Erratum: Author Correction: Surgical Standards for Management of the Axilla in Breast Cancer Clinical Trials with Pathological Complete Response Endpoint.

[This corrects the article DOI: 10.1038/s41523-018-0074-6.].

Surgical Standards for Management of the Axilla in Breast Cancer Clinical Trials with Pathological Complete Response Endpoint.

Advances in the surgical management of the axilla in patients treated with neoadjuvant chemotherapy, especially those with node positive disease at diagnosis, have led to changes in practice and more judicious use of axillary lymph node dissection that may minimize morbidity from surgery. However, there is still significant confusion about how to optimally manage the axilla, resulting in variation among practices. From the viewpoint of drug development, assessment of response to neoadjuvant chemotherapy remains paramount and appropriate assessment of residual disease-the primary endpoint of many drug therapy trials in the neoadjuvant setting-is critical. Therefore decreasing the variability, especially in a multicenter clinical trial setting, and establishing a minimum standard to ensure consistency in clinical trial data, without mandating axillary lymph node dissection, for all patients is necessary. The key elements which include proper staging and identification of nodal involvement at diagnosis, and appropriately targeted management of the axilla at the time of surgical resection are presented. The following protocols have been adopted as standard procedure by the I-SPY2 trial for management of axilla in patients with node positive disease, and present a framework for prospective clinical trials and practice.

Is pleomorphic lobular carcinoma really a distinct clinical entity?

BACKGROUND: Attempts to define the clinical behavior of pleomorphic lobular carcinoma (PLC) have been limited to small series, and clinical management strategies have yet to be established. We describe our experience with PLC as compared to classic ILC and invasive ductal carcinoma (IDC). METHODS: From 9/1996 to 5/2003, clinical and histopathologic data for 5,635 patients undergoing primary surgical treatment and sentinel lymph node biopsy for breast cancer were collected. Four hundred eighty one (8.5%) patients were diagnosed with ILC; 3,978 (70.6%) with IDC. Of those with ILC, 356 (74%) patients had material available for pathologic re-review and comprise our study population: 52 were classified as PLC; 298 were classified as classic ILC; and 6 cases were reclassified as IDC. We compared clinical, pathologic, and treatment factors for patients with PLC, ILC, and IDC using the Wilcoxon rank sum and Fisher's exact tests. RESULTS: PLC were larger than ILC and IDC (20 vs. 15 vs. 13, P < 0.001), had more positive nodes (median 1 vs. 0 vs. 0, P < 0.05) and more frequently required mastectomy (63.5% vs. 38.7% vs. 28.8%, P < 0.001). In addition, more patients with PLC had developed metastatic disease compared to patients with ILC (11.5% vs. 3.7%, P < 0.05). CONCLUSIONS: These findings suggest that PLC is a distinct clinical entity that presents at a more advanced stage and may require more aggressive surgical and adjuvant treatment.

Outcomes for women with ductal carcinoma-in-situ and a positive sentinel node: a multi-institutional audit.

BACKGROUND: A positive sentinel lymph node (SLN) has been reported in 6% to 13% of patients with ductal carcinoma in situ (DCIS). Although it is well established that nodal status for invasive disease is prognostically important, the clinical relevance of a positive SLN in patients with DCIS remains undetermined. METHODS: SLN biopsy was performed on 470 high-risk patients with DCIS (22% of all patients with DCIS) at 3 institutions. Of these, 43 (9%) had SLN metastases. Pathology findings of positive cases were reviewed, and follow-up was obtained. At 2 of the 3 institutions, data were also collected on DCIS patients who had negative findings on SLN biopsy. For these 414 patients, univariate analyses of tumor characteristics were performed to identify factors associated with node positivity. RESULTS: Extensive disease requiring mastectomy (p = 0.02) and the presence of necrosis (p = 0.04) were associated with an increased risk of nodal positivity. Three (7%) of the 43 SLN-positive patients had macrometastases (pN1), 4 (9%) had micrometastases (pN1mi), and 36 (84%) had single tumor cells or small clusters (pN0(i+)). Of the 25 women that underwent completion axillary dissection, one was found to have a macrometastasis. On pathological review of the primary lesion, 2 (5%) of 43 patints were found to have microinvasion, and 2 (5%) lymphovascular invasion. Nine of 43 (21%) high-risk DCIS patients with a positive SLN and 9/470 (2%) of all high-risk DCIS patients were upstaged to AJCC stage I or II as a result of the SLN biopsy. At a median (range) follow-up of 27 (3-88) months, 1 patient had developed hepatic metastases. This patient had immunohistochemistry detected isolated tumor cells in her SLN (N0(i+)), and upon pathologic review, was found to have high-grade DCIS with microinvasion. CONCLUSION: SLN biopsy for high-risk DCIS patients is a mean of detecting those who may have unrecognized invasive disease and therefore are at risk for distant disease.

Locoregional recurrence after mastectomy: incidence and outcomes.

BACKGROUND: Locoregional recurrences (LRR) after mastectomy may be ominous events, but incidence and outcomes data are limited by heterogeneous study populations and the time period studied. We sought to evaluate the rate of LRR at a single institution in the era of multimodality therapy, identify predictors for isolated LRR, and examine treatment strategies and outcomes of postmastectomy patients with isolated LRR. STUDY DESIGN: In a prospective database, we identified 1,057 patients who underwent mastectomy for invasive cancer at Memorial Sloan-Kettering Cancer Center from 1995 to 1999. Predictive factors for isolated LRR were determined by univariate and multivariate analyses. Treatments and outcomes of patients with isolated LRR were reviewed. All patients with at least 2 years of followup were included. Median followup was 6 years. RESULTS: Overall, LRR developed in 93 of 1,057 (8.8%) patients. Thirty-four (3.2%) had synchronous distant metastases. Distant recurrences developed in thirty-one (2.9%) during the followup period (median followup, 6 years). Twenty-eight patients with LRR (2.6%) remained free of distant disease during the study period. Multivariate analysis showed age less than 35 years, lymphovascular invasion, and multicentricity as major predictors for isolated LRR. In the 28 patients with isolated LRR, 24 had recurrence in the chest wall, 2 in the axilla, and 2 in more than 1 local site. Seventy-eight percent (22 of 28) of patients were rendered disease free with surgery (15 of 22), radiotherapy (13 of 22), chemotherapy (6 of 22), or hormones (9 of 22). CONCLUSIONS: Despite widespread use of adjuvant therapies during the study period, we found an LRR rate after mastectomy of 9%. But for patients presenting with LRR without evidence of distant disease, aggressive multimodality therapy is warranted because many of these patients can be rendered disease free.

Utility of breast magnetic resonance imaging in patients with occult primary breast cancer.

BACKGROUND: Although carcinoma presenting as axillary metastases is assumed to be due to breast cancer, identification of the primary lesion may prove problematic. We investigated the ability of breast magnetic resonance imaging (MRI) to identify the primary tumor, thereby confirming the diagnosis and broadening treatment options. METHODS: From 1995 to 2001, 69 patients at our institution presented with occult primary breast cancer. All patients had negative breast examinations and mammograms and underwent breast MRI. RESULTS: Of 69 patients, 55 had axillary adenopathy without evidence of distant disease (stage II); 14 had stage IV disease. In patients with stage II disease, MRI revealed suspicious lesions in 76% (42 of 55). In 62% (26 of 42), the MRI finding proved to be the occult primary tumor. Of these, 58% (15 of 26) were candidates for breast conservation. MRI did not identify the primary tumor in 25 women; 12 underwent mastectomy. Cancer was found in 33% (4 of 12) of these. Thirteen patients were treated with primary breast irradiation; three were lost to follow-up, one developed distant disease, and nine were without evidence of disease with a median follow-up of 4.5 years. In women with stage IV disease, MRI identified the primary tumor in 5 of 9 patients with regional adenopathy and 2 of 5 patients with distant disease (overall 50%; 7 of 14). MRI identified the primary tumor in women with both mammographically dense (19 of 44; 43%) and less dense (10 of 20; 50%) breasts. CONCLUSIONS: Breast MRI detects mammographically occult cancer in half of women with axillary metastases, regardless of breast density. MRI is a powerful tool for stage II and stage IV patients with occult primary breast cancer.

Pericardiocentesis with extended catheter drainage: an effective therapy.

BACKGROUND: The most effective method for managing pericardial effusions has yet to be identified. This study evaluates the efficacy and safety of echocardiographic-guided placement of indwelling catheters into the pericardial space. METHODS: This study consists of a 5-year retrospective chart review of consecutive patients coded with benign or malignant pericardial effusions who presented for drainage procedures to a single surgeon at a 260-bed hospital. Complication, recurrence, and survival rates were studied. RESULTS: Between January 1996 and August 2001, a total of 29 pericardial drainage procedures were performed; eight of those also underwent talc sclerosis. Mean follow-up was 16 months. Three patients (10%) required conversion to thoracotomy; of those remaining, 25 of the 26 procedures were performed under local anesthesia with intravenous sedation. The identified etiologies for pericardial effusions were malignancy (76%), idiopathic (14%), postcoronary artery bypass grafting procedure (3%), viral pericarditis (3%), and uremia (3%). Echocardiographic features of tamponade were documented in 72%. Mean +/- SEM length of postprocedure in-hospital stay was 6.7 +/- 0.82 days. The overall complication rate was 10% (pneumothorax and cardiac injury). Recurrence rate within 30 days was 7%. Thirty-day mortality was 21%, and more than 90-day survival was 72%. CONCLUSIONS: Pericardiocentesis with extended catheter drainage is a safe treatment for management of clinically significant, malignant and benign, pericardial effusions and can be performed effectively under local anesthesia with intravenous sedation.