Clinical impact and frequency of anatomic pathology errors in cancer diagnoses

BACKGROUND: To the authors' knowledge, the frequency and clinical impact of errors in the anatomic pathology diagnosis of cancer have been poorly characterized to date. METHODS: The authors examined errors in patients who underwent anatomic pathology tests to determine the presence or absence of cancer or precancerous lesions in four hospitals. They analyzed 1 year of retrospective errors detected through a standardized cytologic-histologic correlation process (in which patient same-site cytologic and histologic specimens were compared). Medical record reviews were performed to determine patient outcomes. The authors also measured the institutional frequency, cause (i.e., pathologist interpretation or sampling), and clinical impact of diagnostic cancer errors. RESULTS: The frequency of errors in cancer diagnosis was found to be dependent on the institution (P < 0.001) and ranged from 1.79-9.42% and from 4.87-11.8% of all correlated gynecologic and nongynecologic cases, respectively. A statistically significant association was found between institution and error cause (P < 0.001); the cause of errors resulting from pathologic misinterpretation ranged from 5.0-50.7% (the remainder were due to clinical sampling). A statistically significant association was found between institution and assignment of the clinical impact of error (P < 0.001); the aggregated data demonstrated that for gynecologic and nongynecologic errors, 45% and 39%, respectively, were associated with harm. The pairwise kappa statistic for interobserver agreement on cause of error ranged from 0.118-0.737. CONCLUSIONS: Errors in cancer diagnosis are reported to occur in up to 11.8% of all reviewed cytologic-histologic specimen pairs. To the authors' knowledge, little agreement exists regarding whether pathology errors are secondary to misinterpretation or poor clinical sampling of tissues and whether pathology errors result in serious harm.     

分子肿瘤病理学的新进展

分子肿瘤病理学是一门新兴的学科.它是分子生物学和肿瘤病理学相结合的产物.与传统的肿瘤病理学以形态学为基础的诊断不同,分子肿瘤病理学是从分子水平运用客观的科学证据来作出诊断.分子肿瘤病理学与传统肿瘤病理学不但相辅相成,而且能在传统肿瘤病理学的基础上进一步预测肿瘤的生物学行为及指导治疗.本综述在概述分子肿瘤病理学的基本概念和理论的基础上,运用几个真实的病例来阐明分子肿瘤病理学的临床应用及指导作用.这些例子虽然不能代表分子肿瘤病理学的方方面面,但希望能向读者说明分子肿瘤病理学在肿瘤的诊断、指导治疗、预测预后,以及预防等方面能给临床医生带来的帮助.     

Intramural and extramural vascular invasion in colorectal cancer: prognostic significance and quality of pathology reporting

BACKGROUND:

Blood vessel invasion has been associated with poor outcome in colorectal cancer (CRC), whereas the prognostic impact of lymphatic invasion is less clear. The authors of this report evaluated venous and lymphatic invasion as potential prognostic indicators in patients with CRC focusing on lymph node‐negative patients and compared routine and review pathology diagnoses.

METHODS:

In total, 381 tumors from randomly selected patients were retrospectively reviewed. The presence of vascular invasion was related to disease‐free and cancer‐specific survival using the Kaplan‐Meier method. For multivariable analysis, Cox proportional hazards regression models were performed.

RESULTS:

Lymphatic invasion and venous invasion were observed in 126 patients (33%) and 87 patients (23%), respectively, and were associated significantly with tumor classification, lymph node status, American Joint Committee on Cancer/International Union Against Cancer (AJCC/UICC) disease stage, tumor differentiation, pattern of invasion, and extent of tumor budding. The detection of vascular invasion was related to the number of examined tissue blocks. Venous and lymphatic invasion proved to be significant prognostic variables in univariable and multivariable analyses. Extramural vascular involvement was of particular significance. When the analysis was restricted to patients with (AJCC/UICC) stage II disease, venous invasion, but not lymphatic invasion, was identified as an independent prognostic variable. Review pathology diagnoses differed significantly from routine diagnoses with respect to prognostic impact.

CONCLUSIONS:

Venous and lymphatic invasion proved to be significant prognostic variables in patients with CRC. The detection of vascular invasion and, consequently, risk stratification of affected patients were related to the quality of pathology workup, ie, the number of examined tissue blocks. Observed differences between review and routine pathology diagnoses illustrated the need for high‐quality pathology reporting and also for standardized quality control. Cancer 2012;. © 2011 American Cancer Society.     

Réduire le temps préanalytique dans le diagnostic anatomopathologique des affections mammaires, utopie ou réalité ?

Surgical pathology diagnosis of a breast lesion is an important stage in the diagnostic process of breast diseases. Quality of the pre-analytical phase is essential to ensure reliable and reproducible diagnoses, and is based on neutral-buffered formalin fixation of tissue specimens. It is important to respect aminimum fixation timewithformalin inorder to guarantee the quality of subsequent morphological, immunohistochemical and cytogenetic studies. We present here an alternative to formalin fixation, based on tissue dehydration, enabling the shortening of technical stages and sign out. Furthermore, this method ensures better nucleic acid preservation, which opens the way for the development of high-throughput molecular testing in breast cancer.     

Medication errors involving oral chemotherapy

BACKGROUND:

Given the expanding use of oral chemotherapies, the authors set out to examine errors in the prescribing, dispensing, administration, and monitoring of these drugs.

METHODS:

Reports were collected of oral chemotherapy‐associated medication errors from a medical literature and Internet search and review of reports to the Medication Errors Reporting Program and MEDMARX. The authors solicited incident reports from 14 comprehensive cancer centers, and also collected incident reports, pharmacy interventions, and prompted clinician reports from their own center. They classified the type of incident, severity, stage in the medication use process, and type of medication error. They examined the yield of the various reporting methods to identify oral chemotherapy‐related medication errors.

RESULTS:

The authors identified 99 adverse drug events, 322 near misses, and 87 medical errors with low risk of harm. Of the 99 adverse drug events, 20 were serious or life‐threatening, 52 were significant, and 25 were minor. The most common medication errors involved wrong dose (38.8%), wrong drug (13.6%), wrong number of days supplied (11.0%), and missed dose (10.0%). The majority of errors resulted in a near miss; however, 39.3% of reports involving the wrong number of days supplied resulted in adverse drug events. Incidents derived from the literature search and hospital incident reporting system included a larger percentage of adverse drug events (73.1% and 58.8%, respectively) compared with other sources.

CONCLUSIONS:

Ensuring oral chemotherapy safety requires improvements in the way these drugs are ordered, dispensed, administered, and monitored. Cancer 2010. © 2010 American Cancer Society.     

The United States experience with diagnosing and treating esophageal cancer during the SARS-CoV-2 pandemic: A retrospective cohort study

The downstream effects on healthcare delivery during the initial wave of the COVID-19 pandemic remain unclear. The purpose of this study was to determine how the healthcare environment surrounding the pandemic affected the oncologic care of patients diagnosed with esophageal cancer. This was a retrospective cohort study evaluating patients in the National Cancer Database (2019–2020). Patients with esophageal cancer diagnoses were divided into pre-pandemic (2019) and pandemic (2020) groups. Patient demographics, cancer-related variables, and treatment modalities were compared. Among 26,231 esophageal cancer patients, 14,024 patients (53.5%) were in the pre-pandemic cohort and 12,207 (46.5%) were in the pandemic cohort. After controlling for demographics, patients diagnosed during the pandemic were more likely to have poorly differentiated tumors (odds ratio [OR] 1.24, 95% confidence interval [CI] 1.08–1.42), pathologic T3 disease compared to T1 (OR 1.25, 95% CI 1.02–1.53), positive lymph nodes on pathology (OR 1.36, 95% CI 1.14–1.64), and to be pathologic stage IV (OR 1.51, 95% CI 1.29–1.76). After controlling for oncologic characteristics, patients diagnosed during the pandemic were more likely to require at least two courses of systemic therapy (OR 1.78, 95% CI 1.48–2.14) and to be offered palliative care (OR 1.13, 95% CI 1.04–1.22). While these patients were offered curative therapy at lower rates, this became non-significant after risk-adjustment (p = .15). The pandemic healthcare environment was associated with significantly increased risk-adjusted rates of patients presenting with advanced esophageal cancer. While this led to significant differences in treatment, most of these differences became non-significant after controlling for oncologic factors.     

Cancer screening in theory and in practice.

Improvements in technology have led to a number of tests that can be used to suggest that a patient has a cancer. Advances in cancer biology and medical imaging have led to a number of cancer screening tests. Cancer screening is commonly advocated, but its complexity is often lost in guidelines that have sound-bite quality. It is commonly viewed as of no harm, when in fact there are harms associated with every known screening test. Indeed, many screening experts believe a screening test should only be used when the potential for benefit clearly outweighs the potential for harm. Cancer screening principles are classically within the realm of the epidemiologist. As more screening tests are developed, these principles have become more relevant to the practicing clinician. What is known and what is unknown about screening is distinctly different from what is believed by the public and many practicing clinicians. Many tests have both screening and diagnostic uses, and it is only the context in which these are used that determines whether they are screening or diagnostic. A screening test is done on asymptomatic individuals who receive the test principally because they are of the age or sex at risk for the cancer. A diagnostic test is done on an individual because of clinical suspicion of disease.     

Diagnostic accuracy and limitations of fine‐needle aspiration cytology of bone and soft tissue lesions

BACKGROUND:

Fine‐needle aspiration (FNA) cytology is increasingly being used as a diagnostic modality for soft tissue and bone lesions. These diagnoses can be challenging because of a variety of factors, including interpretation and sampling issues. This study investigates the diagnostic utility of FNA biopsy, in addition to the diagnostic pitfalls, in soft tissue and bone cytopathology.

METHODS:

We retrospectively reviewed the soft tissue and bone FNAs over a 4‐year period (2004‐2008), along with available ancillary studies, pathological follow‐up, and clinical data. The cases with a cytologic‐histologic discrepancy were then reviewed.

RESULTS:

A total of 1114 soft tissue and bone FNAs were identified. Of the 1114 aspirates, 525 (47%) were positive for malignant cells, 505 (45.5%) were benign aspirates (including 189 benign lesions/neoplasms), 37 (3.5%) were inadequate, 34 (3%) had atypical cells, and 13 (1%) were suspicious for malignancy. Of the 586 cases (53%) with follow‐up, including 445 cases with histological follow‐up and 141 with ancillary studies, the overall sensitivity was 96%, the specificity was 98%, the positive predictive value was 99%, and the negative predictive value was 92%. A total of 15 false negatives and 3 false positives were identified with errors because of sampling (9 cases), interpretation (7 cases), and screening (2 cases).

CONCLUSIONS:

This large series demonstrates that there can be a high sensitivity and specificity in diagnosing bone and soft tissue lesions by FNA. Our data supports prior studies in the literature in showing that FNA cytology can be a valuable method for diagnosing these lesions. Cancer (Cancer Cytopathol) 2010. © 2010 American Cancer Society.     

Cancer-related fatigue: evaluation and treatment

Cancer-related fatigue is one of the most common and disabling conditions referred by patients with neoplastic diseases. However, it is one of the symptoms related to cancer and its treatment, oncologists largely underestimate. The guidelines of the National Comprehensive Cancer Network on the diagnosis and treatment of this multifactorial pathology are illustrated. Attention is focused on the most recent evidences present in the literature about the therapeutic benefit of physical exercise and its effects on muscular function, cardiorespiratory performance and life quality of oncologic patients.     

Completeness and accuracy of registration of ovarian cancer in the cancer registry of Norway

Completeness of reporting and accuracy of the diagnosis of ovarian cancer from one health region in Norway to the Cancer Registry were examined. Data kept by the Cancer Registry were evaluated against discharge diagnosis data from all 8 hospitals in the health region during the period of 1987-1996. The assessment of the accuracy of the diagnosis recorded in the Cancer Registry was based on review of all medical records in the hospital setting and on slide review of all histologic diagnoses. The overall completeness of reporting ovarian cancer to the Cancer Registry was 99.6%. The organ specific completeness of registration of histologic verified ovarian cancer within the Cancer Registry was 95.3%; 0.9% was erroneously coded and 3.5% had their diagnosis changed to ovarian cancer at re-evaluation. Of all ovarian cancer cases registered at the Cancer Registry, 91% had a primary histologic diagnosis. Among 591 cases identified with a histologic diagnosis in the Cancer Registry, the accuracy of the diagnosis was estimated at 92%. Coding errors were found in 2% of these cases, while in 6% of the cases it was not possible to reproduce the original diagnosis of ovarian cancer at re-evaluation. In order to provide data of high quality for cancer surveillance a cancer registry needs several data providers, such as histopathologic laboratory reports and clinical reports. In addition, assessment of reported data through stringent quality assurance procedures within the registry are necessary for reaching a nearly 100% completeness of registration as found for ovarian cancer in the Cancer Registry of Norway.     

Incidence and Survival of Childhood Cancer Cases Diagnosed between 1998 and 2000 in Hiroshima City,Japan

There have been few studies on cancer incidence and survival among children in Japan. Childhood cancercases in Hiroshima City can be ascertained almost perfectly in terms of completeness and validity as both apopulation-based cancer registry and a tissue registry cover the whole area. We report here recent incidenceand survival of childhood cancer in Hiroshima City. Subjects were cancer patients less than 15 years of age inHiroshima City registered in the Hiroshima City Cancer Registry and/or the Hiroshima Prefecture TumorRegistry (tissue registry) between 1998 and 2000. Cancer incidence in Hiroshima City was calculated for 12diagnostic groups according to the International Classification of Childhood Cancer, and compared with generalincidence in Japan. Five-year survival was calculated by the Kaplan-Meier method. There were 63 children whohad a cancer newly diagnosed during 1998-2000, with only one death-certificate-only case (1.6%). Agestandardizedincidence rates (per million) was 144.3 for boys and 93.9 for girls. Leukemia was the most frequent(29%) among the 12 diagnostic groups. There were 13 cancer deaths during this period and five-year survivalwas 79% (95% Confidence Interval: 67%-87%). Childhood cancer incidence was slightly higher than that forall of Japan, but the relative distribution of patients by diagnostic group was compatible with the general pattern.Both of these observations might be due to the high quality of the tumor and tissue registries.     

Quality of breast cancer care: what do we know?

PURPOSE: To critically review studies that describe patterns of care for breast cancer patients and to examine the data sources used for case identification and determining patterns of care. METHODS: We searched the MEDLINE database (National Library of Medicine, Bethesda, MD) in August 2001 for studies of breast cancer care published from January 1985 to June 2001. Thirty-eight articles, describing 32 studies, met the inclusion criteria for this review. RESULTS: According to the patterns of care literature, approximately 10% of women do not have an axillary lymph node dissection, 11% to 26% do not have their hormone receptor status reported, 20% do not receive radiation after breast-conserving surgery, and 30% to 70% of women with lymph node-positive breast cancer are not prescribed tamoxifen. Twenty-five (78%) of the studies relied on cancer registries for case identification. Cancer registries (47%) and the medical record (38%) were the most frequent sources of data on process of care. Twenty percent of the articles reported using more than one data source to determine patterns of care. CONCLUSION: Although more patterns of care research has taken place in breast cancer than in any other oncologic condition, we found the available data had many limitations. These limitations highlight the challenges of quality-of-care research. To track changes in the quality of cancer care that may result from our rapidly transforming health care system, we need reliable data on the quality of current practice.     

Diagnostik maligner Lymphome

In the diagnostics of malignant lymphoma by pathology a definition of standards is difficult. In the diagnostic staged process in pathology, the type and number of analyses of the immunophenotype and the molecular characteristics are dependent on many parameters, such as tissue quality, differential diagnoses and also the experience of the pathologist. If investigations which are necessary for making a diagnosis are considered separately from investigations on the prognostic and predictive subtypes, it becomes clear that vast majority of lymphomas can be diagnosed exclusively using histopathology. A good communication of clinical findings to the pathologist can specify the classification of lymphomas and help to identify difficult differential diagnoses, for example in the diagnosis of Hodgkin’s lymphoma. The importance of molecular analyses lies especially in the identification of prognostic and predictive subgroups within the histopathologically defined entities, which is clearly exemplified by diffuse large cell B-cell lymphoma with the subtype defined via the gene expression.     

Breast cancer predictive factor testing: the challenges and importance of standardizing tissue handling

The introduction of breast biomarkers into clinical practice and their critically important role in adjuvant treatment decisions has created new challenges for the surgical pathology laboratory. In most institutions, the current standards for collection and preservation of clinical samples have been in place for decades and have focused on tissue preservation for morphologic examination, with little if any attention paid to preserving the quality of macromolecules that may be in the tissue. Because of the importance of these markers for determining the most appropriate treatments available for each patient, there is a need for standardizing pre-analytic variables, with the goal of developing standardized methods of tissue procurement and processing, and documenting how these variables affect the quality of tissue for biomarker testing and molecular analysis. By better defining specimen handling requirements and approaching diagnostic tissue samples as analytes, we can improve the quality of routine diagnostic samples, which in turn will enhance adjuvant treatment decisions when dealing with breast cancer and other solid tumor malignancies. The quality of archival tissue samples for future biomarker research will also benefit.     

A prospective study of risk-reducing salpingo-oophorectomy and longitudinal CA-125 screening among women at increased genetic risk of ovarian cancer: design and baseline characteristics: a Gynecologic Oncology Group study.

BACKGROUND: Women who are genetically predisposed to ovarian cancer are at very high risk of developing this disease. Although risk-reducing salpingo-oophorectomy (RRSO) and various screening regimens are currently recommended to reduce ovarian cancer risk, the optimal management strategy has not been established nor have multiple additional issues been adequately addressed. We developed a collaboration among the Clinical Genetics Branch (National Cancer Institute's Intramural Research Program), the Gynecologic Oncology Group (GOG), and the Cancer Genetics Network to address these issues. METHODS: This is a prospective, international, two-cohort, nonrandomized study of women at genetic risk of ovarian cancer, who chose either to undergo RRSO or screening, at study enrollment. Primary study objectives include quantifying and comparing ovarian and breast cancer incidence in the two study groups, assessing feasibility and selected performance characteristics of a novel ovarian cancer screening strategy (the Risk of Ovarian Cancer Algorithm), evaluating various aspects of quality of life and nononcologic morbidity related to various interventions in at-risk women, and creating a biospecimen repository for subsequent translational research. RESULTS: Study accrual is complete as of November 2006; 2,605 participants enrolled: 1,030 (40%) into the surgical cohort and 1,575 (60%) into the screening cohort. Five years of prospective follow-up ends in November 2011. Verification of BRCA mutation carrier status is under way, either through patient-provided reports from clinical genetic testing done before enrollment or through research-based genetic testing being conducted as part of the protocol. Patient eligibility is currently under evaluation and baseline, surgical, pathology, and outcome data are still being collected. The study design and selected baseline characteristics of cohort members are summarized. CONCLUSION: This National Cancer Institute intramural/extramural collaboration will provide invaluable prospectively collected observational data on women at high familial ovarian cancer risk, including substantial numbers of women carrying BRCA1/2 mutations. These data will aid in elucidating the effect of RRSO on breast/ovarian cancer risk and the effects of two management strategies, on quality of life and other issues that may influence patient care, as well as providing preliminary estimates of test specificity and positive predictive value of a novel ovarian cancer screening strategy.     

Evaluating the Impact of the COVID-19 Pandemic on New Cancer Diagnoses and Oncology Care in Manitoba

Individuals with cancer are vulnerable to infection with SARS-CoV-2, the virus causing COVID-19. Physical distancing, the reallocation of health care resources, and the implementation of procedures to reduce the spread of COVID-19 may also have serious consequences for people with cancer. We evaluated the impact of COVID-19 on new cancer diagnoses and oncology care in Manitoba, Canada using an interrupted time series design and data from the Manitoba Cancer Registry and CancerCare Manitoba’s (CCMB) electronic medical record. In April 2020, there was a 23% decrease in new cancer diagnoses, a 21% decrease in pathology reports, and a 43% reduction in surgical resections. There was no difference in new cancer diagnoses by August 2020, surgery by July 2020, and pathology reports by September 2020. From April 2020 to June 2021, there was a 13% decrease in radiotherapy (RT) fractions, an 18% decrease in UCC visits, and a 52% decrease in in-person visits. There was no change in intravenous chemotherapy visits per month, first RT visits, or overall patient visits. The impact of COVID-19 on shifts in the stage at diagnosis and survival will be assessed in future analyses.     

Patient-facing communication for cytopathologists: A framework for disclosing diagnostic error

Medical errors are a major source of harm to patients. Regulatory bodies mandate and patient safety experts advocate the disclosure of medical errors to patients to promote transparency and to create accountability for improving health care processes. Although pathologists regularly report errors—either to pathology or clinical colleagues or via internal safety reporting systems—few pathologists directly disclose those errors to patients. Yet many pathologists are interested in participating in the direct disclosure of medical errors to patients and may even be mandated to do so. When surveyed on why they do not directly disclose errors to patients, pathologists commonly cite a lack of confidence and a lack of training. Another barrier cited is the lack of a preexisting relationship between the pathologist and the patient. With respect to this last barrier, cytopathologists have a distinct advantage over surgical or clinical pathologists, as many cytopathologists regularly interact with and develop a rapport with patients when they are performing fine-needle aspiration (FNA) procedures. To improve the safety culture in pathology, direct error disclosure practices must be developed, supported, and strengthened. It is critical for cytopathologists to be comfortable with disclosing errors to patients. Being comfortable with disclosing an error, however, requires training, practice, and advance reflection. Using a practical, case-based format centered around FNA examples, this article addresses how to disclose a medical error to a patient. It provides a framework, heuristic principles, and structured conversation systems and talking points to guide the inexperienced pathologist to find his or her voice in a challenging disclosure conversation.     

Inequalities in the decline and recovery of pathological cancer diagnoses during the first six months of the COVID-19 pandemic: a population-based study

Background The restructuring of healthcare systems to cope with the demands of the COVID-19 pandemic has led to a reduction in clinical services such as cancer screening and diagnostics.Methods Data from the four Northern Ireland pathology laboratories were used to assess trends in pathological cancer diagnoses from 1st March to 12th September 2020 overall and by cancer site, sex and age. These trends were compared to the same timeframe from 2017 to 2019.Results Between 1st March and 12th September 2020, there was a 23% reduction in cancer diagnoses compared to the same time period in the preceding 3 years. Although some recovery occurred in August and September 2020, this revealed inequalities across certain patient groups. Pathological diagnoses of lung, prostate and gynaecological malignancies remained well below pre-pandemic levels. Males and younger/middle-aged adults, particularly the 50–59-year-old patient group, also lagged behind other population demographic groups in terms of returning to expected numbers of pathological cancer diagnoses.Conclusions There is a critical need to protect cancer diagnostic services in the ongoing pandemic to facilitate timely investigation of potential cancer cases. Targeted public health campaigns may be needed to reduce emerging inequalities in cancer diagnoses as the COVID-19 pandemic continues.Subject terms: Cancer epidemiology, Epidemiology, Cancer epidemiology, Pathology, Epidemiology     

Deep learning in cancer pathology: a new generation of clinical biomarkers

Clinical workflows in oncology rely on predictive and prognostic molecular biomarkers. However, the growing number of these complex biomarkers tends to increase the cost and time for decision-making in routine daily oncology practice; furthermore, biomarkers often require tumour tissue on top of routine diagnostic material. Nevertheless, routinely available tumour tissue contains an abundance of clinically relevant information that is currently not fully exploited. Advances in deep learning (DL), an artificial intelligence (AI) technology, have enabled the extraction of previously hidden information directly from routine histology images of cancer, providing potentially clinically useful information. Here, we outline emerging concepts of how DL can extract biomarkers directly from histology images and summarise studies of basic and advanced image analysis for cancer histology. Basic image analysis tasks include detection, grading and subtyping of tumour tissue in histology images; they are aimed at automating pathology workflows and consequently do not immediately translate into clinical decisions. Exceeding such basic approaches, DL has also been used for advanced image analysis tasks, which have the potential of directly affecting clinical decision-making processes. These advanced approaches include inference of molecular features, prediction of survival and end-to-end prediction of therapy response. Predictions made by such DL systems could simplify and enrich clinical decision-making, but require rigorous external validation in clinical settings.Subject terms: Targeted therapies, Tumour biomarkers, Computational science, Cancer imaging     

Trucut biopsy of breast lesions: the first step toward international standards in developing countries

The new concept in breast cancer diagnosis and treatment is based on a less invasive, more accurate and effective strategy, with a multidisciplinary approach in a specialised breast unit. When indicated, conservative surgery has replaced mastectomy with sentinel-node biopsy substituting routine axillary dissection. But the key factor in respect of these new standards is to confirm the cancer before going to the operating room. Trucut biopsy is performed instead of incisional or excisional biopsy and frozen section. The technique is reliable, simple, and reproducible, and not at all expensive; it can be adapted even for low-income developing countries. MATERIALS AND METHODS: Between March 2006 and June 2010, 764 patients under clinical suspicion of cancer and/or with BIRADS (Breast Imaging Reporting and Data System) III-V in imaging in one university and one private hospital in Tehran, Iran underwent trucut biopsy (60% palpable and 40% non-palpable lesions). Cancer was found in 30.8% of the cases. In benign pathology, in concordance with clinical and imaging suspicion, surgery was omitted with short-term follow-up. For palpable symptomatic benign lesions surgery was performed to relieve the patient's symptoms. When the pathology report was not in concordance with clinical/imaging suspicion (1.8%), and in the presence of moderate and severe hyperplasia with or without atypia, in lobular and papillary lesions (4.9%) open biopsy was done to rule out cancer (10 added cancers, 1.3%; total cancers 32.1%). Cancer surgery was done as a single procedure in 89.8% of cases. CONCLUSION: Trucut biopsy for breast lesion assessment is the first step toward a new concept in breast cancer care. It is simple, reduces the number of surgeries (no surgery for non-symptomatic benign lesions and one surgery for cancer), and avoids diagnostic errors with full respect for the patient's rights. We insist on its routine use to extend international guidelines while decreasing the total cost of this common disease in all low-resource countries.