Simona F. Shaitelman

Improved Axillary Evaluation Following Neoadjuvant Therapy for Patients With Node-Positive Breast Cancer Using Selective Evaluation of Clipped Nodes: Implementation of Targeted Axillary Dissection

PURPOSE Placing clips in nodes with biopsy-confirmed metastasis before initiating neoadjuvant therapy allows for evaluation of response in breast cancer. Our goal was to determine if pathologic changes in clipped nodes reflect the status of the nodal basin and if targeted axillary dissection (TAD), which includes sentinel lymph node dissection (SLND) and selective localization and removal of clipped nodes, improves the false-negative rate (FNR) compared with SLND alone. METHODS A prospective study of patients with biopsy-confirmed nodal metastases with a clip placed in the sampled node was performed. After neoadjuvant therapy, patients underwent axillary surgery and the pathology of the clipped node was compared with other nodes. Patients undergoing TAD had SLND and selective removal of the clipped node using iodine-125 seed localization. The FNR was determined in patients undergoing complete axillary lymphadenectomy (ALND). RESULTS Of 208 patients enrolled in this study, 191 underwent ALND, with residual disease identified in 120 (63%). The clipped node revealed metastases in 115 patients, resulting in an FNR of 4.2% (95% CI, 1.4 to 9.5) for the clipped node. In patients undergoing SLND and ALND (n = 118), the FNR was 10.1% (95% CI, 4.2 to 19.8), which included seven false-negative events in 69 patients with residual disease. Adding evaluation of the clipped node reduced the FNR to 1.4% (95% CI, 0.03 to 7.3; P = .03). The clipped node was not retrieved as an SLN in 23% (31 of 134) of patients, including six with negative SLNs but metastasis in the clipped node. TAD followed by ALND was performed in 85 patients, with an FNR of 2.0% (1 of 50; 95% CI, 0.05 to 10.7). CONCLUSION Marking nodes with biopsy-confirmed metastatic disease allows for selective removal and improves pathologic evaluation for residual nodal disease after chemotherapy.

Five-Year Outcome of Patients Classified Using the American Society for Radiation Oncology Consensus Statement Guidelines for the Application of Accelerated Partial Breast Irradiation: An Analysis of Patients Treated on the American Society of Breast Surgeons MammoSite Registry Trial

The American Society for Radiation Oncology (ASTRO) consensus statement (CS) for the application of accelerated partial breast irradiation (APBI) was applied to patients who were treated with this technique on the American Society of Breast Surgeons MammoSite Registry Trial to determine potential differences in clinical outcome based on classification group.

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Acute and Short-term Toxic Effects of Conventionally Fractionated vs Hypofractionated Whole-Breast Irradiation: A Randomized Clinical Trial

IMPORTANCE The most appropriate dose fractionation for whole-breast irradiation (WBI) remains uncertain. OBJECTIVE To assess acute and 6-month toxic effects and quality of life (QOL) with conventionally fractionated WBI (CF-WBI) vs hypofractionated WBI (HF-WBI). DESIGN, SETTING, AND PARTICIPANTS Unblinded randomized trial of CF-WBI (n = 149; 50.00 Gy/25 fractions + boost [10.00-14.00 Gy/5-7 fractions]) vs HF-WBI (n = 138; 42.56 Gy/16 fractions + boost [10.00-12.50 Gy/4-5 fractions]) following breast-conserving surgery administered in community-based and academic cancer centers to 287 women 40 years or older with stage 0 to II breast cancer for whom WBI without addition of a third field was recommended; 76% of study participants (n = 217) were overweight or obese. Patients were enrolled from February 2011 through February 2014 and observed for a minimum of 6 months. INTERVENTIONS Administration of CF-WBI or HF-WBI. MAIN OUTCOMES AND MEASURES Physician-reported acute and 6-month toxic effects using National Cancer Institute Common Toxicity Criteria, and patient-reported QOL using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). All analyses were intention to treat, with outcomes compared using the χ2 test, Cochran-Armitage test, and ordinal logistic regression. RESULTS Of 287 participants, 149 were randomized to CF-WBI and 138 to HF-WBI. Treatment arms were well matched for baseline characteristics, including FACT-B total score (HF-WBI, 120.1 vs CF-WBI, 118.8; P = .46) and individual QOL items such as somewhat or more lack of energy (HF-WBI, 38% vs CF-WBI, 39%; P = .86) and somewhat or more trouble meeting family needs (HF-WBI, 10% vs CF-WBI, 14%; P = .54). Maximum physician-reported acute dermatitis (36% vs 69%; P < .001), pruritus (54% vs 81%; P < .001), breast pain (55% vs 74%; P = .001), hyperpigmentation (9% vs 20%; P = .002), and fatigue (9% vs 17%; P = .02) during irradiation were lower in patients randomized to HF-WBI. The rate of overall grade 2 or higher acute toxic effects was less with HF-WBI than with CF-WBI (47% vs 78%; P < .001). Six months after irradiation, physicians reported less fatigue in patients randomized to HF-WBI (0% vs 6%; P = .01), and patients randomized to HF-WBI reported less lack of energy (23% vs 39%; P < .001) and less trouble meeting family needs (3% vs 9%; P = .01). Multivariable regression confirmed the superiority of HF-WBI in terms of patient-reported lack of energy (odds ratio [OR], 0.39; 95% CI, 0.24-0.63) and trouble meeting family needs (OR, 0.34; 95% CI, 0.16-0.75). CONCLUSIONS AND RELEVANCE Treatment with HF-WBI appears to yield lower rates of acute toxic effects than CF-WBI as well as less fatigue and less trouble meeting family needs 6 months after completing radiation therapy. These findings should be communicated to patients as part of shared decision making. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01266642.

Underuse of Trimodality Treatment Affects Survival for Patients With Inflammatory Breast Cancer: An Analysis of Treatment and Survival Trends From the National Cancer Database

PURPOSE To analyze factors that predict the use of trimodality treatment (chemotherapy, surgery, and radiation therapy [RT]) and evaluate the impact that trimodality treatment use has on survival for patients with inflammatory breast cancer (IBC). METHODS Using the National Cancer Data Base, patients who underwent surgical treatment of nonmetastatic IBC from 1998 to 2010 were identified. We collected demographic, tumor, and treatment data and analyzed treatment and survival trends over time. Logistic regression and Cox proportional hazard models were used to examine factors predicting treatment and survival. RESULTS We identified 10,197 patients who fulfilled study criteria. The use of trimodality therapy fluctuated annually (58.4% to 73.4%). Patients who were older, diagnosed earlier in the study period, lived in regions of the country outside of the Midwest, had lower incomes or public insurance, and had a higher comorbid score were significantly less likely to receive trimodality therapy (all P < .05). Five- and 10-year survival rates were highest among patients receiving trimodality treatment (55.4% and 37.3%, respectively) compared with patients who received the combination of surgery plus chemotherapy, surgery plus RT, or surgery alone. After adjusting for potential confounding variables, use of trimodality therapy remained a significant independent predictor of survival. CONCLUSION Underutilization of trimodality therapy negatively impacted survival for patients with IBC. The use of trimodality therapy increased marginally with time, but there remain significant factors associated with differences in use of trimodality treatment. We have identified specific barriers to care that may be targeted to improve treatment delivery and potentially improve patient outcomes.

Accelerated Partial Breast Irradiation

Whole breast irradiation (WBI) is the standard after breast conservation surgery. However, WBI in selected patients has been questioned. Accelerated partial breast irradiation (APBI) focuses treatment on the lumpectomy bed. Many modalities of delivering APBI have been developed: multicatheter interstitial brachytherapy, MammoSite balloon catheter, single insertion multicatheter devices, three‐dimensional conformal external‐beam radiation therapy and intraoperative techniques. Numerous studies of APBI have demonstrated excellent local control and cosmetic outcomes in early‐stage breast cancer patients. J. Surg. Oncol. 2011; 103:362–368.

Evaluation of Current Consensus Statement Recommendations for Accelerated Partial Breast Irradiation: A Pooled Analysis of William Beaumont Hospital and American Society of Breast Surgeon MammoSite Registry Trial Data

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.

Continuous arc rotation of the couch therapy for the delivery of accelerated partial breast irradiation: a treatment planning analysis.

PURPOSE We present a novel form of arc therapy: continuous arc rotation of the couch (C-ARC) and compare its dosimetry with three-dimensional conformal radiotherapy (3D-CRT), intensity-modulated radiotherapy (IMRT), and volumetric-modulated arc therapy (VMAT) for accelerated partial breast irradiation (APBI). C-ARC, like VMAT, uses a modulated beam aperture and dose rate, but with the couch, not the gantry, rotating. METHODS AND MATERIALS Twelve patients previously treated with APBI using 3D-CRT were replanned with (1) C-ARC, (2) IMRT, and (3) VMAT. C-ARC plans were designed with one medial and one lateral arc through which the couch rotated while the gantry was held stationary at a tangent angle. Target dose coverage was normalized to the 3D-CRT plan. Comparative endpoints were dose to normal breast tissue, lungs, and heart and monitor units prescribed. RESULTS Compared with 3D-CRT, C-ARC, IMRT, and VMAT all significantly reduced the ipsilateral breast V50% by the same amount (mean, 7.8%). Only C-ARC and IMRT plans significantly reduced the contralateral breast maximum dose, the ipsilateral lung V5Gy, and the heart V5%. C-ARC used on average 40%, 30%, and 10% fewer monitor units compared with 3D-CRT, IMRT, and VMAT, respectively. CONCLUSIONS C-ARC provides improved dosimetry and treatment efficiency, which should reduce the risks of toxicity and secondary malignancy. Its tangent geometry avoids irradiation of critical structures that is unavoidable using the en face geometry of VMAT.

Disparities in the Use of Breast-Conserving Therapy Among Patients With Early-Stage Breast Cancer

IMPORTANCE Although breast-conserving therapy (BCT) is an accepted modality for treatment of early-stage breast cancer, many women continue to undergo mastectomy. Detailing the factors associated with choice of BCT may assist with overcoming barriers in the use of this treatment modality. OBJECTIVE To conduct a population-based examination of the factors that influence the use of BCT. DESIGN, SETTING, AND PARTICIPANTS Using the National Cancer Data Base, we examined the surgical choices of women with stage T1 or T2 breast cancer treated between 1998 and 2011. Logistic regression analysis conducted between September 19, 2013, and August 26, 2014, was used to assess the multivariate association between patient and facility variables and the probability of undergoing BCT. MAIN OUTCOMES AND MEASURES Factors associated with the use of BCT. RESULTS A cohort of 727,927 women was identified in the National Cancer Data Base. Use of BCT, determined using odds ratio (OR) and 95% CI, was greater in patients aged 52 to 61 years compared with younger patients (1.14; 1.12-1.15) and in those with the highest educational level (1.16; 1.14-1.19). Rates of BCT were lower in patients without insurance compared with those with private insurance (0.75; 0.72-0.78) and in those with the lowest median income (0.92; 0.90-0.94). Academic cancer programs, US Northeast location, and residence within 27.8 km of a treatment facility were associated with greater BCT rates than were community cancer programs (1.13; 1.11-1.15), Southern location (1.50; 1.48-1.52), and residence farther from a treatment facility (1.25; 1.23-1.27). When comparing BCT use in 1998 with use in 2011, increases were seen across age groups (from 48.2% to 59.7%), in community cancer programs (48.4% in 1998 vs 58.8% in 2011), and in facilities located in the South (45.1% in 1998 vs 55.3% in 2011). CONCLUSIONS AND RELEVANCE Although the use of BCT has increased during the past 14 years, nonclinical factors, including socioeconomic demographics, insurance, and travel distance to the treatment facility, persist as key barriers to receipt of BCT. Interventions that address these barriers may facilitate further uptake of BCT.

Long-Term Outcome in Patients With Ductal Carcinoma In Situ Treated With Breast-Conserving Therapy: Implications for Optimal Follow-up Strategies

PURPOSE To determine 20-year rates of local control and outcome-associated factors for ductal carcinoma in situ (DCIS) after breast-conserving therapy (BCT). METHODS AND MATERIALS All DCIS cases receiving BCT between 1980 and 1993 were reviewed. Patient demographics and pathologic factors were analyzed for effect on outcomes, including ipsilateral breast tumor recurrence (IBTR) and survival. RESULTS One hundred forty-five cases were evaluated; the median follow-up time was 19.3 years. IBTR developed in 25 patients, for 5-, 10-, 15-, and 20-year actuarial rates of 9.9%, 12.2%, 13.7%, and 17.5%, respectively. One third of IBTRs were elsewhere failures, and 68% of IBTRs occurred <10 years after diagnosis. Young age and cancerization of lobules predicted for IBTR at <10 years, and increased slide involvement and atypical ductal hyperplasia were associated with IBTR at later time points. CONCLUSIONS Patients with DCIS treated with BCT have excellent long-term rates of local control. Predictors of IBTR vary over time, and the risk of recurrence seems highest within 10 to 12 years after diagnosis.