Performance of a novel protease-activated fluorescent imaging system for intraoperative detection of residual breast cancer during breast conserving surgery.

PURPOSE: Safe breast cancer lumpectomies require microscopically clear margins. Real-time margin assessment options are limited, and 20-40% of lumpectomies have positive margins requiring re-excision. The LUM Imaging System previously showed excellent sensitivity and specificity for tumor detection during lumpectomy surgery. We explored its impact on surgical workflow and performance across patient and tumor types. METHODS: We performed IRB-approved, prospective, non-randomized studies in breast cancer lumpectomy procedures. The LUM Imaging System uses LUM015, a protease-activated fluorescent imaging agent that identifies residual tumor in the surgical cavity walls. Fluorescent cavity images were collected in real-time and analyzed using system software. RESULTS: Cavity and specimen images were obtained in 55 patients injected with LUM015 at 0.5 or 1.0 mg/kg and in 5 patients who did not receive LUM015. All tumor types were distinguished from normal tissue, with mean tumor:normal (T:N) signal ratios of 3.81-5.69. T:N ratios were 4.45 in non-dense and 4.00 in dense breasts (p = 0.59) and 3.52 in premenopausal and 4.59 in postmenopausal women (p = 0.19). Histopathology and tumor receptor testing were not affected by LUM015. Falsely positive readings were more likely when tumor was present < 2 mm from the adjacent specimen margin. LUM015 signal was stable in vivo at least 6.5 h post injection, and ex vivo at least 4 h post excision. CONCLUSIONS: Intraoperative use of the LUM Imaging System detected all breast cancer subtypes with robust performance independent of menopausal status and breast density. There was no significant impact on histopathology or receptor evaluation.

Long-Term Outcomes of Multiple-Wire Localizations for More Extensive Breast Cancer: Multiple-Wire Excision Does Not Increase Recurrence, Unplanned Imaging, or Biopsies.

BACKGROUND: We previously reported that breast conservation was feasible for women with large or irregularly shaped breast cancers when tumor resection was guided by multiple localizing wires. We now report long-term outcomes of multiple-wire versus single-wire localized lumpectomies for breast cancer. PATIENTS AND METHODS: We retrospectively reviewed wire-localized lumpectomies at our institution from May 2000 to November 2006. Rates of ipsilateral in-breast tumor recurrence, metastasis, and subsequent unplanned diagnostic imaging and biopsy were compared between multiple-wire and single-wire cohorts. RESULTS: We identified 112 multiple-wire and 160 single-wire breast cancer lumpectomies that achieved clear margins. Median age was 64 years in the multiple-wire cohort and 57 years in the single-wire cohort. Mean lumpectomy volume was 75 mL in multiple-wire patients and 49 mL in single-wire patients (P = .003). Invasive tumor size, axillary node status, and use of radiation and systemic therapy were similar, but the multiple-wire group had more patients with ductal carcinoma-in-situ only (38% vs. 28%). At 108 months' median follow-up, there was no significant difference in local or distant recurrence rates between multiple-wire and single-wire cohorts. Six (5%) multiple-wire patients and 6 (4%) single-wire patients had local recurrences and 3 (3%) multiple-wire and 5 (3%) single-wire patients developed metastatic disease. Unplanned diagnostic imaging was required for 53 (47%) multiple-wire and 65 (41%) single-wire patients. Subsequent ipsilateral biopsy occurred in 15 (13%) multiple-wire and 19 (12%) single-wire patients. CONCLUSION: Breast-conserving surgery with multiple localizing wires is a safe alternative to mastectomy for breast cancer patients with large mammographic lesions.

Enhanced Recovery Minimizes Opioid Use and Hospital Stay for Patients Undergoing Mastectomy with Reconstruction.

BACKGROUND: This study examined the effects of an enhanced recovery program on inpatient opioid requirements and hospital length of stay (LOS) for mastectomy patients undergoing immediate reconstruction. METHODS: An enhanced recovery program for patients undergoing mastectomy with immediate tissue expander (TE) or implant reconstruction was evaluated by comparing a contemporary cohort of 611 patients in 2016-2018 with a historical cohort of 188 patients in 2010. Opioid use and LOS were compared over time and stratified by laterality, mastectomy type, axillary procedure, and reconstruction. Associations were assessed by uni- and multivariate analyses. RESULTS: In 2010, 95.2% of patients required intravenous (IV) opioids, with a last dose 15.5 h after completion of surgery, compared with 68.7% of patients in 2016-2018, with a last dose 1.8 h after surgery (p < 0.001). Patients prescribed gabapentin postoperatively were less likely to require inpatient IV or oral opioids (p < 0.001). The mean LOS decreased from 37 h in 2010 to 27.5 h in 2016-2018 without an increase in the readmission rate (6.9% vs. 4.1%; p = 0.112). Patients were more likely to stay more than one night if they were older (p = 0.012), had undergone bilateral mastectomies (p < 0.001) or TE reconstruction (p = 0.012), and had surgery in 2010 compared with 2016-2018 (p < 0.001). Even after adjustment for LOS, IV opioid use remained significantly associated with year of surgery (p < 0.001). CONCLUSIONS: Compared with 2010, patients undergoing mastectomy with TE or implant reconstruction in 2016-2018 required less inpatient opioids and had decreased LOS. The authors attribute this to an enhanced recovery program focused on preoperative counseling, non-opioid analgesics, and improved surgical efficiencies.

Nipple Discharge After Nipple-Sparing Mastectomy With and Without Associated Pregnancy.

BACKGROUND: Nipple-sparing mastectomies (NSMs) preserve the intact nipple, including nipple duct orifices. Retained orifices might remain patent and communicate with the underlying reconstruction. We report the incidence and outcomes of nipple discharge after NSM in pregnant and nonpregnant women. PATIENTS AND METHODS: Retrospective review of all NSMs at our institution from June 2007 to June 2018 was performed. Subsequent pregnancies and nipple discharge were documented. Patient demographic, operative, histopathology, and cancer treatment data were collected. Descriptive analysis was performed for patients who developed nipple discharge. RESULTS: From June 2007 to June 2018, 2778 NSM procedures were performed in 1620 patients, with a mean age of 48 (range, 20-80) years. Fifteen hundred sixty-eight NSMs were therapeutic and 1210 were for risk reduction. Thirty-three subsequent pregnancies were observed in 27 patients, with a mean age of 33 (range, 26-42) years at NSM. Bilateral or unilateral discharge occurred in 6 of 27 (22%) postpartum patients and resolved spontaneously. At 54 months mean follow-up after NSM (range, 16-98 months) and 23 (range, 1-61) months after delivery, no local-regional recurrences were observed. In 1593 patients without subsequent pregnancy, there were 4 patients (0.25%) treated with bilateral NSM with subsequent unilateral watery nipple discharge. There was no evidence of associated malignancy on physical exam, imaging, or cytology, and with 55 to 110 months follow-up, no new or recurrent cancers have been observed. CONCLUSION: Despite extensive removal of nipple and subareolar duct tissue during NSM, milky nipple discharge is possible postpartum. Watery, acellular discharge occurs rarely in nonpregnant patients. To date, no patient with discharge has developed a local recurrence or new breast cancer.