Building trust and diversity in patient-centered oncology clinical trials: An integrated model.

BACKGROUND/AIMS: Trust is the cornerstone of clinical trial recruitment and retention. Efforts to decrease barriers and increase clinical trial participation among diverse populations have yielded modest results. There is an urgent need to better understand the complex interactions between trust and clinical trial participation. The process of trust-building has been a focus of intense research in the business community. Yet, little has been published about trust in oncology clinical trials or the process of building trust in clinical trials. Both clinical trials and business share common dimensions. Business strategies for building trust may be transferable to the clinical trial setting. This study was conducted to understand and utilize contemporary thinking about building trust to develop an Integrated Model of Trust that incorporates both clinical and business perspectives. METHODS: A key word-directed literature search of the PubMed, Medline, Cochrane, and Google Search databases for entries dated between 1 January 1985 and 1 September 2015 was conducted to obtain information from which to develop an Integrated Model of Trust. RESULTS: Successful trial participation requires both participants and clinical trial team members to build distinctly different types of interpersonal trust to effect recruitment and retention. They are built under conditions of significant emotional stress and time constraints among people who do not know each other and have never worked together before. Swift Trust and Traditional Trust are sequentially built during the clinical trial process. Swift trust operates during the recruitment and very early active treatment phases of the clinical trial process. Traditional trust is built over time and operates during the active treatment and surveillance stages of clinical trials. The Psychological Contract frames the participants' and clinical trial team members' interpersonal trust relationship. The "terms" of interpersonal trust are negotiated through the psychological contract. Contract renegotiation occurs in response to cyclical changes within the trust relationship throughout trial participation. CONCLUSION: The Integrated Model of Trust offers a novel framework to interrogate the process by which diverse populations and clinical trial teams build trust. To our knowledge, this is the first model of trust-building in clinical trials that frames trust development through integrated clinical and business perspectives. By focusing on the process, rather than outcomes of trust-building diverse trial participants, clinical trials teams, participants, and cancer centers may be able to better understand, measure, and manage their trust relationships in real time. Ultimately, this may foster increased recruitment and retention of diverse populations to clinical trials.

Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT).

BACKGROUND: The study of disparities in minority recruitment to cancer clinical trials has focused primarily on inquiries among minority populations. Yet very little is known about the perceptions of individuals actively involved in minority recruitment to clinical trials within cancer centers. Therefore, the authors assessed the perspectives of cancer center clinical and research personnel on barriers and facilitators to minority recruitment. METHODS: In total, 91 qualitative interviews were conducted at 5 US cancer centers among 4 stakeholder groups: cancer center leaders, principal investigators, research staff, and referring clinicians. All interviews were recorded and transcribed. Qualitative analyses of response data was focused on identifying prominent themes related to barriers and facilitators to minority recruitment. RESULTS: The perspectives of the 4 stakeholder groups were largely overlapping with some variations based on their unique roles in minority recruitment. Four prominent themes were identified: 1) racial and ethnic minorities are influenced by varying degrees of skepticism related to trial participation, 2) potential minority participants often face multilevel barriers that preclude them from being offered an opportunity to participate in a clinical trial, 3) facilitators at both the institutional and participant level potentially encourage minority recruitment, and 4) variation between internal and external trial referral procedures may limit clinical trial opportunities for racial and ethnic minorities. CONCLUSIONS: Multilevel approaches are needed to address barriers and optimize facilitators within cancer centers to enhance minority recruitment for cancer clinical trials.

Five National Cancer Institute-designated cancer centers' data collection on racial/ethnic minority participation in therapeutic trials: a current view and opportunities for improvement.

BACKGROUND: To ensure that National Institutes of Health-funded research is relevant to the population's needs, specific emphasis on proportional representation of minority/sex groups into National Cancer Institute (NCI) cancer centers' clinical research programs is reported to the NCI. METHODS: EMPaCT investigators at 5 regionally diverse comprehensive cancer centers compared data reported to the NCI for their most recent Cancer Center Support Grant competitive renewal to assess and compare the centers' catchment area designations, data definitions, data elements, collection processes, reporting, and performance regarding proportional representation of race/ethnicity and sex subsets. RESULTS: Cancer centers' catchment area definitions differed widely in terms of their cancer patient versus general population specificity, levels of specificity, and geographic coverage. Racial/ethnic categories were similar, yet were defined differently, across institutions. Patients' socioeconomic status and insurance status were inconsistently captured across the 5 centers. CONCLUSIONS: Catchment area definitions and the collection of patient-level demographic factors varied widely across the 5 comprehensive cancer centers. This challenged the assessment of success by cancer centers in accruing representative populations into the cancer research enterprise. Accrual of minorities was less than desired for at least 1 racial/ethnic subcategory at 4 of the 5 centers. Institutions should clearly and consistently declare their primary catchment area and the rationale and should report how race/ethnicity and sex are defined, determined, collected, and reported. More standardized, frequent, consistent collection, reporting, and review of these data are recommended, as is a commitment to collecting socioeconomic data, given that socioeconomic status is a primary driver of cancer disparities in the United States.

Costs and outcomes evaluation of patient navigation after abnormal cancer screening: evidence from the Patient Navigation Research Program.

BACKGROUND: Navigators can facilitate timely access to cancer services, but to the authors' knowledge there are little data available regarding their economic impact. METHODS: The authors conducted a cost-consequence analysis of navigation versus usual care among 10,521 individuals with abnormal breast, cervical, colorectal, or prostate cancer screening results who enrolled in the Patient Navigation Research Program study from January 1, 2006 to March 31, 2010. Navigation costs included diagnostic evaluation, patient and staff time, materials, and overhead. Consequences or outcomes were time to diagnostic resolution and probability of resolution. Differences in costs and outcomes were evaluated using multilevel, mixed-effects regression modeling adjusting for age, race/ethnicity, language, marital status, insurance status, cancer, and site clustering. RESULTS: The majority of individuals were members of a minority (70.7%) and uninsured or publically insured (72.7%). Diagnostic resolution was higher for navigation versus usual care at 180 days (56.2% vs 53.8%; P = .008) and 270 days (70.0% vs 68.2%; P < .001). Although there were no differences in the average number of days to resolution between the 2 groups (110 days vs 109 days; P = .63), the probability of ever having diagnostic resolution was higher for the navigation group versus the usual-care group (84.5% vs 79.6%; P < .001). The added cost of navigation versus usual care was $275 per patient (95% confidence interval, $260-$290; P < .001). There was no significant difference in stage distribution among the 12.4% of patients in the navigation group vs 11% of the usual-care patients diagnosed with cancer. CONCLUSIONS: Navigation adds costs and modestly increases the probability of diagnostic resolution among patients with abnormal screening test results. Navigation is only likely to be cost-effective if improved resolution translates into an earlier cancer stage at the time of diagnosis.

Development and Validation of the Perceptions of Research Trustworthiness Scale to Measure Trust Among Minoritized Racial and Ethnic Groups in Biomedical Research in the US.

Importance: Historically, trust in biomedical research has been lower among minoritized racial and ethnic groups who are underrepresented in and excluded from research, with the same groups experiencing worse health outcomes. Unfortunately, instruments that measure trust may not capture components of trust relevant to minoritized racial and ethnic groups. Objective: To develop and validate a scale to measure trust in biomedical research among minoritized racial and ethnic groups. Design, Setting, and Participants: This cross-sectional, community-based survey study compared trust and distrust in biomedical research among Black, Latino, and White subgroups in the US using the Perceptions of Research Trustworthiness (PoRT) scale. The scale was developed between March 22, 2016, and September 19, 2018, as part of this study, and its structure, reliability, and validity were examined during pilot (n = 381) and validation (n = 532) phases between February 4, 2019, and July 27, 2021. Convenience samples of adult participants (aged ≥18 years) were recruited locally (Nashville, Tennessee, and San Antonio, Texas) and nationally through the ResearchMatch and Cint online platforms. Main Outcomes and Measures: Overall and individual item Trust and Distrust subscale scores were compared. Overall Trust and Distrust scores were compared by race and ethnicity using a Kruskal-Wallis H test and individual item scores were compared using independent samples t test. Results: Of the 532 participants in the scale validation study, 144 (27.1%) were Black, 90 (16.9%) were Latino, and 282 (53.0%) were White. Participants had a median age of 43 years (range, 18-90 years), 352 (66.2%) were women, and 198 (37.2%) had educational attainment levels less than a college degree. Factor analysis of the 18-item PoRT scale revealed a 2-factor structure with two 9-item PoRT subscales (Trust and Distrust), which demonstrated high internal consistency (Cronbach α = 0.72 and 0.87, respectively). Mean (SD) Trust subscale scores were lower among Black (34.33 [2.02]) and Latino (34.55 [1.97]) participants compared with White participants (36.32 [1.81]; P < .001). Mean (SD) Distrust subscale scores were higher among Black (21.0 [2.15]) and Latino (20.53 [2.21]) participants compared with White participants (18.4 [2.03]; P < .001). Individual item results showed that Black and Latino participants were less trusting and more distrusting than White individuals on items related to risks, harms, secrecy, confidentiality, and privacy. Conclusions and Relevance: These findings suggest that the PoRT scale incorporates trust and trustworthiness concepts relevant among Black and Latino individuals and may allow more precise assessment of trust in research among these groups.

Co-expression of urokinase with haptoglobin in human carcinomas.

BACKGROUND: We have shown that colon and breast cancer contains large amounts of urokinase (uPA), and that these cells are the actual sites of its synthesis. We isolated a large complex molecule consisting of the beta-chain of uPA, both chains of haptoglobin (Hp), and part or all of an NCAM-like molecule. The question arose whether it would be possible to show the presence of Hp in the same cells where uPA was found. MATERIALS AND METHODS: Human colon and breast adenocarcinomas were investigated for expression of Hp and uPA by immunohistochemistry. Fluorescence in situ hybridization was used to identify the cells of origin of these antigens. RESULTS: Hp was expressed in 8 of 11 colon adenocarcinomas, and in 10 of 12 breast tumors. uPA was demonstrable on the cell membrane and in the cytoplasm of all 11 colon adenocarcinomas studied, and cytoplasmic uPA-mRNA was found in all cases. While uPA was also detected in some stromal and inflammatory cells, Hp was present abundantly in such cells, as well as in capillary endothelial cells. Hp-mRNA was also found in both colon and breast tumors wherever the antigens were expressed. CONCLUSIONS: uPA and Hp are produced by the cancer cells and are not taken up by stromal elements. While the role of uPA in the malignant process is well documented, that of Hp is largely unexplored. Its ubiquity, shown here, suggests that it is also involved in some aspects of that process.

Ambivalence: A Key to Clinical Trial Participation?

Trust exerts a multidimensional influence at the interpersonal level in the clinical trials setting. Trust and distrust are dynamic states that are impacted, either positively or negatively, with each participant-clinical trials team interaction. Currently, accepted models of trust posit that trust and distrust coexist and their effects on engagement and retention in clinical trials are mediated by ambivalence. While understanding of trust has been informed by a robust body of work, the role of distrust and ambivalence in the trust building process are less well understood. Furthermore, the role of ambivalence and its relationship to trust and distrust in the clinical trials and oncology settings are not known. Ambivalence is a normal and uncomfortable state in the complex decision making process that characterizes the recruitment and active treatment phases of the clinical trials experience. The current review was conducted to understand the constructs of ambivalence as a mediator of trust and distrust among vulnerable, minority participants through different stages of the oncology clinical trials continuum, its triggers and the contextual factors that might influence it in the setting of minority participation in oncology clinical trials. In addition, the researchers have sought to link theory to clinical intervention by investigating the feasibility and role of Motivational Interviewing in different stages of the clinical trials continuum. Findings suggest that ambivalence can be processed and managed to enable a participant to generate a response to their ambivalence. Thus, recognizing and managing triggers of ambivalence, which include, contradictory goals, role conflicts, membership dualities, and supporting participants through the process of reducing ambivalence is critical to successfully managing trust. Contextual factors related to the totality of one's previous health-care experience, specifically among the marginalized or vulnerable, can contribute to interpersonal ambivalence. In addition, changes in information gathering as a moderator of interpersonal ambivalence may have enormous implications for gathering, assessing, and accepting health information. Finally, motivational Interviewing has widespread applications in healthcare settings, which includes enabling participants to navigate ambivalence in shared-decision making with their clinician, as well as executing changes in participant behavior. Ultimately, the Integrated Model of Trust can incorporate the role of therapeutic techniques like Motivational Interviewing in different stages of the clinical trials continuum. Ambivalence is a key component of clinical trial participation; like trust, ambivalence can be managed and plays a major role in the management of trust in interpersonal relationships over time. The management of ambivalence may play a major role in increasing clinical trial participation particularly among the marginalized or the vulnerable, who may be more susceptible to feelings of ambivalence.

Surgical management of breast cancer.

Breast cancer treatment outcomes have improved as a result of early detection and multidisciplinary treatment approaches. Treatment options continue to expand as understanding increases regarding the relationship between disease burden, biology, and outcome. In this article we present the current principles and challenges that face the clinician who is treating breast disease. Better understanding of the biology of high-risk lesions and the significance of minimal metastatic disease permits better treatment. Advances in reconstructive surgery, continued refinement of resection techniques, and the management of less common presentations of breast cancer are presented.

Plasminogen activator system localization in 60 cases of ductal carcinoma in situ.

BACKGROUND: The lack of prognostic factors in ductal carcinoma in situ (DCIS) that reliably identifies biologically aggressive tumors adversely affects optimal management. The urokinase-type plasminogen activator (uPA) system, comprised of its receptor, uPAR, and its inhibitor (PAI-1), are critical elements for tumor invasion and their expression in invasive breast cancer can predict clinical outcome. Expression of the uPA system in DCIS may be relevant in defining histological subsets of DCIS with invasive potential. METHODS: Localization of uPA, uPAR, and PAI-1 was investigated immunohistochemically in 60 DCIS tumors. FISH experiments were performed to determine whether uPA was present in cancer cells themselves or derived from stromal elements. RESULTS: uPA was ubiquitously expressed in the malignant ductal epithelium of 95% (57/60) of DCIS tumors studied. uPA-mRNA was detected in the malignant ductal epithelium but not the adjacent normal ductal epithelium and stromal elements. uPAR was expressed in 27% (6/22) of high-grade and 24% (9/38) of non-high-grade DCIS. In comparing coexpression, uPA and uPAR were coexpressed in only 25% (15/60) of tumors. PAI-1 was infrequently expressed in high grade (3/22) and absent in non-high-grade DCIS. CONCLUSIONS: This study identifies the presence of uPA, uPAR, and PAI-1 in both high-grade and non-high-grade DCIS. It may be speculated that coexpression of uPA and its receptor may identify subsets of DCIS with an increased risk for progression to invasive disease. If so, then expression of uPA system components may have prognostic and therapeutic significance in DCIS.

Evaluation of urinary plasminogen activator, its receptor, matrix metalloproteinase-9, and von Willebrand factor in pancreatic cancer.

PURPOSE: Pancreatic cancer remains a devastating problem with the majority of patients succumbing to death from this disease. A hallmark of pancreatic cancer is the loss of basement membrane that may be attributed to the action of urinary plasminogen activator (uPA) and matrix metalloproteinase-9 (MMP-9). These enzymes are also implicated in angiogenesis. uPA and microvessel density have been shown to be good prognostic indicators for breast and colon cancer. MMP-9 and microvessel density have not been investigated in pancreatic cancer. We have therefore investigated by immunohistochemistry: (a) frequency of uPA expression and its receptor uPAR and the site of synthesis of uPA by in situ hybridization (ISH); (b) MMP-9 and its coexpression with uPA; (c) microvessel density as determined by von Willebrand factor staining and its relationship to uPA and MMP-9 expression; and (d) correlation of these parameters with survival. EXPERIMENTAL DESIGN: Archival paraffin sections of 27 pancreatic tumors were semiquantitatively investigated by immunohistochemistry using the following antibodies: (a) monoclonal antibodies (MAbs) uPA(1) and uPA(2) (3689 and 394, respectively); (b) MAb uPAR, (no. 3932); (c) MAb MMP-9 (no. 936); and (d) rabbit anti-F8RA/vWF. ISH was performed using a uPA cDNA. RESULTS: Both uPA antibodies revealed overexpression of uPA (93%) often with uniform staining of tumor cells. uPAR and MMP-9 showed focal staining in only 52 and 37% of tumors, respectively. Morphologically normal appearing ductal cells in close proximity to tumors overexpressed uPA in contrast to distally located normal cells (P = <0.001). uPA staining was also investigated in pancreatic intraepithelial neoplasia (PanIN) lesions. PanIN 1A/B staining for uPA was seen in 8 cases (30%), that for PanIN 2 in 19 cases (70%), and for PanIN3 in 12 cases (44%). Lumen of microvessels in the tumor stroma also revealed staining of uPA in 10 cases (37%). ISH experiments revealed the presence of uPA mRNA not only in the cytoplasm of tumor cells but also in adjacent normal appearing ducts as well as in PanIN lesions. Patients with overexpression of uPA, uPAR, or MMP-9 had a trend toward poorer survival than those who did not express it. Microvessel density did not show any significant relationship with uPA, uPAR, and MMP-9 expression and survival. CONCLUSIONS: We conclude that uPA and MMP-9 are potential prognostic indicators in pancreatic cancer, whereas microvessel density may not be one. This study confirms our previous observation that uPA is made by the tumor cells themselves. Presence of uPA in vessels of tumor stroma suggests that uPA is in circulation, and its measurement and that of MMP-9 in the blood of these patients may aid in prognosis. Patients showing overexpression of uPA and MMP-9 have a trend toward shorter survival time.

Factors that affect breast cancer treatment: underserved and minority populations.

Breast cancer treatment in underserved populations continues to deviate from established guidelines. Significant barriers persist at the system, physician, and patient levels that ultimately may affect survival adversely. Successful strategies to reduce the disparities must be developed to improve outcomes in this population of women.

An evaluation of the integration of non-traditional learning tools into a community based breast and cervical cancer education program: the Witness Project of Buffalo.

BACKGROUND: Breast and cervical cancer continue to represent major health challenges for African American women. among Caucasian women. The underlying reasons for this disparity are multifactorial and include lack of education and awareness of screening and early detection. Traditional educational methods have enjoyed varied success in the African American community and spawned development of novel educational approaches. Community based education programs employing a variety of educational models have been introduced. Successful programs must train and provide lay community members with the tools necessary to deliver strong educational programs. METHODS: The Witness Project is a theory-based, breast and cervical cancer educational program, delivered by African American women, that stresses the importance of early detection and screening to improve survival and teaches women how to perform breast self examination. Implementing this program in the Buffalo Witness Project of Buffalo required several modifications in the curriculum, integration of non-traditional learning tools and focused training in clinical study participation. The educational approaches utilized included repetition, modeling, building comprehension, reinforcement, hands on learning, a social story on breast health for African American women, and role play conversations about breast and cervical health and support. RESULTS: Incorporating non-traditional educational approaches into the Witness Project training resulted in a 79% improvement in the number of women who mastered the didactic information. A seventy-two percent study participation rate was achieved by educating the community organizations that hosted Witness Project programs about the informed consent process and study participation. CONCLUSION: Incorporating non-traditional educational approaches into community outreach programs increases training success as well as community participation.

Breast cancer in pregnancy: a literature review.

HYPOTHESIS: Breast cancer in pregnancy will increase as more women postpone childbearing until later in life. OBJECTIVE: To review the literature on diagnosis, staging, treatment, and prognosis. DESIGN AND METHODS: Articles were obtained from MEDLINE (1966-present) using the keywords breast, cancer, carcinoma, and pregnancy. Additional articles were sought using the references of those obtained. A total of 171 articles were found, 125 in English. More than 100 were reviewed, including 7 prospective and 40 retrospective studies, 6 case reports, and at least 47 review articles on various aspects of pregnancy and cancer. Data extraction was performed by 1 reviewer. RESULTS: Diagnostic delays are shorter than in the past but remain common. Mammography has a high false-negative rate during pregnancy. Biopsy or needle aspiration are needed for diagnosis and cannot be postponed until after delivery. Pregnancy-associated cancers tend to occur at a later stage and be estrogen receptor-negative. However, they carry a similar prognosis to other breast cancers when matched for stage and age. Although modified radical mastectomy is the traditional treatment, breast-conserving therapy is increasingly common. Therapeutic radiation is contraindicated, but chemotherapy is relatively safe after the first trimester. Tamoxifen should be avoided in the first trimester and possibly beyond. CONCLUSIONS: Physicians should perform a thorough breast examination at the first prenatal visit and maintain a high index of suspicion for cancer. Patients who wish to continue their pregnancies have a growing array of treatment options.

Overexpression of urinary plasminogen activator (uPA) protein and mRNA in thyroid carcinogenesis.

OBJECTIVE: Urinary plasminogen activator (uPA), a protease, is one of the critical components of tumor invasion and metastasis. Its expression in thyroid carcinoma and potential role in thyroid tumorigenesis are unknown. The objective of this study was to determine whether uPA is differentially expressed in benign and malignant thyroid tumors. DESIGN: uPA expression was evaluated by immunohistochemistry (IHC) in 20 thyroid tumors (six classic papillary thyroid cancers (PTC) and three tall cell variants (TCV) and 11 adenomas). To validate IHC results, in situ hybridization was performed on both adenomas and cancer tissues to explore the expression of uPA at the mRNA level. The Fisher exact test was used to compare protein as well as mRNA expressions in adenomas and thyroid cancer. RESULTS: Intense granular cytoplasmic staining for uPA was observed in five of nine (56%) of thyroid cancers: 2/6 classic PTC (33%) and all tall cell variant PTC. Furthermore, uPA mRNA expression was found in the malignant thyroid epithelium but not in adjacent normal thyroid follicles or the stromal elements. None of the adenomas expressed uPA (P = .008). uPA staining was absent in histologically normal follicles adjacent to malignant thyroid follicles. CONCLUSIONS: uPA is expressed in thyroid carcinoma but not in benign adenomas or normal adjacent follicles. The selective expression of uPA in thyroid carcinoma provides evidence that uPA is useful in distinguishing benign and malignant thyroid neoplasms. More importantly, uPA may represent molecular target for therapeutic treatment of this malignancy.

A logic model for community engagement within the Clinical and Translational Science Awards consortium: can we measure what we model?

The Clinical and Translational Science Award (CTSA) initiative calls on academic health centers to engage communities around a clinical research relationship measured ultimately in terms of public health. Among a few initiatives involving university accountability for advancing public interests, a small CTSA workgroup devised a community engagement (CE) logic model that organizes common activities within a university-community infrastructure to facilitate CE in research. Whereas the model focuses on the range of institutional CE inputs, it purposefully does not include an approach for assessing how CE influences research implementation and outcomes. Rather, with communities and individuals beginning to transition into new research roles, this article emphasizes studying CE through specific relationship types and assessing how expanded research teams contribute to the full spectrum of translational science.The authors propose a typology consisting of three relationship types-engagement, collaboration, and shared leadership-to provide a foundation for investigating community-academic contributions to the new CTSA research paradigm. The typology shifts attention from specific community-academic activities and, instead, encourages analyses focused on measuring the strength of relationships through variables like synergy and trust. The collaborative study of CE relationships will inform an understanding of CTSA infrastructure development in support of translational research and its goal, which is expressed in the logic model: better science, better answers, better population health.

Evaluating the cost-effectiveness of cancer patient navigation programs: conceptual and practical issues.

Patient navigators-individuals who assist patients through the healthcare system to improve access to and understanding of their health and healthcare-are increasingly used for underserved individuals at risk for or with cancer. Navigation programs can improve access, but it is unclear whether they improve the efficiency and efficacy of cancer diagnostic and therapeutic services at a reasonable cost, such that they would be considered cost-effective. In the current study, the authors outline a conceptual model for evaluating the cost-effectiveness of cancer navigation programs. They describe how this model is being applied to the Patient Navigation Research Program, a multicenter study supported by the National Cancer Institute's Center to Reduce Cancer Health Disparities. The Patient Navigation Research Program is testing navigation interventions that aim to reduce time to delivery of quality cancer care (noncancer resolution or cancer diagnosis and treatment) after identification of a screening abnormality. Examples of challenges to evaluating cost-effectiveness of navigation programs include the heterogeneity of navigation programs, the sometimes distant relation between navigation programs and outcome of interest (eg, improving access to prompt diagnostic resolution and life-years gained), and accounting for factors in underserved populations that may influence both access to services and outcomes. In this article, the authors discuss several strategies for addressing these barriers. Evaluating the costs and impact of navigation will require some novel methods, but will be critical in recommendations concerning dissemination of navigation programs.

Axillary recurrence in women with a negative sentinel lymph node and no axillary dissection in breast cancer.

OBJECTIVES: Sentinel lymph node biopsy (SLNB) is widely used for staging breast cancer. SLNB accurately determines axillary lymph node status with a low false negative rate. There remains concern that omitting axillary dissection may lead to recurrence in the axilla, and impact long term survival. The purpose of this study was to determine the frequency of axillary lymph node recurrence in patients who had a negative sentinel lymph node and did not undergo axillary node dissection. METHODS: Data was collected on all patients who had negative SLNB at Roswell Park Cancer Institute between July 1997 and June 2002. Demographics, type of operation, postoperative systemic, and radiation therapy, co-morbidity score, hormone receptor status, and the pathologic features of the tumor were abstracted for each patient. For each woman with recurrence, the dates of recurrence, the site(s) of recurrence, and the treatment for recurrence were recorded. RESULTS: With a median follow-up of 33 months, 15 of 335 (4.5%) women who had negative SLNBs and who did not undergo completion axillary dissection developed a cancer recurrence. Only two patients (0.6%) had an axillary recurrence. CONCLUSIONS: The rate of axillary recurrence following a negative sentinel node biopsy is the same or less than axillary lymph node dissection (ALND) alone. Concerns that omitting completion axillary dissection following a negative SLNB will increase the rate of axillary recurrence appear unfounded.

Effect of stereotactic core needle biopsy on pathologic measurement of tumor size of T1 invasive breast carcinomas presenting as mammographic masses.

BACKGROUND: Stereotactic core needle biopsy (SCNB) may change the size of the tumor defined pathologically at excision. This may alter tumor stage and affect recommendations for adjuvant systemic therapy. This study evaluated the effect of SCNB on assessment of pathologic tumor size and staging for invasive breast carcinomas presenting as mammographic masses. METHODS: The authors reviewed the mammographic and pathologic size of 138 mammographically detected invasive carcinomas manifested as a measurable mass lesion on mammography and as a 20 mm or smaller lesion on pathologic evaluation. Group A included 61 patients with SCNB before surgical excision and the Group B (the control group) included 77 patients who had surgical excision without SCNB. The size of the mammographic central mass was compared with the pathologic tumor size. The difference between the mammographic and pathologic size was determined and the findings in Group A and B were compared by the Mann-Whitney U test. RESULTS: The mean mammographic size was 12.2 and 11.83 mm and the mean pathologic size was 9.85 and 9.87 mm for Groups A and B, respectively. The mean difference between mammographic and pathologic size in Groups A and B was 2.3 mm and 1.96 mm, respectively (P = not significant). CONCLUSIONS: For soft tissue masses, the difference between mammographic size and pathologic size of invasive carcinoma at excision does not appear to be affected by the use of SCNB. Except in the circumstance of complete removal of the cancer by SCNB, the pathologic size and stage of the excised tumor after SCNB is not altered significantly by SCNB.

Replication and dissemination of a cancer education model for African American women.

The purpose of this study was to investigate the effectiveness of replicating an evidence-based model, the Witness Project, for increasing breast and cervical cancer screening with African American women in a variety of locations and organizations in the United States. The quantitative and qualitative methods included a cadre of process and outcome measures to evaluate the effectiveness of the four-phase replication process. The intervention was replicated in 25 sites with 401 volunteers, delivering cancer education and screening programs to over 10,000 women. Key components and criteria of successful replication were established, and preliminary screening outcomes demonstrated a 43.4% increase in mammography in women aged 40 and older. This study demonstrates that the Witness Project model can be effectively replicated, that the replication process can be standardized, and that the replication sites were able to obtain positive screening results comparable to the original intervention outcomes. The model was not able to be effectively replicated with just the "turnkey" toolbox approach, but required additional technical assistance.