Warning sign on your hands and fingers could be rare silent killer infection

Doctors have issued a warning about an alarming sign on your hands that could be a symptom of a silent killer. Endocarditis, a rare and potentially fatal infection of the inner lining of the heart, is usually caused by bacteria entering the blood and travelling to the heart, the British Heart Foundation says. While symptoms can range from night sweats to swelling in your feet, another sign could be on your palms. If you spot any red or purple marks on your palms or fingers, you may need to seek the advice of a GP. Endocarditis is very rare in people with normal hearts who have no other risk factors but the symptoms have sometimes been known to start suddenly and are severe – in some cases it can even be fatal. Although the heart is usually well protected against infection, it may be easier for bacteria to bypass the immune system in people who have: an artificial heart valve congenital heart disease hypertrophic cardiomyopathy – where the heart muscle cells have enlarged and the walls of the heart chambers thicken damaged heart valves had endocarditis before. Other symptoms of endocarditis The initial symptoms of endocarditis are similar to flu and include a high temperature, chills, headache, joint and muscle pain. Without treatment, the infection damages the heart valves and disrupts the normal flow of blood through the heart. Endocarditis is treated with a course of antibiotics given via a drip and you’ll need to be admitted to hospital for this. It’s also possible to have surgery to repair or replace a damaged valve or to drain any abscesses. The NHS warns that endocarditis is a serious illness, especially if complications develop. Early diagnosis and treatment is vital to improve the outlook for the condition. Marks and Spencer launches summer sale and there’s huge savings on kids’ clothing

ESC Congress 2023 to feature 30 late-breaking clinical trials

The European Society of Cardiology (ESC) will highlight 30 late-breaking studies during Hot Line sessions at its annual meeting Aug. 25-28, 2023, in Amsterdam. The complete list of sessions and studies being presented is below. John McMurray, ESC Congress program committee chair, believes there are several key sessions attendees should be looking forward to as the show approaches. In the Hot Line 1 session, the STEP HFpEF trial will examine the effects of once-weekly semaglutide in people with heart failure with preserved ejection fraction (HFpEF) and obesity. “This is a treatment targeting a common and increasing comorbidity in this type of heart failure. Obesity is associated with much worse symptoms and functional capacity and a higher risk of hospitalization. We hope reducing obesity will help patients with HFpEF,” McMurray said in a statement. The NOAH-AFNET 6 trial, meanwhile, examines oral anticoagulation in patients with atrial high-rate episodes. “This trial attempts to answer the very important clinical question of whether we should use anticoagulant therapy in patients with brief episodes of atrial fibrillation (AFib). We know that sustained AFib leads to a high risk of stroke, which can be effectively and safely (with respect to bleeding) reduced by treatment with an anticoagulant – but is this also true for short episodes of AFib?” The first Hot Line session concludes with COP-AF. “AFib and myocardial injury are common complications of thoracic surgery and are associated with high risks of death, stroke and longer hospital stays. Inflammation may play a role in causing these complications and colchicine has anti-inflammatory activity recently shown to be of benefit in patients with coronary artery disease. This large trial has tested whether starting colchicine pre-operatively reduces the risk of these complications,” McMurray explained. He also emphasized HEART-FID, which will be presented in Hot Line 2. “Iron deficiency is very common in patients with heart failure and reduced ejection fraction (HFrEF) and intravenous iron seems to improve symptoms and exercise tolerance,” McMurray said. “However, the AFFIRM-HF and IRONMAN trials have left some uncertainty about the effects of this therapy on hospitalization and mortality. HEART-FID is by far the largest trial to date using this treatment.” Hot Line 4 could be one of the highlights of the entire conference for many cardiologists, McMurray said. It includes a series of trials – ILUMIEN IV, OCTIVUS and OCTOBER, which compare optical coherence tomography (OCT)-guided, intravascular ultrasound (IVUS)-guided and angiography-guided percutaneous coronary intervention (PCI). “The session also will have a real-time updated network meta-analysis presented, hopefully again providing the definitive evidence to guide the optimal approach to PCI,” he said. Hot Line Session 1 Aug. 25, 11:15 a.m. • STEP HFpEF: once-weekly semaglutide in people with HFpEF and obesity. Speaker: Mikhail Kosiborod, St. Luke’s Mid America Heart Institute – Kansas City, United States. • NOAH-AFNET 6: Oral anticoagulation in patients with atrial high rate episodes. Speaker: Paulus Kirchhof (University Heart and Vascular Center Hamburg, Germany. • COP-AF – Colchicine for the prevention of perioperative atrial fibrillation after major thoracic surgery. Speaker: David Conen, Population Health Research Institute, Hamilton, Canada. Hot Line Session 2 Aug. 26, 8:30 a.m. • Qiliqiangxin in patients with heart failure and reduced ejection fraction – the QUEST study. Speaker: Xinli Li, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China. • BUDAPEST CRT Upgrade: Cardiac resynchronisation therapy upgrade in heart failure with right ventricular pacing – a multicentre, randomised, controlled trial. Speaker: Bela Merkely, Semmelweis University Heart and Vascular Center, Budapest, Hungary. • HEART-FID: Ferric Carboxymaltose in Heart Failure with Iron Deficiency. Speaker: Robert Mentz, Duke University Medical Center – Durham, United States. • Effects of FCM on recurrent HF hospitalizations: an individual participant data meta-analysis. Speaker: Piotr Ponikowski, Wroclaw Medical University, Wroclaw, Poland. Hot Line Session 3 Aug. 26, 4:30 p.m. • FIRE trial: Physiology-Guided Complete PCI in Older MI Patients. Speaker: Simone Biscaglia, University Hospital Santa Anna, Ferrara, Italy. • ECLS-SHOCK – venoarterial membrane oxygenation in cardiogenic shock. Speaker: Holger Thiele, Heart Center Leipzig at University of Leipzig, Germany. • STOPDAPT-3: An Aspirin-Free antithrombotic strategy for percutaneous coronary intervention. Speaker: Masahiro Natsuaki, Saga University, Saga, Japan. Hot Line Session 4 Aug. 27, 8:30 a.m. • ILUMIEN IV: OCT Versus Angiography. Speaker: Ziad Ali, DeMatteis – St Francis, United States • OCT-guided or angiography-guided PCI in complex bifurcation lesions. The OCTOBER trial. Speaker: Lene Nyhus Andreasen, Aarhus University Hospital, Aarhus, Denmark. • OCTIVUS: OCT- vs. IVUS-Guided PCI. Speaker: Duk-Woo Park, Asan Medical Center, Seoul, South Korea • OCT vs. IVUS vs. angiography guidance: a real-time updated network meta-analysis. Speaker: Gregg Stone, Icahn School of Medicine at Mount Sinai, New York, United States. Hot Line Session 5 Aug. 27, 11:15 a.m. • ATTRibute-CM: acoramidis (AG10) in patients with transthyretin amyloid cardiomyopathy. Speaker: Julian Gillmore, Royal Free London NHS Foundation Trust. • ARREST trial: Expedited transfer to a cardiac arrest center for OHCA. Speaker: Tiffany Patterson, Guy’s and St. Thomas’ NHS Trust Hospitals, London. • ADVENT: Pulsed Field Ablation vs. Thermal Ablation (RF/Cryo) for Paroxysmal AF. Vivek Reddy, Icahn School of Medicine at Mount Sinai, New York, United States.

Rare, flesh-eating bacteria has killed 5 in Tampa Bay area since January

TAMPA, Fla. (WFLA) — Five people are confirmed dead in the Tampa Bay area due to a rare, flesh-eating bacteria in the waters. According to Florida Health, Vibrio vulnificus is a bacterium that naturally occurs in warm, brackish seawater and requires salt. Ivermectin still not effective or approved for COVID-19 treatment, FDA says There have been 25 reported cases and five deaths since January 2023. “Living in Florida, being around the marine environment, we need to be aware of what it is,” said Dr. Eric Shamas, an emergency medicine physician at Bayfront Health St. Petersburg. There are two confirmed deaths in Hillsborough County, one in Sarasota County, one in Polk County, and one in Pasco County. In 2022, there were 74 total cases and 17 deaths. Most occurred in Lee County after Hurricane Ian’s waters flooded the community. According to Florida Health, a person can get infected with Vibrio vulnificus when eating raw shellfish, particularly oysters, and entering seawater with an open wound, especially in the summer months Opioids, obesity now ranked as top public health threats in new poll “Whenever you have a break in the skin and you’re in a marine environment then theoretically you’re at risk,” Shamas said. “It’s very important to keep in mind these severe infections are very rare.” Health officials warn citizens to not enter the water if they have fresh cuts or scrapes, as the bacteria can enter the bloodstream rather quickly. Bloodstream infections are fatal 50 percent of the time. “If you have wounds, maybe stay out of the water,” Shamas said. “If you suffer a cut while in the water, just wash it out very thoroughly with soap and water. Monitor your symptoms and follow up with your doctor if you have any questions.” Common symptoms of the flesh-eating bacteria include vomiting, diarrhea, abdominal pain, and infection of the skin (if there is an open wound). Those with healthy immune systems are likely to experience a mild infection. Rare use of power: Why a wedding photographer with a clean record was held in jail for a year, but never charged Those with weakened immune systems, or have chronic liver disease, are more prone to serious and life-threatening illnesses with symptoms like fever, chills, decreased blood pressure, septic shock, and blistering skin lesions. To prevent Vibrio vulnificus infections, avoid eating raw shellfish and oysters, cook shellfish thoroughly, avoid cross-contamination of cooked seafood and raw seafood, avoid exposure of open wounds or broken skin to warm salt or brackish water, and wear protective clothing when handling raw shellfish. Seek medical help right away if you believe you may have an infection. For more information on care and treatment specifics, visit the CDC’s website. Close Modal Suggest a Correction Suggest a Correction

Analysis | What to Know About New Covid Strains Gaining Ground: QuickTake

It may feel like pandemic déjà vu: New Covid-19 variants are afoot, and hospitalizations are again on the rise. Eris recently became the most prevalent Covid variant, but now international health officials have their eyes on a new variant of concern. The latest strain — called BA.2.86 — has so far been detected only in the US, Denmark and Israel. It’s caught the attention of the US Centers for Disease Control and Prevention and the World Health Organization, which are closely monitoring the situation. For now, experts aren’t too concerned. 1. What is BA.2.86? The strain was first spotted by virus trackers in mid-August. Not much is known yet about how it stacks up against other variants. It appears to be a descendant of the BA.2 variant that first emerged in early 2022, but this lineage has more than 30 mutations on its spike protein, which helps the virus latch onto cells and cause infection. That could make it better at evading immunity from vaccines and past infections. 2. What about Eris? Eris, formally called EG.5, is a descendant of a group of coronavirus strains labeled XBB. These are all offshoots of the omicron variant, which arose in late 2021. EG.5 made up an estimated 17.4% of global cases in the week ending July 23, according to the WHO, up from only 7.6% four weeks earlier. It recently became the most common strain in the US, according to estimates by the CDC. 3. How concerning are the new variants? Eris poses a low risk to global public health, the WHO said. Although it’s growing in prevalence in comparison with other strains and appears to be better at evading the body’s immune defenses, there’s no evidence it causes more severe disease or can spread more easily than other versions of Covid. Pfizer Inc. and Moderna Inc. have both said that their updated Covid vaccines, formulated to target the variant known as XBB.1.5, protected against Eris in early studies. As for BA.2.86, its mutations give it “all the hallmark features of something that could take off,” said Kristian Andersen, a Scripps Research immunologist and microbiologist. However, it’s too early to tell. 4. What symptoms does it cause? Share this articleShare The symptoms of Eris and other variants seem to be the same as those caused by previous strains, according to Thomas Russo, chief of the Division of Infectious Diseases at the University of Buffalo’s medical school. Common ones include a runny nose, headache, fatigue, a sore throat and sneezing. People who are older, have compromised immune systems or suffer from multiple other conditions are at higher risk for more severe effects. These may include lower respiratory disease, chest pain and shortness of breath. The virus still kills hundreds of people each week in the US, so it’s important to get tested if you think you may be infected. 5. What’s causing a rise in US hospitalizations? The number of people admitted to the hospital with Covid-19 is on the rise for the first time this year in the US, and wastewater data has also shown cases ticking up. Hospitalizations are up in multiple other countries as well. But there’s no evidence linking increased hospitalizations to new strains, the WHO says. Experts point to other likely culprits: Extreme heat is driving gatherings indoors, where the coronavirus spreads more easily. Also, with the pandemic over, people are traveling again and no longer wearing masks. And for many people, it’s been months since they last got a vaccine or contracted the virus, meaning their immunity against infection is waning. 6. Is the US prepared for a rise in Covid-19? The US has scaled back its response to Covid-19. The government no longer purchases vaccines and treatments for the public, and free tests aren’t as widely available. Still, experts say the US isn’t likely to see the kind of surge in cases that upended life in the early years of the pandemic. Because of vaccination and prior infections, the population has widespread protection from severe disease, and therapies like Pfizer’s Paxlovid antiviral drug can reduce the risk of hospitalization and death if they’re taken early on. Even after recent increases, hospital admissions are lower than at at any other point since at least August 2020, according to CDC data. 7. What can you do to protect yourself? New booster vaccines will be available later this year, and experts say they’re especially important for vulnerable people. If you’re at higher risk and you’re going to be in a situation where exposure is likely, such as a large gathering, Russo says you can consider getting a booster shot of one of the older vaccines that are already on the market. In any case, masks help protect against infection. Pharmacies still offer Covid-19 testing services and sell at-home tests. If you’re at high risk and you develop symptoms, a test can help determine whether you should start taking Paxlovid. More stories like this are available on bloomberg.com ©2023 Bloomberg L.P.

Flesh-Eating Bacteria at the Beach? What You Need to Know.

Infections with Vibrio vulnificus are rare, especially in the Northeast. But a few recent cases suggest that precautions are wise for some wading into the water. The News With Labor Day and the start of a new school year looming, throngs of New Yorkers will head to the beach this weekend, braving traffic, sunburns, maybe sharks — and Vibrio vulnificus, a nasty, flesh-eating bacteria that thrives in warm seas and brackish water. Since the beginning of July, four people in the greater New York area have been infected with the bacteria, including three who have died, according to health officials in New York and Connecticut. Two of the people sickened in Connecticut had been exposed to saltwater or brackish water in the Long Island Sound. One had eaten raw oysters, which can become infected with the bacteria during warm spells. (The cause of the fourth infection, which killed a Suffolk County resident, is not known.) “If we were having this conversation 15 years ago, we’d be talking about infections along the Gulf Coast,” said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University School of Medicine. “But now these infections are creeping up the East Coast.” The bacteria Vibrio vulnificus is related to the type that causes cholera.Janice Haney Carr/Centers for Disease Control and Prevention The Back Story: An infection that surprises beachgoers. It’s not clear whether the appearance of these cases farther north than usual may be a result of better diagnosis or to warming waters associated with climate change. The illness, technically called vibriosis, may be caused by infection with several related bacteria. Among the worst is V. vulnificus, which is relatively rare but can be deadly for those who are vulnerable, with survival rates as low as 33 percent, according to one scientific paper. The bacterium spreads most commonly in two ways. When people swim in waters contaminated with V. vulnificus, an open sore or cut can provide an entry point for the organism. From there it spreads, becoming a so-called flesh-eating infection that extends quickly beyond the wound into healthy tissue. Then it may spill over into the bloodstream, causing a life-threatening condition called sepsis. The bacterium also spreads when people who are immunocompromised or have liver disease eat raw oysters that are contaminated. Physicians warn patients with these conditions against eating raw oysters, which become infected by seawater they filter for food. Older people are generally at greater risk. The three patients who fell ill in Connecticut were all over age 60. People who take medications to reduce stomach acid may also be more likely to get infected or to develop complications following infection. If you’re among the vulnerable, wear shoes that protect against cuts and scrapes when you’re in salty or brackish water. Wear protective gloves when handling raw seafood. Avoid swimming in the ocean if you have a cut, scrape or other abrasion that might let in the bacterium. What to Watch: The bacterium seizes on openings. Vibriosis causes a wide range of symptoms, including diarrhea and stomach cramps, vomiting, fever, chills, ear infections and wound infections. The intestinal problems occur more quickly in people who have ingested the bacterium, usually by eating raw oysters. Ear and wound infections will become red, swollen and extremely painful over a bit more time. Blisters filled with clear liquid may appear on the skin. Symptoms usually appear within 12 to 24 hours of exposure, and people should seek medical care as soon as possible. Tell doctors about the exposure: The infection can spread quickly if left untreated. “If the wound starts to look red, puffy and painful, or has a discharge, or redness spreading beyond the edges of the wound, you need to get medical attention right away,” Dr. Schaffner said. “Don’t try to tough it out and wait to see if it gets worse tomorrow.” A lab test is needed to make the diagnosis. Treatment involves antibiotics and supportive care, but surgery may be required to clean out an infected wound and stop the spread of the infection. Your Beach Weekend: The vulnerable should exercise caution. Consider avoiding the water, and not even walking on the beach or wading, if you have an open wound, including one from a recent surgical operation or piercing or tattoo. An open wound means any cut, scrape or other abrasion that might allow the bacterium into your body. If there is a chance your wound could come into contact with saltwater or brackish water, marine life, or raw or undercooked seafood while you’re cooking, swimming, fishing, boating or walking on the beach, cover the open wound with a waterproof bandage. If a wound or cut does comes into contact with brackish water or saltwater, raw seafood or its juices, wash it thoroughly with soap and water. If you develop a skin infection, let your health provider know quickly — this is an infection that can spread rapidly. What’s Next: Watch for the infection in unexpected places. Climate change will test all of us in unexpected ways. Vibrio infection is something Americans living in the Northeast may need to watch for now. If you have cancer, are immunocompromised, have liver disease or take drugs to lower stomach acid, doctors say you should not eat raw or undercooked oysters or other raw or undercooked shellfish. (Of course, the same is true for pregnant women.) If you’re handling raw shellfish, wash your hands thoroughly with soap and water afterward.

Give blood at any of these upcoming pop-ups

TEXOMA (KFDX/KJLT) — In case you missed Blood Battle 2023, Our Blood Institute is giving Texomans all over additional chances to donate blood and platelets. Blood Battle ’23: Results are in! Our Blood Institute, or OBI, has urged everyone over 16 years old or 125 pounds to donate their time and blood for the greater good. OBI supports the inventory for patients in eight major hospitals in the region, the organization said in a press release. “Blood donations don’t tend to stay steady during the summer months and lives are dependent on us,” said Dr. John Armitage, president and CEO of Our Blood Institute said. “Your blood donation can save the lives of up to three people and is essential in keeping up the blood supply in your local hospitals.” Look for OBI’s BloodMobile at any of these locations across Texoma throughout the month of August. All donors will receive a “Life is Better” t-shirt and a free ticket to Science Museum Oklahoma, Frontier City or Hurricane Harbor. August 23, 2023: The GMC lot at Foundation Automotive of Wichita Falls from 1:30 p.m. to 5 p.m. August 23, 2023: The Berend Family Center in Windthorst from 1 p.m. to 6 p.m. August 24, 2023: The Senior Citizens Activity Center in Burkburnett on 5th Street from 2:30 p.m. to 6 p.m. August 27, 2023: Walk-ins at Texas Blood Institute on Gregory Street from 1:30 p.m. to 6 p.m. Donors can also enjoy a free meal from a baked potato bar August 29, 2023: The Crowell High School Gymnasium from 11 a.m. to 4 p.m. August 29, 2023: Best Buy of Wichita Falls on Kemp from 3:30 p.m. to 6 p.m. Blood can be given every 56 days, and platelets can be given as often as every seven days, up to 24 times a year. Check out OBI’s website or call them at (580) 350-6151 to learn more about OBI’s importance in the community.

CNA Explains: Singapore’s blood stocks and what happens when levels hit low or critical

Each year, almost 30,000 patients rely on a safe and steady stream of blood supply to sustain or improve their quality of life, said the Singapore Red Cross, which is the national blood donor recruiter. In June, Health Minister Ong Ye Kung said blood usage had increased in recent months, as hospitals caught up on the backlog of elective surgeries and treatments that were postponed during COVID-19. Health Sciences Authority (HSA) CEO Mimi Choong May Ling said: “While we consistently strive to meet the demand for blood, there have been instances when our blood stocks dropped to low or critical levels due to low collection during long weekends and school holidays and surges in blood usage.” WHAT HAPPENS WHEN BLOOD STOCKS HIT CRITICAL? Blood stocks can become low when there is a sudden increase in usage or a drop in collection. This drop in collection typically happens during festive seasons, as well as long weekends and school holidays, said HSA. Blood stocks can dip as much as 20 per cent during these periods. The Singapore Red Cross said blood stocks may dip in the September school holidays. Additionally, travelling to certain countries or regions with insect-borne infection risks may make donors ineligible for a period of time. There have been times when blood stocks have dipped to low or critical levels. When it hits critical, it means there is less than a six-day stockpile and it is only enough to support emergency cases. That is when the Singapore Red Cross urgently needs donors to come forward. The only way Singapore replenishes its blood stocks is through donations. “There is no replacement for blood donation from altruistic donors. This is why we need more people to come forward to donate blood and more donors to donate regularly, at least twice a year,” said HSA. “With the support of our donors, we managed to recover the blood stocks quickly. No patients needing blood transfusion had to be turned away,” said the Singapore Red Cross. WHICH BLOOD TYPES ARE IN DEMAND? In its latest update on Aug 18, the Singapore Red Cross showed that O+ blood stock is low, with A+, A-, and B- in moderate levels. B+, O-, AB+ and AB- blood stocks are at healthy levels. Group O is the universal blood type for red cell transfusions. It is used during emergencies when patients’ blood groups are unknown. Close to half of Singapore’s population are blood group O, translating to a higher usage of blood group O red cells compared to the other blood groups in hospitals. This also makes it more susceptible to blood stock fluctuations, said HSA.

Ban on blood donations from LGBTQ+ community lifted

(WFSB) – A historic milestone is happening in Connecticut. The gay community is no longer banned from donating blood. The ban went into effect in the 1980s, which meant members of the LGBTQ+ community could not give blood. It was mainly because of the AIDS epidemic. Now the FDA has changed its policy. The American Red Cross held a blood drive Friday in Wethersfield and two gay men were proud to be there and donate. One of them is Paul Shipman, who has always wanted to give blood. “It felt after a time like the FDA wasn’t paying attention to the science, to the reality and finally they are. I know these things move slowly for me it was frustration,” Shipman said. The FDA altered its policy over the last few years by allowing gay men to give, but only if they had not had sex with another man in the past three months. “We no longer ask the sexual orientation of any of our donors which opening our doors to many more donors,” said Mario Bruno with the American Red Cross of Connecticut and Rhode Island. The Red Cross does a health assessment. They also test all the blood that is taken. “Discrimination against donors based on sexual orientation, against gay or bi-sexual people has no scientific basis, none,” said Sen. Richard Blumenthal. Adam Volchko said this is important for everyone. “I actually was never turned away, I just knew the rules. So there was no point in trying to,” Volchko said. “I feel like I have joined not only my family but a big family of people who just step up to help,” said Shipman. The drive also comes at a critical time. Summer months are slow when it comes to donating. To find a blood drive near you, click HERE. New rules allow gay community to give blood Copyright 2023 WFSB. All rights reserved.

Avelumab Increases PFS Rates in dMMR/MSI Metastatic CRC

Avelumab in dMMR/MSI Metastatic CRC | Image Credit: © PIC4U – stock.adobe.com Patients with mismatch repair–deficient and/or microsatellite instability (dMMR/MSI) metastatic colorectal cancer (CRC) experienced a progression-free survival (PFS) benefit with longer disease control following treatment with avelumab (Bavencio) compared with standard second-line chemotherapy, according to findings from the phase 2 SAMCO-PRODIGE 54 trial (NCT03186326) published in JAMA Oncology. At a median follow-up of 33.3 months (95% CI, 28.3-34.8), patients who received the anti–PD-L1 monoclonal antibody (n = 61) experienced a median PFS of 4.1 months (range, 2.31-5.68) compared with 6.2 months (range, 4.11-7.29) among patients who received standard chemotherapy (n = 61). However, study authors noted that because the Kaplan-Meier curves crossed at 7.3 months corresponding to a PFS rate of 36%, the log-rank test and the hazard ratio of PFS analyses were not sufficient (log-rank P = .30). Using the Qiu and Sheng statistical test that appeared better suited for this analysis, investigators determined that avelumab was superior to chemotherapy in terms of PFS (P = .03); the estimated 12- and 18-month PFS rates were 31.2% (95% CI, 20.1%-42.9%) and 27.4% (95% CI, 16.8%-39.0%), respectively, in the avelumab arm compared with 19.4% (95% CI, 10.6%-30.2%) and 9.1% (95% CI, 3.2%- 18.8%), respectively, in the control arm. Additionally, the estimated restricted mean survival time for PFS was 12.3 months (95% CI, 8.7-15.8) vs 8.1 months (95% CI, 6.2-10.0) in the avelumab and chemotherapy arms, respectively, after 36 months of follow-up (P = .04). The overall response rates (ORR) were comparable with 29.5% of patients in the avelumab arm vs 26.2% in the chemotherapy arm experiencing a response. The disease control rate was 70.5% in the avelumab arm vs 77.0% in the chemotherapy arm, and among these patients the rate of ongoing disease control at 18 months was 75.7% vs 19.1%, respectively. The median duration of disease control was 16.7 months (interquartile range [IQR], 5.7-33.4) vs 7.3 months (IQR, 4.9-11.9), respectively (P < .001). SAMCO-PRODIGE 54 was an open-label trial that was conducted at 40 centers in France. To be included in the study, patients needed to be at least 18 years of age with unresectable dMMR/MSI stage IV CRC, a World Health Organization (WHO) performance status score of 1 or less, and adequate organ function. All patients experienced disease progression after receiving a first-line standard chemotherapy regimen with or without a targeted agent based on RAS status. Patients who were enrolled on the study were randomly assigned in a 1:1 manner to receiveavelumab at a dose of 10 mg/kg every 2 weeks intravenously or investigator’s choice of second-line chemotherapy. In the chemotherapy arm, patients were also allowed to receive a targeted agent according to first-line treatment regimen and RAS/BRAF status; if progression occurred, patients could receive an immune checkpoint inhibitor at the investigator’s discretion. Treatment proceeded until disease progression, unacceptable toxicity, or withdrawal. Stratification occurred by center, WHO performance status, BRAF status, and age. The primary end point was PFS by RECIST v1.1 criteria, and patients who were alive without progression were censored on the date of last news. Secondary end points included overall survival (OS), ORR, time to best response, duration of disease control, and safety. The baseline patient characteristics were well balanced between the avelumab and chemotherapy arms; the median age was 66 years (IQR, 54-75) and 67 years (IQR, 60-75), respectively. Most patients in both arms had right-sided primary tumors (87% vs 77%) and had previously received FOLFOX/CAPOX with or without targeted therapy (65.6% vs 70.5%). BRAF V600E (41% vs 44%) and RAS (23% vs 21%) mutations were present in patients in both arms. Additionally, patients had more than 5 metastases at rates of 41% in the avelumab arm vs 44% in the chemotherapy arm. Additional findings showed that patients in both the avelumab and chemotherapy arms experienced complete response (6.6% vs 4.9%), partial response (23.0% vs 21.3%), stable disease (41.0% vs 50.8%), and progressive disease (27.9% vs 16.4%). The time to best response was 3.5 months (IQR, 2.0-8.0) vs 2.0 months (IQR, 1.8-2.5), respectively. The median duration of treatment in the avelumab and chemotherapy arms was 7.4 months (range, 0.03-46.5) vs 5.1 months (range, 0.03-19.7), respectively, and the median OS was 25.8 months (95% CI, 14.1-not reported [NR]) vs 23.4 months (95% CI, 13.0-NR), respectively (HR, 0.94; 95% CI, 0.57- 1.53; P = .79). At the May 23, 2022, data cutoff, 32 patients in each arm had died. Most patients in the chemotherapy arm (50.8%) were subsequently treated with an immune checkpoint inhibitor. Overall, 83.8% of patients in the chemotherapy arm who received a subsequent line of therapy were treated with an immune checkpoint inhibitor. In the avelumab arm, 29.5% of patients were still being treated with the agent and 53.5% of patients who experienced disease progression received a subsequent anticancer therapy. In terms of safety, in the 63-patient avelumab arm and the 64-patient chemotherapy arm treatment-related adverse effects (TRAEs) of any grade occurred at rates of 88.9% vs 98.4%, respectively. TRAEs of grade 3 or 4 severity occurred at rates of 31.7% vs 53.1%, respectively, and included abnormal liver test results (7.9% vs 1.6%), diarrhea (4.8% vs 7.8%), neurotoxicity (1.6% vs 3.1%), and hypertension (1.6% vs 10.9%), among others. Grade 3 or 4 neutropenia was reported in 18.8% of patients in the chemotherapy arm. Immune-mediated AEs occurred in 17.5% of patients in the avelumab arm, including grade 1 to 2 hypothyroidism (n = 6), grade 1 to 2 hyperthyroidism (n = 5), grade 3 colitis (n = 1), grade 2 infusion-related reactions (n = 2), and a grade 3 infusion-related reaction (n = 1). In the chemotherapy arm, 3.1% of patients experienced cetuximab (Erbitux) infusion–related reactions. Six patients in the avelumab arm and 7 patients in the chemotherapy arm discontinued treatment due to an AE. No grade 5 AEs were reported in either arm. Reference Taïeb J, Bouche O, André T, et al. Avelumab vs standard second-line chemotherapy in patients with metastatic colorectal cancer and microsatellite instability: a randomized clinical trial. JAMA Oncol.