Indocyanine green angiography guidance for vascular preservation in skin and nipple sparing mastectomy.

PURPOSE: The skin and/or nipple-sparing approach has become an oncologically sound and desirable choice for women choosing mastectomy. Indocyanine green (ICG) perfusion imaging has been shown to reduce ischemic complications in mastectomy skin flaps. Immediate reconstruction requires a well-vascularized skin flap capable of tolerating full expansion. Identification of the perforating subcutaneous vessels to the skin envelope may allow for better and more consistent blood vessel preservation and flap perfusion. METHODS: The authors conducted an institutional review board-approved prospective study with 41 patients to assess the feasibility of using ICG perfusion imaging to visualize, cutaneously map, and preserve the vessels that supply the skin flap and nipple-areolar complex. For each patient, the number of vessels initially mapped, the number of vessels preserved, the extent to which each vessel was preserved, and the proportion of the flap with adequate perfusion (as defined by the SPY-Q > 20% threshold) was recorded and analyzed. RESULTS: Vessels were able to be identified and marked in a high majority of patients (90%). There was a moderate linear relationship between the number of vessels marked and the number preserved. Successful mapping of vessels was associated with lower rates of wound breakdown (p = 0.036). Mapping and preserving at least one vessel led to excellent flap perfusion (> 90%). No increase in complications was observed from utilizing ICG angiography preoperatively. CONCLUSION: This prospective study using preoperative ICG perfusion mapping demonstrated safety, feasibility, and good prognostic outcomes. LEVEL OF EVIDENCE: III.

Breast-Specific Sensuality in Breast Cancer Survivors: Sexually Active or Not.

BACKGROUND: We sought to better understand breast-specific sensuality (BSS) in sexually inactive breast cancer survivors. METHODS: We conducted an anonymous cross-sectional survey of breast cancer survivors during surveillance appointments from 2014 to 2016. Sexual inactivity was defined as no sexual activity within 4 weeks prior. Categorical data were analyzed using Fisher's exact test. Multiple logistic regression adjusted for age and menopausal status, and Firth's bias correction accommodated sparse data. RESULTS: Of 585 respondents, 546 (93.3%) were between the ages of 40 and 79 years, of whom 285 (48.7%) were sexually inactive. Favorable post-treatment appearance satisfaction was reported by 413 (71.0%) respondents. Sexually inactive respondents were more likely to score discomfort with their partner seeing their chest after surgery compared with sexually active respondents (41 [20.4%] vs. 34 [11.4%]; p = 0.002). Both sexually inactive and active respondents reported that their chest was important in intimacy after surgery but at significantly different rates (117 [44.3%] vs. 217 [72.6%]; p < 0.001). Post-surgical appearance satisfaction for sexually inactive respondents was positively associated with level of comfort with partner seeing their chest after surgery (p < 0.001) and with rating of a pleasurable caress of the treated breast (p < 0.001). CONCLUSIONS: Over 40% of sexually inactive respondents reported their chest was important in intimacy after surgery, suggesting that BSS may be a route to intimacy for sexually inactive breast cancer survivors. Post-surgical breast appearance satisfaction significantly correlated with comfort being seen by one's partner and appreciation of a pleasurable breast caress. Optimizing breast cancer surgical aesthetic outcomes may improve survivorship.

Resection of Cavity Shave Margins in Stage 0-III Breast Cancer Patients Undergoing Breast Conserving Surgery: A Prospective Multicenter Randomized Controlled Trial.

OBJECTIVE: Single-center studies have demonstrated that resection of cavity shave margins (CSM) halves the rate of positive margins and re-excision in breast cancer patients undergoing partial mastectomy (PM). We sought to determine if these findings were externally generalizable across practice settings. METHODS: In this multicenter randomized controlled trial occurring in 9 centers across the United States, stage 0-III breast cancer patients undergoing PM were randomly assigned to either have resection of CSM ("shave" group) or not ("no shave" group). Randomization occurred intraoperatively, after the surgeon had completed their standard PM. Primary outcome measures were positive margin and re-excision rates. RESULTS: Between July 28, 2016 and April 13, 2018, 400 patients were enrolled in this trial. Four patients (2 in each arm) did not meet inclusion criteria after randomization, leaving 396 patients for analysis: 196 in the "shave" group and 200 to the "no shave" group. Median patient age was 65 years (range; 29-94). Groups were well matched at baseline for demographic and clinicopathologic factors. Prior to randomization, positive margin rates were similar in the "shave" and "no shave" groups (76/196 (38.8%) vs. 72/200 (36.0%), respectively, P = 0.604). After randomization, those in the "shave" group were significantly less likely than those in the "no shave" group to have positive margins (19/196 (9.7%) vs. 72/200 (36.0%), P < 0.001), and to require re-excision or mastectomy for margin clearance (17/196 (8.7%) vs. 47/200 (23.5%), P < 0.001). CONCLUSION: Resection of CSM significantly reduces positive margin and re-excision rates in patients undergoing PM.

A Three-Dimensional Bioabsorbable Tissue Marker for Volume Replacement and Radiation Planning: A Multicenter Study of Surgical and Patient-Reported Outcomes for 818 Patients with Breast Cancer.

BACKGROUND: Accurate identification of the tumor bed after breast-conserving surgery (BCS) ensures appropriate radiation to the tumor bed while minimizing normal tissue exposure. The BioZorb® three-dimensional (3D) bioabsorbable tissue marker provides a reliable target for radiation therapy (RT) planning and follow-up evaluation while serving as a scaffold to maintain breast contour. METHODS: After informed consent, 818 patients (826 breasts) implanted with the BioZorb® at 14 U.S. sites were enrolled in a national registry. All the patients were prospectively followed with the BioZorb® implant after BCS. The data collected at 3, 6, 12, and 24 months included all demographics, treatment parameters, and provider/patient-assessed cosmesis. RESULTS: The median follow-up period was 18.2 months (range, 0.2-53.4 months). The 30-day breast infection rate was 0.5 % of the patients (n = 4), and re-excision was performed for 8.1 % of the patients (n = 66), whereas 2.6 % of the patients (n = 21) underwent mastectomy. Two patients (0.2 %) had local recurrence. The patient-reported cosmetic outcomes at 6, 12, and 24 months were rated as good-to-excellent by 92.4 %, 90.6 %, and 87.3 % of the patients, respectively and similarly by the surgeons. The radiation oncologists reported planning of target volume (PTV) reduction for 46.2 % of the patients receiving radiation boost, with PTV reduction most commonly estimated at 30 %. CONCLUSIONS: This report describes the first large multicenter study of 818 patients implanted with the BioZorb® tissue marker during BCS. Radiation oncologists found that the device yielded reduced PTVs and that both the patients and the surgeons reported good-to-excellent long-term cosmetic outcomes, with low adverse effects. The BioZorb® 3D tissue marker is a safe adjunct to BCS and may add benefits for both surgeons and radiation oncologists.

Nipple pain: Raynaud's beyond fingers and toes.

Raynaud's phenomenon of the nipple (RPN) is a cause of nipple pain scarcely reported in the literature and frequently missed by physicians. We present a case of RPN in a pregnant mother who sought breast surgical consultation for episodic nipple pain. Review of the literature reveals RPN is predominant in lactating and pregnant patients and missed diagnosis can cause cessation of breastfeeding or mistreatment with antifungals. Clinical suspicion should be raised if symptoms are precipitated by cold, associated with color change, occur during pregnancy or breastfeeding, or with a history of Raynaud's. Treatment is generally supportive, with nifedipine used for severe cases.

Dermatofibrosarcoma protuberans with fibrosarcomatous transformation arising at the site of breast implant.

Fibrosarcomatous transformation of dermatofibrosarcoma protuberans (DFSP) is a rare variant with higher risk of recurrence and metastasis, and no known associations with breast implants. We report a rare case of fibrosarcomatous dermatofibrosarcoma protuberans arising at the site of breast implant in a 33-year-old patient followed by brief discussion on fibrosarcomatous DFSP.

Sexual Dysfunction in Survivorship; the Impact of Menopause and Endocrine Therapy.

BACKGROUND: Sexual dysfunction is common for breast cancer survivors. Premenopausal women with breast cancer are increasingly offered ovarian suppression and aromatase inhibitor (AI) therapy. We evaluated the association of menopausal status and treatment modalities on sexual dysfunction. METHODS: We conducted a cross-sectional anonymous Female Sexual Function Index (FSFI) survey of breast cancer survivors between 2000 and 2016. Analysis utilized Kruskal-Wallis test for FSFI scores, Chi square, or Fisher's exact test for categorical data, and regression analysis for associations. RESULTS: Of 585 respondents, 278 (47.5%) had complete FSFI scores. Of these, 24 (8.6%) were premenopausal and 80 (28.8%) were pre/perimenopausal at survey completion. Median FSFI scores for premenopausal (31.2, interquartile range [IQR] 26.8-33.6) and pre/perimenopausal (29.2, IQR 25.9-32.2) were similar, whereas postmenopausal women (25.9, IQR 21.0-30.3) were significantly lower (p = 0.0007 and p = 0.0002, respectively). Premenopausal women were less likely to meet criteria for sexual dysfunction (FSFI score ≤ 26.55) than postmenopausal women (21 versus 55%, p < 0.0001, univariate analysis [odds ratio (OR) 0.32, 95% confidence interval (CI) 0.18-0.56]). Adjusting for treatment modality did not impact the significance (OR 0.43, 95% [CI] 0.23-0.80) but revealed that AIs independently are associated with sexual dysfunction (OR 2.41, 95% CI 1.32-4.40). The interaction between menopausal status and AIs was not significant (p = 0.24). CONCLUSIONS: Our study demonstrates that menopausal status is associated with sexual dysfunction in breast cancer patients and sexual dysfunction in premenopausal women is not impacted by treatment modality outside of aromatase inhibitor therapy. As more premenopausal patients are treated with ovarian suppression, these data may guide clinicians in counseling patients regarding sexual dysfunction expectations.

Predicting Breast Tumor Size for Pre-operative Planning: Which Imaging Modality is Best?

We sought to compare breast tumor size predicted by imaging modality to the actual pathologic size in order to determine which imaging modality is best at estimating tumor size. We identified 261 patients with biopsy-proven invasive ductal (IDC) and/or invasive lobular (ILC) carcinomas with documented tumor dimensions predicted by imaging and maximum dimensions determined by final pathology. Results of imaging-predicted dimension were correlated with final pathological size. Spearman correlations were calculated and compared by Zou's method and agreement was assessed by McNemar's test. There was no significant difference (p > 0.05) between correlations of pathologic size by ultrasound (r = 0.71) and magnetic resonance imaging (MRI) (0.76). The correlations between MRI or ultrasound and pathologic size are significantly stronger than the correlations between mammography or clinical breast exam and pathologic size (p < 0.05). MRI and ultrasound are both strongly correlated with pathologic size overall and within grades in both IDC and ILC. The correlations between MRI or ultrasound and pathologic size are significantly better than the correlations between mammography or clinical breast exam and pathologic size (p < 0.05).

Influential Forces in Breast Cancer Surgical Decision Making and the Impact on Body Image and Sexual Function.

BACKGROUND: Shared decision making with one's partner and body image satisfaction may affect surgical choices of breast cancer patients. This study analyzed whether partner opinion was associated with choice of operation and whether comfort level with one's partner was altered postoperatively. METHODS: A prospective anonymous survey was administered to breast cancer patients who underwent breast surgery between 2000 and 2014. Categorical variables were compared by χ (2) or Fisher's exact test. RESULTS: Women who elected to undergo mastectomy with reconstruction (MR) placed greater emphasis on their own decision making than on input from their partner, surgeon, or others (56.5 vs. 8.3 vs. 23.2 vs. 12, respectively), whereas those who chose lumpectomy (L) placed similar weight on surgeon input and self-input (44.2 vs. 42.7 %). Only 7.5 % of all patients identified their partner as the greatest influence on their surgical choice. Preoperatively, the L group was the most comfortable with their partner seeing their chest (91.9 % L vs. 83.9 % MR vs. 75.9 % mastectomy alone (M); p = 0.01), and postoperatively, the comfort levels for all were remarkably decreased. Furthermore, if a patient was a candidate for L but chose MR, the role her chest played in intimacy dropped more compared with those who chose L (83.8 % L vs. 91.7 % MR; p = 0.3 preoperatively to 65.1 % L vs. 42.9 % MR; p = 0.01 postoperatively). CONCLUSIONS: When making surgical decisions, most patients indicate that they value their own opinion over that of others. Mastectomy, regardless of reconstruction, leads to a significant reduction in comfort with one's partner postoperatively compared with lumpectomy. This information may be helpful in counseling couples at the time of consultation for breast cancer treatment.

Phase II Trial of Five-Fraction Accelerated Partial Breast Irradiation Using Noninvasive Image-Guided Breast Brachytherapy.

PURPOSE/OBJECTIVE(S): NIBB has potential advantages over other APBI techniques by delivering highly conformal radiation with minimal collateral dose to the heart and lung compared with external beam techniques, but unlike other brachytherapy techniques NIBB is non-invasive. Previous data has shown encouraging outcomes using a 10-fraction regimen. To improve efficiency, convenience, and cost, reduction in the fraction number is desirable. Final results of a prospective phase II trial are reported. MATERIALS/METHODS: NIBB APBI was delivered using 28.5Gy in 5 fractions daily over 1 week. Patient eligibility criteria required: invasive carcinoma ≤2.0 cm or DCIS ≤3.0 cm, ER positive (if invasive), lymph node negative, LVI absent, and lumpectomy with margins negative by 2mm. The primary endpoint was grade ≥ 2 subcutaneous fibrosis/induration <30%. Secondary endpoints included any late toxicity, cosmetic outcome, and local control. RESULTS: 40 patients were treated with a median follow-up of 59.7 months. The mean age was 67 years (50-89 years) and tumor size was 1.0cm (0.3-2.0cm). 80% had invasive carcinoma. The mean breast separation with compression was 6.7cm (3.5-8.9cm). The 5-year actuarial local control was 96.6% and overall survival was 96.9%. Grade 2 and 3 late toxicities were 15% and 0%, respectively. The rate of grade 2 subcutaneous fibrosis/induration was 2.5% (+/-2.5%) meeting the study's primary endpoint. The most common late toxicity of any grade was skin telangiectasia; 22.5% grade 1 and 15% grade 2. Only breast separation was associated with telangiectasia risk, p=0.002. Overall cosmetic outcome was excellent, good, and fair/poor in 75%, 25%, and 0%, respectively. CONCLUSIONS: NIBB APBI delivered in 5 fractions results in a low rate of late toxicity and a high rate of good/excellent cosmetic outcomes. Telangiectasia risk can be minimized by keeping breast separation ≤7.0cm. The local failure rate was appropriately low. Further investigation of this technique is warranted.

Comparison of Tumor Bed Delineation Using a Novel Radiopaque Filament Marker Versus Surgical Clips for Targeting Breast Cancer Radiotherapy.

BACKGROUND: Accuracy of tumor bed (TB) delineation is essential for targeting boost doses or partial breast irradiation. Multiple studies have shown high interobserver variability with standardly used surgical clip markers (CMs). We hypothesize that a radiopaque filament marker (FM) woven along the TB will improve TB delineation consistency. METHODS: An FDA-approved FM was intraoperatively used to outline the TB of patients undergoing lumpectomy. Between January 2020 and January 2022, consecutive patients with FM placed after either (1) lumpectomy or (2) lumpectomy with oncoplastic reconstruction were identified and compared with those with CM. Six "experts" (radiation oncologists specializing in breast cancer) across 2 institutions independently defined all TBs. Three metrics (volume variance, dice coefficient, and center of mass [COM] deviation). Two-tailed paired samples t tests were performed to compare FM and CM cohorts. RESULTS: Twenty-eight total patients were evaluated (14 FM and 14 CM). In aggregate, differences in volume between expert contours were 29.7% (SD ± 58.8%) with FM and 55.4% (SD ± 105.9%) with CM ( P < 0.001). The average dice coefficient in patients with FM was 0.54 (SD ± 0.15), and with CM was 0.44 (SD ± 0.22) ( P < 0.001). The average COM deviation was 0.63 cm (SD ± 0.53 cm) for FM and 1.05 cm (SD ± 0.93 cm) for CM; ( P < 0.001). In the subset of patients who underwent lumpectomy with oncoplastic reconstruction, the difference in average volume was 21.8% (SD ± 20.4%) with FM and 52.2% (SD ± 64.5%) with CM ( P <0.001). The average dice coefficient was 0.53 (SD ± 0.12) for FM versus 0.39 (SD ± 0.24) for CM ( P < 0.001). The average COM difference was 0.53 cm (SD ± 0.29 cm) with FM versus 1.25 cm (SD ± 1.08 cm) with CM ( P < 0.001). CONCLUSION: FM consistently outperformed CM in the setting of both standard lumpectomy and complex oncoplastic reconstruction. These data suggest the superiority of FM in TB delineation.

Factors Affecting Time to Surgery in Breast Cancer Patients.

BACKGROUND: We sought to determine factors affecting time to surgery (TTS) to identify potential modifiable factors to improve timeliness of care. METHODS: Patients with clinical stage 0-3 breast cancer undergoing partial mastectomy in 2 clinical trials, conducted in ten centers across the US, were analyzed. No preoperative workup was mandated by the study; those receiving neoadjuvant therapy were excluded. RESULTS: The median TTS among the 583 patients in this cohort was 34 days (range: 1-289). Patient age, race, tumor palpability, and genomic subtype did not influence timeliness of care defined as TTS ≤30 days. Hispanic patients less likely to have a TTS ≤30 days (P = .001). There was significant variation in TTS by surgeon (P < .001); those practicing in an academic center more likely to have TTS ≤30 days than those in a community setting (55.1% vs 19.3%, P < .001). Patients who had a preoperative ultrasound had a similar TTS to those who did not (TTS ≤30 days 41.9% vs 51.9%, respectively, P = .109), but those who had a preoperative MRI had a significantly increased TTS (TTS ≤30 days 25.0% vs 50.9%, P < .001). On multivariate analysis, patient ethnicity was no longer significantly associated with TTS ≤30 (P = .150). Rather, use of MRI (OR: .438; 95% CI: .287-.668, P < .001) and community practice type (OR: .324; 95% CI: .194-.541, P < .001) remained independent predictors of lower likelihood of TTS ≤30 days. CONCLUSIONS: Preoperative MRI significantly increases time to surgery; surgeons should consider this in deciding on its use.

Breast-Specific Sensuality and Appearance Satisfaction: Comparison of Breast-Conserving Surgery and Nipple-Sparing Mastectomy.

BACKGROUND: We demonstrated previously that lumpectomy (L) patients reported higher appearance satisfaction, appreciation of a pleasurable breast caress, and persistence of the breast during intimacy than mastectomy with reconstruction, which we used to describe breast-specific sensuality. Our current objective was to compare breast-specific sensuality between L and nipple-sparing mastectomy (NSM). DESIGN: An anonymous, cross-sectional survey was distributed to breast cancer survivors between 2014 and 2016. Eligible patients underwent operation between 2000 and 2014, were adults older than 18 years, English-speaking, and at least one year into the post-operative period. Demographic characteristics, treatment details, Female Sexual Function Index metrics, and investigator-generated questions about appearance satisfaction and breast-specific sensuality were collected. RESULTS: Of the 600 women who participated, 585 surveys were eligible. Surgical modality was reported as L by 406 (69.4%), mastectomy alone by 50 (8.5%), and mastectomy with reconstruction by 129 (22.1%). Nipple-preservation data were available for 47 of 129 mastectomy with reconstruction patients (36.4%), with 21 NSM and 26 non-nipple-sparing mastectomy patients. Favorable postoperative appearance satisfaction was reported by 76.2% of L and 71.4% of NSM (p = 0.039). Lumpectomy patients reported feeling more comfortable being seen undressed than NSM patients (82.4% vs 71.4%; p = 0.0003). The chest remained a part of intimacy for 65.4% of L patients vs 42.9% of NSM patients (p = 0.0009). A pleasurable breast caress was reported more frequently by L patients than NSM patients (66.2% vs 20%; p ≤ 0.0001). The breast caress was unpleasant for 40% of NSM patients, nearly 4-fold higher than L patients (11.3%; p < 0.0001). CONCLUSIONS: NSM patients were significantly less satisfied with appearance, less comfortable being seen undressed, had decreased persistence of breast intimacy, and experienced a less pleasurable breast caress than L patients. Counseling patients about these findings will empower informed decision making, optimize expectations, and can enhance postoperative satisfaction.

Nipple-sparing Mastectomy and Ptosis: Using a Free Nipple Graft with Tissue Expander Reconstruction.

BACKGROUND: Nipple-sparing mastectomies are increasingly offered to women with breast cancer given the evidence for oncologic safety and improved cosmetic outcomes. Women with significant ptosis are often excluded due to potential nipple malposition and increased risk of nipple ischemia. The use of a harvested free nipple graft may allow women with ptosis to conserve their nipple -areolar complex. METHODS: This is an IRB approved retrospective study of breast cancer patients at an academic center with ptosis who underwent free-nipple graft mastectomies with a single plastic surgeon and 5 dedicated breast surgeons from 2014-2017. The primary outcomes were free nipple graft viability and the need for revision. Secondary outcomes included post-operative complications. RESULTS: Fourteen women with ptosis underwent skin and nipple-sparing mastectomy with breast reconstruction involving use of harvested free-nipple graft. More than half of the women were diagnosed with early-stage invasive breast cancer (42% stage 1, 14% stage 2). Four women underwent mastectomy for prophylaxis or other benign reasons. All of the women had significant ptosis during the pre-operative evaluation (57% grade 2 ptosis, 36% grade 3 ptosis, and 7% uncategorized), with an average BMI of 30. None were active smokers. In the postoperative period, one had partial nipple necrosis in combination with skin flap necrosis and positive margin (7%). Other complications included infection (14%) and hypopigmentation (14%). All nipples lost sensation and full projection. CONCLUSIONS: This is a novel approach using a free nipple graft with a skin envelope reducing mastectomy and immediate expander-based reconstruction. This successful approach allows women with ptosis to undergo nipple-sparing mastectomy with preservation of the nipple -areolar complex.

Sexual Dysfunction in Breast Cancer Survivors: Is it Surgical Modality or Adjuvant Therapy?

OBJECTIVES: Sexual dysfunction is common in breast cancer survivors. Our survey study aimed to delineate the relative associations between sexual dysfunction and breast cancer treatment including surgical modalities and adjuvant therapies. METHODS: Women in surveillance following breast cancer surgery were eligible for our survey incorporating the Female Sexual Function Index. Analysis involved multiple log-binomial regression to evaluate the association between sexual dysfunction (Female Sexual Function Index≤26.55) and treatment modality. RESULTS: Of the 600 completed surveys, the final eligible analytic sample included 278 sexually active respondents. Overall, 65%, 27%, and 8% underwent lumpectomy, mastectomy with reconstruction, and mastectomy alone, respectively. In total, 74.5% reported receipt of radiation; 47.8% chemotherapy; 27.3% tamoxifen, and 31.4% aromatase inhibitor (AI). No significant difference in prevalence of sexual dysfunction was observed by surgical modality, even when adjusted for adjuvant therapy. Chemotherapy or radiation was not associated with sexual dysfunction when adjusted for surgical modality. The prevalence of sexual dysfunction was 1.6 times higher for the AI group compared with the no endocrine therapy group (P=0.01), when adjusted for other treatment groups. CONCLUSIONS: Our study demonstrated that the highest rates of sexual dysfunction were among breast cancer survivors treated with AI. Neither surgical modality, chemotherapy, nor radiation was associated with sexual dysfunction. These data may guide clinicians in counseling sexually active breast cancer patients in treatment planning and survivorship.

Axillary Ultrasound Fine Needle Aspiration Biopsy: Is There a Role in the Post Z-0011 Era?

OBJECTIVES: Axillary ultrasound with fine needle aspiration (AXUSFNA) in early-stage breast cancer has required reappraisal. ACOSOG Z-0011 and after mapping of the axilla: radiotherapy or surgery have shown that women with limited nodal disease at sentinel lymph node biopsy got no survival advantage with completion axillary node dissection. We hypothesize that AXUSFNA may be sufficiently accurate for staging for some patients and sentinel lymph node biopsy need not be performed. We define the false negative rate (FNR) of AXUSFNA in different subsets of patients. MATERIALS AND METHODS: This retrospective cohort study included node positive patients who also underwent AXUSFNA between 1/2006 and 12/2010 followed by axillary surgery. The FNR was calculated for the entire group and for subgroups determined by tumor, nodal, and ultrasound findings. RESULTS: Out of ∼700 AXUSFNA patients, 128 node positive patients were included in the study. The overall AXUSFNA FNR was 35.9% (95% confidence interval, 28.1%-44.6%). There was a significantly higher FNR with smaller tumors and presence of ductal carcinoma in situ on multivariate analysis. On ultrasound, benign-appearing nodes had a higher FNR than indeterminate nodes (78.9% vs. 60.9%, P=0.2) and significantly higher than suspicious nodes (78.9% vs. 2.9%, P<0.0001). CONCLUSIONS: In our cohort, the FNR for AXUSFNA was comparable with the rate of residual disease in the control arms of Z-0011 (27.4%) and after mapping of the axilla: radiotherapy or surgery (33%). However, our analysis suggests that we may be able to identify more appropriate patients for AXUSFNA and halve the FNR. As primary tumor characteristics and genomics drive systemic therapeutic recommendations, there may be an ongoing role for AXUSFNA in axillary staging.

Five fraction accelerated partial breast irradiation using noninvasive image-guided breast brachytherapy: Feasibility and acute toxicity.

PURPOSE: To improve efficiency, convenience, and cost, a prospective phase II trial was initiated to evaluate accelerated partial breast irradiation delivered with noninvasive image-guided breast brachytherapy (NIBB) via five once-daily fractions. METHODS AND MATERIALS: Women ≥50 years old with early-stage breast cancer undergoing breast conserving surgery were enrolled. Eligibility criteria included invasive carcinoma ≤2.0 cm or ductal carcinoma in situ ≤3.0 cm, ER positive (if invasive), lymph node negative, LVI absent, and margins negative by 2 mm. Patients received a total dose of 28.5 Gy in five daily fractions. NIBB was delivered using two orthogonal axes for each fraction. Applicators were selected to encompass the lumpectomy cavity with a 1.0 cm clinical target volume margin and 0 to 0.5 cm planning target volume margin. Acute and late toxicity was assessed based on CTCAE v3.0. RESULTS: Forty patients with a mean age of 67 years underwent protocol treatment. Mean tumor size was 1.0 cm (0.3-2.0 cm). Eighty percent had invasive carcinoma and the remainder had ductal carcinoma in situ. Mean tumor bed volume was 21 cc (5-79 cc) and mean breast volume was 1319 cc (499-3044 cc). Mean breast separation with compression was 6.7 cm (3.5-8.9 cm). All patients tolerated well. Median discomfort with compression was 1 (range: 0-7) on a 10-point pain scale. Acute skin reaction was Grade 0-1 in 70%, Grade 2 in 28%, and Grade 3 in 3%. Acute skin toxicity was not associated with breast size but was associated with larger breast separation with compression (p < 0.01) and larger applicator size (p < 0.01). No Grade 3+ late toxicity or local recurrences have been observed at a median followup of 14 months. CONCLUSIONS: Accelerated partial breast irradiation delivered using NIBB over five daily fractions is a convenient treatment option that is feasible and well tolerated.