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The Guardian
a day ago
- Health
- The Guardian
Cancer experts warn of coffee enemas and juice diets amid rise in misinformation
Cancer patients are snubbing proven treatments in favour of quackery such as coffee enemas and raw juice diets amid an 'alarming' increase in misinformation on the web, doctors have said. Some were dying needlessly or seeing tumours spread as a result, oncologists said. They raised their concerns at the world's largest cancer conference in Chicago, the annual meeting of the American Society of Clinical Oncology (Asco). Dr Fumiko Chino, a cancer researcher and assistant professor at MD Anderson Cancer Centre in Houston, Texas, co-authored a paper presented in Chicago that said cancer misinformation had 'acutely worsened in the past decade'. With more people being diagnosed amid a growing and ageing global population, misleading or false information about cancer had become a significant public health concern, the study said. While most people trusted doctors, the paper found, more than half of those surveyed said experts seemed to contradict one another. One in 20 had no trust in scientists to provide cancer information. 'We're losing the battle for communication. We need to regain that battlefield,' Chino said. Dr Julie Gralow, Asco's chief medical officer, said: 'Several patients of mine wanted an all-natural treatment approach after I had explained my treatment recommendations. They go online and search for something natural and they find a clinic in Mexico which promises an all natural treatment for cancer, which includes caffeine colonics, vitamin C infusions and other things.' Instead of scolding patients for shunning surgery, radiotherapy or chemotherapy, Gralow said she tried to win their trust by still offering support. 'In several cases, they came back after three months and didn't feel any better. And then they stayed in our clinic and eventually we could gently ease them into more evidence-based treatments,' she said. 'A few times, they didn't come back. And then I would learn within nine months they tragically had died.' Liz O'Riordan, a retired breast surgeon who was diagnosed with breast cancer, shares evidence-based information with her thousands of followers on social media. She said: 'There is a huge amount of cancer misinformation online. Every day I get messages from scared women who want to know if they need to stop eating dairy, soy, flaxseeds. Do they need to stop wearing underwired bras, using deodorants? Is it true that juicing can cure cancer? What about miracle supplement cures like mushrooms and CBD?' O'Riordan wants more doctors to engage with patients online. 'But this is hard as it takes a lot of time to script, film, edit and publish content as well as the effort needed to grow a community to get your voice heard above the noise … And when you don't have a million followers, it's impossible to get traction,' she said. 'What we're saying isn't sexy or exciting – we can't promise a cure. The drugs we give have side-effects and some people still die.' Speaking at Asco, Dr Richard Simcock, the chief medical officer of Macmillan Cancer Support, said misinformation was 'very worrying' as it had 'exponentially increased the problem' of misconceptions about cancer. 'I have recently seen two young women who have declined all proven medical treatments for cancer and are instead pursuing unproven and radical diets, promoted on social media,' he said. 'A person is perfectly entitled to decline that therapy but when they do that on the basis of information which is frankly untrue or badly interpreted, it makes me very sad. It's clear that we have work to do to build back trust in evidence-based medicine.' Prof Stephen Powis, the national medical director of NHS England, said: 'Social media can provide a supportive community for people faced with a cancer diagnosis but at the same time, we're also seeing an alarmingly high level of misinformation on some of these platforms. 'I would urge people to be sceptical of any 'miracle cures' you may see on social media around cancer and use trusted, credible sources like the NHS website or your care team to verify anything you are unsure of – because these fairytales aren't just misleading, they can be harmful.'
Associated Press
3 days ago
- Business
- Associated Press
Kite Presents New Real-World Data Supporting Use of Potentially Curative Yescarta® in Outpatient Care Setting for Patients with Relapsed/Refractory Large B-Cell Lymphoma at ASCO 2025
SANTA MONICA, Calif.--(BUSINESS WIRE)--Jun 1, 2025-- Kite, a Gilead Company (Nasdaq: GILD), today announced real-world data evaluating the safety and effectiveness of Yescarta ® (axicabtagene ciloleucel) for patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) assigned to treatment in an outpatient setting (no planned hospital stay) versus those assigned to an inpatient setting in a hospital. The analysis, based on data collected from the Center for International Blood and Marrow Transplant Research (CIBMTR) registry, observed that safety and effectiveness outcomes for people treated as outpatients were comparable to those patients who received treatment in a hospital. The results were shared in a presentation (Abstract #7023) during the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. 'The encouraging results from this study corroborate reports from treatment centers and prior studies in the real world that illustrate the potential feasibility of administering axi-cel in the outpatient setting for people with relapsed or refractory large B-cell lymphoma,' said Dr. Fateeha Furqan, lead investigator, The University of Texas MD Anderson Cancer Center. 'Outpatient administration of axi-cel has cost-effective advantages over inpatient treatment, including less burden on hospitals. These clinical results reflect the fact that the knowledge and experience needed to safely administer the therapy has only grown since axi-cel was first approved in 2017.' Data were collected from the CIBMTR observational database (between July 2021 to Nov 2023). The final analysis assessed data on patients with R/R LBCL from 75 treatment centers, comparing 119 individuals who were assigned to receive Yescarta in the outpatient setting to 119 patients assigned to receive Yescarta in the inpatient setting. With a median follow-up of 12 months, no general differences were found between the 2 groups in the rates of cytokine release syndrome, neurologic events or immune effector cell-associated neurotoxicity syndrome grade ≥ 3. Almost one-fourth of 119 patients who were assigned to receive Yescarta in the outpatient setting did not require hospital admission within 30 days, and half of 119 patients did not require hospital admission within 3 days based on propensity score-matched dataset. These real-world data are not currently in the U.S. Prescribing Information. 'We are seeing a growing body of evidence that suggests outpatient administration of Yescarta could be reliable and safe in suitable settings, with benefits for the patient, their family and healthcare system,' said Dominique Tonelli, M.D., Vice President and Global Head of Medical Affairs, Kite. 'We are confident that these promising results will help inform providers to expand the number of patients who can achieve the curative potential of a one-time treatment with Yescarta.' Patients assigned to the outpatient and inpatient treatment groups were matched by age, sex, comorbidities, lactate dehydrogenase (LDH), bulky disease, prior lines of therapy, chemosensitivity and infusion year. Patients assigned to the outpatient group had a median age of 63 years (25% ≥ 70), 66% were male and 67% had ≥ 1 comorbidity. Half had elevated LDH and 73% had 1 prior line of therapy. Bulky disease was reported in 3% and 60% had chemo-resistant disease. About LBCL Globally, LBCL is the most common type of non-Hodgkin lymphoma. In the United States, more than 18,000 people are diagnosed with LBCL each year. About 30-40% of patients with LBCL will need second-line treatment, as their cancer will either relapse (return) or become refractory (not respond) to initial treatment. About Yescarta Please see full Prescribing Information, including BOXED WARNING below and Medication Guide. YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma. U.S. IMPORTANT SAFETY INFORMATION BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES and SECONDARY HEMATOLOGICAL MALIGNANCIES CYTOKINE RELEASE SYNDROME (CRS) CRS, including fatal or life-threatening reactions, occurred following treatment with YESCARTA. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL) receiving YESCARTA, including ≥ Grade 3 (Lee grading system1) CRS in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 CRS in 9%. Among patients with LBCL who died after receiving YESCARTA, four had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1 to 12 days) and the median duration of CRS was 7 days (range: 2 to 58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1 to 10 days) and the median duration was 7 days (range: 2 to 43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 CRS in 8%. Among patients with iNHL who died after receiving YESCARTA, one patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1 to 20 days) and the median duration was 6 days (range: 1 to 27 days) for patients with iNHL. Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include, cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) . The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in two subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events. CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1 to 8 days) and the median duration of CRS was 7 days (range: 2 to 16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS at which point the patients were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing Grade 3 or higher CRS. The median time to onset of CRS was 5 days (range: 1 to 15 days) and the median duration of CRS was 4 days (range: 1 to 10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities. Ensure that 2 doses of tocilizumab are available prior to infusion of YESCARTA. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 4 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. NEUROLOGIC TOXICITIES Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life- threatening occurred. Neurologic toxicities occurred in 78% (330/422) of all patients with NHL receiving YESCARTA, including ≥ Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including ≥ Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including ≥ Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range:1- 133 days) and median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including ≥ Grade 3 in 21%. The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion for 87% of affected patients with LBCL and 74% of affected patients with iNHL. The most common neurologic toxicities (≥ 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred. The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41) and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities, 8% (3/39) developed Grade 3, and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset and decrease the duration of CRS. Monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly. REMS Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained about the management of CRS and neurologic toxicities. Further information is available at or 1-844-454-KITE (5483). HYPERSENSITIVITY REACTIONS Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA. SERIOUS INFECTIONS Severe or life-threatening infections occurred. Infections (all grades) occurred in 45% of patients with NHL. Grade 3 or higher infections occurred in 17% of patients, including ≥ Grade 3 or higher infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Febrile neutropenia was observed in 36% of all patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated. In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. PROLONGED CYTOPENIAS Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. ≥ Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion. HYPOGAMMAGLOBULINEMIA B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment. SECONDARY MALIGNANCIES Patients treated with YESCARTA may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period. ADVERSE REACTIONS The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting. The most common adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias. The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with pathogen unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness. About Kite Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on achieving cures with cell therapy. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial supply and commercial product manufacturing. For more information on Kite, please visit About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. Gilead acquired Kite in 2017. Forward-Looking Statements This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving Yescarta; uncertainties relating to regulatory applications and related filing and approval timelines, including pending or potential applications for indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements. Yescarta, Gilead, the Gilead logo, Kite, and the Kite logo are trademarks of Gilead Sciences, Inc., or its related companies. For more information on Kite, please visit the company's website Follow Kite on social media on X (@KitePharma) andLinkedIn. View source version on CONTACT: Blair Baumwell, Media [email protected] Ross, Investors [email protected] KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: RESEARCH HOSPITALS FDA CLINICAL TRIALS OTHER HEALTH BIOTECHNOLOGY PHARMACEUTICAL HEALTH SCIENCE ONCOLOGY SOURCE: Gilead Sciences, Inc. Copyright Business Wire 2025. PUB: 06/01/2025 08:00 AM/DISC: 06/01/2025 08:01 AM
Medscape
5 days ago
- General
- Medscape
Is It Time to Refer My Dementia Patient to Palliative Care?
For the first time, an international expert panel has developed referral criteria for specialist palliative care for patients with dementia, which could help standardize referral across various care settings and lead to earlier referral. With more than 55 million people living with dementia worldwide — more than 6 million in the United States alone — the guidance is sorely needed. The lack of uniform criteria has meant that many patients with dementia who might have benefited from an interdisciplinary palliative care team received the services too late — if at all, Panelist Yuchieh Kathryn Chang, DO, told Medscape Medical News . 'Unfortunately, current practice often sees specialist palliative care referrals occurring late in the dementia illness trajectory,' said Chang, with the Department of Palliative Care, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston. So Chang and more than 60 other dementia experts spent nearly 2 years developing a list of 15 major and 42 minor criteria for specialist palliative care referral. Their work was published on May 14 in JAMA Network Open . How Were the Criteria Developed — and Why Now? Dementia is a growing public health issue, with prevalence expected to triple by 2050 due to population aging. 'Patients with dementia have many supportive care needs, such as distressing symptoms, information gaps, complex decisions, and fragmented care coordination,' Chang said. 'Their families also often experience significant caregiver burden. Many of these may be better addressed with specialist palliative care teams.' The World Health Organization identifies specialist palliative care as a component of comprehensive dementia care, yet referrals are often late or inconsistent . A systematic review by Chang and colleagues found considerable heterogeneity in the referral criteria for patients with dementia to specialist palliative care, suggesting a lack of uniformity in clinical practice. To address this gap, a multidisciplinary panel of 63 expert clinicians from five continents were invited to take part in three rounds of Delphi surveys to rate 83 putative referral criteria, which were generated from a prior systematic review and steering committee discussion. Panelists were required to have expertise in geriatrics, neurology, psychiatry, and/or palliative care, with at least 5 years post-qualification clinical experience with patients with dementia and an affiliation with a center offering specialist dementia care. Reviews of the first Delphi round survey took place in September 2022, with the final round concluding in February 2023. What Did the Panel Agree On? More than 90% of panelists participated in all three survey rounds. From the 83 initial proposed criteria for specialist palliative care referral, panelists achieved consensus on 15 'major' referral criteria, with a level of agreement at 70% or higher. The 15 major criteria fall under five categories broadly classified as needs-based criteria (symptom distress and psychosocial factors or decision-making) and disease-based criteria (dementia type, comorbidities or complications, and hospital use). The panelists determined that six of the eight needs-based referral criteria and four of the seven disease-based referral criteria are appropriate starting at the moderate stage of dementia — a nod to earlier referral — while the rest are applicable only for patients at the severe stage. The six needs-based criteria appropriate for referral at the moderate stage are severe physical symptoms; severe spiritual or existential distress; request for hastened death, assisted suicide, euthanasia; hospice referral or discussion; patient or family request; and patient and/or family decline to seek care at an acute care facility. 'For example, patients with refractory physical symptoms, even though they are not in a severe stage of dementia, should be referred to specialist palliative care to address their specific needs while continuing overall care with the referring physician,' the authors advised. The four disease-based criteria for referral at the moderate stage are rapidly progressive dementia; withdrawal or de-escalation of life-prolonging interventions; two or more episodes of aspiration pneumonia in the past year; and one or more intensive care unit admissions within the past 3 months. Although 70% of panelists agreed that fulfilling even one criterion meant palliative care referral was appropriate, they also said that failure to meet any of the 15 major criteria does not necessarily mean that they are not candidates for specialist palliative care. They also identified 42 'minor' referral criteria that may, in combination, be considered as potential triggers for specialist palliative care referral. The panel cautioned, however, that future research needs to examine how to best incorporate the minor criteria and whether their use might result in earlier referral. Where Was There No Consensus? The panel did not reach consensus regarding referral criteria for early-stage dementia, 'an outcome we interpret as an emphasis on a balanced approach between primary and specialist palliative care roles,' Chang told Medscape Medical News . The panel also could not reach consensus on functional impairment or time-based factors or family/caregiver distress/burden as major referral criteria. They acknowledged that this was 'somewhat surprising' given that functional impairment and time-based factors are commonly considered in the literature and family/caregiver distress/burden is an area that specialist palliative care is known to focus on. Laura Morrison, MD, with the Yale Palliative Care Program at Yale University, New Haven, Connecticut, was also surprised by the lack of consensus in prioritizing family and caregiver focused dementia referral criteria. 'I hope this can be an area of focused investigation going forward given that that number of caregivers is increasing quickly with many of the needs well documented,' Morrison told Medscape Medical News . 'With the enormous toll on the family/caregiver in dementia, exploring the lack of prioritization is warranted,' Morrison wrote in an invited commentary on the referral criteria. 'Another priority area in my mind is how to apply the international perspective and expertise represented by these consensus criteria to the breadth of international settings, accounting for the rich diversity of cultural practices and available health care and financial resources,' Morrison said. How Might the Criteria Change Practice? Given limited specialist palliative care resources, a set of simple, robust, and valid criteria may help identify a subgroup of patients with dementia most likely benefit from specialist palliative care referral (as opposed to primary palliative care alone), thereby improving timely access and resource use, the panel said. 'We envision these consensus referral criteria as a first step to help clinicians, such as geriatric, neurology, and primary care teams, to identify patients who may be appropriate for specialist palliative care referral,' Chang told Medscape Medical News . The fact that panelists felt that most of the major referral criteria can be applied starting at the moderate stage supports earlier referral. In fact, 75% of the experts noted that patients in their own clinical settings were referred to specialist palliative care too late in the course of their dementia. 'We advocate for earlier referral than is typical, drawing on the benefits observed in oncology (improved symptom control, mood, patient and caregiver satisfaction, quality end-of-life care, and survival), while acknowledging that further research is necessary to determine if these benefits translate to the dementia care setting,' Chang said. The next step is to test the referral criteria in clinical settings or in clinical trials to study whether they can be used to improve the referral process and boost patient and caregiver outcomes. 'These criteria are intended as an initial step in this direction. It is crucial to emphasize that they are meant to support, not replace, clinical judgment,' Chang said. Morrison told Medscape Medical News the proposed criteria are 'an important contribution in providing a broad perspective on all the considerations for possible referral and the areas where consensus is still lacking. Clinicians and investigators can now begin to test models of delivery with different proposed criteria and measure patient- and family-centered outcomes.'
Asharq Al-Awsat
23-05-2025
- Health
- Asharq Al-Awsat
Weight-Loss Drugs May Lower Cancer Risk in People with Diabetes, a Study Suggests
Excess body weight can raise the risk of certain cancers, leading researchers to wonder whether blockbuster drugs like Wegovy, Ozempic and Zepbound could play a role in cancer prevention. Now, a study of 170,000 patient records suggests there's a slightly lower risk of obesity-related cancers in US adults with diabetes who took these popular medications compared to those who took another class of diabetes drug not associated with weight loss. This type of study can't prove cause and effect, but the findings hint at a connection worth exploring. More than a dozen cancers are associated with obesity. 'This is a call to scientists and clinical investigators to do more work in this area to really prove or disprove this,' said Dr. Ernest Hawk of MD Anderson Cancer Center in Houston, who was not involved in the study. The findings were released Thursday by the American Society of Clinical Oncology and will be discussed at its annual meeting in Chicago. The study, funded by the National Institutes of Health, was led by Lucas Mavromatis, a medical student at New York University's Grossman School of Medicine. 'Chronic disease and chronic disease prevention are some of my passions,' said Mavromatis, a former research fellow with an NIH training program. GLP-1 receptor agonists are injections used to treat diabetes, and some are also approved to treat obesity. They work by mimicking hormones in the gut and the brain to regulate appetite and feelings of fullness. They don't work for everyone and can produce side effects that include nausea and stomach pain. In the study, researchers analyzed data from 43 US health systems to compare two groups: people with obesity and diabetes who took GLP-1 drugs and other people with the same conditions who took diabetes drugs like sitagliptin. The two groups were equal in size and matched for other characteristics. After four years, those who took GLP-1 drugs had a 7% lower risk of developing an obesity-related cancer and an 8% lower risk of death from any cause compared to those who took the other type of diabetes drug. There were 2,501 new cases of obesity-related cancer in the GLP-1 group compared to 2,671 cases in the other group. The effect was evident in women, but not statistically significant in men. The study couldn't explain that difference, but Mavromatis noted that differences in blood drug concentration, weight loss, metabolism or hormones could be at play.
Associated Press
23-05-2025
- Business
- Associated Press
Rakuten Medical Announces Trial in Progress Poster Presentation at ASCO 2025 and Enrollment Expansion to Taiwan for Global Phase 3 ASP-1929-381
SAN DIEGO, May 22, 2025 /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing Alluminox™ platform-based photoimmunotherapy, today announced that it will present a Trial in Progress poster at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which will take place May 30 – June 3, 2025, in Chicago, Illinois. The poster will feature Rakuten Medical's ongoing global Phase 3 clinical trial evaluating ASP-1929 photoimmunotherapy in combination with pembrolizumab (anti-PD-1) as a first-line therapy for patients with recurrent head and neck squamous cell carcinoma (HNSCC) (Protocol number: ASP-1929-381 / Acronym: ECLIPSE / Identifier: NCT06699212 ). The poster will also highlight interim findings from the completed Phase 1b/2 study (ASP-1929-181 / Identifier: NCT04305795 ) which evaluated ASP-1929 photoimmunotherapy in combination with anti-PD-1 in recurrent or metastatic HNSCC. 'We are honored that our Trial in Progress poster has been accepted for presentation at ASCO 2025,' said Anastasios Maniakas, MD, PhD, Assistant Professor in the Department of Head and Neck Surgery and an investigator of the ASP-1929-381 study at The University of Texas MD Anderson Cancer Center. 'This Phase 3 study represents a significant step forward in evaluating the potential synergistic efficacy of ASP-1929 photoimmunotherapy and pembrolizumab as a first-line treatment for patients with recurrent HNSCC. We look forward to sharing our progress with the global oncology community and advancing innovative approaches for the treatment of patients facing this challenging disease.' Rakuten Medical is also pleased to announce that it has recently initiated patient enrollment in Taiwan as part of its global expansion of the Phase 3 ASP-1929-381 study. Currently, over 10 clinical sites across the United States and Taiwan are actively enrolling patients. Additional sites are expected to be activated in both regions, with patient enrollment in Japan anticipated to begin shortly. 'We are pleased to be part of this global Phase 3 study and to contribute to the development of an innovative treatment approach like photoimmunotherapy,' said Kai-Ping Chang, MD, PhD, Professor of the Department of Otolaryngology - Head & Neck Surgery and Principal Investigator of the ASP-1929-381 study at Chang Gung Memorial Hospital in Taiwan. 'Head and neck cancer ranks third in male cancer incidence and fourth in male cancer mortality in Taiwan1. Local recurrence or metastasis is one of the leading causes of death in these patients2, and nearly half of those with recurrent or metastatic disease survive for less than one year3. By participating in this trial, we hope to help advance new therapeutic options that may prolong overall survival of patients with recurrent HNSCC, both in Taiwan and around the world.' ASCO attendees are invited to visit Rakuten Medical at booth #33110 to learn more about the ASP-1929-381 study and the company's broader Alluminox™ platform. Rakuten Medical's Trial in Progress Poster Overview Rakuten Medical Exhibit Booth About ASP-1929-381 Study The ASP-1929-381 study is a multi-regional multi-center, randomized, open-label Phase 3 trial, designed to assess the efficacy and safety of ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line treatment for locoregional recurrent HNSCC without distant metastases. 412 patients globally will be randomized to either an experimental arm receiving ASP-1929 photoimmunotherapy in combination with pembrolizumab, or a control arm receiving the current pembrolizumab-based standard of care (SOC), where patients may receive pembrolizumab alone or in combination with chemotherapy according to the physician's choice. The primary endpoint is Overall Survival (OS), with key secondary endpoints including Complete Response Rate (CRR) and Overall Response Rate (ORR). Disclaimer: Rakuten Medical's Alluminox™ platform-based photoimmunotherapy is investigational outside Japan. About Rakuten Medical, Inc. Rakuten Medical, Inc. is a global biotechnology company developing and commercializing Alluminox™ platform-based photoimmunotherapy, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing. Rakuten Medical's photoimmunotherapy is currently investigational outside Japan. Rakuten Medical is committed to its mission to conquer cancer by developing its pioneering treatments as quickly as possible to as many patients as possible all over the world. The company has offices in 5 countries/regions, including the United States, where it is headquartered, Japan, Taiwan, Switzerland and India. For more information, visit About Alluminox™ platform The Alluminox™ platform is Rakuten Medical's investigational technology platform that combines pharmaceuticals, medical devices, medical technology, and other peripheral technologies. Rakuten Medical is developing Alluminox platform-based photoimmunotherapy, which involves two key steps: 1) drug administration and 2) targeted illumination using medical devices. The drug component consists of a cell-targeting moiety conjugated to a light-activatable dye, such as IRDye® 700DX (IR700), that selectively binds to the surface of targeted cells, such as tumor cells. The device component consists of a light source that locally illuminates the targeted cells with red light (690nm) to transiently activate the drug. Rakuten Medical's pre-clinical data have shown that this activation elicits rapid and selective necrosis of targeted cells through a biophysical process that compromises the membrane integrity of the targeted cells. Therapies developed on the Alluminox platform may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted tumor cells and/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Photoimmunotherapy was originally developed by Dr. Hisataka Kobayashi and his team at the National Cancer Institute in the United States. Outside Japan, Rakuten Medical's Alluminox platform-based photoimmunotherapy is investigational. About ASP-1929 Rakuten Medical's first pipeline drug developed on its Alluminox™ platform is ASP-1929, an antibody-dye conjugate comprised of the anti-EGFR antibody cetuximab and IRDye® 700DX, a light activatable dye. ASP-1929 binds to epidermal growth factor receptor (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck, breast, lung, colorectal, prostate and pancreatic cancers. After binding to cancer cells, ASP-1929 is locally activated by illumination with red light (690 nm), emitted by a laser device system to produce a photochemical reaction. This reaction is believed to cause damage to the membrane of cancer cells, leading to selective necrosis of cancer cells. In Japan, ASP-1929 received marketing approval from the Japanese Ministry of Health, Labor, and Welfare for unresectable locally advanced or recurrent head and neck cancer in September 2020, under the Sakigake Designation System and the Conditional Early Approval System. ASP-1929 photoimmunotherapy in combination with pembrolizumab is currently under investigation in a global Phase 3 clinical trial as a first-line therapy for recurrent head and neck cancer. Outside Japan, ASP-1929 has not yet been approved for commercial use by any regulatory authority. Contact Us View original content to download multimedia: SOURCE Rakuten Medical, Inc.
