ONCOLOGY
Vitamin D3 protects some from advanced cancer
A study was designed to investigate whether vitamin D3 supplementation reduces the risk of developing advanced (metastatic or fatal) cancer in adults without a diagnosis of cancer at baseline. The study, a secondary analysis of a multicenter randomized clinical trial of vitamin D3 (cholecalciferol, 2,000 international units/d) and marine omega-3 fatty acids (1 g/d), involved 25,871 patients. Participants included men age 50 or older and women age 55 or older who were free of cancer and cardiovascular disease at baseline. The primary outcome was a composite incidence of metastatic and fatal invasive total cancer. Secondary analyses included examination of body mass index (BMI) as effect modifiers of the observed associations.
Results showed that supplementation with vitamin D3 reduced the incidence of advanced cancer in the overall cohort, with strongest risk reduction in individuals with normal weight and no reduction among individuals with overweight or obesity. In other words, the protective effect of vitamin D3 was found for those who have normal BMI but not those with elevated BMI.
Source: Chandler PD, Chen WY, Ajala ON, et al., for the Vital Research Group. Effect of vitamin D3 supplements on development of advanced cancer: a secondary analysis of the VITAL randomized clinical trial. JAMA Netw Open. 2020;3(11):e2025850.
INFLUENZA PREVENTION
Indications for Xofluza expanded
The FDA has expanded the approved indications for Xofluza (baloxavir marboxil) to include postexposure prevention of influenza in patients age 12 years and older after contact with someone who has the flu. It was previously approved to treat uncomplicated flu in patients age 12 and older who had been symptomatic for 48 hours or less.
Treating patients with antiviral drugs within 48 hours of exposure to influenza can reduce symptoms and duration of illness. An FDA spokesperson noted that although vaccination is the best way to prevent influenza, the expanded indication for Xofluza provides another important option to help prevent disease in a flu season coinciding with the COVID-19 pandemic.
In addition to oral tablets, Xofluza is also now available as granules for mixing in water. Patients should not take Xofluza if they have had an allergic reaction to Xofluza because hypersensitivity reactions are possible. Xofluza should not be coadministered with dairy products, calcium-fortified beverages, or laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, aluminum, or zinc.
Source: US Food and Drug Administration. FDA expands approval of influenza treatment to post-exposure prevention. News release. November 23, 2020.
GLUCOSAMINE/CHONDROITIN
Joint supplement reduces mortality
Glucosamine with chondroitin is a combination supplement widely used to treat osteoarthritis and joint pain. To date, little evidence supports its efficacy for treating joint pain, but some research suggests a surprising link between consumption of glucosamine/chondroitin and mortality. To investigate the association between regular consumption of this supplement and overall and cardiovascular (CVD) mortality, researchers analyzed a national sample of 16,686 US adults. The study sample included 658 participants (3.9%) who had been taking glucosamine/chondroitin for a year or longer. A median follow-up of 107 months revealed 3,366 total deaths (20%); 674 of these deaths (20%) were due to CVD.
After controlling for age, researchers found that the use of glucosamine/chondroitin was associated with a 39% reduction in all-cause mortality and a 65% reduction in CVD mortality. The association was maintained after adjustments for gender, race, education, smoking status, and physical activity.
The study authors write that their results are "consistent with two recent large epidemiologic studies in the state of Washington and in the United Kingdom, and point to the need for long-term prospective studies."
Source: King DE, Xiang J. Glucosamine/chondroitin and mortality in a US NHANES cohort. J Am Board Fam Med. 2020;33(6):842-847.
GI BLEEDING
Prolonged aspirin use risky for older adults
Data from the landmark ASPREE (ASPirin in Reducing Events in the Elderly) controlled randomized trial indicate that prolonged aspirin use increases the risk of gastrointestinal (GI) bleeding by 60% in older adults. The ASPREE trial was an aspirin-versus-placebo primary prevention study conducted from 2010 to 2017 in community-dwelling adults age 70 and older. It involved 19,114 participants, half taking 100 mg of aspirin daily and half taking a placebo.
In the follow-up period of almost 5 years, 264 incidents of upper or lower GI bleeding occurred: 162 in patients taking aspirin and 102 in those taking a placebo. Older age, smoking, hypertension, chronic kidney disease, and obesity increased bleeding risk.
The study authors noted that the 5-year absolute risk of serious bleeding is modest in younger, healthy individuals. "These data may assist patients and their clinicians to make informed decisions about prophylactic use of aspirin."
Sources: Mahady SE, Margolis KL, Chan A, et al. Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial. Gut. [e-pub Aug. 3, 2020] Kohli KR. Prolonged aspirin use increases GI bleeding risk significantly in elderly: ASPREE trial. Medical Dialogues. https://medicaldialogues.in/gastroenterology/news/prolonged-aspirin-use-increase.
PROSTATE CANCER
FDA approves new diagnostic agent
The FDA has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11), a radioactive diagnostic agent indicated for patients with suspected prostate cancer metastasis who are potentially curable by surgery or radiation therapy. Administered I.V., it is the first drug approved for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. Although two other drugs are available for prostate cancer PET, they are approved only for patients with suspected cancer recurrence. Ga 68 PSMA-11 is also indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen levels.
Once administered via injection, Ga 68 PSMA-11 binds to PSMA, which is usually elevated in patients with prostate cancer. Because this radioactive drug emits positrons, Ga 68 PSMA-11 can be imaged by PET to indicate the presence of PSMA-positive prostate cancer lesions throughout the body.
No serious adverse reactions were attributed to Ga 68 PSMA-11 during clinical trials. Because Ga 68 PSMA-11 binding may occur in other types of cancer and certain nonmalignant processes, interpretation errors are possible. In addition, Ga 68 PSMA-11 contributes to a patient's overall long-term cumulative radiation exposure, which is associated with an increased risk for cancer.
Source: US Food and Drug Administration. FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer. News release. December 1, 2020.