For individuals with type 2 diabetes (T2D), semaglutide is associated with a modestly increased risk for nonarteritic anterior ischemic optic neuropathy (NAION), according to a study published online Feb. 20 in JAMA Ophthalmology.

Cindy X. Cai, M.D., from the Johns Hopkins School of Medicine in Baltimore, and colleagues conducted a retrospective study across 14 databases to examine the potential association between semaglutide and NAION. Adults with T2D taking semaglutide, other glucagon-like peptide 1 receptor agonists (GLP-1 RAs; dulaglutide and exenatide), or non-GLP-1 RA medications (empagliflozin, sitagliptin, and glipizide) from Dec. 1, 2017, to Dec. 31, 2023, were included. Of 37.1 million individuals with T2D, there were 810,390 new semaglutide users.

The researchers found that among semaglutide users, the incidence rate of NAION was 14.5 per 100,000 person-years. Using the sensitive NAION definition, the hazard ratio for NAION among new users of semaglutide was not different compared with that of the non-GLP-1 RA medications empagliflozin, sitagliptin, and glipizide. Using the specific definition, the risk was higher for semaglutide users compared with patients taking empagliflozin (hazard ratio, 2.27). The risk for NAION was increased in a self-controlled case series analysis of semaglutide exposure (meta-analysis incidence rate ratio, 1.32).

"In the absence of a known mechanism for this association, we urge clinicians to weigh the concern for an increased risk of a rare but potentially blinding eye condition with the many therapeutic benefits of semaglutide," the authors write.

Several authors disclosed ties to industry.

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The pooled prevalence of chronic painful neuropathy is 41.22 percent among individuals with chemotherapy-induced peripheral neuropathy (CIPN), according to a meta-analysis published online Jan. 28 in Regional Anesthesia & Pain Medicine.

Ryan S. D'Souza, M.D., from the Mayo Clinic in Rochester, Minnesota, and colleagues conducted a systematic review and meta-analysis to examine the prevalence of chronic painful neuropathy among patients diagnosed with CIPN. Estimates from each study were transformed using double arcsine transformation and pooled in a meta-analysis. Data were included from 77 studies from 28 countries, encompassing 10,962 patients with CIPN.

The researchers found that the pooled prevalence of those reporting chronic painful neuropathy among those diagnosed with CIPN was estimated at 41.22 percent. Across studies, there was considerable heterogeneity (I2 = 95.27 percent). Patients treated with platinum-based agents and taxanes had the highest prevalence of chronic painful CIPN (40.44 and 38.35 percent, respectively); among primary cancers, the highest prevalence was reported by those with lung cancer (60.26 percent). Nonsignificant moderators of prevalence estimates included study design, human development index, and publication year.

"The wide variability in prevalence rates across different countries, continents, chemotherapy regimens, and primary cancer history underscores the need for tailored strategies to address this debilitating condition," the authors write.

One author disclosed ties to the biopharmaceutical industry.

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Fourteen-day continuous glucose monitoring (CGM) traces added to Diabetes Control and Complications Trial (DCCT) data can predict microvascular diabetes complications similarly to glycated hemoglobin, according to a study published online Jan. 8 in Diabetes Technology & Therapeutics.

Boris P. Kovatchev, Ph.D., from the University of Virginia in Charlottesville, and colleagues examined the association of CGM metrics with microvascular complications of type 1 diabetes observed during the DCCT and established time-in-range (TIR) as a marker for glycemic control. Virtual CGM traces were added to the original DCCT data for each participant using a multistep machine-learning procedure.

The researchers found that TIR (70 to 180 mg/dL) computed from virtual CGM data for 14 days prior to each glycated hemoglobin measure reflected the observed differences in glycemic control between the intensive and conventional DCCT groups, with TIR >60 percent and <40 percent in these groups, respectively. TIR was associated with the risk for development or progression of retinopathy, nephropathy, and neuropathy, similar to glycated hemoglobin. TIR predicted retinopathy and microalbuminuria similarly to the original glycated hemoglobin data.

"We have demonstrated a strong association of TIR with the risk of development or progression of retinopathy and with the development of microalbuminuria," the authors write.

Several authors disclosed ties to the biopharmaceutical industry.

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Use of once-weekly semaglutide more than doubles the risk for nonarteritic anterior ischemic optic neuropathy (NAION) in individuals with type 2 diabetes, according to a study published online Dec. 18 in the International Journal of Retina and Vitreous.

Jakob Grauslund, D.M.Sci., Ph.D., M.D., from Odense University Hospital in Denmark, and colleagues prospectively evaluated the use of semaglutide and risk for NAION in people with type 2 diabetes. The analysis included 424,152 individuals (2018 to 2024) exposed (106,454 individuals) or not exposed (317,698 individuals) to once-weekly semaglutide.

The researchers found that semaglutide exposure was significantly associated with a higher incidence rate (0.228 versus 0.093 per 1,000 person-years) and independently predicted a higher risk for upcoming NAION (hazard ratio, 2.19), even when accounting for multiple other factors. Of the 67 persons exposed to semaglutide who developed NAION, there was a median time from first prescription to event of 22.2 months (interquartile range, 10.2 to 37.8 months).

"During five years of observation of all persons with type 2 diabetes in Denmark, use of once-weekly semaglutide independently more than doubled the risk of NAION," the authors write. "Given the irreversible nature of NAION, it is important to acknowledge this risk, and upcoming studies should aim to identify high-risk subgroups."

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Incident use of gabapentin is not associated with an increase in fall-related hospital visits compared with duloxetine use, according to a study published online Jan. 7 in the Annals of Internal Medicine.

Alexander Chaitoff, M.D., M.P.H., from the University of Michigan School of Medicine in Ann Arbor, and colleagues describe the risk for fall-related outcomes in older adults with diabetic neuropathy, postherpetic neuralgia, or fibromyalgia starting gabapentin versus duloxetine treatment.

The analytic cohort included 57,086 older adults initiating treatment with gabapentin (52,152 adults) or duloxetine (4,934 adults). The researchers found that the weighted cumulative incidence rates of a fall-related visit at 30, 90, and 180 days were 103.60, 90.44, and 84.44 per 1,000 person-years, respectively, for gabapentin users and 203.43, 177.73, and 158.21 per 1,000 person-years, respectively, for duloxetine users. A lower hazard of falls was seen for incident gabapentin users at six-month follow-up (hazard ratio, 0.52), but no difference was seen in the risk for experiencing severe falls. Across sensitivity and subgroup analyses, the results were similar.

"Incident gabapentin use, compared with incident duloxetine use, was associated with fewer fall-related health care visits and smaller differences in absolute measures and was not associated with an increase in more severe fall-related events," the authors write. "These considerations should be incorporated into conversations with patients who are considering starting gabapentin treatment."

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Generic medications reduce the out-of-pocket (OOP) costs for common neurological conditions, apart from multiple sclerosis, for which costs continue to increase, according to a study published online Oct. 30 in Neurology.

Amanda V. Gusovsky, Ph.D., M.P.H., from the Wexner Medical Center at The Ohio State University in Columbus, and colleagues examined medical cost trends for five common neurologic conditions. Annual OOP and total medication costs were quantified for 186,144 patients with epilepsy; 54,676 with multiple sclerosis; 45,909 with Parkinson disease; 169,127 with peripheral neuropathy; and 60,861 with dementia/Alzheimer disease who were seen by a neurologist.

The researchers observed an increase in OOP costs for multiple sclerosis medications, by an average of 217 percent. Higher OOP costs were seen for branded epilepsy medications versus generics. In the years after generic introduction, the annual OOP costs of duloxetine, pregabalin, rasagiline, rivastigmine, and memantine decreased 48 to 80 percent.

"Branded neurologic medication costs continue to increase. Using generics remains a powerful strategy for affordable prescribing," the authors write. "Multiple sclerosis medication costs remain exceptionally high, pose a substantial financial burden, and demand policy solutions such as cost caps."

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Neuropathy and retinopathy are positively associated with moderate/severe periodontitis, according to a study published online Aug. 5 in the Journal of Dental Research.

Fernando Valentim Bitencourt, D.D.S., from Aarhus University in Denmark, and colleagues investigated the association between individual and combined diabetic microvascular complications (i.e., neuropathy and retinopathy) and moderate/severe periodontitis. The analysis included 15,922 individuals with type 2 diabetes participating in the Health in Central Denmark study.

The researchers found that in an adjusted analysis, diabetic neuropathy (odds ratio [OR], 1.36) and retinopathy (OR, 1.21) were associated with moderate/severe periodontitis. The coexistence of microvascular complications increased the odds of moderate/severe periodontitis (OR, 1.51). There was an additive effect for modification of dyslipidemia, indicating a positive relative excess risk due to interaction of 0.24 for neuropathy, 0.11 for retinopathy, and 0.44 for both complications. Unmeasured confounders and microvascular complication definitions were ruled out as explanatory factors in a sensitivity analysis. There was an association between diabetic neuropathy and retinopathy, individually and combined, with moderate/severe periodontitis. Dyslipidemia had an additive positive effect modification on diabetic microvascular complications, increasing the odds of moderate/severe periodontitis.

"Dentists should consider recommending a screening for microvascular complications in persons with type 2 diabetes who have moderate/severe periodontitis, especially those with dyslipidemia," the authors write.

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The U.S. Food and Drug Administration has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma (MM) who are eligible for an autologous stem cell transplant (ASCT).

The approval was based on a phase 3 trial comparing the efficacy and safety of D-VRd during induction and consolidation versus VRd during induction and consolidation in patients with MM eligible for ASCT. Findings showed significant improvement in the primary end point of progression-free survival (hazard ratio, 0.40). Compared with VRd (32.5 percent), minimal residual disease (MRD) negativity rates were 57.5 percent with D-VRd and MRD negativity rates in patients with complete response or better were 76.6 versus 58.5 percent.

The most common adverse reactions (≥20 percent) with D-VRd were peripheral neuropathy, fatigue, edema, pyrexia, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, insomnia, and rash.

"Multiple myeloma has a highly varied clinical course among patients and in each individual patient, and there is a continued need for innovation and therapies that employ different targets and combinations to provide patients with treatment options at diagnosis and throughout the course of their disease," Amrita Y. Krishnan, M.D., from the Judy and Bernard Briskin Multiple Myeloma Center at City of Hope in Duarte, California, said in a statement. "The efficacy data supporting this new quadruplet regimen, combined with its established safety and tolerability profile, provide compelling evidence that adding D-VRd upon initial diagnosis as compared to VRd can deepen responses and prolong remissions in the context of autologous stem cell transplantation."

Approval of Darzalex Faspro was granted to  Johnson & Johnson.

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Plasma biomarkers of Alzheimer disease (AD) neuropathy increase with age and are associated with known dementia risk factors, according to a study published online July 28 in the Journal of the American Medical Association to coincide with the Alzheimer's Association International Conference, held from July 28 to Aug. 1 in Philadelphia.

Yifei Lu, Ph.D., from the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill, and colleagues examined temporal plasma biomarker changes and their association with all-cause dementia among 1,525 participants from the U.S.-based Atherosclerosis Risk in Communities study. Plasma biomarkers were measured using stored specimens collected in midlife (mean age, 58.3 years) and late life (mean age, 76.0 years); participants were followed until a mean age of 80.7 years. The associations of biomarkers with incident all-cause dementia were assessed in a subgroup of 1,339 individuals.

Of the 1,525 participants, 16.5 percent developed dementia. The researchers found that from midlife to late life, there was a decreasing ratio of amyloid-β 42 to amyloid-β 40 (Aβ42:Aβ40) and increasing phosphorylated tau at threonine 181 (p-tau181), neurofilament light (NfL), and glial fibrillary acidic protein; more rapid changes in biomarkers were seen for participants harboring the apolipoprotein E epsilon 4 allele. Long-term associations were seen for AD-specific biomarkers in midlife with late-life dementia (hazard ratio per standard deviation [SD] lower Aβ42:Aβ40 ratio, 1.11; per SD higher p-tau181, 1.15). Significant associations were seen for all plasma biomarkers in late life with late-life dementia, with the largest association for NfL (hazard ratio per 1-SD increase, 1.92).

"The association of AD-specific biomarkers with dementia starts in midlife, whereas late-life measures of AD, neuronal injury, and astrogliosis biomarkers are all associated with dementia," the authors write.

Two authors disclosed ties to the biopharmaceutical industry.

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Psoriasis and psoriatic arthritis may be associated with an increased risk of polyneuropathy, according to a study published online June 28 in Muscle & Nerve.

Pietro E. Doneddu, M.D., from the IRCCS Humanitas Research Hospital in Milan, and colleagues evaluated the risk and features of peripheral neuropathy in patients with psoriasis and psoriatic arthritis. Analysis included 100 consecutive patients with psoriasis or psoriatic arthritis and 100 controls.

The researchers found that nine patients were diagnosed with confirmed polyneuropathy, compared to no controls (relative risk, 19.00). In psoriasis patients, the relative risk for polyneuropathy was 22.09, while those with psoriatic arthritis had a relative risk of 18.75. In the nine patients with polyneuropathy, presentation was length-dependent, symmetrical, and predominantly sensory, with minimal or no disability. Compared to controls, comorbidities and exposure to therapies known to increase the risk of polyneuropathy were more frequent in those with psoriasis or psoriatic arthritis (4 versus 42 percent). When excluding possible contributory causes, risk of polyneuropathy was not significant in patients with psoriasis or psoriatic arthritis.

"This increased risk seems to be linked to the higher prevalence of contributing factors for polyneuropathy, rather than a direct increase in neuropathy risk specifically related to psoriasis and psoriatic arthritis," the authors write.

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Neuromuscular training reduces the onset of chemotherapy-induced peripheral neuropathy (CIPN), according to a study published online July 1 in JAMA Internal Medicine.

Fiona Streckmann, Ph.D., from the University of Basel in Switzerland, and colleagues examined whether sensorimotor training (SMT) and whole-body vibration (WBV) training reduce symptoms and decrease onset of CIPN among patients undergoing treatment with oxaliplatin or vinca alkaloids. A total of 158 patients were randomly assigned into three groups: SMT (55 patients), WBV (53 patients), and treatment as usual (TAU; 50 patients).

The researchers found that the incidence of CIPN was significantly lower in SMT and WBV groups compared with TAU (30.0 and 41.2 percent, respectively, versus 70.6 percent) in intention-to-treat analysis. The most benefit was seen for patients receiving vinca alkaloids and performing SMT. In a per-protocol analysis, the results were more pronounced (28.6 and 37.5 percent, respectively, versus 73.3 percent). For balance control bipedal with eyes open, bipedal with eyes closed, monopedal, vibration sensitivity, sense of touch, lower leg strength, pain reduction, burning sensation, chemotherapy dose reductions, and mortality, improvements were seen in favor of SMT versus TAU.

"We were able to show that SMT can decrease CIPN, as well as maintain and improve subjective and objective outcomes, such as vibration sensitivity, sense of touch, lower leg strength, pain, burning sensation, and balance control," the authors write. "WBV showed a reduced incidence of CIPN and improved balance in a bipedal stance."

Two authors disclosed ties to the pharmaceutical industry.

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Semaglutide is associated with nonarteritic anterior ischemic optic neuropathy (NAION) among patients with type 2 diabetes (T2D) and those with overweight/obesity, according to a study published online July 3 in JAMA Ophthalmology.

Jimena Tatiana Hathaway, M.D., M.P.H., from the Harvard T.H. Chan School of Public Health in Boston, and colleagues examined the potential association between semaglutide and the risk for NAION in a retrospective matched cohort study. Data were obtained for 16,827 patients, including 710 with T2D (194 prescribed semaglutide; 516 prescribed non-glucagon like peptide 1 receptor agonist [GLP1-RA] antidiabetic medications) and 979 with overweight or obesity (361 prescribed semaglutide; 618 prescribed non-GLP1 RA weight-loss medications).

The researchers observed 17 and six NAION events in patients prescribed semaglutide and non-GLP1 RA medications, respectively. Over 36 months, the cumulative incidence of NAION among patients with T2D was 8.9 and 1.8 percent for the semaglutide and non-GLP1 RA cohorts, respectively. The risk for NAION was significantly higher for patients receiving semaglutide (hazard ratio, 4.28) in a Cox proportional hazards regression model. Among patients with overweight or obesity, there were 20 and three NAION events in the semaglutide and non-GLP1 RA cohorts, respectively. The cumulative incidence of NAION over 36 months was 6.7 and 0.8 percent for semaglutide and non-GLP1 RA medications, respectively, with a higher risk for NAION seen for patients prescribed semaglutide (hazard ratio, 7.64).

"There has been no prior mention, to our knowledge, of an increased risk of NAION in association with semaglutide, and our study does not inform a mechanism to link semaglutide to NAION," the authors write.

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The annual meeting of the American Society of Clinical Oncology was held from May 30 to June 4 in Chicago and hosted more than 34,000 participants from around the world, including clinicians, academicians, allied health professionals, and others interested in oncology. The conference featured the latest advances in clinical cancer research, including oral abstract presentations and poster presentations in disease-based and specialty tracks. Presentations focused on novel targeted therapies as well as improvements in chemotherapy and radiation therapy approaches.

In one study, Jefferson DeKloe, M.D., of Thomas Jefferson University in Philadelphia, and colleagues found that human papillomavirus (HPV) vaccination reduces the risk for cervical cancer and precancerous dysplasia in female patients and may reduce the incidence of other HPV-associated cancers, including head and neck cancers in men.

The authors performed a retrospective cohort study using the data from the TriNetX U.S. Collaborative Network. Patients aged 9 to 39 years who received any vaccine between Jan. 1, 2010, and Dec. 31, 2023, were included in the analysis. Patients were divided into two cohorts: those vaccinated for HPV at least five years prior and those with no history of HPV vaccination. The development of malignancies across various organ systems, including head and neck, cervix, anus and anal canal, penis, vulva, and vagina, was assessed.

The researchers observed lower rates of cervical cancer in female participants vaccinated for HPV compared with those not vaccinated. Furthermore, lower rates of head and neck cancer were observed in male patients vaccinated for HPV compared with those not vaccinated.

"There are still many variables that influence the risk of developing an HPV-associated cancer and future research may inform us what is causing the reduced incidence of head and neck cancers in HPV-vaccinated males," DeKloe said. "This work shows that the HPV-vaccination efforts in the United States may already have some apparent benefit measured through the reduction of HPV-associated cancers. Given the rise in HPV-related cancers in the past few decades, HPV vaccination is an important means of cancer prevention that should be emphasized for male and female patients in clinical practice."

One author disclosed a financial relationship with AstraZeneca.

Abstract No. 10507

In a large-scale comparative effectiveness trial across 22 cancer centers, Joseph Greer, M.D., of Massachusetts General Hospital and Harvard Medical School in Boston, and colleagues demonstrated equivalence for the effect of delivering early palliative care via video versus in-person visits on quality of life in patients with advanced lung cancer.

The authors focused on the use of video visits to deliver palliative care, as according to the authors, they require fewer clinical resources and may be a more efficient way for clinicians to provide care. The researchers also note that video visits save patients time and money compared with going to the hospital or clinic to meet with the clinician.

The trial included 1,250 patients, with 633 in the video-visit palliative care group and 617 in the in-person palliative care group. In addition, 548 caregivers (i.e., a family member or friend who was involved in the patient's care) were enrolled in the study. All patients who participated in the study received early palliative care that began soon after their diagnosis and continued throughout the course of their disease. Patients in both study groups had contact with the palliative care clinician every four weeks, with the visits occurring predominantly in clinic for those randomly assigned to in-person palliative care and via video visits for those assigned to telehealth palliative care.

The researchers found that medical care, such as palliative care, can be delivered through video visits and patients and their family caregivers receive the same quality-of-life benefits as with in-person palliative care. The two study groups also did not differ in their reported satisfaction with care or with respect to patient- and caregiver-reported mood symptoms.

"The equivalence of these modalities in a population with serious illness underscores the urgent need for clinicians, health care systems, and policymakers to expand equitable access to evidence-based palliative care and develop guidelines for a new standard of care that includes the broad adoption of telehealth services," Greer said.

Several authors disclosed ties to the biopharmaceutical industry.

Abstract No. LBA3

In a prospective study, Kimia Sorouri, M.D., of the Dana-Farber Cancer Institute in Boston, and colleagues followed breast cancer survivors over 10 years to determine fertility outcomes in those attempting pregnancy, with the majority achieving pregnancy and most experiencing live births.

The authors evaluated women with stage 0 to III breast cancer included in the Young Women's Breast Cancer Study who reported attempting pregnancy postdiagnosis (1,213 eligible female participants, including 197 reporting any attempt of pregnancy). The researchers found that 73 percent reported at least one pregnancy after diagnosis and 65 percent experienced at least one live birth after diagnosis.

"This is the first prospective study with greater than 10 years of follow-up to report fertility outcomes in young breast cancer survivors accounting for attempting pregnancy," the authors write. "Our findings can be incorporated into the counseling of young breast cancer patients and survivors, and highlight the need for accessibility of fertility preservation services for this population."

Several authors disclosed ties to the pharmaceutical, medical device, and medical technology industries.

Abstract No. 1518

ASCO: Germline Variation Does Not Predict Taxane-Induced Peripheral Neuropathy

FRIDAY, June 7, 2024 (HealthDay News) -- Germline variation does not predict the risk of taxane-induced peripheral neuropathy in Black women receiving paclitaxel (once weekly) or docetaxel (every three weeks) for early-stage breast cancer, according to a study published online June 3 in the Journal of Clinical Oncology to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago.

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ASCO: Ivonescimab Improves Progression-Free Survival in EGFR+ Lung Cancer

THURSDAY, June 6, 2024 (HealthDay News) -- For patients with non-small cell lung cancer with the epidermal growth factor receptor variant, ivonescimab plus chemotherapy improves progression-free survival, according to a study published online May 31 in the Journal of the American Medical Association to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago.

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ASCO: Osimertinib Improves Progression-Free Survival in EGFR-Mutated Lung Cancer

WEDNESDAY, June 5, 2024 (HealthDay News) -- For patients with unresectable stage III EGFR-mutated non-small cell lung cancer, treatment with osimertinib results in significantly longer progression-free survival, according to a study published online June 2 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago.

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ASCO: Neoadjuvant Ipilimumab + Nivolumab Ups Survival in Resectable Melanoma

WEDNESDAY, June 5, 2024 (HealthDay News) -- Neoadjuvant ipilimumab plus nivolumab followed by surgery results in longer event-free survival than surgery followed by adjuvant nivolumab among patients with resectable, macroscopic stage III melanoma, according to a study published online June 2 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago.

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ASCO: Asciminib Has Superior Efficacy to TKIs for Newly Diagnosed Leukemia

WEDNESDAY, June 5, 2024 (HealthDay News) -- For patients with newly diagnosed chronic myeloid leukemia, asciminib shows superior efficacy and a favorable safety profile compared with investigator-selected tyrosine kinase inhibitors, according to a study published online May 31 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago.

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ASCO: Stepped-Care Model Noninferior to Early Palliative Care for Advanced Cancer

TUESDAY, June 4, 2024 (HealthDay News) -- For patients with advanced lung cancer, a stepped-care model with palliative care visits occurring at key points in patients' cancer trajectory is noninferior to early palliative care, according to a study published online June 2 in the Journal of the American Medical Association to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago.

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ASCO: Conjugated Equine Estrogen May Increase Risk for Ovarian Cancer

TUESDAY, May 28, 2024 (HealthDay News) -- Conjugated equine estrogen taken alone for menopause may increase the risk for developing and dying from ovarian cancer, according to a study presented at the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago.

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ASCO: Survivors of Early Breast Cancer Can Successfully Attempt Pregnancy

THURSDAY, May 23, 2024 (HealthDay News) -- Most survivors of stage 0 to III breast cancer who attempt pregnancy postdiagnosis are able to become pregnant and have a live birth, according to a study presented at the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago.

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ASCO: HPV Vaccination Positively Affecting More Than Just Cervical Cancer Risk

THURSDAY, May 23, 2024 (HealthDay News) -- Human papillomavirus vaccination is associated with reduced odds of several types of HPV-related cancers, not just cervical cancer, according to a study presented at the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago.

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Germline variation does not predict the risk of taxane-induced peripheral neuropathy (TIPN) in Black women receiving paclitaxel (once weekly) or docetaxel (every three weeks) for early-stage breast cancer, according to a study published online June 3 in the Journal of Clinical Oncology to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago.

Bryan P. Schneider, M.D., from the Indiana University Melvin and Bren Simon Comprehensive Cancer Center in Indianapolis, and colleagues validated germline predictors of TIPN and compared rates of TIPN and dose reductions in Black women receiving (neo)adjuvant paclitaxel once weekly and docetaxel once every three weeks for early-stage breast cancer. Germline neuropathy risk was determined by performing genotyping; genotype data were available for 240 patients. Of the patients, 91 of 117 receiving once-weekly paclitaxel and 87 of 118 receiving once-every-three-weeks docetaxel were classified as high-risk.

The researchers observed no significant difference in physician-reported grade 2 to 4 TIPN in high- versus low-risk genotype groups with once-weekly paclitaxel or once-every-three-weeks docetaxel. The once-weekly paclitaxel group had significantly higher grade 2 to 4 TIPN than the once-every-three-weeks docetaxel arm by physician-rated Common Terminology Criteria for Adverse Events (CTCAE) (45 versus 29 percent) and patient-reported outcome CTCAE (40 versus 24 percent). More dose reductions because of TIPN or any cause occurred in patients receiving once-weekly paclitaxel.

"Key, clinically relevant long-term follow-up data will be crucial to understand the true scope of impact," the authors write.

Several authors disclosed ties to the pharmaceutical industry.

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FRIDAY, May 10, 2024 (HealthDay News) -- Significant hearing improvements have been achieved in an infant with profound hearing loss due to a biallelic otoferlin gene (OTOF) mutation, according to the results of a first-in-human gene therapy trial presented at the annual meeting of the American Society of Gene & Cell Therapy, held from May 7 to 11 in Baltimore.

The gene therapy that the 10-month-old female infant with auditory neuropathy received involved the transmission into her right ear of a working copy of the OTOF gene, delivered during surgery into the ear's cochlea via a harmless virus called AAV1. The baby girl was also fitted out with a cochlear implant in her left ear. Six months later, she could respond to sound even when her left ear cochlear implant was switched off. She could even detect low sounds such as whispers in her treated right ear.

"These results are spectacular and better than I expected," Manohar Bance, M.B.,Ch.B., an ear surgeon at Cambridge University in the United Kingdom and chief investigator of the new trial, said in a statement. "Gene therapy has been the future in otology and audiology for many years and I'm so excited that it is now finally here. This is hopefully the start of a new era for gene therapies for the inner ear and many types of hearing loss."

The gene deficiency behind auditory neuropathy often goes undetected in newborn screenings, so children with the condition are often not diagnosed until age 2 or 3, when delays in speech have set in.

"We have a short time frame to intervene because of the rapid pace of brain development at this age," Bance said. "Delays in the diagnosis can also cause confusion for families as the many reasons for delayed speech and late intervention can impact children's development.”

The global trial is ongoing, and experts believe gene therapy could revolutionize the treatment of hearing loss.

The trial is sponsored by Regeneron.

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WEDNESDAY, May 8, 2024 (HealthDay News) -- Distal symmetric polyneuropathy (DSP) is common and is frequently undiagnosed, according to a study published online May 8 in Neurology.

Melissa A. Elafros, M.D., Ph.D., from the University of Michigan in Ann Arbor, and colleagues examined whether data accurately reflect the prevalence, risk factors, and burden of DSP in the population. The cross-sectional study included patients older than 40 years presenting to an outpatient internal medicine clinic mainly serving Medicaid patients. The modified Toronto Clinical Neuropathy Score (mTCNS) was used to define DSP.

The study enrolled 200 patients; 85 percent completed all data collection. The population was mainly female and non-Hispanic Black (55 and 69 percent, respectively). The researchers found that 73 percent of the population had DSP, of which 75 percent were previously undiagnosed. Overall, 57 percent of participants with DSP had neuropathic pain. DSP based on mTCNS criteria was associated with older age and metabolic syndrome (odds ratios, 1.1 and 4.4, respectively). Lower odds of DSP were seen for non-Hispanic Black participants compared with non-Hispanic White and Hispanic participants (odds ratio, 0.1). The burden of DSP was high, with increased pain and health-related worry and lower quality of life.

"The amount of people with neuropathy in this study, particularly undiagnosed neuropathy, was extraordinarily high with almost three fourths of the study population," Elafros said in a statement. "This highlights the urgent need for interventions that improve diagnosis and management of this condition, as well as the need for managing risk factors that can lead to this condition."

One author disclosed ties to DynaMed.

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Low-intensity pulsed ultrasound with concomitant administration of IV microbubbles (LIPU-MB) can be used to open the blood-brain barrier, allowing the delivery of drugs to the brain. In a recent phase 1 trial, researchers at Northwestern University used LIPU-MB to successfully deliver IV albumin-bound paclitaxel to 17 people with recurrent glioblastoma multiforme. 

Existing treatments focus on resection followed by radiotherapy and chemotherapy with temozolomide - a drug that can cross the blood-brain barrier but is relatively weaker. In this treatment, an ultrasound device was implanted into a skull window after tumor resection and paclitaxel was infused every 3 weeks for up to six cycles. Of the 17 patients who received a median of 3 cycles each, encephalopathy occurred in one patient during the first cycle and another patient during the second cycle. In both cases, toxicity resolved when treatment continued at a lower dose. Peripheral neuropathy was also observed in one patient, but no progressive neurological deficits were attributed to the treatment. The most common adverse events included: headache (71%), neutropenia (47%), leukopenia (29%), and hypertension  (29%). No deaths were reported. 

The study shows promising advancements in using LIPU-MB  to open the blood-brain barrier for the delivery of cytotoxic drugs to the brain. A phase 2 study combining LIPU-MB with carboplatin is now underway...Read more

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