Archive for month: December, 2024

There are several strategies for the early detection of prostate cancer. The first step is often a blood test for prostate-specific antigen (PSA). If PSA levels exceed a certain threshold, the next step typically involves taking a tissue sample for analysis. Another option is to use magnetic resonance imaging (MRI) to search for signs of a tumor before deciding whether a biopsy is necessary, reserving biopsies only for cases where abnormalities are detected. Researchers at Charité – Universitätsmedizin Berlin conducted a study to determine whether this MRI-first approach is safe over the long term. Their findings show that this strategy poses no additional risk to patients for at least three years. The study has now been published in the journal JAMA Oncology.*

The conventional approach to diagnosing prostate cancer includes clinical examination and prostate-specific antigen (PSA) testing. PSA testing measures the levels of this protein in the blood, which can be elevated in prostate cancer. However, elevated levels can also result from non-cancerous conditions. Traditionally, elevated PSA levels have led to a punch biopsy, where ten to 12 tissue samples are taken systematically from the prostate – a procedure that is associated with unpleasant side effects for several days afterward and carries a certain risk of infection. Additionally, PSA-driven “blind” biopsies often result in overdiagnosis of slow-growing, clinically insignificant cancers while risking the oversight of aggressive cancers.

“These side effects of systematic biopsies urged us to find out if MRI is reliable and safe for biopsy decision-making in men with suspected prostate cancer, and if men without abnormal MRI findings can safely skip immediate biopsy and enter clinical follow-up”, says Dr. Charlie Hamm, the first author of the publication and a physician at the Department of Radiology at Charité who is also a Junior Digital Clinician Scientist at the Berlin Institute of Health at Charité (BIH).

No need for a biopsy with negative MRI findings

This approach, in which normal MRI findings are followed by regular urological checks, did in fact prove to be sufficiently reliable: The study found that 96 percent of patients with a normal MRI result would not go on to develop aggressive prostate cancer within three years. Aggressive prostate cancer was detected during further monitoring in just four percent of participants whose initial MRI findings had been negative.

“That means the cancer risk is very low when MRI scans of the prostate do not show any cancer suspicious findings,” says Dr. Hamm. “Normal MRI findings alone do not offer one hundred percent certainty, but with regular monitoring, potential cancer can still be detected early enough. For many patients, that means they can avoid the discomfort of a biopsy at first and do not need to worry about having cancer that will remain undetected.”

Monitoring is sufficient for early detection of cancer

The team included and monitored nearly 600 patients with suspected prostate cancer in their study. The subjects underwent multiparametric magnetic resonance imaging (mpMRI) at Charité. This type of MRI detects multiple tissue-specific parameters, including the signal intensity of the prostate tissue, the blood flow or perfusion, and the diffusion of water molecules in the tissue. A team of experienced radiologists interpreted the images. “Tissue samples were taken only if the MRI showed suspicious findings in the prostate. Patients with normal MRI findings underwent regular urological check-ups for three years instead. That allowed us to see whether the MRI pathway is safe,” Dr. Hamm says, explaining the study design.

High-quality MRI findings and safety net are essential

The study has now been completed after eight years. “Our findings are an important step toward personalized care of prostate cancer patients. By using MRI for biopsy decision-making, we can ensure that patients receive the right tests and treatments at the right time,” Dr. Hamm says.

The results are also relevant for doctors when it comes to supporting their patients in deciding when a biopsy is really needed. The European Association of Urology (EAU) guidelines already recommend that an MRI should be performed before a prostate biopsy. However, it was previously unclear how safe it would be to skip the biopsy altogether in cases of negative MRI results. “Our results now show that the MRI pathway is safe and effective, including in a decentralized outpatient care network,” Dr. Hamm comments. “We hope the study will serve as impetus to further enhance the standing of MRI as an aid to deciding for or against a biopsy in the German guidelines, and elsewhere.”

However, the study’s authors say two other aspects are crucial if the new findings are to be incorporated into practice in the near term. First, a high-quality MRI scan must be performed and analyzed by experienced experts; that means training more radiologists in the detailed and accurate interpretation of prostate MRI scans and using standardized methods. Second, it is important to create a safety net for patients who do not undergo immediate biopsy. “That means clear guidelines for PSA testing, follow-up MRIs, and criteria for when a biopsy might be needed later on,” Dr. Hamm points out.

Reference:

Hamm CA, Asbach P, Pöhlmann A, et al. Oncological Safety of MRI-Informed Biopsy Decision-Making in Men With Suspected Prostate Cancer. JAMA Oncol. Published online December 12, 2024. doi:10.1001/jamaoncol.2024.5497

Hair loss during chemotherapy can cause enough distress for some women to lose self-confidence, which experts say may discourage them from seeking chemotherapy in the first place.

Oral minoxidil is a commonly prescribed treatment for hair loss. The drug is also the active ingredient in over-the-counter Rogaine. The prescription treatment is known, however, to dilate blood vessels, and experts worry that this could increase the heart-related side effects of chemotherapy and lead to chest pain, shortness of breath, or fluid buildup.

Now, a study in women with breast cancer suggests that low oral doses of minoxidil, taken during or after cancer treatment, appear to regrow hair in most patients and without causing any serious heart-related side effects that require additional therapies or hospitalization.

Led by researchers at NYU Langone Health, the new analysis included 51 women who were treated for various stages of breast cancer, of whom 25 had some combination of surgery or radiation in addition to chemotherapy, and 26 had only the former two therapies.

“Our results should offer reassurance to breast cancer patients that there is indeed a safe way to combat their hair loss,” said study co-lead author, Devyn Zaminski, BA, a medical student at NYU Grossman School of Medicine.

While past studies have examined the use of minoxidil in breast cancer patients, the new work is among the most comprehensive to date to look at both the safety and benefits of minoxidil on breast cancer patients, the researchers say.

A report on the investigation published online Dec. 3 in the Journal of the American Academy of Dermatology.

For the analysis, the research team collected data from NYU Langone Health’s electronic health record system from 2012 to 2023. Out of hundreds of breast cancer patients who were also prescribed oral minoxidil for hair loss, the investigators identified 51 women who had taken the medication for longer than one month and who had data in their charts regarding how well the drug was tolerated. Researchers took into account age, race, and past medical history. They looked at breast cancer details, other medications, and additional demographic factors.

Based on both physician assessments and the patients’ self-reports, all who took a low dose of oral minoxidil saw either improvements in hair growth or stabilization of their hair loss within three to six months of starting the therapy.

“Based on these findings, minoxidil has been shown to be safe for patients while also being effective,” said co-senior author, Kristen Lo Sicco, MD, associate professor in the Ronald O. Perelman Department of Dermatology at NYU Grossman School of Medicine. “The effectiveness of minoxidil may therefore help patients restore their sense of self and some control in a situation where it has been visibly taken away,” said Lo Sicco.

Lo Sicco suggests that additional research is needed to affirm the new results in more patients and people with other forms of cancer and chemotherapy regimens.

The research team cautions that patients may not have disclosed mild heart-related side effects, such as minor fluid buildup, because they could have occurred without any symptoms. As a result, issues may not have been entered into the patients’ health charts. Another limitation of the study, the team notes, is that some of the assessments by physicians and patients were self-reported or observed.

Reference:

Zaminski, Devyn et al., Tolerability and effectiveness of low-dose oral minoxidil for alopecia in patients with breast cancer: a retrospective cohort study, Journal of the American Academy of Dermatology, DOI: 10.1016/j.jaad.2024.11.048 

Digital healthcare consultations are not enough for a safe assessment of tonsillitis, according to a study from the University of Gothenburg. Reliability will not be sufficient, thus increasing the risk of over- or undertreatment of a sore throat.

Tonsillitis is a common reason for visits to the doctor and prescriptions of antibiotics in primary care. To determine whether a patient needs antibiotics, doctors use the so-called Centor Criteria for tonsillitis. The criteria include fever, tender and swollen lymph nodes in the angles of the jaw and inspection of the tonsils.

However, it has been unclear how well these criteria can be assessed during digital healthcare consultations compared to traditional in-person consultations. This lack of scientific evidence has become a growing concern as digital healthcare consultations become more common.

Digital vs physical assessment

The current study, published in the journal Infectious Diseases, examines whether digital assessments are as reliable as physical examinations in determining whether antibiotic treatment is warranted. The study includes 189 patients who sought care at healthcare clinics and urgent care clinics in Region Västra Götaland, Sweden, between January 2020 and October 2023.

Each patient in the study underwent two assessments: a digital medical assessment via video and a physical examination conducted by another doctor. The results show that digital healthcare consultations are not sufficient to assess some of the most important criteria, such as tonsil inspection and lymph node examination.

Digital not safe enough

One of the driving forces behind the study is Patrycja Woldan-Gradalska, a PhD student at Sahlgrenska Academy at the University of Gothenburg and a Resident Physician at Sätila Healthcare Clinic.

“Our study shows that although digital healthcare consultations are convenient for many patients, they are not reliable enough to assess tonsillitis. To ensure a correct diagnosis and treatment, it is still important to conduct a physical examination,” she says.

Reference:

Woldan-Gradalska, P., Gradalski, W., Moradi, S., Franzelius, M., Folkerman, S., Fuchs, E. M., … Sundvall, P. D. (2024). Inter-rater reliability of Centor score assessments between telemedicine and in-person examinations in patients with an acute sore throat. Infectious Diseases, 1–9. https://doi.org/10.1080/23744235.2024.2434878

A new study published in the Annals of Internal Medicine found that anticoagulation at therapeutic dose decreased 28-day mortality when compared to prophylactic dose. Thrombosis and systemic inflammation are common in COVID-19 hospitalized patients. Many randomized trials have examined the role of thromboprophylaxis with anticoagulants, most commonly low-molecular-weight heparins, unfractionated heparin, and direct-acting oral anticoagulants.

These trials have reported clinical benefit, no benefit, and potential harm with different anticoagulation drugs and doses in patients with varying severity of COVID-19. Prior to this, the World Health Organization (WHO) Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group published prospective meta-analyses assessing sodium-glucose cotransporter-2 inhibitors, corticosteroids, and interleukin-6 antagonists in these individuals.

This study was set to determine the relationships between higher-versus lower-dose anticoagulation and significant bleeding, thromboembolic events, progression to invasive mechanical ventilation (IMV) or death, and mortality by 28 days following randomization in patients hospitalized with COVID-19.

Without restriction to trial status or language, randomized studies were found using ClinicalTrials.gov and the International Clinical Studies Registry Platform of the World Health Organization. Patients hospitalized with COVID-19 were allocated to higher-dose anticoagulation vs lower-dose anticoagulation in eligible randomized studies.

The data from 20 eligible studies was submitted in a manner that was agreed upon in advance. On the basis of published data, two more investigations were included. All-cause mortality 28 days post-randomization was the main endpoint. Major bleeding, thromboembolic events, and death or progression to invasive mechanical ventilation were secondary outcomes.

Heparin-based therapeutic anticoagulation decreased 28-day mortality when compared to preventive anticoagulation. The odds ratios for 28-day mortality were 0.95 for intermediate-dose anticoagulation versus prophylactic-dose anticoagulation and 1.21 for therapeutic dose versus intermediate-dose anticoagulation.

Although the power of certain analyses was restricted, treatment effects seemed to be generally consistent across established patient subgroups. Higher-dose anticoagulation was linked to a higher risk of significant bleeding but fewer thromboembolic events than lower-dose anticoagulation.

Overall, therapeutic anticoagulation, as opposed to preventative anticoagulation, decreased 28-day mortality in this prospective meta-analysis of clinical trials evaluating anticoagulant dosages for hospitalized COVID-19 patients. Increased-dose anticoagulation was linked to an increased risk of significant bleeding but fewer thromboembolic events for each comparison.

Reference:

Vale, C. L., Godolphin, P. J., Fisher, D. J., Higgins, J. P. T., McAleenan, A., Spiga, F., Tritschler, T., de Barros e Silva, P. G. M., Berg, D. D., Berger, J. S., Berry, L. R., Bikdeli, B., Blondon, M., Bohula, E. A., Cattaneo, M., Colombo, R., Coluccio, V., DeSancho, M. T., … Murthy, S. (2024). Anticoagulation Among Patients Hospitalized for COVID-19. In Annals of Internal Medicine. American College of Physicians. https://doi.org/10.7326/annals-24-00800