities in structured self-monitoring of blood glucose (SMBG) data and then make appropriate therapeutic changes based on the glycemic patterns observed. RESEARCH DESIGN AND METHODS - In this prospective, randomized, controlled, multicenter study, 288 clinicians (39.6% family practice physicians, 37.9% general internal medicine physicians, and 22.6% nurse practitioners) were randomized to structured SMBG alone (STG; n = 72); structured SMBG with DST (DST; n = 72); structured SMBG with an educational DVD (DVD; n = 72); and structured SMBG with DST and the educational DVD (DST+DVD; n = 72). Clinicians analyzed 30 patient cases (type 2 diabetes), identified the primary abnormality, and selected the most appropriate therapy. RESULTS - A total of 222 clinicians completed all 30 patient cases with no major protocol deviations. Significantly more DST, DVD, and DST+DVD clinicians correctly identified the glycemic abnormality and selected the most appropriate therapeutic option compared with STG clinicians: 49, 51, and 55%, respectively, vs. 33%(all P < 0.0001) with no significant differences among DST, DVD, and DST+DVD clinicians. CONCLUSIONS - Use of structured SMBG, combined with the DST, the educational DVD, or both, enhances clinicians' ability to correctly identify significant glycemic patterns and make appropriate therapeutic decisions to address those patterns. Structured testing interventions using either the educational DVD or the DST are equally effective in improving data interpretation and utilization. The DST provides a viable alternative when comprehensive education is not feasible, and it may be integrated into medical practices with minimal training. © 2012 by the American Diabetes Association.

Arthur D.W.,Virginia Commonwealth University | Vicini F.A.,William Beaumont Hospital | Todor D.A.,Virginia Commonwealth University | Julian T.B.,Allegheny General Hospital | Lyden M.R.,BioStat International Inc.
International Journal of Radiation Oncology Biology Physics | Year: 2011

Purpose: Dosimetric findings in patients treated with the Contura multilumen balloon (MLB) breast brachytherapy catheter to deliver accelerated partial breast irradiation (APBI) on a multi-institutional Phase IV registry trial are presented. Methods and Materials: Computed tomography-based three-dimensional planning with dose optimization was performed. For the trial, new ideal dosimetric goals included (1) ≥95% of the prescribed dose (PD) covering ≥90% of the target volume, (2) a maximum skin dose ≤125% of the PD, (3) maximum rib dose ≤145% of the PD, and (4) the V150 ≤50 cc and V200 ≤10 cc. The ability to concurrently achieve these dosimetric goals using the Contura MLB was analyzed. Results: 144 cases were available for review. Using the MLB, all dosimetric criteria were met in 76% of cases. Evaluating dosimetric criteria individually, 92% and 89% of cases met skin and rib dose criteria, respectively. In 93% of cases, ideal target volume coverage goals were met, and in 99%, dose homogeneity criteria (V150 and V200) were satisfied. When skin thickness was ≥5 mm to <7 mm, the median skin dose was limited to 120.1% of the PD, and when skin thickness was <5 mm, the median skin dose was 124.2%. When rib distance was <5 mm, median rib dose was reduced to 136.5% of the PD. When skin thickness was <7 mm and distance to rib was <5 mm, median skin and rib doses were jointly limited to 120.6% and 142.1% of the PD, respectively. Conclusion: The Contura MLB catheter provided the means of achieving the imposed higher standard of dosimetric goals in the majority of clinical scenarios encountered. © 2011 Elsevier Inc Printed in the USA. All rights reserved.

Khan A.J.,Cancer Institute of New Jersey | Arthur D.,Virginia Commonwealth University | Vicini F.,William Beaumont Hospital | Beitsch P.,Dallas Breast Center | And 4 more authors.
Annals of Surgical Oncology | Year: 2012

Background. The American Society of Breast Surgeons (ASBrS) enrolled women in a registry trial to prospectively study patients treated with the MammoSite RTS device. This report presents 6-year data on treatment-related toxicities from the trial. Methods. A total of 1449 primary early-stage breast cancers were treated with accelerated partial breast irradiation (APBI) using the MammoSite device (34 Gy in 10 fractions) in 1440 women. Of these, 1255 case (87%) had invasive breast cancer (IBC) (median size = 10 mm) and 194 cases (13%) had ductal carcinoma in situ (DCIS) (median size = 8 mm). Median follow-up was 59 months. Fisher exact test was performed to correlate categorical covariates with toxicity. Results. Breast seromas were reported in 28% of cases (35.5% with open cavity and 21.7% with closed cavity placement). Also, 13% of all treated breasts developed symptomatic seromas, and 77% of these seromas developed during the 1st year after treatment. There were 172 cases (11.9%) that required drainage to correct. Use of chemotherapy and balloon fill[50 cc were associated with the development of symptomatic seromas. Also, 2.3% of patients developed fat necrosis (FN). The incidence of FN during years 1 and 2 were 0.9% and 0.8%, respectively. Seroma formation, use of hormonal therapy, breast infection, and A/B cup size were associated with fat necrosis. There were 138 infections (9.5%) recorded; 98% occurred during the 1st year after treatment. Chemotherapy and seroma formation were associated with the development of infections. Conclusions. Treatment-related toxicities 6 years after treatment with APBI using the MammoSite device are similar to those reported with other forms of APBI with similar follow-up. © Society of Surgical Oncology 2011.

Shah C.,William Beaumont Hospital | Vicini F.,William Beaumont Hospital | Keisch M.,University of Miami | Kuerer H.,University of Texas M. D. Anderson Cancer Center | And 3 more authors.
Cancer | Year: 2012

Background: The objective of this study was to examine clinical outcomes and patterns of failure in patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) after breast-conserving therapy (BCT) using accelerated partial breast irradiation (APBI). Methods: In total, 1440 patients (1449 tumors) with early stage breast cancer who underwent BCT were treated with the MammoSite device to deliver APBI (34 Gray [Gy] in 3.4-Gy fractions). One thousand two hundred fifty-five patients (87%) had invasive breast cancer (IBC) (median tumor size, 10 mm), and 194 patients (13%) had ductal carcinoma in situ (DCIS) (median tumor size, 8 mm). The median follow-up was 60 months. Results: Fifty patients (3.5%) developed an IBTR for a 5-year actuarial rate of 3.61% (3.65% for IBC and 3.36% for DCIS). It was determined that 36 recurrences (72%) represented new primary cancers, and 14 recurrences (28%) represented recurrences of the index lesion. Of the 32 recurrences with known histology, 78% were IBC, and 22% were DCIS. After IBTR, 28 of 38 patients (74%) underwent salvage mastectomy, and 9 of 38 patients (26%) had a second attempt at BCT. Adjuvant therapies included tamoxifen in 8 patients (16%) and systemic chemotherapy in 6 patients (12%). The 3-year rates of disease-free survival, cause-specific survival, and overall survival after IBTR were 58.7%, 92.1%, and 80.5%, respectively. Conclusions: With 5 years of follow-up, APBI produced clinical outcomes and patterns of failure comparable to those achieved with whole breast irradiation. Patients who developed an IBTR after APBI had excellent 3-year survival outcomes after salvage treatments. © 2011 American Cancer Society.

Purpose: We applied the ASTRO Consensus Panel (CP) guidelines for the application of accelerated partial breast irradiation (APBI) to patients treated with this technique on the ASBS MammoSite® registry trial to determine potential differences in outcome of patients classified in the "unsuitable" category. Methods: Of 1,449 cases treated with APBI on the registry trial, 176 fit the criteria for the unsuitable category: 130 cases were <50 years of age, 13 had positive margins, 38 had positive nodes, 6 had tumors >3 cm, and 9 had an EIC >3 cm. Rates of ipsilateral breast tumor recurrence (IBTR) and regional nodal failure (RNF) were assessed. Median follow-up was 53.6 months. Results: The 5-year actuarial rate of IBTR for unsuitable cases was 5.25% (RNF rate was 0.63%). By comparison, the 5-year actuarial IBTR rates for various subsets of patients were: all 1,449 cases, 3.89% (p = 0.2365); all 1,449 cases excluding unsuitable cases [n = 1,273] (3.6%, p = 0.1683); invasive only cases [n = 1,255] (3.86%, p = 0.2464); and invasive only cases excluding unsuitable invasive cases [n = 1,105] (3.89%, p = 0.2396). On univariate analysis for variables potentially associated with IBTR in all 1,255 cases with invasive cancer (including age, tumor size, nodal status, overall stage, margin status, ER status, presence of an EIC, and ASTRO unsuitable category), only negative ER (-) status was associated with the 5-year rate of IBTR (p = 0002). No other variable (including unsuitable CP designation) was associated with IBTR. Conclusions: The ASTRO CP guideline designation of unsuitable did not differentiate a subset of patients with a significantly worse rate of IBTR when treated with the MammoSite® breast brachytherapy catheter to deliver APBI. © 2010 Society of Surgical Oncology.

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