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Use of fine-needle aspiration biopsy (FNAB) specimens on Xpert Breast Cancer STRAT4 Assay (STRAT4; Cepheid, Sunnyvale, CA, USA), a CE-marked in-vitro diagnostic medical device, could potentially increase access to breast cancer biomarker testing in resource-constrained settings. We aimed to assess the performance of a research use-only version of STRAT4 using FNAB specimens in Tanzania. In this prospective diagnostic accuracy study, patients aged 18 years or older with palpable breast masses presenting to the FNAB Clinic at Muhimbili National Hospital (Dar es Salaam, Tanzania) were recruited consecutively. Patients who were pregnant, lactating, or had a previous diagnosis of breast cancer were excluded. STRAT4 testing was performed on off-label FNAB samples using four protocols: the 1 × protocol (using the standard lysate method) on FNAB smears (1 × FNAB), quick lysis and Maui protocols (both on FNAB smears), and the 1 × protocol on formalin-fixed paraffin-embedded (FFPE) cell block material (1 × cell block). For 1 × FNAB and 1 × cell block, tissue was processed using FFPE lysis reagent, incubated at 80°C with proteinase K, and followed by addition of 95% or higher ethanol. Quick lysis was processed using FFPE lysis reagent and 95% or higher ethanol, whereas Maui was processed using a proprietary research-use only lysis reagent. The primary outcomes were overall concordance, sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) of STRAT4 as compared with immunohistochemistry or immunohistochemistry plus fluorescence in-situ hybridisation performed on cell blocks using clinically validated protocols in a Clinical Laboratory Improvement Amendments-accredited laboratory at the University of California, San Francisco (San Francisco, CA, USA). Between Nov 29, 2017, and Dec 17, 2020, 208 patients were enrolled. Of 208 cases, 51 (25%) were excluded from analysis because of insufficient tissue in the cell block or absent cell blocks, leaving 157 participants (all female) for analysis. For oestrogen receptor, 1 × FNAB had the best performance, with an overall concordance of 95% (95% CI 90–100), sensitivity of 94% (85–100), specificity of 97% (90–100), and AUC of 0·96 (0·81−1·00). For progesterone receptor, 1 × cell block had the best overall performance (overall concordance 89% [95% CI 84–95], sensitivity 91% [82–99], and specificity 89% [81–97], with an AUC of 0·93 [0·89−0·99]) and 1 × FNAB performed the best among the smear protocols, with a concordance of 84% (95% CI 74–93), sensitivity of 63% (43–82), specificity of 97% (92–100), and AUC of 0·91 (0·72−0·97). For HER2, Maui had the highest agreement, with an overall concordance of 93% (95% CI 89–98), sensitivity of 96% (88–100), specificity of 92% (87–98), and AUC of 0·95 (0·98–1·00). For Ki67, Maui had the best performance of smear protocols, with a concordance of 73% (95% CI 64–82), sensitivity of 70% (58–81), specificity of 81% (66–96), and AUC of 0·80 (0·54−0·82). Processing FNAB samples with STRAT4 is feasible in Tanzania, and performance for the oestrogen receptor is robust. Further optimisation of STRAT4 for FNAB has the potential to improve timely access to breast cancer diagnostics in resource-constrained settings. US National Institutes of Health; UCSF Global Cancer Program, Helen Diller Family Comprehensive Cancer Center; UCSF Department of Pathology; and Cepheid.

Abstract Background The incidence of breast and colorectal cancer (CRC) in younger-than-average-age patients is rising and poorly understood. This is the largest study on patients with both cancers who are less than 60 years old and aims to characterize demographic, clinicopathologic, and genetic features and describe therapeutic dilemmas and management strategies. Materials and Methods This is a retrospective medical records review of patients at the University of California San Francisco with both primary breast and CRC before age 60. Results Fifty-one patients were identified; 41 had detailed medical records. Median age of diagnosis with breast cancer was 43 (range 27-59) and CRC was 50 (28-59). Most were Caucasian (38, 74.5%) and never smokers (23, 56.1%); about half were current alcohol consumers (20, 48.8%) and about one-third had sedentary jobs (14, 34.1%). Average BMI was 25.8 (range: 14-49), and 30% were overweight or obese. Breast was the first cancer diagnosed in 36 patients (70.6%) and 44 (86.3%) had a metachronous CRC diagnosis. Breast cancer was early stage (0-2) in 32 (78.0%) patients whereas CRC was split between early stage (1-2) in 14 (34.1%) and later stage (3-4) in 19 (46.2%). Ten patients (24.3%) had a known germline mutation, although 23 (56.1%) had a family history of cancer in a first-degree relative. Conclusion Younger patients with both breast and CRC are a unique cohort, often without known risk factors. Alcohol consumption and sedentary jobs were the most common risk factors, and about one-quarter had a known genetic predisposition. Comanagement of both cancers requires individualized, multidisciplinary care. Little is known about the proportion of young patients affected by dual diagnoses of breast cancer and colorectal cancer. This is the largest study to date on patients with both cancers who are younger than 60 years.

Background Over 1.3 million people live with colorectal cancer in the United States. Physical activity is associated with lower risk of colorectal cancer recurrence and mortality. Interventions are needed to increase physical activity in colorectal cancer survivors. Methods We conducted a 2-arm non-blinded pilot randomized controlled trial at the University of California, San Francisco among 42 individuals who had completed curative-intent treatment for colorectal cancer to determine the feasibility and acceptability of a 12-week (84 days) physical activity intervention using a Fitbit Flex™ and daily text messages. Participants were randomized 1:1 to receive the intervention with print educational materials or print educational materials alone. We explored the impact of the intervention versus usual care on physical activity using ActiGraph GT3X+ accelerometers pre−/post-intervention. Results We screened 406 individuals and randomized 42 to intervention ( n  = 21) or control ( n  = 21) groups. During the 12-week study, the intervention arm wore their Fitbits a median of 74 days [88% of days in study period, interquartile range: 23–83 days] and responded to a median of 34 (out of 46) text messages that asked for a reply (interquartile range: 13–38 text messages). Among the 16 intervention participants who completed the feedback survey, the majority (88%) reported that the intervention motivated them to exercise and that they were satisfied with their experience. No statistically significant difference in change in moderate-to-vigorous physical activity was found from baseline to 12 weeks between arms. Conclusion A 12-week physical activity intervention with a Fitbit and text messages was feasible and acceptable among colorectal cancer patients after curative treatment. Larger studies are needed to determine whether the intervention increases physical activity. Trial registration Clinicaltrials.gov Identifier NCT02966054 . Registered 17 November 2016, retrospectively registered.

Women with breast cancer in sub-Saharan Africa are commonly diagnosed at advanced stages. In Tanzania, more than 80% of women are diagnosed with stage III or IV disease, and mortality rates are high. This study explored factors contributing to delayed diagnostic evaluation among women with breast cancer in Tanzania. A qualitative study was performed at Muhimbili National Hospital in Dar es Salaam, Tanzania. Twelve women with symptomatic pathologically proven breast cancer were recruited. In-depth, semi-structured interviews were conducted in Swahili. Interviews explored the women's journey from symptom recognition to diagnosis, including the influence of breast cancer knowledge and pre-conceptions, health seeking behaviors, psychosocial factors, preference for alternative treatments, and the contribution of culture and norms. Audio-recorded interviews were transcribed and translated into English. Thematic analysis was facilitated by a cloud-based qualitative analysis software. All women reported that their first breast symptom was a self-identified lump or swelling. Major themes for factors contributing to delayed diagnostic presentation of breast cancer included lack of basic knowledge and awareness of breast cancer and misconceptions about the disease. Participants faced barriers with their local primary healthcare providers, including symptom mismanagement and delayed referrals for diagnostic evaluation. Other barriers included financial hardships, fear and stigma of cancer, and use of traditional medicine. The advice and influence of family members and friends played key roles in healthcare-seeking behaviors, serving as both facilitators and barriers. Lack of basic knowledge and awareness of breast cancer, stigma, financial barriers, and local healthcare system barriers were common factors contributing to delayed diagnostic presentation of breast cancer. The influence of friends and family also played key roles as both facilitators and barriers. This information will inform the development of educational intervention strategies to address these barriers and improve earlier diagnosis of symptomatic breast cancer in Tanzania.

PurposeNo information is available on cancer patients’ knowledge of and experiences with COVID-19. We undertook an evaluation of differences in COVID-19 symptom occurrence rates, COVID-19 testing rates, clinical care activities, knowledge of COVID-19, and use of mitigation procedures between patients who were and were not receiving active cancer treatment.MethodsPatients enrolled were > 18 years of age; had a diagnosis of cancer; and were able to complete the emailed study survey online.ResultsOf the 174 patients who participated, 27.6% (n = 48) were receiving active treatment, 13.6% were unemployed because of COVID-19, 12.2% had been tested for COVID-19, and 0.6% had been hospitalized for COVID-19. Patients who were not on active treatment reported a higher mean number of COVID-19 symptoms (3.1 (± 4.2) versus 1.9 (± 2.6)), and patients who reported a higher number of COVID-19 symptoms were more likely to be tested. Over 55% of the patients were confident that their primary care provider could diagnose COVID-19, and the majority of the patients had high levels of adherence with the use of precautionary measures (e.g., social distancing, use of face coverings).ConclusionThe high level of COVID-19 symptoms and the significant overlap of COVID-19 and cancer-related symptoms pose challenges for clinicians who are assessing and triaging oncology patients for COVID-19 testing. For patients on active treatment, clinicians face challenges with how to assess and manage symptoms that, prior to COVID-19, would be ascribed to acute toxicities associated with cancer treatments or persistent symptoms in cancer survivors.

Background/Aim: The majority of colorectal cancer (CRC) cases, which are microsatellite stable (MSS) and do not harbor mismatch repair deficiency/microsatellite instability, are resistant to immunotherapy. Identification of patients with exceptional responses in MSS CRC and predictive biomarkers is an unmet need that needs to be addressed. Case Report: We report three cases of MSS CRC with durable clinical benefit from immunotherapy with anti-PD-1 checkpoint inhibitors. Two cases bear a POLE P286R mutation, which has been associated with lack of immunotherapy response in MSS CRC. Two cases bear alterations in Ataxia-Telangiectasia Mutated (ATM) which may contribute to observed responses, including interaction with a co-administered intratumoral stimulator of interferon genes (STING) pathway agonist in one patient. Conclusion: Novel DNA damage repair alterations, including mutations in ATM, can provide insight into additional mechanisms by which genomic alterations can sensitize MSS CRC to diverse immunotherapies.

Background Extrahepatic disease progression limits clinical efficacy of Yttrium-90 ( 90 Y) radioembolization (TARE) for patients with chemotherapy-refractory metastatic colorectal cancer (mCRC). Trifluridine and tipiracil (TAS-102) has overall survival benefit for patients with refractory mCRC and may be a radiosensitizer. Methods Sequential lobar TARE using 90 Y resin microspheres in combination with TAS-102 in 28-day cycles were used to treat adult patients with bilobar liver-dominant chemo-refractory mCRC according to 3 + 3 dose escalation design with a 12-patient dose expansion cohort. Study objectives were to establish safety and determine maximum tolerated dose (MTD) of TAS-102 in combination with TARE. Results A total of 21 patients (14 women, 7 men) with median age of 60 years were enrolled. No dose limiting toxicities were observed. Treatment related severe adverse events included cytopenias (10 patients, 48%) and radioembolization-induced liver disease (2 patients, 10%). Disease control rate in the liver lobes treated with TARE was 100%. Best observed radiographic responses were partial response for 4 patients (19%) and stable disease for 12 patients (57%). Conclusions The combination of TAS-102 and TARE for patients with liver-dominant mCRC is safe and consistently achieves disease control within the liver. Trial registration ClinicalTrials.gov identifier NCT02602327 (first posted 11/11/2015).

Persisting sex- and gender-based disparities in access to high-quality, personalized health care in the United States can lead to devastating outcomes with long-lasting consequences. Strategic use of virtual resources could expand equitable health care access for women. However, optimal approaches and timing for individualized, virtually delivered health care for women are unclear. This study aims to conduct a detailed analysis of the current literature to answer the following question: \"According to women and their health care teams, what are the reported successes and challenges in accessing, delivering, and participating in synchronous virtual health care for women?\" We conducted a qualitative evidence synthesis using a best-fit framework approach based on the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework and concepts from the Public Health Critical Race Praxis. We searched MEDLINE, Embase, and CINAHL from January 1, 2010, to October 10, 2022, using a combination of database-specific, relevant, controlled vocabulary terms and keywords; this search was updated in MEDLINE through January 2024. Additional citations were identified through handsearching. Our eligibility criteria were developed using the Sample, Phenomenon of Interest, Design, Evaluation, Research type tool to identify qualitative studies addressing synchronous virtual care for women. Citations were screened in duplicate, and eligible articles were abstracted. An iterative thematic synthesis approach was used to identify descriptive themes related to the successes and challenges related to delivering high-quality virtual care. Data reduction was performed using inductive and deductive reasoning. Quality assessment was conducted using the Critical Appraisal Skills Program and certainty of evidence using Confidence in the Evidence from Reviews of Qualitative Research approaches. Of 85 eligible articles, we sampled 51 (60%) for data extraction based on representation of patient and clinician perspectives, marginalized voices, and relevance to a variety of clinical contexts. We identified themes across NASSS domains, including difficulty building rapport and emotional connections in the virtual setting, the amplification of barriers for women with preexisting challenges (eg, language barriers, limited transportation, and family and social commitments), and differing perceptions of privacy and safety related to virtual care depending on patient home context. Themes found to have high confidence included the value of convenience and cost savings offered by virtual care, the importance of patient choice in visit modality, the potential for negative impact on user well-being, considering the clinical context of modality choice, the importance of technology usability, and the value of virtual care for women located in regions without adequate supply of clinical offerings. The benefits of virtual care for health care access may be more acutely felt by women, especially those with preexisting challenges. Strategic incorporation of virtual modalities into health care delivery for women could improve equitable access to high quality, patient-centered care. PROSPERO CRD42021283791; https://www.crd.york.ac.uk/PROSPERO/view/CRD42021283791. RR2-10.1089/heq.2023.0089.

We estimated the 5-year overall, age at diagnosis- and stage-specific colorectal cancer survival in patients treated through their coverage with Seguro Popular. We conducted a retrospective study using a dataset that included 1418 colorectal cancer patients covered by Seguro Popular (Mexico’s public health insurance system covering 60 % of the population) between 2013 and 2016. Deaths were identified using the Epidemiologic Death Statistics Subsystem registry, with a specialized algorithm for record linkage. The Kaplan-Meier method was used to estimate overall survival curves and the proportion of patients alive at various follow-up time points. We compared survival curves across subgroups using the log-rank test. In this study the average age at diagnosis was 56 years with 31.9 % of patients diagnosed before the age of 50. Most cases (78.1 %) were diagnosed in advanced stages (i.e., III and IV), with nearly half of the cases originating in the rectum. The overall 5-year survival was 50 %, with higher survival (74 %) for patients with stage I-II and lower survival for those with stage III (58 %) and IV (33 %). While age at diagnosis was not associated with survival for early-stage colorectal cancer, younger patients with metastatic disease had a worse prognosis compared to older patients. The 5-year overall colorectal cancer survival was 50 %, with variation by clinical stage. Almost 80 % of the population was diagnosed with advanced stages, underscoring the need for screening programs. Younger patients with metastatic disease exhibited a worse prognosis, highlighting the need for targeted interventions. •Advanced colorectal cancer stages at diagnosis is common among a cohort of Mexican patients.•Seguro Popular data reveals that only half of colorectal cancer patients survived past five years.•Rising colorectal mortality among Mexicans under 50 highlights early screening need.