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Available retrospective data suggest the upgrade rate for intraductal papilloma (IP) without atypia on core biopsy (CB) ranges from 0 to 12%, leading to variation in recommendations. We conducted a prospective multi-institutional trial (TBCRC 034) to determine the upgrade rate to invasive cancer (IC) or ductal carcinoma in situ (DCIS) at excision for asymptomatic IP without atypia on CB. Prospectively identified patients with a CB diagnosis of IP who had consented to excision were included. Discordant cases, including BI-RADS > 4, and those with additional lesions requiring excision were excluded. The primary endpoint was upgrade to IC or DCIS by local pathology review with a predefined rule that an upgrade rate of ≤ 3% would not warrant routine excision. Sample size and confidence intervals were based on exact binomial calculations. Secondary endpoints included diagnostic concordance for IP between local and central pathology review and upgrade rates by central pathology review. The trial included116 patients (median age 56 years, range 24–82) and the most common imaging abnormality was a mass (n = 91, 78%). Per local review, 2 (1.7%) cases were upgraded to DCIS. In both of these cases central pathology review did not confirm DCIS on excision. Additionally, central pathology review confirmed IP without atypia in core biopsies of 85/116 cases (73%), and both locally upgraded cases were among them. In this prospective study of 116 IPs without atypia on CB, the upgrade rate was 1.7% by local review, suggesting that routine excision is not indicated for IP without atypia on CB with concordant imaging findings.

The after mapping of the axilla: radiotherapy or surgery (AMAROS) trial concluded that for patients with cT1-2 N0 breast cancer and one or two positive sentinel lymph nodes (SLNs), axillary radiotherapy (AxRT) provides equivalent locoregional control and a lower incidence of lymphedema compared with axillary lymph node dissection (ALND). The study prospectively assessed how often ALND could be replaced by AxRT in a consecutive cohort of patients undergoing mastectomy for cT1-2 N0 breast cancer. In November 2015, our multidisciplinary group agreed to omit routine intraoperative SLN evaluation for cT1-2 N0 patients undergoing upfront mastectomy and potentially eligible for postmastectomy radiation therapy (PMRT), including those 60 years of age or younger and those older than 60 years with high-risk features. Patients with one or two positive SLNs on final pathology were reviewed to determine whether PMRT including the full axilla was an appropriate alternative to ALND. From November 2015 to December 2016, 154 patients met the study criteria, and 114 (74%) formed the final study cohort. Intraoperative SLN evaluation was omitted for 76 patients (67%). Of these patients, 20 (26%) had one or two positive SLNs, and 14 of these patients received PMRT + AxRT as an alternative to ALND. Three patients returned for ALND, and three patients were observed. On univariate analysis, tumor size, LVI, number of positive lymph nodes, and receipt of chemotherapy were associated with receipt of PMRT. For the majority of patients with one or two positive SLNs, ALND was avoided in favor of PMRT + AxRT. With appropriate multidisciplinary strategies, intraoperative evaluation of the SLN and immediate ALND can be avoided for patients meeting the AMAROS criteria and eligible for PMRT.

Introduction Nipple sparing mastectomy (NSM) is oncologically safe and provides excellent cosmetic outcomes. Complications after surgery may impact patient reported outcomes (PROs). We assessed the impact of complications on PROs after NSM. Methods We enrolled 63 patients (pts) who met eligibility criteria for NSM from September 2011 until August 2014. PROs were administered before surgery and at 1 year. Clinical data were collected from the electronic health record. Analyses were performed in SPSS Statistics for Windows (version 21.0). Pts with and without complications were compared using a one-way ANOVA. Data Sixty-three women were enrolled with a median age of 46. Postoperative complications requiring surgical treatment were seen in 10 patients (15.9%). Two patients required nipple excision due to necrosis (3.1%). No statistically significant differences in BREAST-Q scores were seen between pts with and without complications. Conclusion Experiencing a complication after initial NSM surgery is not associated with decrease in PROs.

BACKGROUND Surgical management of breast cancer in pregnancy (BCP) requires balancing benefits of therapy with potential risks to the developing fetus. Minimal data describe outcomes after mastectomy with immediate breast reconstruction (IR) in pregnant patients. METHODS Retrospective review was performed of patients who underwent IR after mastectomy within a BCP cohort. Parameters included intra- and post-operative complications, short-term maternal/fetal outcomes, surgery duration, and delayed reconstruction in non-IR cohort. RESULTS Of 82 patients with BCP, 29 (35%) had mastectomy during pregnancy: 10 (34%) had IR, 19(66%) did not. All IR utilized tissue expander (TE) placement. Mean gestational age (GA) at IR was 16.2 weeks. Mean surgery duration was 198 min with IR versus 157 min without IR. Those with IR delivered at, or close to, term infants of normal birthweight. No fetal or major obstetrical complications were seen. Post-mastectomy radiation (PMRT) was provided after pregnancy in 2 (20%) patients in the IR cohort and 12 (63%) in the non-IR cohort. All patients in the IR cohort successfully transitioned to permanent implant. CONCLUSIONS This report represents one of the largest series describing IR during BCP. IR after mastectomy increased surgery duration, but was not associated with adverse obstetrical or fetal outcomes. IR with TE may preserve reconstructive options when PMRT is indicated. J. Surg. Oncol. 2016;114:140-143. © 2016 Wiley Periodicals, Inc.

Highlights • Recurrence of breast cancer at the site of a prior core needle biopsy after definitive surgery is very rare—only 13 cases have been reported. • The majority are recurrent invasive cancers forming palpable masses in dermis and subcutaneous tissue at the skin puncture site of the core needle biopsy. • Diagnosis can be delayed if a lesion is not initially recognized as being at a needle biopsy site. • We report the first case of needle puncture site recurrence as Paget disease of the epidermis (ductal carcinoma in situ). • It is important to document the site of the skin puncture of a needle biopsy to aid in early detection, and recognition, of needle track recurrences., Introduction Core needle biopsy has become the preferred method of diagnosing breast carcinomas prior to definitive surgery. The possibility of displacing tumor cells into the needle track is a concern. Presentation of case A 38 year old woman was diagnosed with right breast ductal carcinoma in situ (DCIS) with microinvasion by core needle biopsy. Bilateral skin sparing mastectomies with immediate autologous reconstruction were performed. One and a half years later the patient noted erythema and a scaling crust on the skin of the right breast that progressed over several months. Punch biopsy revealed Paget disease restricted to the epidermis. Subsequent comparison to initial clinical photographs confirmed the cancer was associated with the skin puncture site of the needle biopsy. The patient underwent complete excision with skin grafting and remains free of disease three years later. Discussion Only 13 cases of needle track recurrences have been reported. The majority presented as invasive carcinoma forming a subcutaneous mass. In the current case, detection was delayed due to not initially noting that a skin lesion was at the puncture site of the original needle biopsy. This is the only case of recurrence as tumor limited to the epidermis. Conclusion Although recurrence in a needle track occurs very infrequently, clinicians should be aware of this phenomenon and investigate any changes, particularly when occurring at a needle biopsy site. Recording the skin puncture site can aid in early detection of recurrences. Recognition of a recurrence is important for prompt treatment and optimal prognosis.

Surgical management of breast cancer in pregnancy (BCP) requires balancing benefits of therapy with potential risks to the developing fetus. Minimal data describe outcomes after mastectomy with immediate breast reconstruction (IR) in pregnant patients.Retrospective review was performed of patients who underwent IR after mastectomy within a BCP cohort. Parameters included intra- and post-operative complications, short-term maternal/fetal outcomes, surgery duration, and delayed reconstruction in non-IR cohort.Of 82 patients with BCP, 29 (35%) had mastectomy during pregnancy: 10 (34%) had IR, 19(66%) did not. All IR utilized tissue expander (TE) placement. Mean gestational age (GA) at IR was 16.2 weeks. Mean surgery duration was 198 min with IR versus 157 min without IR. Those with IR delivered at, or close to, term infants of normal birthweight. No fetal or major obstetrical complications were seen. Post-mastectomy radiation (PMRT) was provided after pregnancy in 2 (20%) patients in the IR cohort and 12 (63%) in the non-IR cohort. All patients in the IR cohort successfully transitioned to permanent implant.This report represents one of the largest series describing IR during BCP. IR after mastectomy increased surgery duration, but was not associated with adverse obstetrical or fetal outcomes. IR with TE may preserve reconstructive options when PMRT is indicated. J. Surg. Oncol. 2016;114:140-143. © 2016 Wiley Periodicals, Inc.

584Background: Recent trials have demonstrated the feasibility of SLN biopsy in cN1 patients who become cN0 after NAC. We sought to evaluate success of SLN mapping and accuracy of intraop frozen se...

Sentinel lymph node biopsy (SNB) in pregnant women with breast cancer is uncommonly pursued given concern for fetal harm. This study evaluated efficacy and safety outcomes in pregnant breast cancer patients undergoing SNB.Patients who underwent SNB while pregnant were identified from a retrospective parent cohort of women diagnosed with breast cancer during pregnancy. Chart review was performed to tabulate patient/tumor characteristics, method/outcome of SNB, and short-term maternal/fetal outcomes.Within a cohort of 81, 47 clinically node-negative patients had surgery while pregnant: 25 (53.2 %) SNB, 20 (42.6 %) upfront axillary lymph node dissection, and 2 (4.3 %) no lymph node surgery. Of SNB patients, 8, 9, and 8 had SNB in the first, second, and third trimesters, respectively. 99 m-Technetium (99-Tc) alone was used in 16 patients, methylene blue dye alone in 7 patients, and 2 patients had unknown mapping method. Mapping was successful in all patients. There were no SNB-associated complications. At a median of 2.5 years from diagnosis, there was one locoregional recurrence, one new primary contralateral tumor, three distant recurrences, and one breast cancer death. Among patients who underwent SNB, there were 25 liveborn infants, of whom 24 were healthy, and 1 had cleft palate (in the setting of other maternal risk factors).SNB in pregnant breast cancer patients appears to be safe and accurate using either methylene blue or 99-Tc. This is one of the largest reported experiences of SNB during pregnancy; however, numbers remain limited. SNB rates in this cohort were lower than in non-pregnant breast cancer patients.

Breast cancer diagnosed during pregnancy poses unique challenges. Application of standard treatment algorithms is limited by lack of level I evidence from randomized trials. This study describes contemporary multidisciplinary treatment of pregnancy-associated breast cancer (PABC) in an academic setting and explores early maternal and fetal outcomes. A search of the Dana-Farber/Harvard Cancer Center clinical databases was performed to identify PABC cases. Sociodemographic, disease, pregnancy, and treatment information, as well as data on short-term maternal and fetal outcomes, were collected through retrospective chart review. 74 patients were identified, the majority with early-stage breast cancer. Most (73.5%) underwent surgical resection during pregnancy, including 40% with sentinel lymph node biopsy and 32% with immediate reconstruction. A total of 36 patients received anthracycline-based chemotherapy during pregnancy; of those, almost 20% were on a dose-dense schedule and 8.3% also received paclitaxel. 68 patients delivered liveborn infants; over half were delivered preterm (< 37 weeks), most scheduled to allow further maternal cancer therapy. For the infants with available data, all had normal Apgar scores and over 90% had birth weight >10th percentile. The rate of fetal malformations (4.4%) was not different than expected population rate. Within a multidisciplinary academic setting, PABC treatment followed contemporary algorithms without apparent increase in maternal or fetal adverse outcomes. A considerable number of preterm deliveries were observed, the majority planned to facilitate cancer therapy. Continued attention to maternal and fetal outcomes after PABC is required to determine the benefit of this delivery strategy.

Mortality reduction from mammographic screening is controversial. Individual randomized trials and meta-analyses demonstrate statistically significant mortality reductions in all age groups invited to screening. In women actually screened, mortality reductions are greater. Individual trials and meta-analyses show varying rates of mortality reduction, leading to questions about screening's value and whether treatment advances have diminished the importance of early detection. This study hypothesized that breast cancer deaths predominantly occurred in unscreened women.Invasive breast cancers diagnosed between 1990 and 1999 were followed through 2007. Data included demographics, mammography use, surgical and pathology reports, and recurrence and death dates. Mammograms were categorized as screening or diagnostic based on absence or presence of breast signs or symptoms, and were substantiated by medical records. Breast cancer deaths were defined after documentation of prior distant metastases. Absence of recurrent cancer and lethal other diseases defined death from other causes.Invasive breast cancer failure analysis defined 7301 patients between 1990 and 1999, with 1705 documented deaths from breast cancer (n = 609) or other causes (n = 905). Among 609 confirmed breast cancer deaths, 29% were among women who had been screened (19% screen-detected and 10% interval cancers), whereas 71% were among unscreened women, including 2 years since last mammogram (6%), or never screened (65%). Overall, 29% of cancer deaths were screened, whereas 71% were unscreened. Median age at diagnosis of fatal cancers was 49 years; in deaths not from breast cancer, median age at diagnosis was 72 years.Most deaths from breast cancer occur in unscreened women. To maximize mortality reduction and life-years gained, initiation of regular screening before age 50 years should be encouraged.

1117 Background: SNB in PABC is not often pursued due to concerns for potential fetal harm. There are only limited data available regarding the safety and efficacy of SNB in patients (pts) with PABC. Methods: Pts with PABC who underwent SNB were identified from within an existing multi-institutional PABC cohort diagnosed 1996-2013. Factors evaluated included method and result of SNB evaluation, maternal disease outcome, and fetal outcomes. Results: Within a cohort of 78 PABC pts, 53 had breast surgery while pregnant; 23 (43%) underwent SNB, 27 (51%) underwent initial axillary node (AN) dissection, 18 of whom were clinically node negative, and 3 had no nodal evaluation. Of SNB pts, 21 (91%) had stage 1-2 disease; 14 (61%) had ER/PR+ disease and 7 (30%) HER2+. Eight (35%), 9 (39%), and 6 (26%) women had SNB in the first, second, and third trimesters, respectively. 99-Technetium-labelled sulfur colloid (99-Tc) alone was used for SNB in 14 pts; methylene blue (MB) dye alone was used in 7. SN was identified in 100% of pts; see Table. There were no SNB-associated complications. At a median of 2.4 years from diagnosis, there were no locoregional recurrences, 3 (13%) distant recurrences, and 1 (4%) death from breast cancer. Among pts who underwent SNB, there were 20 liveborn infants and 3 pregnancies ongoing. Of the 20 infants born, 18 were healthy, 1 unknown, and 1 had cleft palate (in setting of maternal risk factors including smoking and methadone). Conclusions: SNB in PABC appears to be a safe and accurate procedure using either 99-Tc or MB techniques. This is one of the largest experiences reported to date of SNB during PABC; however, numbers remain limited and rates of SNB in our cohort were lower than current rates in non-PABC patients. Additional research and monitoring for safety of this procedure is warranted in women with PABC. [Table: see text]

1133 Background: Management of pregnancy-associated breast cancer (PABC) requires balancing benefits of therapy with potential risks to the developing fetus. Surgical management can be influenced by gestational age of fetus and tumor stage. Minimal data describe surgical and obstetrical outcomes after mastectomy with immediate breast reconstruction (IR) in a pregnant patient (pt). Methods: Pts who underwent IR after mastectomy were identified within a multi-institutional PABC cohort. Retrospective chart review was performed for outcomes including adverse intraoperative events, immediate postoperative complications, gestational age at delivery and fetal weight. Other parameters evaluated included stage at presentation, duration of surgery, and use of delayed reconstruction in pts who did not receive IR. Results: Within a cohort of 79 PABC pts, 25 (32%) had mastectomy while pregnant, 8 (32%) of whom had IC; 17 (68%) did not undergo IR. Mean gestational age at time of IR was 16.6 weeks (range 10-30) and all IR utilized tissue expander (TE) placement followed by permanent implant placement in 7 pts. In the IR cohort, 1 (12.5%) pt was stage 0, 3 (37.5%) stage I and 4 (50%) stage IIB. There were no intraoperative or immediate postoperative surgical complications. The mean duration of surgery was 198 min with IR (7 pts) vs. 157 min without IR (available for 12 pts). All women who underwent IR delivered at, or close to, term infants of normal birthweight. One pt had pre-term labor after surgery at 29 weeks which resolved with tocolysis. Mean gestational age at delivery was 37.3 weeks in the IR cohort vs. 36.3 weeks in the non-IR cohort. No fetal abnormalities or major obstetrical complications were seen after IR. Post-mastectomy radiation (PMRT) was provided after pregnancy in 2 pts (25%) in the IR cohort and cosmetic outcome was not adversely affected. Conclusions: This report represents one of the largest series describing IR after mastectomy in PABC. Results suggest immediate tissue expander placement after mastectomy may increase duration of surgery but does not lead to adverse obstetrical or fetal outcomes. IR with tissue expanders may preserve reconstructive options when PMRT is indicated.