BACKGROUND Under the auspices of the College of American Pathologists, a multidisciplinary group of clinicians, pathologists, and statisticians considered prognostic and predictive factors in breast cancer and stratified them into categories reflecting the strength of published evidence. MATERIALS AND METHODS Factors were ranked according to previously established College of American Pathologists categorical rankings: category I, factors proven to be of prognostic import and useful in clinical patient management; category II, factors that had been extensively studied biologically and clinically, but whose import remains to be validated in statistically robust studies; and category III, all other factors not sufficiently studied to demonstrate their prognostic value. Factors in categories I and II were considered with respect to variations in methods of analysis, interpretation of findings, reporting of data, and statistical evaluation. For each factor, detailed recommendations for improvement were made. Recommendations were based on the following aims: (1) increasing uniformity and completeness of pathologic evaluation of tumor specimens, (2) enhancing the quality of data collected about existing prognostic factors, and (3) improving patient care. RESULTS AND CONCLUSIONS Factors ranked in category I included TNM staging information, histologic grade, histologic type, mitotic figure counts, and hormone receptor status. Category II factors included c-erbB-2 (Her2-neu), proliferation markers, lymphatic and vascular channel invasion, and p53. Factors in category III included DNA ploidy analysis, microvessel density, epidermal growth factor receptor, transforming growth factor-alpha, bcl-2, pS2, and cathepsin D. This report constitutes a detailed outline of the findings and recommendations of the consensus conference group, organized according to structural guidelines as defined.

https://www.hormonebalance.org/images/documents/Page%2099%20Prognostic%20factors%20in%20BCa%20Concensus%20Statement.pdf

Prognostic factors in breast cancer. College of American Pathologists Consensus Statement 1999.

Purpose: To assess the relative importance of 10 prognostic factors in pT1N0M0 breast cancer (≤2 cm in diameter, node negative). Experimental design: Women diagnosed with breast cancer in Finland from 1991 to 1992 were identified from the files of the Finnish Cancer Registry, and individual clinicopathological data were collected from the hospital case records of women living in five regions comprising about one-half of the Finnish population. Of the women with minimum required information available (n = 2842), 852 had unilateral pT1N0M0 cancer. The median follow-up time was 9.5 years, and only 5% had received systemic adjuvant therapy. Estrogen receptor (ER), progesterone receptor, erbB2, p53, and Ki-67 expression was determined from tumor tissue microarrays using immunohistochemistry, and the erbB2 (HER-2) amplification status was determined using chromogenic in situ hybridization. Results: Primary tumor size ≤5 mm and histological grade 1 were associated with 100 and 95% (95% confidence interval, 92–98%) 9-year distant disease-free survival, respectively, whereas strong erbB2 expression or the presence of >20% Ki-67-positive cells was associated with >20% risk. ER and progesterone receptor values obtained from the hospital case records or tumor microarrays showed weaker association with outcome than the erbB2 status. Small (≤10 mm) erbB2-negative cancers were associated with >90% 9-year distant disease-free survival, irrespective of histological grade. Conclusions: Prognosis of pT1N0M0 breast cancer is generally well defined by the histological grade and primary tumor size. The erbB2 status was superior to ER as a prognostic factor in these tumors.

https://clincancerres.aacrjournals.org/content/clincanres/9/3/923.full.pdf

Amplification of erbB2 and erbB2 expression are superior to estrogen receptor status as risk factors for distant recurrence in pT1N0M0 breast cancer: a nationwide population-based study.

Staging Classification and Clinical Practice Guidelines of Gynaecologic Cancers

Background: Uncertainty about prognosis and treatment of axillary lymph node-negative patients with estrogen receptor (ER)-negative or ER-positive invasive breast tumors of 1 cm or less prompted the analysis of data from five National Surgical Adjuvant Breast and Bowel Project randomized clinical trials. Methods: Two hundred thirty-five patients with ER-negative tumors and 1024 patients with ER-positive tumors were identified in these trials. Patients with ERnegative tumors received surgery alone or surgery and chemotherapy. Patients with ER-positive tumors received surgery alone; surgery and tamoxifen; or surgery, tamoxifen, and chemotherapy. End points were relapse-free survival (RFS), event-free survival, and overall survival. A result was considered to be statistically significant with a P value of .05 or less; all statistical tests were two-sided. Results: The 8-year RFS of women with ER-negative tumors who received surgery alone or with chemotherapy was 81% and 90%, respectively (P = .06). Survival was similar in both groups (93% and 91%; P = .65). The 8-year RFS of women with ER-positive tumors was 86% after surgery alone, 93% when tamoxifen was added (P = .01), and 95% after the addition of tamoxifen and chemotherapy (P = .07 compared with tamoxifen). Survival in the three groups was 90%, 92% (P = .41), and 97%, respectively. The difference between the latter two groups was significant (P = .01). Regardless of ER status or treatment, overall mortality was 8%; one half of the deaths were related to breast cancer. Several covariates affected the risk of recurrence in ER-negative and ERpositive patients. Risk was greater in women with tumors of 1 cm than in those with tumors of less than 1 cm, in women aged 49 years or younger than in those aged 50 years or older, and in women with infiltrating ductal or lobular carcinoma than in those with other histologic tumor types. Conclusions: Chemotherapy and/or tamoxifen should be considered for the treatment of women with ER-negative or ERpositive tumors of 1 cm or less and negative axillary lymph nodes. [J Natl Cancer Inst 2001;93:112–20]

/pdf/prognosis-and-treatment-of-patients-with-breast-tumors-of-5126jfemhy.pdf

Prognosis and Treatment of Patients With Breast Tumors of One Centimeter or Less and Negative Axillary Lymph Nodes

Obvious peritumoral emboli: an elusive prognostic factor reappraised. Multivariate analysis of 1320 node-negative breast cancers

Background. The frequency of small (≤ 1 cm) axillary lymph node negative invasive breast cancers (T1a,b N0 M0) is increasing because of wider implementation of breast cancer screening. Identification of prognostic factors for these patients has been based largely on retrospective pathology review. The authors analyzed histologic factors recorded in the original pathology reports to determine predictors of recurrence for patients with T1a,b N0 M0 breast cancer. Methods. Two hundred eighteen patients were studied. Potential prognostic factors including measured millimeter tumor size in three dimensions, histologic grade, nuclear grade, and presence or absence of lymphatic vessel invasion were documented prospectively in routine surgical pathology reports of a large community (nonuniversity based) hospital. Follow-up was performed annually by the tumor registry. Results. With a median follow-up of 6.9 years (range, 3-15.8 years), overall recurrence free survival was 93%. Poor nuclear grade (hazard ratio, 5.8 ; 95% confidence interval, 1.70-19.82 ; P = 0.004) and lymphatic vessel invasion (hazard ratio, 4.6 ; 95% confidence interval, 1.34-15.61; P = 0.01) were independent predictors of recurrence. Only 10% of patients had cancers with both poor nuclear grade and lymphatic vessel invasion and their 67% 7-year recurrence free survival (RFS) rate was significantly lower than the 92% RFS rate observed for patients with one of these two factors (P = 0.007) and the 99% RFS for patients with neither poor risk factor (P = 0.0001). Conclusions. The combination of poor nuclear grade and lymphatic vessel invasion identifies a very small subset (10%) of patients with T1a,b N0 M0 breast cancer with a significant relapse risk that warrants consideration of adjuvant systemic therapy. However, the majority of patients with T1a,b N0 M0 breast cancer have an exceptionally good prognosis.

Predictors of recurrence for patients with small (one centimeter or less) localized breast cancer (T 1 a,b NO MO)

Introduction: Nasopharyngeal swabs (NPS) are considered the gold standard for diagnosis of respiratory syncytial virus (RSV). Although highly sensitive, NPS come with sampling burden, a time interval between sampling and PCR test results, and high personnel and resource costs. Moreover, collection can cause discomfort in the patient. A saliva-based method for RSV detection would make large-scale and frequent clinical and community sampling more feasible. In this study, we evaluated detection of RSV in paired NPS and saliva samples. Methods:&nbsp;Matched NPS and saliva samples were obtained by trained study personnel from hospitalised infants with viral respiratory infection. NPS and saliva samples were tested with SalivaDirect+, a saliva-based PCR test authorized by the US FDA for detection of SARS-CoV-2, expanded to also target RSV. Results:&nbsp;To date, 29 paired samples have been collected from infants with medically-attended respiratory infections. As a proof of concept, we analysed the first 10 samples including 5 samples from RSV positive infants and 5 from infants with other respiratory viruses. RSV, rhinovirus, and enterovirus could be detected in all 10&nbsp;samples in both NPS and saliva. Sampling discomfort was considered to be significantly higher for NPS compared to saliva.&nbsp;More data will be available at the time of the conference. Conclusion:&nbsp;We detected RSV in all saliva samples.&nbsp;Our preliminary findings indicate that saliva is a viable and preferable alternative to NPS for RSV detection. Saliva could allow for frequent repeated testing.&nbsp;With further validation, widespread implementation of saliva sampling&nbsp;could transform RSV diagnosis and surveillance in children.

Saliva as an alternative to nasopharyngeal swabs for detection of respiratory syncytial virus (RSV) in children

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Predictors of recurrence for patients with small (one centimeter or less) localized breast cancer (T 1 a,b NO MO)

Saliva as an alternative to nasopharyngeal swabs for detection of respiratory syncytial virus (RSV) in children