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ABSTRACT: The American Society for Radiation Oncology (ASTRO) issued a consensus statement in 2009 regarding patient selection for accelerated partial breast irradiation (APBI) following breast-conserving surgery (BCS) for breast cancer (BC). We reviewed our single-institution experience with APBI in patients considered "cautionary" by ASTRO to determine patterns of recurrence.
An institutional review board-approved, retrospective chart review was conducted from January 2004 to November 2009. We identified 106 "cautionary" patients with 109 BC. All patients were treated with BCS followed by APBI via balloon catheter brachytherapy. "Cautionary" criteria include patients aged 50-59 years, tumor size 2.1-3.0 cm, close margins (<2 mm), focal lymphovascular invasion, estrogen receptor (ER)-negative tumors, invasive lobular carcinoma, or ductal carcinoma in situ (DCIS) ≤ 3 cm. Rates of recurrence at any site were evaluated.
Median follow-up was 3 years. There were 3 IBTR (2.8%) at a median of 3.2 years. The 3-year actuarial IBTR rate was 1.8%. Patients with ER-negative invasive cancers had a higher IBTR rate compared with ER-positive patients (11.8% vs. 2.2%), although this did not reach statistical significance (P = 0.18). There were no IBTR in 46 patients with DCIS. On univariate analysis, there was no association between "cautionary" criteria and risk of local, regional, or distant recurrence.
Patients considered "cautionary" for APBI based on ASTRO guidelines had low rates of IBTR. ER-negative patients trended toward a higher IBTR rate with APBI compared with ER-positive patients. Longer follow-up is needed to establish the safety of APBI in "cautionary" patients.
Annals of Surgical Oncology 07/2011; 19(2):553-9. · 4.17 Impact Factor
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David N Krag,
Stewart J Anderson,
Thomas B Julian,
Ann M Brown,
Seth P Harlow,
Joseph P Costantino,
Takamaru Ashikaga,
Donald L Weaver,
Eleftherios P Mamounas,
Lynne M Jalovec, Thomas G Frazier,
R Dirk Noyes,
André Robidoux,
Hugh Mc Scarth,
Norman Wolmark
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ABSTRACT: Sentinel-lymph-node (SLN) surgery was designed to minimise the side-effects of lymph-node surgery but still offer outcomes equivalent to axillary-lymph-node dissection (ALND). The aims of National Surgical Adjuvant Breast and Bowel Project (NSABP) trial B-32 were to establish whether SLN resection in patients with breast cancer achieves the same survival and regional control as ALND, but with fewer side-effects.
NSABP B-32 was a randomised controlled phase 3 trial done at 80 centres in Canada and the USA between May 1, 1999, and Feb 29, 2004. Women with invasive breast cancer were randomly assigned to either SLN resection plus ALND (group 1) or to SLN resection alone with ALND only if the SLNs were positive (group 2). Random assignment was done at the NSABP Biostatistical Center (Pittsburgh, PA, USA) with a biased coin minimisation approach in an allocation ratio of 1:1. Stratification variables were age at entry (≤ 49 years, ≥ 50 years), clinical tumour size (≤ 2·0 cm, 2·1-4·0 cm, ≥ 4·1 cm), and surgical plan (lumpectomy, mastectomy). SLN resection was done with a blue dye and radioactive tracer. Outcome analyses were done in patients who were assessed as having pathologically negative sentinel nodes and for whom follow-up data were available. The primary endpoint was overall survival. Analyses were done on an intention-to-treat basis. All deaths, irrespective of cause, were included. The mean time on study for the SLN-negative patients with follow-up information was 95·6 months (range 70·1-126·7). This study is registered with ClinicalTrials.gov, number NCT00003830.
5611 women were randomly assigned to the treatment groups, 3989 had pathologically negative SLN. 309 deaths were reported in the 3986 SLN-negative patients with follow-up information: 140 of 1975 patients in group 1 and 169 of 2011 in group 2. Log-rank comparison of overall survival in groups 1 and 2 yielded an unadjusted hazard ratio (HR) of 1·20 (95% CI 0·96-1·50; p=0·12). 8-year Kaplan-Meier estimates for overall survival were 91·8% (95% CI 90·4-93·3) in group 1 and 90·3% (88·8-91·8) in group 2. Treatment comparisons for disease-free survival yielded an unadjusted HR of 1·05 (95% CI 0·90-1·22; p=0·54). 8-year Kaplan-Meier estimates for disease-free survival were 82·4% (80·5-84·4) in group 1 and 81·5% (79·6-83·4) in group 2. There were eight regional-node recurrences as first events in group 1 and 14 in group 2 (p=0·22). Patients are continuing follow-up for longer-term assessment of survival and regional control. The most common adverse events were allergic reactions, mostly related to the administration of the blue dye.
Overall survival, disease-free survival, and regional control were statistically equivalent between groups. When the SLN is negative, SLN surgery alone with no further ALND is an appropriate, safe, and effective therapy for breast cancer patients with clinically negative lymph nodes.
US Public Health Service, National Cancer Institute, and Department of Health and Human Services.
The lancet oncology 10/2010; 11(10):927-33. · 14.47 Impact Factor
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ABSTRACT: Breast magnetic resonance imaging (MRI) is used to identify residual and additional disease in patients with invasive carcinoma. The use of MRI in assessing extent of disease for ductal carcinoma in situ (DCIS) is less well defined. This study assessed the value of MRI in the preoperative evaluation of DCIS.
We identified 98 patients with DCIS in 2007. Of these, 63 underwent stereotactic biopsy, followed by MRI. There were 35 who underwent stereotactic biopsy alone. Concordance between MRI and histopathology was defined as the presence or absence of residual disease.
There was no significant difference in mastectomy rates between the MRI and non-MRI group (20.3% vs 25.7%, P = .62). In patients undergoing breast-conserving surgery (BCS), there were fewer positive margins in the MRI versus the non-MRI group (21.2% vs 30.8%, P = .41). Of the 64 cases that underwent preoperative MRI, 43 (67.2%) were concordant. Also, 15 of 43 cases (34.8%) had MRI results that accurately predicted pathologic size. In 28 of 43 patients (65.2%), MRI overestimated disease in 20, by a mean of 1.97 cm. In patients with MRI tumor size >2 cm, MRI overestimated disease by a mean of 3.17 cm. Of the 64 cases, 21 (32.8%) were discordant. Also, 10 of 21 (47.6%) had a positive MRI and no residual disease on histopathology, and 11 of 21 (52.3%) had negative MRI and residual disease on pathology.
MRI does not accurately predict extent of disease in patients with extensive DCIS. In patients with MRI tumor size < or = 2 cm, MRI may assist in surgical planning. MRI results in patients with DCIS should be interpreted with caution; decision for mastectomy should not be made on MRI findings alone.
Annals of Surgical Oncology 03/2010; 17(9):2395-400. · 4.17 Impact Factor
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David N Krag,
Stewart J Anderson,
Thomas B Julian,
Ann M Brown,
Seth P Harlow,
Takamaru Ashikaga,
Donald L Weaver,
Barbara J Miller,
Lynne M Jalovec, Thomas G Frazier,
R Dirk Noyes,
André Robidoux,
Hugh M C Scarth,
Denise M Mammolito,
David R McCready,
Eleftherios P Mamounas,
Joseph P Costantino,
Norman Wolmark
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ABSTRACT: The goals of axillary-lymph-node dissection (ALND) are to maximise survival, provide regional control, and stage the patient. However, this technique has substantial side-effects. The purpose of the B-32 trial is to establish whether sentinel-lymph-node (SLN) resection can achieve the same therapeutic goals as conventional ALND but with decreased side-effects. The aim of this paper is to report the technical success and accuracy of SLN resection plus ALND versus SLN resection alone.
5611 women with invasive breast cancer were randomly assigned to receive either SLN resection followed by immediate conventional ALND (n=2807; group 1) or SLN resection without ALND if SLNs were negative on intraoperative cytology and histological examination (n=2804; group 2) in the B-32 trial. Patients in group 2 underwent ALND if no SLNs were identified or if one or more SLNs were positive on intraoperative cytology or subsequent histological examination. Primary endpoints, including survival, regional control, and morbidity, will be reported later. Secondary endpoints are accuracy and technical success and are reported here. This trial is registered with the Clinical Trial registry, number NCT00003830.
Data for technical success were available for 5536 of 5611 patients; 75 declined protocol treatment, had no SLNs removed, or had no SLN resection done. SLNs were successfully removed in 97.2% of patients (5379 of 5536) in both groups combined. Identification of a preincision hot spot was associated with greater SLN removal (98.9% [5072 of 5128]). Only 1.4% (189 of 13171) of SLN specimens were outside of axillary levels I and II. 65.1% (8571 of 13 171) of SLN specimens were both radioactive and blue; a small percentage was identified by palpation only (3.9% [515 of 13 171]). The overall accuracy of SLN resection in patients in group 1 was 97.1% (2544 of 2619; 95% CI 96.4-97.7), with a false-negative rate of 9.8% (75 of 766; 95% CI 7.8-12.2). Differences in tumour location, type of biopsy, and number of SLNs removed significantly affected the false-negative rate. Allergic reactions related to blue dye occurred in 0.7% (37 of 5588) of patients with data on toxic effects.
The findings reported here indicate excellent balance in clinical patient characteristics between the two randomised groups and that the success of SLN resection was high. These findings are important because the B-32 trial is the only trial of sufficient size to provide definitive information related to the primary outcome measures of survival and regional control. Removal of more than one SLN and avoidance of excisional biopsy are important variables in reducing the false-negative rate.
The Lancet Oncology 11/2007; 8(10):881-8. · 22.59 Impact Factor
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ABSTRACT: The purpose of the study was to determine if ductal lavage could predict the occurrence of breast cancer as well as further stratify patients at high-risk for developing breast cancer.
Ductal lavage was performed in 116 high-risk patients (Gail Risk score > or = 1.7%, previous breast cancer, strong family history, previous suspicious biopsy specimen). If atypia or papillary cells were identified, a standard protocol of evaluation was initiated.
Two hundred twenty-three lavages were performed on 116 patients. Twenty-seven lavages in 25 patients yielded atypical or papillary-like cells. The 15 patients who underwent further evaluation for atypia had no evidence of cancerous or precancerous lesions. All patients were followed-up: 2 developed breast cancer, both of whom had had normal previous lavage. No patient with abnormal lavage developed cancer during follow-up.
We find ductal lavage to be of limited value in the screening of high-risk patients and have removed it from our treatment algorithm.
American journal of surgery 10/2007; 194(4):463-6. · 2.36 Impact Factor
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The Breast Journal 13(1):106-7. · 1.64 Impact Factor
