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Vicini F.,Beaumont Cancer Institute | Beitsch P.,Dallas Breast Center | Gittleman M.,Sacred Heart Hospital | Fine R.,Breast Center | And 5 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2011

Purpose: To present 5-year data on treatment efficacy, cosmetic results, and toxicities for patients enrolled on the American Society of Breast Surgeons MammoSite breast brachytherapy registry trial. Methods and Materials: A total of 1440 patients (1449 cases) with early-stage breast cancer receiving breast-conserving therapy were treated with the MammoSite device to deliver accelerated partial-breast irradiation (APBI) (34 Gy in 3.4-Gy fractions). Of 1449 cases, 1255 (87%) had invasive breast cancer (IBC) (median size, 10 mm) and 194 (13%) had ductal carcinoma in situ (DCIS) (median size, 8 mm). Median follow-up was 54 months. Results: Thirty-seven cases (2.6%) developed an ipsilateral breast tumor recurrence (IBTR), for a 5-year actuarial rate of 3.80% (3.86% for IBC and 3.39% for DCIS). Negative estrogen receptor status (p = 0.0011) was the only clinical, pathologic, or treatment-related variable associated with IBTR for patients with IBC and young age (<50 years; p = 0.0096) and positive margin status (p = 0.0126) in those with DCIS. The percentage of breasts with good/excellent cosmetic results at 60 months (n = 371) was 90.6%. Symptomatic breast seromas were reported in 13.0% of cases, and 2.3% developed fat necrosis. A subset analysis of the first 400 consecutive cases enrolled was performed (352 with IBC, 48 DCIS). With a median follow-up of 60.5 months, the 5-year actuarial rate of IBTR was 3.04%. Conclusion: Treatment efficacy, cosmesis, and toxicity 5 years after treatment with APBI using the MammoSite device are good and similar to those reported with other forms of APBI with similar follow-up. Copyright © 2011 Elsevier Inc.

Giuliano A.E.,John Wayne Cancer Institute | Hunt K.K.,University of Texas M. D. Anderson Cancer Center | Ballman K.V.,Mayo Medical School | Beitsch P.D.,Dallas Surgical Group | And 6 more authors.
JAMA - Journal of the American Medical Association | Year: 2011

Context: Sentinel lymph node dissection (SLND) accurately identifies nodal metastasis of early breast cancer, but it is not clear whether further nodal dissection affects survival. Objective: To determine the effects of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer. Design, Setting, and Patients: The American College of Surgeons Oncology Group Z0011 trial, a phase 3 noninferiority trial conducted at 115 sites and enrolling patients from May 1999 to December 2004. Patients were women with clinical T1-T2 invasive breast cancer, no palpable adenopathy, and 1 to 2 SLNs containing metastases identified by frozen section, touch preparation, or hematoxylin-eosin staining on permanent section. Targeted enrollmentwas 1900 women with final analysis after 500 deaths, but the trial closed early because mortality rate was lower than expected. Interventions: All patients underwent lumpectomy and tangential whole-breast irradiation. Those with SLN metastases identified by SLND were randomized to undergo ALND or no further axillary treatment. Those randomized to ALND underwent dissection of 10 or more nodes. Systemic therapy was at the discretion of the treating physician. Main Outcome Measures: Overall survival was the primary end point, with a non-inferiority margin of a 1-sided hazard ratio of less than 1.3 indicating that SLND alone is noninferior to ALND. Disease-free survival was a secondary end point. Results: Clinical and tumor characteristics were similar between 445 patients randomized to ALND and 446 randomized to SLND alone. However, the median number of nodes removed was 17 with ALND and 2 with SLND alone. At a median follow-up of 6.3 years (last follow-up, March 4, 2010), 5-year overall survival was 91.8% (95% confidence interval [CI], 89.1%-94.5%)with ALND and 92.5% (95% CI, 90.0%-95.1%) with SLND alone; 5-year disease-free survival was 82.2% (95% CI, 78.3%-86.3%) with ALND and 83.9% (95% CI, 80.2%-87.9%) with SLND alone. The hazard ratio for treatment-related overall survival was 0.79 (90% CI, 0.56-1.11) without adjustment and 0.87 (90% CI, 0.62-1.23) after adjusting for age and adjuvant therapy. Conclusion: Among patients with limited SLN metastatic breast cancer treated with breast conservation and systemic therapy, the use of SLND alone compared with ALND did not result in inferior survival. Trial Registration clinicaltrials.gov Identifier: NCT00003855. ©2011 American Medical Association. All rights reserved.

Giuliano A.E.,John Wayne Cancer Institute | McCall L.,The American College | Beitsch P.,Dallas Surgical Group | Whitworth P.W.,Nashville Breast Center | And 6 more authors.
Annals of Surgery | Year: 2010

Background and Objective: Sentinel lymph node dissection (SLND) has eliminated the need for axillary dissection (ALND) in patients whose sentinel node (SN) is tumor-free. However, completion ALND for patients with tumor-involved SNs remains the standard to achieve locoregional control. Few studies have examined the outcome of patients who do not undergo ALND for positive SNs. We now report local and regional recurrence information from the American College of Surgeons Oncology Group Z0011 trial. Methods: American College of Surgeons Oncology Group Z0011 was a prospective trial examining survival of patients with SN metastases detected by standard H and E, who were randomized to undergo ALND after SLND versus SLND alone without specific axillary treatment. Locoregional recurrence was evaluated. Results: There were 446 patients randomized to SLND alone and 445 to SLND + ALND. Patients in the 2 groups were similar with respect to age, Bloom-Richardson score, estrogen receptor status, use of adjuvant systemic therapy, tumor type, T stage, and tumor size. Patients randomized to SLND + ALND had a median of 17 axillary nodes removed compared with a median of only 2 SN removed with SLND alone (P < 0.001). ALND also removed more positive lymph nodes (P < 0.001). At a median follow-up time of 6.3 years, there were no statistically significant differences in local recurrence (P = 0.11) or regional recurrence (P = 0.45) between the 2 groups. Conclusions: Despite the potential for residual axillary disease after SLND, SLND without ALND can offer excellent regional control and may be reasonable management for selected patients with early-stage breast cancer treated with breast-conserving therapy and adjuvant systemic therapy. © 2010 by Lippincott Williams & Wilkins.

Shah C.,University of Washington | Arthur D.,Virginia Commonwealth University | Riutta J.,Beaumont Health System | Whitworth P.,Nashville Breast Center | Vicini F.A.,Michigan Healthcare Professionals 21st Century Oncology
Breast Journal | Year: 2012

With improved outcomes following treatment of breast cancer, chronic toxicities including breast cancer related lymphedema (BCRL), gain increased significance with limited evidence-based guidelines present. This review attempts to summarize data addressing these concerns and provides recommendations based on currently published data. Substantial differences exist in rates of BCRL reported in the literature ranging from less than 5% to 65% based on locoregional therapy. Based on recent data, early diagnosis of BCRL appears critical and requires careful attention to patient risk factors and the use of newer diagnostic tools. Initial treatment with decongestive lymphatic therapy/compressive stockings can provide significant improvement in patient symptoms and volume reduction of edematous extremities. At this time, consensus recommendations for disease classification, diagnostic testing and treatment are still lacking. Awareness of the frequency of this toxicity is now important as more accurate clinical aids have become accessible to diagnose the condition at an earlier stage allowing timely intervention providing the opportunity for treatment strategies to be more effective. © 2012 Wiley Periodicals, Inc.

Giuliano A.E.,The Surgical Center | Giuliano A.E.,Cedars Sinai Medical Center | Hawes D.,University of Southern California | Ballman K.V.,Mayo Medical School | And 9 more authors.
JAMA - Journal of the American Medical Association | Year: 2011

Context: Immunochemical staining of sentinel lymph nodes (SLNs) and bone marrow identifies breast cancer metastases not seen with routine pathological or clinical examination. Objective: To determine the association between survival and metastases detected by immunochemical staining of SLNs and bone marrow specimens from patients with early-stage breast cancer. Design, Setting, and Patients: From May 1999 to May 2003, 126 sites in the American College of Surgeons Oncology Group Z0010 trial enrolled women with clinical T1 to T2N0M0 invasive breast carcinoma in a prospective observational study. Interventions: All 5210 patients underwent breast-conserving surgery and SLN dissection. Bone marrow aspiration at the time of operation was initially optional and subsequently mandatory (March 2001). Sentinel lymph node specimens (hematoxylineosin negative) and bone marrow specimens were sent to a central laboratory for immunochemical staining; treating clinicians were blinded to results. Main Outcome Measures: Overall survival (primary end point) and disease-free survival (a secondary end point). Results: Of 5119 SLN specimens (98.3%), 3904 (76.3%) were tumor-negative by hematoxylin-eosin staining. Of 3326 SLN specimens examined by immunohistochemistry, 349 (10.5%) were positive for tumor. Of 3413 bone marrow specimens examined by immunocytochemistry, 104 (3.0%) were positive for tumors. At a median follow-up of 6.3 years (through April 2010), 435 patients had died and 376 had disease recurrence. Immunohistochemical evidence of SLN metastases was not significantly associated with overall survival (5-year rates: 95.7%; 95% confidence interval [CI], 95.0%-96.5% for immunohistochemical negative and 95.1%; 95% CI, 92.7%-97.5% for immunohistochemical positive disease; P=.64; unadjusted hazard ratio [HR], 0.90; 95% CI, 0.59-1.39; P=.64). Bone marrow metastases were associated with decreased overall survival (unadjusted HR for mortality, 1.94; 95% CI, 1.02-3.67; P=.04), but neither immunohistochemical evidence of tumor in SLNs (adjusted HR, 0.88; 95% CI, 0.45-1.71; P=.70) nor immunocytochemical evidence of tumor in bone marrow (adjusted HR, 1.83; 95% CI, 0.79-4.26; P=.15) was statistically significant on multivariable analysis. Conclusion: Among women receiving breast-conserving therapy and SLN dissection, immunohistochemical evidence of SLN metastasis was not associated with overall survival over a median of 6.3 years, whereas occult bone marrow metastasis, although rare, was associated with decreased survival. Trial Registration: clinicaltrials.gov Identifier: NCT00003854. ©2011 American Medical Association. All rights reserved.

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