Changing the Default: A Prospective Study of Reducing Discharge Opioid Prescription after Lumpectomy and Sentinel Node Biopsy.

BACKGROUND: Whether routinely prescribed opioids are necessary for pain control after discharge among lumpectomy/sentinel node biopsy (Lump/SLNB) patients is unclear. We hypothesize that Lump/SLNB patients could be discharged without opioids, with a failure rate < 10%. This study prospectively examines outcomes after changing standard discharge prescription from an opioid/non-steroidal anti-inflammatory drug (NSAID) to NSAID/acetaminophen. PATIENTS AND METHODS: Standard discharge pain medication orders included opioids in the first 3-month study period and were changed to NSAID/acetaminophen in the second 3-month period. Patient-reported medication consumption and pain scores were collected by post-discharge survey. Frequency of discharge with opioid, NSAID/acetaminophen failure rate, opioid use, and pain scores were examined. RESULTS: From May to October 2019, 663 patients had Lump/SLNB: 371 in the opioid study period and 292 in the NSAID period. In the opioid period, 92% (342/371) of patients were prescribed an opioid at discharge; of 142 patients who documented opioid use on the survey, 86 (61%) used zero tablets. Among 56 (39%) patients who used opioids, the median number taken by POD 5 was 4. After the change to NSAID/acetaminophen, rates of opioid prescription decreased to 14% (41/292). The NSAID/acetaminophen failure rate was 2% (5/251). Among survey respondents, there was no significant difference in the maximum reported pain scores (POD 1-5) between the opioid period and the NSAID period (p = 0.7). CONCLUSIONS: In Lump/SLNB patients, a change to default discharge with NSAID/acetaminophen resulted in a 78% absolute reduction in opioid prescription, with a failure rate of 2% and no difference in patient-reported pain scores. Most Lump/SLNB patients can be discharged with NSAID/acetaminophen.

Axillary Dissection and Nodal Irradiation Can Be Avoided for Most Node-positive Z0011-eligible Breast Cancers: A Prospective Validation Study of 793 Patients.

OBJECTIVE: To determine rates of axillary dissection (ALND) and nodal recurrence in patients eligible for ACOSOG Z0011. BACKGROUND: Z0011 demonstrated that patients with cT1-2N0 breast cancers and 1 to 2 involved sentinel lymph nodes (SLNs) having breast-conserving therapy had no difference in locoregional recurrence or survival after SLN biopsy alone or ALND. The generalizability of the results and importance of nodal radiotherapy (RT) is unclear. METHODS: Patients eligible for Z0011 had SLN biopsy alone. Prospectively defined indications for ALND were metastases in ≥3 SLNs or gross extracapsular extension. Axillary imaging was not routine. SLN and ALND groups and radiation fields were compared with chi-square and t tests. Cumulative incidence of recurrences was estimated with competing risk analysis. RESULTS: From August 2010 to December 2016, 793 patients met Z0011 eligibility criteria and had SLN metastases. Among them, 130 (16%) had ALND; ALND did not vary based on age, estrogen receptor, progesterone receptor, or HER2 status. Five-year event-free survival after SLN alone was 93% with no isolated axillary recurrences. Cumulative 5-year rates of breast + nodal and nodal + distant recurrence were each 0.7%. In 484 SLN-only patients with known RT fields (103 prone, 280 supine tangent, 101 breast + nodes) and follow-up ≥12 months, the 5-year cumulative nodal recurrence rate was 1% and did not differ significantly by RT fields. CONCLUSIONS: We confirm that even without preoperative axillary imaging or routine use of nodal RT, ALND can be avoided in a large majority of Z0011-eligible patients with excellent regional control. This approach has the potential to spare substantial numbers of women the morbidity of ALND.

How Often Does Neoadjuvant Chemotherapy Avoid Axillary Dissection in Patients With Histologically Confirmed Nodal Metastases? Results of a Prospective Study.

BACKGROUND: In breast cancer patients with nodal metastases at presentation, false-negative rates lower than 10 % have been demonstrated for sentinel node biopsy (SLNB) after neoadjuvant chemotherapy (NAC) when three or more negative sentinel nodes (SLNs) are retrieved. However, the frequency with which axillary dissection (ALND) can be avoided is uncertain. METHODS: Among 534 prospectively identified consecutive patients with clinical stages 2 and 3 cancer receiving NAC from November 2013 to November 2015, all biopsy-proven node-positive (N+) cases were identified. Patients clinically node-negative after NAC were eligible for SLNB. The indications for ALND were failed mapping, fewer than three SLNs retrieved, and positive SLNs. RESULTS: Of 288 N+ patients, 195 completed surgery, with 132 (68 %) of these patients eligible for SLNB. The median age was 50 years. Of these patients, 73 (55 %) were estrogen receptor-positive (ER+), 21 (16 %) were ER- and human epidermal growth factor receptor-2-positive (HER2+), and 38 (29 %) were triple-negative. In four cases, SLNB was deferred intraoperatively. Among 128 SLNB attempts, three or more SLNs were retrieved in 110 cases (86 %), one or two SLNs were retrieved in 15 cases (12 %), and failed mapping occurred in three cases (2 %). In 66 cases, ALND was indicated: 54 (82 %) for positive SLNs, 9 (14 %) for fewer than three negative SLNs, and 3 (4 %) for failed mapping. Persistent disease was found in 17 % of the patients with fewer than three negative SLNs retrieved. Of the 128 SLNB cases, 62 (48 %) had SLNB alone with three or more SLNs retrieved. Among 195 N+ patients who completed surgery, nodal pathologic complete response (pCR) was achieved for 49 %, with rates ranging from 21 % for ER+/HER2- to 97 % for ER-/HER2+ cases, and was significantly more common than breast pCR in ER+/HER2- and triple-negative cases. CONCLUSIONS: Nearly 70 % of the N+ patients were eligible for SLNB after NAC. For 48 %, ALND was avoided, supporting the role of NAC in reducing the need for ALND among patients presenting with nodal metastases.

Axillary dissection can be avoided in the majority of clinically node-negative patients undergoing breast-conserving therapy.

BACKGROUND: The extent to which ACOSOG Z0011 findings are applicable to patients undergoing breast-conserving therapy (BCT) is uncertain. We prospectively assessed how often axillary dissection (ALND) was avoided in an unselected, consecutive patient cohort meeting Z0011 eligibility criteria and whether subgroups requiring ALND could be identified preoperatively. METHODS: Patients with cT1,2cN0 breast cancer undergoing BCT were managed without ALND for metastases in <3 sentinel nodes (SNs) and no gross extracapsular extension (ECE). Patients with and without indications for ALND were compared using Fisher's exact and Wilcoxon rank sum tests. RESULTS: From August 2010 to November 2012, 2,157 invasive cancer patients had BCT. A total of 380 had histologic nodal metastasis; 93 did not meet Z0011 criteria. Of 287 with ≥1 H&E-positive SN (209 macrometastases), 242 (84 %) had indications for SN only. ALND was indicated in 45 for ≥3 positive SNs (n = 29) or ECE (n = 16). The median number of SNs removed in the SN group was 3 versus 5 in the ALND group (p < 0.0001). Age, hormone receptor and HER2 status, and grade did not differ between groups; tumors were larger in the ALND group (p < 0.0001). Of ALND patients, 72 % had additional positive nodes (median = 1; range 1-19). No axillary recurrences have occurred (median follow-up, 13 months). CONCLUSIONS: ALND was avoided in 84 % of a consecutive series of patients having BCT, suggesting that most patients meeting ACOSOG Z0011 eligibility have a low axillary tumor burden. Age, ER, and HER2 status were not predictive of ALND, and the criteria used for ALND (≥3 SNs, ECE) reliably identified patients at high risk for residual axillary disease.

Training a new generation of breast surgeons: are we succeeding?

BACKGROUND: Society of Surgical Oncology (SSO)-approved fellowships in Breast Oncology began training fellows in 2004. Here we ascertain methods of evaluating and improving the fellowship experience through fellowship alumni experience. METHODS: We conducted an electronic survey of fellowship graduates to learn perceived successes and weaknesses of their fellowship training, as well as their current practice experiences. Our electronic survey focused on their preparedness for practice, their job opportunities, and their use of image-guided biopsies in practice. RESULTS: Between 2005 and 2009, 142 fellows graduated and received our survey; 85 (60%) responded. Although 98% of graduates though that they were well prepared by their fellowship for performing breast cancer surgery, fewer thought that they were well prepared to perform oncoplastic techniques (53%), ultrasound (39%), and ultrasound-guided biopsies (28%). Nevertheless, many acquired additional training, and 63% were performing ultrasound-guided biopsies in practice. The majority (76%) were performing breast surgery exclusively, with 14% identifying themselves as director of a breast center and only 29% describing themselves as being in private practice-the rest being employed at a hospital or university. Only 8% of respondents were disappointed with the job market, and 67% stated they had received at least three job offers; 82% were satisfied in their current job. CONCLUSIONS: SSO breast oncology fellowships appear to be training confident, well-prepared graduates with good job outlooks, and many are achieving leadership positions. Deficiencies in sonography training, some advanced surgical techniques, and administrative experiences should be addressed by program directors as graduates do perceive the need for such training.

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.

Sentinel lymph node biopsy and axillary dissection: added morbidity of the arm, shoulder and chest wall after mastectomy and reconstruction.

Axillary lymph node surgery is essential for the treatment of breast cancer but can produce both short-term and long-term morbidities, including lymphedema, shoulder restriction, numbness, weakness, and pain syndromes which impact on the quality of life of the estimated 2 million breast cancer survivors living in the United States today. They occur with both sentinel node biopsy and axillary dissection, though less frequently with the former. The incidence and etiology of these complications are investigated as are the risk factors, and methods of prevention and treatment. Recommendations for avoiding these morbidities for postoperative rehabilitation are discussed.

Influence of frozen-section analysis of sentinel lymph node and lumpectomy margin status on reoperation rates in patients undergoing breast-conservation therapy.

BACKGROUND: Frozen-section analysis (FS) of the sentinel lymph node (SLN) is performed to avoid reoperation for axillary lymph node dissection (ALND), but it can miss micrometastatic disease, is labor intensive for the pathologist, and does not alter the number of breast-conservation therapy (BCT) patients needing reoperation for positive margins. The purpose of this study was to determine if eliminating FS would change reoperation rates in BCT patients. STUDY DESIGN: Between January 2004 and December 2005, 1,218 patients had simultaneous BCT and SLN biopsy for invasive breast cancer. FS of the SLN was used selectively at the surgeon's discretion. Clinical and pathologic data were collected. RESULTS: Overall, 542 of 1,218 (44%) patients had positive margins. FS of the SLN was performed in 931 of 1,218 (76%) patients. In those having FS, the SLN positivity rate was 33% (306 of 931). FS identified the positive SLN in 170 of 306 (56%) patients with positive nodes, allowing for immediate ALND. But 101 of these 170 patients had positive lumpectomy margins; and FS of the SLN saved 69 of 931 (7%) patients a second operation. Of patients not having FS, 48 of 287 (17%) had a positive SLN on final pathology. Only 18 of 48 (those seen on routine hematoxylin and eosin) might have been seen on FS, potentially sparing reoperation. Half of patients not having FS required reexcision for positive margins. FS would have spared reoperation for only 8 of 287 (3%) patients in this group. Overall, of 354 of 1,218 patients with SLN metastases, 170 had immediate ALND and 98 had delayed ALND. Of those having delayed ALND, 68 of 98 also had positive margins. CONCLUSIONS: Among patients having BCT with SLN biopsy, FS identified the positive SLN in 56% of patients with positive SLNs, allowing immediate ALND, and was false negative in 44%. Margin status remains a frequent indication for reoperation in BCT; routine FS analysis of the SLN ultimately saves only a minority of patients a second operation.

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.

Can sentinel lymph node biopsy be omitted in patients with favorable breast cancer histology?

BACKGROUND: The widespread use of sentinel lymph node biopsy (SLNB) to replace axillary dissection has broadened the indications for axillary staging in breast cancer. Recent studies have demonstrated a finite risk of lymphedema and sensory morbidity associated with SLNB. We undertook this study to determine whether SLNB could be omitted in clinically node-negative patients with favorable-histology breast cancer. METHODS: We conducted a retrospective review of a prospective database of SLNBs performed at Memorial Sloan-Kettering Cancer Center from 1996 to 2003 to determine the incidence of lymph node metastases by histological subtype. For the favorable subtypes, the patient's age, tumor size, estrogen receptor status, lymphovascular invasion, nuclear grade, and histological grade were compared by nodal status to determine their predictive value. RESULTS: A total of 196 cases with favorable breast cancer subtypes were identified with a 4.1% (8 of 196) sentinel lymph node (SLN) positivity rate. Each of the histological subtypes included patients with positive SLNs, with the exception of adenoid cystic (n = 4) and secretory (n = 1) breast carcinoma, which were quite rare in our series. When compared by nodal status, the patient's age, tumor size, estrogen receptor status, lymphovascular invasion, nuclear grade, and histological grade failed to predict those with positive SLNs. CONCLUSIONS: Patients with favorable breast cancer histology have a small risk of axillary SLN metastases. The use of SLNB in these patients should be individualized, taking into consideration the small incidence of axillary metastases and the risks and benefits associated with the SLN procedure.