Timing of Breast Cancer Related Lymphedema Development Over 3 Years: Observations from a Large, Prospective Randomized Screening Trial Comparing Bioimpedance Spectroscopy (BIS) Versus Tape Measure.

BACKGROUND: The PREVENT randomized control trial monitored progression to chronic breast cancer-related lymphedema (cBCRL) following intervention for subclinical breast cancer-related lymphedema (sBCRL) assessed by bioimpedance spectroscopy (BIS) versus tape-measure (TM). This multi-institutional trial demonstrated a 92% risk reduction of developing cBCRL. This secondary analysis reviews the timing of sBCRL and cBCRL following breast cancer (BC) treatment. PATIENTS AND METHODS: Women at risk of cBCRL (n = 919) were screened regularly up to 36 months after BC treatment using either BIS or TM. Following diagnosis of sBCRL, patients underwent a 4-week compression sleeve intervention. The time in months from BC treatment to detection was reviewed at 3-month intervals. RESULTS: In total 209 patients developed sBCRL (BIS: n = 89, TM: n = 120) and were eligible for intervention. 30 progressed to cBCRL postintervention (BIS: 7, TM: 23). More than half of patients had measurements consistent with sBCRL within 9 months of BC treatment. Patients continued to have initial detections of sBCRL, regardless of screening method, with rates remaining consistent in years two and three (p > 0.242) post surgery. Additionally, 39 patients progressed to cBCRL without developing sBCRL or receiving intervention across the 3-year period. CONCLUSIONS: The timing of sBCRL detection demonstrates that patients continue to be at risk years after treatment and may continue to progress to cBCRL years after surgery. Early detection of sBCRL allows for early intervention decreasing the likelihood of progression to cBCRL. Patients should continue to be monitored for a minimum of 3 years following completion of cancer treatment. Specifically, careful targeted monitoring over the initial 9-month period is important.

Pain Control in Breast Surgery: Survey of Current Practice and Recommendations for Optimizing Management-American Society of Breast Surgeons Opioid/Pain Control Workgroup.

INTRODUCTION: The opioid epidemic in the United States is a public health crisis. Breast surgeons are obligated to provide good pain control for their patients after surgery but also must minimize administration of narcotics to prevent a surgical episode of care from becoming a patient's gateway into opioid dependence. METHODS: A survey to ascertain pain management practice patterns after breast surgery was performed. A review of currently available literature that was specific to breast surgery was performed to create recommendations regarding pain management strategies. RESULTS: A total of 609 surgeons completed the survey and demonstrated significant variations in pain management practices, specifically within regards to utilization of regional anesthesia (e.g., nerve blocks), and quantity of prescribed narcotics. There is excellent data to guide the use of local and regional anesthesia. There are, however, fewer studies to guide narcotic recommendations; thus, these recommendations were guided by prevailing practice patterns. CONCLUSIONS: Pain management practices after breast surgery have significant variation and represent an opportunity to improve patient safety and quality of care. Multimodality approaches in conjunction with standardized quantities of narcotics are recommended.

Benchmarking the American Society of Breast Surgeon Member Performance for More Than a Million Quality Measure-Patient Encounters.

BACKGROUND: Nine breast cancer quality measures (QM) were selected by the American Society of Breast Surgeons (ASBrS) for the Centers for Medicare and Medicaid Services (CMS) Quality Payment Programs (QPP) and other performance improvement programs. We report member performance. STUDY DESIGN: Surgeons entered QM data into an electronic registry. For each QM, aggregate "performance met" (PM) was reported (median, range and percentiles) and benchmarks (target goals) were calculated by CMS methodology, specifically, the Achievable Benchmark of Care™ (ABC) method. RESULTS: A total of 1,286,011 QM encounters were captured from 2011-2015. For 7 QM, first and last PM rates were as follows: (1) needle biopsy (95.8, 98.5%), (2) specimen imaging (97.9, 98.8%), (3) specimen orientation (98.5, 98.3%), (4) sentinel node use (95.1, 93.4%), (5) antibiotic selection (98.0, 99.4%), (6) antibiotic duration (99.0, 99.8%), and (7) no surgical site infection (98.8, 98.9%); all p values < 0.001 for trends. Variability and reasons for noncompliance by surgeon for each QM were identified. The CMS-calculated target goals (ABC™ benchmarks) for PM for 6 QM were 100%, suggesting that not meeting performance is a "never should occur" event. CONCLUSIONS: Surgeons self-reported a large number of specialty-specific patient-measure encounters into a registry for self-assessment and participation in QPP. Despite high levels of performance demonstrated initially in 2011 with minimal subsequent change, the ASBrS concluded "perfect" performance was not a realistic goal for QPP. Thus, after review of our normative performance data, the ASBrS recommended different benchmarks than CMS for each QM.

MACRA and the Changing Medicare Payment Landscape.

BACKGROUND: The Medicare Access and CHIP Reauthorization Act (MACRA) is being implemented in 2017 by the Centers for Medicare and Medicaid Services (CMS) as the Quality Payment Program (QPP) and will have important and far reaching effects on how physicians are reimbursed and on how they practice. The QPP modifies the Medicare physician payment system by eliminating the Sustainable Growth Rate formula and incorporating the existing Physician Quality Reporting System, EHR Incentive Program, and the Value Modifier into a single new Merit-based Incentive Payment System (MIPS). METHODS: The authors reviewed the MACRA legislation as well as the CMS resources on the QPP and other sources to summarize the regulations pertaining to the new program, particularly for the first performance period. RESULTS: CMS has taken great care to create a smooth transition for Medicare physicians. Clinicians can avoid any penalty for performance in 2017 by submitting a minimal amount of quality data, attesting to a single improvement activity, or successfully attaining the base score for the advancing care information portion of MIPS. The reduced reporting period also makes it possible for participants to begin collecting data as late as October 2nd and still achieve the full possible score in the program. CONCLUSIONS: Surgeons should be taking steps now to ensure that they are prepared to succeed in the QPP. The transition period creates a clear pathway for avoiding penalties while providing an opportunity to test one's ability to participate and improve performance.

Intraoperative Tumor Detection Using a Ratiometric Activatable Fluorescent Peptide: A First-in-Human Phase 1 Study.

BACKGROUND: Positive surgical margins remain a significant challenge in breast cancer surgery. This report describes the use of a novel, first-in-human ratiometric activatable cell-penetrating peptide in breast cancer surgery. METHODS: A two-part, multi-institutional phase 1 trial of AVB-620 with a 3+3 dose escalation and dose-expansion cohorts was conducted. The patients received an infusion of AVB-620 2-20 h before planned lumpectomy/mastectomy and sentinel node biopsy/axillary dissection. Imaging analysis was performed on images obtained from the surgical field as well as post-excision surgical specimens. Pathology reports were obtained to correlate imaging results with histopathologic data. Information on physical adverse events and laboratory abnormalities were recorded. RESULTS: A total of 27 patients received infusion of AVB-620 and underwent surgical excision of breast cancer. The findings showed no adverse events or laboratory values attributable to infusion of AVB-620. The 8-mg dose was selected from the dose-escalation cohort for use with the expansion cohort based on imaging data. Region-of-interest (ROI) imaging analysis from the 8-mg cohort demonstrated measurable changes between pathology confirmed tumor-positive and tumor-negative tissue. CONCLUSION: Intraoperative imaging of surgical specimens after infusion with AVB-620 allowed for real-time tumor detection. Infusion of AVB-620 is safe and may improve intraoperative detection of malignant tissue during breast cancer operations.

Measures of Appropriateness and Value for Breast Surgeons and Their Patients: The American Society of Breast Surgeons Choosing Wisely (®) Initiative.

BACKGROUND: Current breast cancer care is based on high-level evidence from randomized, controlled trials. Despite these data, there continues to be variability of breast cancer care, including overutilization of some tests and operations. To reduce overutilization, the American Board of Internal Medicine Choosing Wisely (®) Campaign recommends that professional organizations provide patients and providers with a list of care practices that may not be necessary. Shared decision making regarding these services is encouraged. METHODS: The Patient Safety and Quality Committee of the American Society of Breast Surgeons (ASBrS) solicited candidate measures for the Choosing Wisely (®) Campaign. The resulting list of "appropriateness" measures of care was ranked by a modified Delphi appropriateness methodology. The highest-ranked measures were submitted to and later approved by the ASBrS Board of Directors. They are listed below. RESULTS: (1) Don't routinely order breast magnetic resonance imaging in new breast cancer patients. (2) Don't routinely excise all the lymph nodes beneath the arm in patients having lumpectomy for breast cancer. (3) Don't routinely order specialized tumor gene testing in all new breast cancer patients. (4) Don't routinely reoperate on patients with invasive cancer if the cancer is close to the edge of the excised lumpectomy tissue. (5) Don't routinely perform a double mastectomy in patients who have a single breast with cancer. CONCLUSIONS: The ASBrS list for the Choosing Wisely (®) campaign is easily accessible to breast cancer patients online. These measures provide surgeons and their patients with a starting point for shared decision making regarding potentially unnecessary testing and operations.

Prevention and management of lymphedema after breast cancer treatment.

Lymphedema of the arm after breast cancer treatment continues to challenge clinicians worldwide. In this review, we examine the main modalities, both nonsurgical and surgical, to prevent and treat this as yet incurable condition.

Incidence of inflammatory breast cancer in women, 1992-2009, United States.

BACKGROUND: The annual incidence of inflammatory breast cancer (IBC) in the United States reportedly increased during the last quarter of the twentieth century. We investigated whether that increase has continued into the twenty-first century. METHODS: We queried the Surveillance Epidemiology and End Results database for all cases of IBC in women age 20 and older between 1992 and 2009. Cases were breast tumors with at least one of the following codes: extent of disease size 998, extension 70, or ICD-3-O morphology 8530 or 8533. Age-adjusted incidence was also examined. RESULTS: During 1992-2009, the annual incidence of IBC did not increase over time in any age group, nor did it vary significantly from year to year, except between 2003 and 2004, when there was a jump from 1.6 (95 % confidence interval 1.4-1.8) to 3.1 (2.8-3.4) cases per 100,000 women. Similar changes occurred in all age and racial groups before gradually returning to prejump levels. Overall, the incidence of IBC rose steeply with age until reaching a plateau at age 65. The incidence was greatest among black women (3.0; 2.8-3.2), intermediate among white women (2.1; 2.1-2.2), and lowest among Asian women (1.4; 1.3-1.6). CONCLUSIONS: The incidence of IBC has remained essentially stable for nearly two decades. A transient jump in 2003-2004 occurred in all age and racial groups, suggesting adjustment to coding changes at that time. Often described as a disease of younger women, IBC in fact disproportionately affects older women. Racial/ethnic variation in the incidence of IBC suggests that dietary, lifestyle, or genetic factors contribute to its pathogenesis.

Tumor response ratio predicts overall survival in breast cancer patients treated with neoadjuvant chemotherapy.

BACKGROUND: Neoadjuvant chemotherapy (NAC) is commonly used to treat locally advanced breast cancer. Pathologic complete response (pCR) predicts improved overall survival (OS); however, prognosis of patients with partial response remains unclear. We evaluated whether tumor response ratio (TRR) is a better predictor of OS than current staging methods. METHODS: Using the National Comprehensive Cancer Network Breast Cancer Outcomes Database, we identified patients with stage I-III breast cancer who had NAC and pretreatment imaging at City of Hope (1997-2010). Patient demographics, tumor characteristics, and OS were analyzed. TRR was calculated as residual in-breast disease divided by size on pre-NAC imaging. Four TRR groups were stratified; TRR 0 (pCR), TRR > 0-0.4 (strong partial response, SPR), TRR > 0.4-1.0 (weak partial response, WPR), or TRR > 1.0 (tumor growth, TG). OS was estimated by the Kaplan-Meier method and tested by the log-rank test. Cox regression was performed to evaluate associations between OS and TRR in a multivariable analysis while controlling for potential confounders. RESULTS: There were 218 eligible patients identified; 59 (27 %) had pCR, 61 (28 %) SPR, 72 (33 %) WPR, and 26 (12 %) TG. Five-year OS decreased continuously with increasing TRR:pCR (90 %), SPR (79 %), WPR (66 %), and TG (60 %). TRR was the only measure that significantly predicted OS (p = 0.0035); pathologic stage (p = 0.23) and pre-NAC clinical tumor stage (cT) (p = 0.87) were not significant. TRR continued to be statistically significant by multivariable analysis (p = 0.016). CONCLUSIONS: TRR takes into account both pretreatment and residual disease and more accurately predicts OS than pathologic stage and pre-NAC cT. TRR may be useful to more accurately assess prognosis and OS in breast cancer patients undergoing NAC.

Short-term outcomes of screening mammography using computer-aided detection: a population-based study of medicare enrollees.

BACKGROUND: Computer-aided detection (CAD) has rapidly diffused into screening mammography practice despite limited and conflicting data on its clinical effect. OBJECTIVE: To determine associations between CAD use during screening mammography and the incidence of ductal carcinoma in situ (DCIS) and invasive breast cancer, invasive cancer stage, and diagnostic testing. DESIGN: Retrospective cohort study. SETTING: Medicare program. PARTICIPANTS: Women aged 67 to 89 years having screening mammography between 2001 and 2006 in U.S. SEER (Surveillance, Epidemiology and End Results) regions (409 459 mammograms from 163 099 women). MEASUREMENTS: Incident DCIS and invasive breast cancer within 1 year after mammography, invasive cancer stage, and diagnostic testing within 90 days after screening among women without breast cancer. RESULTS: From 2001 to 2006, CAD prevalence increased from 3.6% to 60.5%. Use of CAD was associated with greater DCIS incidence (adjusted odds ratio [OR], 1.17 [95% CI, 1.11 to 1.23]) but no difference in invasive breast cancer incidence (adjusted OR, 1.00 [CI, 0.97 to 1.03]). Among women with invasive cancer, CAD was associated with greater likelihood of stage I to II versus III to IV cancer (adjusted OR, 1.27 [CI, 1.14 to 1.41]). In women without breast cancer, CAD was associated with increased odds of diagnostic mammography (adjusted OR, 1.28 [CI, 1.27 to 1.29]), breast ultrasonography (adjusted OR, 1.07 [CI, 1.06 to 1.09]), and breast biopsy (adjusted OR, 1.10 [CI, 1.08 to 1.12]). LIMITATION: Short follow-up for cancer stage, potential unmeasured confounding, and uncertain generalizability to younger women. CONCLUSION: Use of CAD during screening mammography among Medicare enrollees is associated with increased DCIS incidence, the diagnosis of invasive breast cancer at earlier stages, and increased diagnostic testing among women without breast cancer. PRIMARY FUNDING SOURCE: Center for Healthcare Policy and Research, University of California, Davis.

Utilization of mastectomy and reconstruction in the outpatient setting.

BACKGROUND: Reconstruction rates after mastectomy have been reported to range from 25-40%; however, most studies have focused on patients treated in an inpatient setting. We sought to determine the utilization of outpatient mastectomy and use of breast reconstruction in Southern California. METHODS: Postmastectomy reconstruction rates were determined from the California Office of Statewide Health Planning and Development database from 2006-2009 using CPT codes and similarly from an inpatient database using ICD-9 codes. Reconstruction rates were compared between the inpatient and outpatient setting. For the outpatient setting, univariate and multivariate odds ratios with 95% confidence intervals were estimated for relative odds of immediate reconstruction versus mastectomy alone. RESULTS: The percentage of patients undergoing outpatient mastectomy ranged from 20.4 to 23.9% of the total number of all patients undergoing mastectomy. Whereas immediate inpatient reconstruction increased from 29.2 to 41.6% (overall rate 35.5%), the proportion of outpatients undergoing reconstruction only increased from 7.7 to 10.3% (overall rate 9.1%). Similar to the inpatient setting, in multivariate analysis, age, insurance status, race/ethnicity, and type of hospital were significantly associated with the use of reconstruction in the outpatient setting. CONCLUSIONS: A substantial number of patients undergo outpatient mastectomy with low rates of reconstruction. Although the choice of an outpatient mastectomy may certainly represent a selection bias for those not choosing reconstruction, an increase in the use of outpatient mastectomy may result in decreases in the use of postmastectomy reconstruction.

Trends in radiotherapy after breast-conserving surgery in elderly patients with early-stage breast cancer.

BACKGROUND: The benefit of adjuvant radiotherapy (RT) in elderly breast cancer patients is debatable. The purpose of this study was to evaluate trends in RT rates after breast-conserving surgery. METHODS: Breast cancer patients ≥70 years treated from 2000 to 2009 were identified using the Surveillance, Epidemiology, and End Results (SEER) database. Patients were estrogen receptor positive with negative or unknown lymph node status. Trends in RT recommendation over years were evaluated with the Jonckheere-Terpstra test. Multiple logistic regression and Cox proportional hazard tests were used to determine factors associated with radiation recommendation and survival. RESULTS: Of 46,581 patients, 31,989 (68.7 %) were recommended RT and 14,592 (31.3 %) were not. The recommendation for RT decreased from 70.3 % in 2000 to 67.4 % in 2009 (p < 0.0001). Seven of 18 registries exhibited decreased radiation recommendation rates, and 4 of 18 exhibited an increase. Recommendation of RT was associated with earlier year of diagnosis, younger age, Asian/Pacific Islander race, and negative lymph nodes. Predictors of worse survival were no radiation [hazard ratio (HR) 1.68, 95 % confidence interval (CI) 1.61-1.75], no nodes examined (HR 1.83, 95 % CI 1.75-1.91), large (>2-5 cm) tumor size (HR 2.02, 95 % CI 1.86-2.19), older age (80+, HR 2.38, 95 % CI 2.25-2.53), and black race (HR 1.13, 95 % CI1.03-1.23). CONCLUSIONS: Rates of radiation recommendation in the elderly have been steadily decreasing without appreciable acceleration in this decline. This trend was not consistent across all registries. Continued research is necessary to assess differences in clinical practice and its impact on patient outcomes.

Hidradenocarcinoma of the finger.

Hidradenocarcinoma is a rare adnexal neoplasm representing the malignant counterpart of hidradenoma derived from eccrine sweat glands. Misdiagnosis of this disease is common due to the wide variety of histological patterns and rarity of this malignancy. We report an 87-year-old man presenting with a rare case of biopsy-proven hidradenocarcinoma of the finger. There is no standard care of treatment of hidradenocarcinoma, especially of those tumors in rare locations such as the fingers, given its rarity, variable tumor behavior and histology. Although limited treatment strategies exist, detailed data including TNM, location, histologic type and grade, and patient age should be gathered for optimal treatment strategy. The literature supports a 3-fold approach to these malignancies involving margin-free resection, sentinel lymph node biopsy to evaluate possible metastasis, and long-term follow-up given high risk of recurrence. Our treatment strategy involved a 4-fold, multidisciplinary approach involving reconstruction to optimize tumor-free remission and hand function.

Impact of measuring quantification of blood loss versus estimation of blood loss during cesarean deliveries.

OBJECTIVE: Our objective was to determine whether there is a numerical difference between quantitative blood loss (QBL) versus visual estimation of blood loss (EBL) during cesarean delivery (CD), and whether initiation of QBL leads to increased recognition and intervention for postpartum hemorrhage. METHODS: A retrospective review was conducted of 250 patients undergoing CD with only EBL documented and 250 patients undergoing CD with both EBL and QBL documented at Montefiore Medical Center between October 2017 and November 2018. Since May 2018, the protocol for all CD included documentation of EBL and QBL. RESULTS: Average EBL when documented alone (897.0 ml ± 301.0 ml) trended lower than average EBL when documented with QBL (940.0 ml ± 371.0 ml, P = 0.161). For CD with both blood loss documented, average EBL (940.0 ml ± 371.0 ml) was significantly lower than average QBL (1065.3 ml ± 649.8 ml, P = 0.0001). CD with both blood loss documented had a greater number of blood transfusions (24 CD, 9.6%) versus only EBL documented (14 CD, 5.6%) (P = 0.125). CONCLUSION: The use of QBL may function in the algorithm to determine up-front resuscitative intervention to improve maternal outcomes and merits further study.

Do radiation use disparities influence survival in patients with advanced breast cancer?

BACKGROUND: The authors previously identified racial/ethnic disparities in the use of radiation therapy (RT) in patients with advanced breast cancer (BC). They hypothesized that disparities in the use of RT were associated with survival differences favoring white patients. METHODS: The authors used the Surveillance, Epidemiology, and End Results database to identify white, black, Hispanic, and Asian patients with BC associated with ≥ 10 metastatic lymph nodes diagnosed between 1988 and 2005. Multivariate analyses of overall survival (OS) and disease-specific survival (DSS) assessed age, sex, race, tumor size, histology, estrogen receptor status, progesterone receptor status, RT, and type of surgery. The authors further stratified for use of RT and type of surgery. Risk of mortality was reported as hazard ratios (HRs) with 95% confidence intervals (CIs). RESULTS: Of 15,895 patients with advanced BC, 12,653 met entry criteria. On multivariate analysis, RT was associated with a decreased risk of all-cause (HR, 0.78; 95% CI 0.74-0.83; P < .001) and disease-specific (HR, 0.81; 95% CI, 0.76-0.86; P < .001) mortality; black race was associated with an increased risk of all-cause (HR, 1.54; 95% CI, 1.42-1.68; P < .001) and disease-specific (HR, 1.53; 95% CI, 1.39-1.68; P < .001) mortality. After stratifying by type of surgery and use of RT, blacks demonstrated poorer survival than their white counterparts, regardless of surgery type or receipt of RT. CONCLUSIONS: Only black patients had poorer OS and DSS relative to whites. When stratified by type of surgery and use of RT, blacks continued to demonstrate poorer survival. This survival disparity is unlikely to be because of lack of RT.

Influence of specialty and clinical experience on treatment sequencing in the multimodal management of soft tissue extremity sarcoma.

PURPOSE: Although multimodal management of extremity soft tissue sarcoma (STS) is the standard of care, considerable variation exists in the sequencing of radiotherapy (RT) or chemotherapy (CT). Our goal was to identify factors responsible for this variation. METHODS: Members of specialty societies with an interest in STS were emailed a questionnaire about multimodal treatment of STS. Survey responses were scored on a 5-point Likert scale (1 = always preoperative and 5 = always postoperative) and analyzed by specialty, years in practice, and percentage of practice consisting of STS. RESULTS: The questionnaire was completed by 320 (65%) of 490 physicians, including medical oncologists (18%), radiation oncologists (8%), orthopedic oncologists (22%), surgical oncologists (45%), and others (7%). Respondents were evenly split on the use of neoadjuvant RT (mean 3.03 ± 0.06) and showed a slight preference for neoadjuvant CT (2.89 ± 0.06). Radiation oncologists (2.52 ± 0.18), physicians with a >75% STS practice (2.58 ± 0.17), and those in practice <5 years (2.79 ± 0.12) preferred neoadjuvant RT. Neoadjuvant CT was preferred by orthopedic oncologists (2.62 ± 0.12) and physicians with >75% STS practice (2.51 ± 0.16). Factors influencing the choice for neoadjuvant RT were well-defined treatment volume, increased acute morbidity, and decreased late morbidity, while for CT, they were in-situ disease monitoring and early treatment of micrometastases. CONCLUSIONS: Treatment sequencing in STS is influenced by specialty and clinical experience, with no clear consensus. These patterns may reflect the recent trend toward regionalization of STS care.

Lymph node ratio as a quality and prognostic indicator in stage III colon cancer.

BACKGROUND: The presence and number of nodal metastasis significantly impact colon cancer prognosis. Similarly, the number of resected/evaluated nodes impacts staging accuracy. This ratio of metastatic to examined nodes or lymph node ratio (LNR) may have independent prognostic value in colon carcinoma. PURPOSE: : To evaluate the impact of LNR on overall survival in colon cancer patients with fewer than 12 or 12 examined nodes or more. METHODS: Patients (n = 36,712) with node-positive nonmetastatic colon cancer diagnosed between 1992 and 2004 were identified from the Surveillance, Epidemiology, and End Results database and stratified according to LNR and number of nodes examined. Survival was estimated by Kaplan-Meier method, and differences analyzed by log-rank test. A Cox proportional hazards model was used for multivariate analysis. RESULTS: Patients with fewer than 12 nodes were older and male and had lower primary tumor stage, grade, and N stage (P < 0.01). Survival appeared greater with 12 total nodes examined or more (median 53 vs. 66 months, P < 0.001). Within each LNR stratum, survival with 12 nodes or more was improved for those with less than 10% of nodes positive for cancer, but was worse with higher LNRs (P < 0.01). Lymph node ratio was significantly associated with survival independent of total nodes (HR 1.24-5.12, P < 0.001). Other significant factors included age, race, tumor grade, stage, location, and N stage. CONCLUSION: Metastatic LNR independently estimates survival in Stage III colon cancer, irrespective of number of nodes examined. However, statistically significant differences in each LNR stratum between those with resection of fewer than 12 or 12 nodes or more would indicate that a 12-node minimum may still be necessary for accurate staging.