Understanding Factors Associated With Anaplastic Lymphoma Kinase Testing Delays in Patients With Non-Small Cell Lung Cancer in a Large Real-World Oncology Database.

CONTEXT.­: With multiple therapeutic options available for patients with advanced non-small cell lung cancer, the timely ordering and return of results to determine therapy are of critical importance. OBJECTIVE.­: To assess factors impacting anaplastic lymphoma kinase (ALK) test ordering and time to result delivery. DESIGN.­: A retrospective study using a de-identified electronic health record database was performed. Postdiagnosis ALK tests (n = 14 657) were analyzed from 14 197 patients with advanced non-small cell lung cancer diagnosed between January 2015 and May 2019. Time from non-small cell lung cancer diagnosis to ALK sample receipt in the laboratory was a surrogate for test order time. Test ordering was considered delayed if order time was more than 20 days. Turnaround time from sample received to test result was calculated and considered delayed if more than 10 days. Multivariable logistic regression was used to assess factors associated with order time and turnaround time delays. RESULTS.­: Median ALK test order time was 15 days, and 36.4% (5342) of all 14 657 orders were delayed. Factors associated with delays were non-fluorescence in situ hybridization testing, send-out laboratories, testing prior to 2018, nonadenocarcinoma histology, and smoking history. Median turnaround time was 9 days, and 40.3% (5906) of all 14 657 test results were delayed. Non-fluorescence in situ hybridization testing, tissue sample, and orders combining ALK with other biomarkers were associated with delayed ALK result reporting. CONCLUSIONS.­: This study provides a snapshot of real-world ALK test ordering and reporting time in US community practices. Multiple factors impacted both test ordering time and return of results, revealing opportunities for improvement. It is imperative that patients eligible for targeted therapy be identified in a timely fashion.

The College of American Pathologists Foundation's See, Test & Treat Program®: an Evaluation of a One-Day Cancer Screening Program Implemented in Mississippi.

Women in Mississippi experience significant barriers to healthcare that results in high incidence rates of late-stage breast, cervical, and oropharyngeal cancer. We implemented See, Test, & Treat, a cancer screening and education program, that was aimed at increasing access to cancer screening for underserved women in the Jackson Metropolitan Area. During the event, 103 women between the ages of 21 and 69 years old received breast, cervical, and/or oral cancer screenings. Quantitative and qualitative data were collected to evaluate the effect of the program on the participants' cancer screening knowledge, self-efficacy to obtain medical check-ups, and intentions to engage in health-enhancing behaviors. Of the 57 women who received a mammogram, 18 had abnormal results that required follow-up care. None of the women who received a Pap test had abnormal results, but 8 women were diagnosed with trichomoniasis. One woman was diagnosed with stage 4 oral cancer. The evaluation data indicated that participants found that free cancer screenings and receipt of results on the same day were primary benefits of the program.

Anaplastic lymphoma kinase rearrangement prevalence in patients with advanced non-small cell lung cancer in the United States: retrospective real world data.

OBJECTIVE: This study assessed the prevalence of anaplastic lymphoma kinase (ALK) rearrangements in US oncology practices. MATERIALS AND METHODS: Using a nationwide real-world database, we included adults with advanced non-small cell lung cancer (aNSCLC, stage IIIB- IV) diagnosed January 2015 - May 2019, with documented ALK testing results and smoking status. Rearrangement prevalence was assessed overall and then stratified by patient characteristics. RESULTS: The cohort included 19,895 eligible patients with a mean age 68.5 years, majority ever-smokers (85.5%) and from community centers (92.2%). The overall ALK rearrangement prevalence was 2.6%. Positivity rate varied by histology and smoking status; it was the highest among non-smoking patients with non-squamous histology (9.3%). Differences in ALK status also varied by age and race, with young patients (18-39 years) having a higher prevalence (21.6%) vs. older patients (age ≥55 = 2.2%); Asian patients had a prevalence of 6.3%. Patients that were positive for other mutations or rearrangements had a lower ALK positivity rate (0.5%) and patients positive for PD-L1 had a rate of 3.0%. CONCLUSIONS: The likelihood of finding an ALK translocation was highest in younger patients and nonsmokers; however, age and smoking history were not discriminative enough to exclude testing based on clinical variables.

Philip T. Cagle, MD-Editor-in-Chief of the Archives of Pathology & Laboratory Medicine, 2005-2019.

• The Archives of Pathology & Laboratory Medicine was first published in 1926 as a specialty journal of the American Medical Association. It became the official journal of the College of American Pathologists in 1995. Under the dynamic leadership of its most recent editor-in-chief, Philip T. Cagle, MD, the Archives has dramatically increased its impact factor and become the most widely read general pathology journal. Dr. Cagle has consistently added leading pathologists to the editorial board, and the collective expertise of these individuals is clearly evident in new, cutting-edge journal masthead sections. The Archives has featured innovative content in the field of digital pathology, including articles on the utilization of smart phones in pathology and the incorporation of whole-slide images and videos into the content of articles. During the current editorial board's tenure, special sections were introduced and have proven immensely popular with the journal's readership. As the Archives celebrates its 94th anniversary, its editorial board remains committed to providing insightful and relevant medical knowledge. The journal's open access Web site ( www.archivesofpathology.org ) allows the dissemination of this information to every corner of the globe at no expense to those who wish to expand their knowledge or improve their medical practice. Dr. Cagle, with support from the editorial board and journal staff, has worked tirelessly during his tenure as Archives editor-in-chief to greatly enhance the content of the journal and its stature within pathology and laboratory medicine.

Update on emerging biomarkers in lung cancer.

There has been considerable progress made in identifying oncogenic driver mutations in advanced lung cancer. The recognition that lung cancer is actually an umbrella classification that is comprised of multiple molecular subgroups has had a profound impact on how medical oncologists make treatment decisions. These mutations are clinically important as available targeted therapies can achieve significant responses and prolonged disease control. This review will summarize the current guidelines for biomarker testing and available therapeutic agents.

"Please Help Me See the Dragon I Am Slaying": Implementation of a Novel Patient-Pathologist Consultation Program and Survey of Patient Experience.

CONTEXT.­: Pathologists evaluate human disease and teach medical students, residents, and clinicians. Historically recognized as the "doctor's doctor," pathologists are well suited to be a direct patient resource of individualized, accurate information. OBJECTIVE.­: To develop and implement a pathology consultation service whereby patients review their tissue slides directly with pathologists. DESIGN.­: A pathologist conducted patient consultations, reviewing biopsy or surgery findings on a multiheaded microscope or computer screen. The pathologist evaluated patients' understanding of their disease and invited patients to ask specific questions. We recorded patient demographic data and assessed utilization with a short patient satisfaction survey using 6 questions with a 5-point Likert scale and 2 questions for open response. RESULTS.­: A total of 31 patients came for consultation; 39% (12 of 31) were accompanied by a friend or family member. Patients' median age was 59 years, with a strong female predominance (90%; 28 of 31). The majority of patients had breast cancer (58%; 18 of 31) or hematologic malignancy (19%; 6 of 31). Of the 31 patients, the survey response rate was 58% (18 of 31). Top-box scoring demonstrated program support, with 89% (16 of 18) of respondents strongly recommending the experience to another patient. Additionally, 78% (14 of 18) strongly agreed that they felt more empowered after seeing their disease. Mean scores for Likert-based questions all were higher than 4.0. CONCLUSIONS.­: To our knowledge, this study is the first report of direct patient-pathologist consultation. Early data suggest that the program may provide effective patient-specific education. The high response rate and favorable assessment of the program suggest that it may be a valuable resource for some patients.

The Legal Aspects of Diversity in Academic Pathology.

Diversity and inclusion in academic pathology center on building a diverse, inclusive pathology faculty. Understanding the basics of federal law, and the US Supreme Court cases that interpret those laws, allows one to consider good practices in diversity hire recruitment and retention that protects the pathology chair, the pathology department, and the institution. Consideration of inclusion and unconscious bias are helpful in building and sustaining robust, valuable academic pathology faculty diversity.

Guidelines for Pathologic Diagnosis of Malignant Mesothelioma 2017 Update of the Consensus Statement From the International Mesothelioma Interest Group.

CONTEXT: - Malignant mesothelioma (MM) is an uncommon tumor that can be difficult to diagnose. OBJECTIVE: - To provide updated, practical guidelines for the pathologic diagnosis of MM. DATA SOURCES: - Pathologists involved in the International Mesothelioma Interest Group and others with an interest and expertise in the field contributed to this update. Reference material included up-to-date, peer-reviewed publications and textbooks. CONCLUSIONS: - There was discussion and consensus opinion regarding guidelines for (1) distinguishing benign from malignant mesothelial proliferations (both epithelioid and spindle cell lesions), (2) cytologic diagnosis of MM, (3) recognition of the key histologic features of pleural and peritoneal MM, (4) use of histochemical and immunohistochemical stains in the diagnosis and differential diagnosis of MM, (5) differentiating epithelioid MM from various carcinomas (lung, breast, ovarian, and colonic adenocarcinomas, and squamous cell and renal cell carcinomas), (6) diagnosis of sarcomatoid MM, (7) use of molecular markers in the diagnosis of MM, (8) electron microscopy in the diagnosis of MM, and (9) some caveats and pitfalls in the diagnosis of MM. Immunohistochemical panels are integral to the diagnosis of MM, but the exact makeup of panels employed is dependent on the differential diagnosis and on the antibodies available in a given laboratory. Depending on the morphology, immunohistochemical panels should contain both positive and negative markers for mesothelial differentiation and for lesions considered in the differential diagnosis. Immunohistochemical markers should have either sensitivity or specificity greater than 80% for the lesions in question. Interpretation of positivity generally should take into account the localization of the stain (eg, nuclear versus cytoplasmic) and the percentage of cells staining (>10% is suggested for cytoplasmic and membranous markers). Selected molecular markers are now being used to distinguish benign from malignant mesothelial proliferations. These guidelines are meant to be a practical diagnostic reference for the pathologist; however, some new pathologic predictors of prognosis and response to therapy are also included.