Lack of Racial Diversity in Surgery and Pathology Textbooks Depicting Diseases of the Breast.

INTRODUCTION: The lack of racial diversity depicted in medical education texts may contribute to an implicit racial bias among clinicians. This bias influences outcomes, as familiarity with the various cutaneous manifestations of disease is essential to making an accurate diagnosis. To better understand the racial disparities in breast surgery, we sought to determine the extent of skin tone representation depicted in images of breast surgery and pathology textbooks. METHODS: Textbooks were screened for color images of conditions with sufficient skin tissue present to assign the Fitzpatrick skin phototype (FSP). Figures were independently assigned an FP score (range: 1-6), and subdivided into "light skin" (FP 1-3) and "dark skin" (FP 4-6). Number of figures in each category and percentage of patients with each skin tone were calculated. RESULTS: 557 figures were included. Among 12 textbooks reviewed, seven textbooks were from the discipline of surgery, while five were pathology-related. Textbook year of publication spanned from 1996 to 2018. Overall, 533 (95.7%) figures depicted patients with light skin color versus 24 (4.3%) with dark skin color. There was no association between FP score and year of textbook publication (P = 0.69). CONCLUSIONS: Patient images in breast textbooks are overwhelmingly of light skin tones, excluding patients with darker skin tones. The dearth of images depicting dark skinned individuals did not improve over time. Inclusion of patients of color in future textbooks may help reduce racial disparities within breast cancer care.

The natural history of untreated estrogen receptor-positive, Her2-negative invasive breast cancer.

BACKGROUND: Using prior mammograms from patients with delays in their breast cancer diagnoses, we sought to describe in-vivo growth kinetics of untreated breast cancer to determine if the time they became clinically apparent can be predicted. METHODS: Patient and tumor characteristics were collected from those who presented with "missed," untreated breast cancer to a breast center in a single institution. Only patients whose biopsied masses revealed estrogen receptor-positive, Her2-negative (ER+/Her2-) invasive cancers were included. Two attending radiologists reviewed images from prior mammograms. Rates of change in volume were calculated in mm3/day, and a logarithmic equation was used to calculate tumor volume doubling time (TVDT). A Spearman's Rho correlation was performed for the continuous variables, and the Mann-Whitney U and Kruskal-Wallis tests were used to compare categorical data. A p value < 0.05 was considered statistically significant. Logistic regression was performed to determine if patient or tumor characteristics were correlated to tumor growth velocity. RESULTS: Of the 36 ER+/Her2- invasive breast cancers included in the analysis, 13 (36%) were at least cT2 (of TNM), 7 (19%) were grade 3, and 7 (19%) were node positive at diagnosis. Grade (p = 0.043) and pathologic invasive tumor size (p = 0.001) were positively correlated to tumor growth velocity. Median TVDT was 385 days (23-1897). Age, nodal positivity, Oncotype Dx® Recurrence Score, time of diagnostic delay, and spheroid-ellipsoid discrepancy (SED) were not related to tumor growth velocity in this sample. CONCLUSION: In this cohort of patients with untreated ER+/Her2- invasive breast cancers, grade and pathologic tumor size were found to be positively correlated to growth velocity. The growth rates in a homogeneous group of tumors varied widely and could not be predicted. One possible explanation for this finding is that other difficult-to-measure biologic factors such as tumor microenvironment may play a greater role in tumor progression than traditional clinicopathologic characteristics.

Obese Patients Who Receive an Opioid-Sparing Enhanced Recovery After Surgery (ERAS) Protocol are at Increased Risk of Persistent Pain After Breast Surgery.

BACKGROUND: Obese patients are at increased risk of persistent pain and chronic opioid dependence after surgery. We sought to evaluate the impact of an Enhanced Recovery After Surgery (ERAS) protocol in breast surgery patients to determine whether multimodal analgesia was effective for both obese and non-obese patients. METHODS: A prospective cohort of patients undergoing breast surgery who received an opioid-sparing ERAS protocol was compared with patients who did not receive ERAS, including a historical cohort. Pain scores were compared with respect to body mass index (BMI). Obesity was defined as BMI ≥ 30, and moderate to severe pain was defined as 4-10 of a 10-point scale. Postoperative day one and week one pain scores were compared using the Kruskal-Wallis test. RESULTS: A combined contemporary and historical cohort of 1353 patients underwent lumpectomy and mastectomy without reconstruction. The present analysis comprises 622 patients with pain scores who did and did not receive ERAS between 2015 and 2018. The two groups were demographically similar. The day after surgery, those who received ERAS reported lower rates of moderate to severe pain, regardless of BMI (obese: 46.3% vs. 21.8%, p < 0.001; non-obese: 36.3% vs. 19.4%, p = 0.002). One week after surgery, obese patients who received ERAS had higher rates of persistent pain compared with non-obese patients (18.6% vs. 11.1%, p = 0.042). CONCLUSIONS: An opioid-sparing ERAS protocol utilizing multimodal analgesia significantly improved postoperative pain control for obese and non-obese patients. However, it appears that obese patients are still at relatively greater risk for persistent pain after surgery.

Leveraging the variable natural history of ductal carcinoma in situ (DCIS) to select optimal therapy.

PURPOSE: Ductal carcinoma in situ (DCIS) is a non-obligate precursor to invasive ductal carcinoma. The authors sought to discuss the evidence suggesting that not all DCIS will progress to invasive disease if left untreated. RESULTS: Four lines of evidence align to suggest that not all of this in-situ disease progresses to invasive cancer: its prevalence on screening mammography, studies of missed diagnoses, incidental findings in autopsy specimens, and large retrospective reviews of those treated with excision alone. CONCLUSION: A clearer understanding of the variable history of DCIS coupled with advances in genomic profiling of the disease holds the promise of reducing widespread over-treatment of this non-invasive cancer. Additionally, identification of higher risk of recurrence subsets may select patients for whom more aggressive treatment may be appropriate.

A pilot study of a breast surgery Enhanced Recovery After Surgery (ERAS) protocol to eliminate narcotic prescription at discharge.

BACKGROUND: The evolving conceptualization of the management of surgical pain was a major contributor to the supply of narcotics that led to the opioid crisis. We designed and implemented a breast surgery-specific Enhanced Recovery After Surgery (ERAS) protocol using opioid-sparing techniques to eliminate narcotic prescription at discharge without sacrificing perioperative pain control. METHODS: A pilot observational study included patients with and without cancer undergoing lumpectomy. The convenience sample consisted of an ERAS group and a control usual care (UC) group who underwent surgery during the same time period. Discharge narcotic prescriptions were compared after converting to oral morphine milligram equivalents (MME's). Postoperative day one and week one pain scores were also compared between the two groups. RESULTS: Ninety ERAS and 67 UC patients were enrolled. Most lumpectomies were wire-localized, and half of the patients in each group had breast cancer. There were more obese patients in the ERAS group. UC lumpectomy patients were discharged with a median of 54.5 MMEs (range 0-120), while the ERAS lumpectomy patients were discharged with none (p < 0.001). Postoperative pain scores were not significantly different between groups, and there were few complications. CONCLUSION: A breast surgery-specific ERAS protocol employing opioid-sparing techniques successfully eliminated postoperative narcotic prescription without sacrificing perioperative pain control or increasing postoperative complications. By promoting the adoption of similar protocols, surgeons can continue to improve patient outcomes while decreasing the quantity of narcotics available for diversion within our patients' communities.

Rapid Adoption of an Interdisciplinary Care Team Model for Surgical Residents Managing Coronavirus Disease-19.

Introduction: Patients infected with SARS-Cov-2, the causative virus behind the coronavirus disease-19 (COVID-19) pandemic, have been increasing rapidly in New York City. New York City has the highest incidence in the United States and fully 45% of all deaths from COVID-19. Our medical center is located within a high-density region of cases in south Brooklyn and, in fact, three of our neighborhood zip codes are in the top seven in New York in incidence. As a result, our center has experienced a dramatic increase in hospitalizations, particularly respiratory distress secondary to COVID-19, which rapidly exceeded the capacity of our internal medicine service. This necessitated the formation of new COVID-19 units throughout the hospital, replacing all former service lines. These units employed management teams composed of residents from many medical and surgical disciplines, including general surgery residents. Methods: Our general surgery residency program established a surgical COVID-19 (SCOVID) management team. Initially, 4 surgical residents (2 senior and 2 junior), 1 attending surgeon, and 1 attending internal medicine physician were allocated to the initial SCOVID team. On day 3 of implementation, to achieve more rapid competence in the complex management of these patients, a senior medicine resident with direct experience in the care of COVID-19 patients was added in an advisory capacity. Results: The addition of an experienced senior medical resident and attending allowed for the quick adoption of uniform management protocols by surgical residents and attendings. Discussion: We describe a protocol for the establishment of COVID-19 management teams staffed with general surgical residents, as well as a strategy for the achievement of rapid increases in competency. The addition of a senior internal medicine resident and attending to our SCOVID team allowed for rapid achievement of competency in the care of COVID-19 patients in our large institution at the epicenter of the COVID-19 pandemic.

Larvae of Musca domestica (common house fly) found intraoperatively in a male breast abscess.

A 62-year-old male with type 2 diabetes mellitus presented to our nationally accredited breast center with bilateral breast masses present for 7 years and new-onset pink nipple discharge for several months. Mammography and ultrasound demonstrated a left 2.7 retroareolar cystic lesion and a right 2.1 cm retroareolar solid lesion. Given the suspicious nature of the bilateral breast discharge, core needle biopsies were performed to rule out underlying malignancy. The biopsies revealed benign results, but the discordance between the biopsy, imaging, and suspicious discharge led to the decision to perform bilateral excisional biopsies. Intraoperatively, a small organism resembling a larva was encountered. The abnormal tissue was sent for histopathological examination, along with the organism, which was identified as the larvae of Musca domestica, or common house fly.

A Review of Pregnancy-Associated Breast Cancer: Diagnosis, Local and Systemic Treatment, and Prognosis.

The incidence of pregnancy-associated breast cancer (PABC) increases as more women choose to delay childbearing and the population-based incidence of breast cancer rises. Reliably and safely staging PABC is necessary to choose between starting with local or systemic therapy. With regard to local therapy, both lumpectomy and mastectomy can be considered depending on gestational age and the stage at diagnosis. By mirroring nonpregnant treatment regimens as much as possible, chemotherapy may improve long-term oncologic outcomes while allowing for surgical downstaging during pregnancy. Delaying treatment due to misconceptions regarding risk of local and systemic therapy most certainly worsens oncologic outcomes, and most neonatal morbidity is related to gestational age at delivery and not in utero exposures. Pregnancy itself was once considered an independent risk factor for worse outcome, but the prognosis of these patients is not significantly different than nonpregnant counterparts of a similar age.

Mastectomy is no longer an indication for postoperative opioid prescription at discharge.

BACKGROUND: A 10-step protocol employing multimodal analgesia was implemented in patients undergoing mastectomy to decrease the quantity of opioids prescribed at discharge. METHODS: Patients who received the Enhanced Recovery After Surgery (ERAS) protocol were compared to a control group. Inpatient and discharge prescription of opioids were compared using oral morphine equivalents (OMEs), along with postoperative pain scores. RESULTS: Between 2017 and 2018, fifty-seven patients were eligible for inclusion: 20 patients received ERAS and 37 received usual care (UC). The ERAS group received a mean of 2.4 (0-13) inpatient OMEs and the UC group received 13.7 (0-80) (p = 0.002). The ERAS group received 2.0 (0-40) OMEs at discharge and the UC group received 59.8 (0-120) (p < 0.001). Postoperative pain scores were significantly lower in the patients who received the ERAS protocol. CONCLUSIONS: Patients who received the ERAS protocol required less postoperative opioids and reported lower pain scores when compared to a control group.

MRI screening in a clinic population with a family history of breast cancer.

BACKGROUND: Breast MRI is increasingly being used in patients at increased risk for breast cancer; however, guidelines for MRI screening are inadequately defined. We describe our experience with MRI screening in a large population of women with a family history of breast cancer. METHODS: We retrospectively reviewed the Memorial Sloan-Kettering breast cancer surveillance program prospective database from April 1999 to July 2006. Patients with a family history of breast cancer and at least 1 year follow-up were identified. All patients were offered biannual clinical breast examination (CBE) and annual mammography (MMG). MRI screening was performed at the discretion of the physician and patient. RESULTS: Family history profiles revealed 1,019 eligible patients; median follow-up was 5.0 years. MRI screening was performed in 374 (37%) patients resulting in a total of 976 MRIs during the study period. Cancer was detected in 9/374 patients (2%) undergoing MRI screening. Seven cancers were detected by MRI only, for a cancer detection rate of 0.7% (7/976) for screening MRI. When stratified by family risk profile, the positive predictive value (PPV) of MRI was higher (13%) in those patients with the strongest family histories and lower (6%) in patients with less significant family histories. CONCLUSIONS: MRI screening can be a useful adjunct to CBE and MMG in patients with high-risk family histories of breast cancer, yet it has low yield in patients with lower-risk family histories. These data suggest that MRI screening should be reserved for those at highest risk.

Analysis of genetic variation in Ashkenazi Jews by high density SNP genotyping.

BACKGROUND: Genetic isolates such as the Ashkenazi Jews (AJ) potentially offer advantages in mapping novel loci in whole genome disease association studies. To analyze patterns of genetic variation in AJ, genotypes of 101 healthy individuals were determined using the Affymetrix EAv3 500 K SNP array and compared to 60 CEPH-derived HapMap (CEU) individuals. 435,632 SNPs overlapped and met annotation criteria in the two groups. RESULTS: A small but significant global difference in allele frequencies between AJ and CEU was demonstrated by a mean FST of 0.009 (P < 0.001); large regions that differed were found on chromosomes 2 and 6. Haplotype blocks inferred from pairwise linkage disequilibrium (LD) statistics (Haploview) as well as by expectation-maximization haplotype phase inference (HAP) showed a greater number of haplotype blocks in AJ compared to CEU by Haploview (50,397 vs. 44,169) or by HAP (59,269 vs. 54,457). Average haplotype blocks were smaller in AJ compared to CEU (e.g., 36.8 kb vs. 40.5 kb HAP). Analysis of global patterns of local LD decay for closely-spaced SNPs in CEU demonstrated more LD, while for SNPs further apart, LD was slightly greater in the AJ. A likelihood ratio approach showed that runs of homozygous SNPs were approximately 20% longer in AJ. A principal components analysis was sufficient to completely resolve the CEU from the AJ. CONCLUSION: LD in the AJ versus was lower than expected by some measures and higher by others. Any putative advantage in whole genome association mapping using the AJ population will be highly dependent on regional LD structure.

Risk-reducing salpingo-oophorectomy in women with a BRCA1 or BRCA2 mutation.

BACKGROUND: Risk-reducing salpingo-oophorectomy is often considered by carriers of BRCA mutations who have completed childbearing. However, there are limited data supporting the efficacy of this approach. We prospectively compared the effect of risk-reducing salpingo-oophorectomy with that of surveillance for ovarian cancer on the incidence of subsequent breast cancer and BRCA-related gynecologic cancers in women with BRCA mutations. METHODS: All women with BRCA1 or BRCA2 mutations identified during a six-year period were offered enrollment in a prospective follow-up study. A total of 170 women 35 years of age or older who had not undergone bilateral oophorectomy chose to undergo either surveillance for ovarian cancer or risk-reducing salpingo-oophorectomy. Follow-up involved an annual questionnaire, telephone contact, and reviews of medical records. The time to cancer in the two groups was compared by Kaplan-Meier analysis and a Cox proportional-hazards model. RESULTS: During a mean follow-up of 24.2 months, breast cancer was diagnosed in 3 of the 98 women who chose risk-reducing salpingo-oophorectomy and peritoneal cancer was diagnosed in 1 woman in this group. Among the 72 women who chose surveillance, breast cancer was diagnosed in 8, ovarian cancer in 4, and peritoneal cancer in 1. The time to breast cancer or BRCA-related gynecologic cancer was longer in the salpingo-oophorectomy group, with a hazard ratio for subsequent breast cancer or BRCA-related gynecologic cancer of 0.25 (95 percent confidence interval, 0.08 to 0.74). CONCLUSIONS: Salpingo-oophorectomy in carriers of BRCA mutations can decrease the risk of breast cancer and BRCA-related gynecologic cancer.

The predictive value of ductography and magnetic resonance imaging in the management of nipple discharge.

BACKGROUND: Standard evaluation (physical examination, mammography, sonography) often fails to identify an underlying lesion in patients with suspicious nipple discharge. The aim of this study was to determine the predictive value of ductography (DG) and magnetic resonance imaging (MRI) in this setting. METHODS: Using ICD-9 codes, we retrospectively identified 376 patients who presented with suspicious nipple discharge (ND) (1995-2005); 306 patients (68%) had negative standard evaluation. RESULTS: Among 306 patients, 186 (61%) underwent further evaluation with DG (n = 163) and/or MRI (n = 52), 35 (11%) underwent major duct excision alone (MDE), and 85 (28%) were followed clinically. Ultimately, 182/306 (59%) patients underwent surgery and/or biopsy. Overall incidence of malignant or high-risk pathology was 15% (46/306). DG was completed in 139/163 (85%) studies and detected 12 cancers and seven high-risk lesions (HRL), but failed to identify four cancers and 2 HRL (PPV 19%, NPV 63%). MRI detected seven cancers and three HRL, but failed to identify one cancer and one HRL (PPV 56%, NPV 87%). MDE alone (n = 35) detected five cancers and three HRL. Of all patients not having surgery, (142/306, 41%), one (0.01%) presented with an invasive cancer at 102 months (median follow-up, 6.3 months; range, 0-124 months). CONCLUSIONS: An underlying malignancy was identified in 30/306 (10%) patients with ND and negative standard evaluation. Ductography is a poor predictor of underlying pathology and cannot exclude malignancy. MRI's higher predictive values may allow for improved patient selection and treatment planning; however, MRI should not replace MDE as the gold standard to exclude malignancy in patients with ND and negative standard evaluation.

Perpendicular inked versus tangential shaved margins in breast-conserving surgery: does the method matter?

BACKGROUND: In breast-conserving surgery (BCS), the method of margin assessment and the definition of a negative margin vary widely. The purpose of this study was to compare the incidence of positive margins and rates of reexcision between two methods of margin assessment at a single institution. STUDY DESIGN: In July 2004, our protocol for margin evaluation changed from perpendicular inked margins (Group A, n=263) to tangential shaved margins (Group B, n=261). In Group A, margins were classified as positive, close, and negative. Margins designated as "close" were further defined as: < or = 1 mm, < or = 2 mm, and < or =3 mm. In Group B, shaved margins (by definition 2 to 3 mm) were reported as positive or negative. RESULTS: The rate of reported "positive" margins was significantly higher in Group B: 127 of 261 (49%) versus 42 of 263 (16%), p < 0.001. But when patients with "positive, close, or both" kinds of margins were combined in Group A, there was no significant difference between the two techniques. Although the shaved margin was 2- to 3-mm thick, the rate of reexcision in Group B was significantly higher when compared with that in patients with "positive, close, or both" < or =3 mm margins in Group A (75% versus 52%, p < 0.001). The likelihood of finding residual disease remained the same (27% versus 32%, p=NS). CONCLUSIONS: The tangential shaved-margin technique results in a higher proportion of reported positive margins and limits the ability of the surgeon to discriminate among patients with close margins, resulting in a higher rate of reexcision. The fact that many, but not all, patients with positive or close margins in both groups underwent reexcision emphasizes the role of surgical judgment in this setting. Longer followup is required to determine equivalency in rates of local recurrence between these two methods of margin assessment.

Nipple-sparing mastectomy for breast cancer and risk reduction: oncologic or technical problem?

BACKGROUND: We evaluated the risks and benefits of nipple-sparing mastectomy in a multiinstitutional experience in the settings of risk-reducing surgery and breast cancer treatment. STUDY DESIGN: We analyzed data on 123 patients who had undergone nipple-sparing mastectomy with breast reconstruction for prophylaxis (n=55), treatment of breast cancer (n=41), or both (n=27) at four large centers. RESULTS: Median patient age was 45 years (range 22 to 70 years). There were 192 procedures (69 bilateral, 54 unilateral). Forty-four patients had invasive cancer; 20 had ductal carcinoma in situ (DCIS); 4 had phyllodes tumor. In all of these patients, the nipple tissue was cancer free on pathologic review. Median followup was 24.6 months (range 2.0 to 570.4 months). Local recurrence developed in two patients: one had DCIS in the upper-outer quadrant, with 71.8 months of followup; the other's cancer was invasive, in the upper-outer quadrant, with 6 months of followup. Distant metastasis developed in a third patient, who died 50 months after the procedure. Breast cancer developed in two patients after prophylactic mastectomy: one in the upper-outer quadrant at 61.8 months; one in the axillary tail at 24.4 months. No patients had recurrences in the nipple-areolar complex. Necrosis of the nipple was reported in 22 of 192 patients (11%) and it was judged minimal (less than one-third total skin of nipple) in 13 of 22 patients (59%). Overall cosmesis was judged by the patient and surgeon as good to excellent in the majority of patients. Level of satisfaction with cosmetic results was similar between prophylactic and treatment patients. CONCLUSIONS: The risk of local relapse was very low in our series of nipple-sparing mastectomies performed for DCIS or invasive cancer. Nipple-sparing mastectomy in the risk-reducing and breast cancer-treatment settings may be feasible in selected patients and should be the subject of additional prospective clinical trials.

Frequent mutation of the PIK3CA gene in ovarian and breast cancers.

PURPOSE: Activation of the phosphatidylinositol 3-kinase (PI3K)-AKT pathway, resulting in increased cell proliferation, survival, and motility, is believed to play an oncogenic role in many cancer types. The PIK3CA gene encodes the p110alpha catalytic subunit of PI3K, and is amplified in some ovarian cancers, whereas the AKT2 gene is amplified in some ovarian, breast, and pancreatic cancers. Recently, in a mutational screen of eight PI3K genes and eight PI3K-like genes, PIK3CA was found to be the only gene affected by somatic mutations, which were observed frequently in gastrointestinal and brain cancers. Here, we test whether PIK3CA is subject to mutation in ovarian and breast cancers. EXPERIMENTAL DESIGN: Exons 9 and 20, encoding the highly conserved helical and kinase domains of PIK3CA, were subjected to sequence analysis in 198 advanced stage epithelial ovarian carcinomas and 72 invasive breast carcinomas (48 of ductal histology and 24 of lobular histology). RESULTS: Somatic missense mutations were observed in 24 of 198 (12%) ovarian carcinomas, and in 13 of 72 (18%) breast carcinomas. CONCLUSIONS: These data indicate that mutations of PIK3CA play an oncogenic role in substantial fractions of ovarian and breast carcinomas, and in consideration of mutation of other components of the PI3K-AKT pathway in both tumor types, confirm the major oncogenic role of this pathway in ovarian and breast carcinomas.

Update on the indications for nipple-sparing mastectomy.

There is renewed interest in the use of nipple-sparing mastectomy (NSM), which combines skin-sparing mastectomy with preservation of the nipple-areola complex. NSM may be an oncologically safe treatment in a subgroup of patients who are candidates for breast-conserving surgery but still prefer to undergo mastectomy. A combination of newer techniques and good coordination between plastic and oncologic surgeons can achieve excellent cosmetic results and a low incidence of postoperative complications. However, major concerns about NSM include the persistent risk for breast cancer development when it is used for prophylaxis as well as the potential failure of local control when it is used for treatment. The reported experience with these newer techniques lacks the power to generate a consensus for its indications because of limited reported series with small populations. Although the current role of NSM seems to be more defined as a prophylactic procedure in high-risk patients, prospective studies and reports are needed to better define its indications.

Increased progesterone receptor expression in benign epithelium of BRCA1-related breast cancers.

The study of pathologically normal breast epithelium of BRCA mutation carriers may yield insights into the early natural history of breast tumorigenesis. Hormone receptor expression was assessed in 24 cases of invasive breast cancer associated with a mutation in BRCA1 (n = 15) or BRCA2 (n = 9) and in 39 sporadic cases matched for patient age and tumor hormone receptor status. Expression of progesterone receptor was significantly (P = 0.0003) more common in normal breast epithelium adjacent to invasive breast carcinoma in BRCA1-linked cases compared with sporadic cases. The wild-type BRCA allele was retained in normal epithelium of all cases tested. We conclude that deregulation of progesterone receptor expression, as a result of BRCA1 haploinsufficiency, may represent an early event in BRCA1-linked breast tumorigenesis.

Revision of the American Joint Committee on Cancer staging system for breast cancer.

PURPOSE: To revise the American Joint Committee on Cancer staging system for breast carcinoma. MATERIALS AND METHODS: A Breast Task Force submitted recommended changes and additions to the existing staging system that were (1) evidence-based and/or consistent with widespread clinical consensus about appropriate diagnostic and treatment standards and (2) useful for the uniform accrual of outcome information in national databases. RESULTS: Major changes included the following: size-based discrimination between micrometastases and isolated tumor cells; identifiers to indicate usage of innovative technical approaches; classification of lymph node status by number of involved axillary lymph nodes; and new classifications for metastasis to the infraclavicular, internal mammary, and supraclavicular lymph nodes. CONCLUSION: This revised staging system will be officially adopted for use in tumor registries in January 2003.