Advisory Committee on Immunization Practices February Meeting Postponed
The latest meeting of the U.S. Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) has been postponed indefinitely to allow time for public comments to be collected, according to federal health officials, Reuters has reported.
ACIP usually holds multiple meetings each year to review scientific data and make recommendations to the director of the CDC. This particular meeting, originally scheduled for Feb. 26 to 28, was to include several important votes, including one about how a key government vaccine distribution program should handle influenza inoculations. The draft agenda also indicated reviews of the GSK meningococcal vaccine and AstraZeneca flu shot.
According to the U.S. Department of Health and Human Services, the public is normally allowed time to submit written comments in advance of ACIP meetings through a federal portal. Prior to the inauguration of President Trump last month, the CDC had posted a formal notice of the February ACIP meeting, noting that comments could be submitted between Feb. 3 and 17. However, a letter to the newly appointed Secretary of the U.S. Department of Health and Human Services, Robert F. Kennedy Jr., signed by more than 50 medical experts and organizations, states that the portal has been "absent," Reuters reported. The signatories also requested the "critical" meeting be rescheduled.
The American College of Physicians echoed that sentiment. "Our country is currently facing the worst epidemic of influenza in several decades, a measles outbreak in Texas, and an ongoing national outbreak of pertussis," Isaac O. Opole, M.B.Ch.B., Ph.D., president of the American College of Physicians, said in a statement. "The CDC must promptly reschedule this critical meeting. We call on Secretary Kennedy and other officials to ensure that the advice of epidemiologists, researchers, physicians, and other experts in disease and immunizations remains primary in helping to ensure the public's health."
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Acalabrutinib-Venetoclax Prolongs Survival in Previously Untreated Leukemia
For patients with previously untreated chronic lymphocytic leukemia (CLL), fixed-duration acalabrutinib-venetoclax with or without obinutuzumab significantly prolongs progression-free survival compared with chemoimmunotherapy, according to a study published online Feb. 5 in the New England Journal of Medicine.
Jennifer R. Brown, M.D., from Dana-Farber Cancer Institute in Boston, and colleagues conducted a phase 3, open-label trial involving patients with CLL aged 18 years or older with an Eastern Cooperative Oncology Group performance-status score of 0 to 2, who did not have a 17p deletion or TP53 mutation. Patients were randomly assigned to receive acalabrutinib-venetoclax, acalabrutinib-venetoclax-obinutuzumab, or chemoimmunotherapy with the investigator's choice of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab (291, 286, and 290 [143 and 147], respectively).
The researchers found that at a median follow-up of 40.8 months, the estimated 36-month progression-free survival was 76.5, 83.1, and 66.5 percent with acalabrutinib-venetoclax, acalabrutinib-venetoclax-obinutuzumab, and chemoimmunotherapy, respectively (hazard ratio for disease progression or death, 0.65 [P = 0.004], for acalabrutinib-venetoclax versus chemoimmunotherapy; P < 0.001 for acalabrutinib-venetoclax-obinutuzumab versus chemoimmunotherapy). The estimated 36-month overall survival was 94.1, 87.7, and 85.9 percent with acalabrutinib-venetoclax, acalabrutinib-venetoclax-obinutuzumab, and chemoimmunotherapy, respectively. The most common adverse event of clinical interest of grade 3 or higher was neutropenia, which was reported in 32.3, 46.1, and 43.2 percent in the three groups, respectively. Ten, 25, and 21 patients died from COVID-19 in the three groups, respectively.
"Continued follow-up will be essential to clarify which patients would be most suitable for acalabrutinib-venetoclax and which for acalabrutinib-venetoclax-obinutuzumab," the authors write.
Several authors disclosed ties to the biopharmaceutical industry, including AstraZeneca, which funded the study.
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Anifrolumab Tied to Less Organ Damage for Patients With Lupus
For patients with moderately to severely active systemic lupus erythematosus (SLE), anifrolumab is associated with less organ damage after 208 weeks compared with patients receiving standard of care (SOC), according to a study published online Feb. 7 in the Annals of Rheumatic Disease.
Zahi Touma, M.D., Ph.D., from the University Health Network in Toronto, and colleagues examined whether anifrolumab plus SOC is associated with reduced organ damage accumulation compared with SOC only among adults with moderately to severely active SLE. The anifrolumab arm included patients who initiated 300 mg anifrolumab in the Treatment of Uncontrolled Lupus via the Interferon Pathway trials; real-world (RW) external controls from the University of Toronto Lupus Clinic cohort received SOC only (354 and 561 patients, respectively).
The researchers found that the mean change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score was 0.416 points lower in the anifrolumab versus the RW SOC arm after weighting. The likelihood of experiencing an increase in SDI within 208 weeks was lower for patients in the anifrolumab arm (hazard ratio, 0.401).
"In addition to the proven effectiveness of anifrolumab for controlling disease activity, attaining Lupus Low Disease Activity State and remission, and enabling glucocorticoid tapering, this study shows that anifrolumab is effective for preventing long-term organ damage compared to RW SOC," the authors write.
Several authors disclosed ties to pharmaceutical companies, including AstraZeneca, which manufactures anifrolumab and funded the study.
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Study Finds Exenatide Not Beneficial for Parkinson Disease
The glucagon-like peptide-1 receptor agonist exenatide does not yield improvement in measures of Parkinson disease severity, according to a study published online Feb. 4 in The Lancet.
Nirosen Vijiaratnam, M.D., from the University College London Queen Square Institute of Neurology, and colleagues conducted a phase 3, multicenter trial at six research hospitals in the United Kingdom involving patients aged 25 to 80 years with a diagnosis of Parkinson disease who were randomly assigned to receive extended-release exenatide 2 mg by subcutaneous pen injection once per week over 96 weeks or visually identical placebo (97 patients in each group).
The analyses included 92 patients in the exenatide group and 96 in the placebo group with at least one follow-up visit. The researchers found that the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale part III score, off dopaminergic medication at 96 weeks, increased (worsened) by a mean of 5.7 and 4.5 points in the exenatide and placebo groups, respectively (adjusted coefficient for the effect of exenatide, 0.92; 95 percent confidence interval, −1.56 to 3.39; P = 0.47). Nine and 11 participants in the exenatide and placebo groups, respectively, had at least one serious adverse event.
"The results of this trial are discordant with previous laboratory and epidemiology data and previous trial results," the authors write. "We aim to do further post-hoc analyses to try and explain the reasons for this inconsistency."
Several authors disclosed ties to biopharmaceutical companies. AstraZeneca provided exenatide for the study.
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Baseline Characteristics ID Risk for Recurrent Endoscopic Sinus Surgery
A few baseline characteristics can predict the need for recurrent endoscopic sinus surgery (ESS) among patients with chronic rhinosinusitis with nasal polyps (CRSwNP), according to a study published online Jan. 29 in Clinical and Translational Allergy.
Sanna Toppila-Salmi, from University of Eastern Finland in Kuopio, and colleagues investigated predictors of revision ESS at one and three years in 3,506 patients with CRSwNP.
The researchers found that 15.9 percent of the patients had at least one revision surgery during the follow-up, with a median time to revision of ESS of 425 days. Higher odds of revision ESS were seen with baseline asthma (odds ratio [OR], 1.58) and antibiotic use (OR, 1.61). Increasing age was associated with lower odds of ESS revision (OR, 0.82). Compared with those who had undergone limited surgery, the highest odds of revision ESS were observed at three years for patients who had undergone extensive surgery at index (OR, 14.13). A higher cumulative dose of oral corticosteroid was seen in patients undergoing multiple ESS revisions (63 percent; median daily dose, 3.29 mg) versus patients without revisions (49 percent; median daily dose, 1.64 mg).
"The results indicate that severe chronic rhinosinusitis with nasal polyps is often associated with asthma," Toppila-Salmi said in a statement. "Patients with a severe form of the disease may benefit from additional treatments, such as biologics, if the disease cannot be managed despite repeated courses of antibiotics, oral corticosteroids, and sinus surgeries."
Several authors disclosed ties to pharmaceutical companies, including AstraZeneca, the study's sponsor.
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FDA Approval Expands Earlier Use of Enhertu for Metastatic Breast Cancer
The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-low or HER2-ultralow breast cancer.
The approval was granted through Priority Review and Breakthrough Therapy Designation pathways, with HR and HER status determined by an FDA-approved test. Additionally, patients had to have had disease progression after one or more endocrine therapies.
Results from the DESTINY-Breast06 phase 3 trial showed that Enhertu demonstrated superiority compared with chemotherapy. Enhertu showed a significant reduction in the risk for disease progression or death versus chemotherapy (hazard ratio, 0.64) in the overall trial population of patients with chemotherapy-naive HER2-low or HER2-ultralow metastatic breast cancer. Patients randomly assigned to Enhertu had a median progression-free survival of 13.2 months compared with 8.1 months seen for those assigned to chemotherapy. Overall, the confirmed objective response rate was 62.6 percent for Enhertu versus 34.4 percent for chemotherapy.
"Building on the practice-changing previous approvals for Enhertu, this new approval brings this important medicine to an earlier treatment setting and a broader patient population with HER2-expressing metastatic breast cancer," Dave Fredrickson, executive vice president of the Oncology Haematology Business Unit at AstraZeneca, said in a statement. "The approval also highlights the importance of testing metastatic breast cancer tumors for detectable staining with a standard immunohistochemistry test to identify those who may be eligible for treatment with Enhertu following endocrine therapy."
Approval of Enhertu was granted to AstraZeneca and Daiichi Sankyo.
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Diabetes Remission Increased With Dapagliflozin Plus Calorie Restriction
For patients with overweight or obesity and type 2 diabetes, dapagliflozin plus regular calorie restriction is associated with a significantly higher rate of remission of diabetes compared with calorie restriction alone, according to a study published online Jan. 22 in The BMJ.
Yuejun Liu, from Fudan University in Shanghai, and colleagues conducted a multicenter, double-blind randomized trial in 16 centers in China from June 12, 2020, to Jan. 31, 2023, involving 328 patients with type 2 diabetes aged 20 to 70 years, with body mass index >25 kg/m2 and diabetes duration of less than six years. Patients were randomly assigned to calorie restriction with dapagliflozin 10 mg/day or placebo.
The researchers found that diabetes remission was achieved in 44 and 28 percent of patients in the dapagliflozin and placebo groups, respectively, over 12 months (risk ratio, 1.56), meeting the predefined primary end point. Significantly greater changes in body weight (difference, −1.3 kg) and homoeostasis model assessment of insulin resistance (difference, −0.8) were seen in the dapagliflozin versus placebo group. Likewise, compared with the placebo group, significantly more improvement was seen in body fat, systolic blood pressure, and metabolic risk factors in the dapagliflozin group. The occurrence of adverse events did not differ between the groups.
"Our findings provide an alternative and more practical strategy than intensive weight management to achieve remission for patients with early type 2 diabetes," the authors write.
The study was partially funded by AstraZeneca, the manufacturer of dapagliflozin.
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Extended Nirmatrelvir/Ritonavir Beneficial for Some With Long COVID
Extended-course nirmatrelvir/ritonavir yields a meaningful reduction in symptoms for some patients with long COVID, but not all benefits persist, according to a case series published online Jan. 6 in Communications Medicine.
Alison K. Cohen, Ph.D., M.P.H., from the University of California San Francisco, and colleagues documented a case series of 13 individuals with long COVID who initiated extended courses (more than five days; range, 7.5 to 30 days) of oral nirmatrelvir/ritonavir outside of and within (11 and two individuals, respectively) the context of an acute severe acute respiratory syndrome coronavirus 2 infection.
The researchers found that some of those taking an extended course of nirmatrelvir/ritonavir outside the context of an acute infection experienced a meaningful reduction in symptoms, but not all benefits persisted. No effect on symptoms was experienced by the other individuals in this group. Due to intense stomach pain, one participant stopped taking the medication early. Both participants who took an extended course of nirmatrelvir/ritonavir within the context of an acute reinfection reported eventually returning to their pre-reinfection baseline.
"These cases provide strong rationale for the ongoing study of antivirals for long COVID to determine if, when, and how they should be used in this patient population," the authors write.
One author disclosed ties to Gilead Sciences and AstraZeneca.
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San Antonio Breast Cancer Symposium, Dec. 10 to 13
The annual San Antonio Breast Cancer Symposium was held from Dec. 10 to 13 in San Antonio. Attendees included medical oncologists, radiation oncologists, researchers, and other health care professionals. The conference highlighted recent advances in the risk, diagnosis, treatment, and prevention of breast cancer, and presentations focused on emerging treatments in hard-to-treat patient populations, including patients with metastatic breast cancer.
As part of the BIG 2-04 MRC SUPREMO phase 3 clinical trial, Ian Kunkler, M.B., B.Chir., of the University of Edinburgh in the United Kingdom, and colleagues found that chest wall irradiation may be omitted among patients with intermediate-risk breast cancer who have undergone mastectomy.
For the study, patients were randomly assigned to receive chest wall irradiation after mastectomy or to omit chest wall irradiation after mastectomy. The researchers found that postmastectomy radiotherapy to the chest wall among women with one to three positive axillary nodes after an axillary clearance or negative on an axillary clearance, axillary node sample, or sentinel node biopsy was not associated with an improvement in 10-year overall survival. The investigators also found that postmastectomy radiotherapy reduced chest wall recurrence by less than 2 percent at 10 years. Furthermore, the approach did not have an impact on metastasis-free survival.
"Postmastectomy radiotherapy National Institute for Health and Care Excellence guidelines currently recommend radiotherapy in women with one to three positive nodes after mastectomy," Kunkler said. "So, our results should change guidelines and practice internationally."
As part of the phase 3 COMET study, Ann Partridge, M.D., M.P.H., of the Dana-Farber Cancer Institute and Harvard Medical School in Boston, and colleagues found that active monitoring is a reasonable approach for the management of patients with grade 1 or 2, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative low-risk ductal carcinoma in situ (DCIS), with no evidence of a higher incidence of microinvasive or invasive disease.
For the study, patients were randomly assigned to either undergo active monitoring or receive guideline-concordant care consisting of surgery with or without adjuvant radiation. During a two-year period, the authors assessed quality of life, anxiety, depression, worries about DCIS, and symptom trajectories via surveys that employed validated quality-of-life measures. Patients filled out surveys prior to randomization, at six months, at one year, and after two years.
The researchers found that the overall lived experience of women randomly assigned to active monitoring was similar to that of those selected to follow the current guideline for care, which is surgery with or without radiation. During the two years of follow-up, health-related quality of life, anxiety, depression, worry, and symptom trajectories were comparable regardless of the treatment received.
"If longer-term follow-up supports the safety of active management from a cancer outcome standpoint, this approach could be considered as an option for women with this condition," Partridge said. "It is critical that we understand how women feel when they are living with an active-monitoring approach and how it impacts their overall quality of life, psychosocial health, worries about DCIS, anxiety and depression, and other related symptoms. These data are reassuring in that respect."
In the multicenter, double-blind OlympiA study, Judy E. Garber, M.D., of the Dana-Farber Cancer Institute in Boston, and colleagues provided further support for the benefits of olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, among patients with high-risk, HER2-negative breast cancer with germline mutations in BRCA1 or BRCA2.
The authors randomly assigned 1,836 patients with BRCA-positive, HER2-negative breast cancer (1:1) to receive either olaparib or placebo for one year following completion of chemotherapy, surgery, and radiation.
The researchers found that after a median follow-up of 6.1 years, patients with high-risk, BRCA-positive breast cancer who received olaparib after standard treatment continued to have better survival outcomes than those who received placebo. The continued demonstration of the efficacy of olaparib in breast cancer patients who carry pathogenic variants in BRCA1/2 makes it important to identify these individuals when they begin their treatment, the authors noted.
"The ongoing data from the OlympiA trial are reassuring in the observations of persistent and increasing benefits in the follow-up phases, improving not only recurrence, but also overall survival. Benefits are demonstrated in both triple-negative breast cancer as well as hormone receptor-positive tumors, despite the shortened follow-up and smaller numbers in the estrogen receptor-positive group," Garber said. "These data also highlight the safety of olaparib and, therefore, the possibility of moving PARP inhibitors to the treatment of BRCA-associated breast cancers that are lower risk."
The study was supported by AstraZeneca and Merck, the manufacturers of olaparib.
SABCS: Chest Wall Irradiation Does Not Impact Survival in Breast Cancer
MONDAY, Dec. 16, 2024 (HealthDay News) -- For patients with intermediate-risk breast cancer, chest wall irradiation after mastectomy does not influence 10-year overall survival, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio.
SABCS: Risk-Reducing Surgery Improves Outcomes in Young Breast Cancer Patients With BRCA Mutations
MONDAY, Dec. 16, 2024 (HealthDay News) -- Risk-reducing mastectomy and salpingo-oophorectomy are both associated with significant improvements in outcomes among young BRCA carriers with breast cancer, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio.
SABCS: Adding Camrelizumab to Neoadjuvant Chemo Beneficial in TNBC
FRIDAY, Dec. 13, 2024 (HealthDay News) -- The addition of camrelizumab to neoadjuvant chemotherapy improves pathological complete response for patients with early or locally advanced triple-negative breast cancer, according to a study published online Dec. 13 in the Journal of the American Medical Association to coincide with the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio.
SABCS: Active Monitoring Noninferior to Guideline Care for Ductal Carcinoma in Situ
FRIDAY, Dec. 13, 2024 (HealthDay News) -- For patients with ductal carcinoma in situ, active monitoring is noninferior to guideline-concordant care that involves surgery with or without adjuvant radiation, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio.
SABCS: Omission of Axillary Staging Noninferior for Node-Negative Breast Cancer
FRIDAY, Dec. 13, 2024 (HealthDay News) -- Omission of surgical axillary staging is noninferior to sentinel lymph-node biopsy for patients with clinically node-negative, T1 or T2 invasive breast cancer, according to a study published online Dec. 12 in the New England Journal of Medicine to coincide with the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio.
SABCS: Imlunestrant Tied to Improved PFS for ER-Positive, HER2-Negative Breast Cancer With ESR1 Mutations
THURSDAY, Dec. 12, 2024 (HealthDay News) -- For patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer, imlunestrant leads to significantly longer progression-free survival among those with ESR1 mutations, according to a study published online Dec. 11 in the New England Journal of Medicine to coincide with the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio.
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Benralizumab Beneficial for Eosinophilic Exacerbations of Asthma, COPD
Benralizumab can be used for the treatment of acute eosinophilic exacerbations of asthma and chronic obstructive pulmonary disease (COPD), according to a study published online Nov. 27 in The Lancet Respiratory Medicine.
Sanjay Ramakrishnan, M.B.B.S., from the University of Western Australia in Perth, and colleagues enrolled patients with blood eosinophil counts of ≥300 cells/µL at the time of an exacerbation of asthma or COPD and randomly assigned them to receive acute treatment with prednisolone 30 mg once daily for five days and 100 mg benralizumab subcutaneous injection once (BENRA plus PRED group; 52 patients); placebo tablets for five days plus 100 mg benralizumab subcutaneous injection once (BENRA group; 53 patients); or prednisolone 30 mg once daily for five days plus placebo subcutaneous injection once (PRED group; 53 patients). The proportion of treatment failures over 90 days and total visual analog scale (VAS) symptoms at day 28 were compared in the pooled BENRA groups and the PRED group.
The researchers found that treatment failures occurred in 74 and 45 percent of patients in the PRED and pooled BENRA groups, respectively, at 90 days (odds ratio, 0.26). The total VAS mean difference was 49 mm at day 28, favoring the pooled BENRA groups. No fatal adverse events occurred, and benralizumab was well tolerated.
"The ABRA [Acute exacerbations treated with BenRAlizumab] study is the first trial to target the eosinophilic treatable trait, during exacerbations," the authors write. "This study shows that benralizumab is effective as an acute treatment of eosinophilic exacerbation."
Several authors disclosed ties to biopharmaceutical companies, including AstraZeneca, which manufactures benralizumab and funded the study.
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Radiotherapy With Adjuvant Durvalumab No Benefit for Head, Neck Cancer
For patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC) with a contraindication for cisplatin, radiotherapy with adjuvant durvalumab does not improve outcomes over radiotherapy with cetuximab, according to a study published online in the December issue of The Lancet Oncology.
Loren K. Mell, M.D., from the University of California San Diego in La Jolla, and colleagues conducted a randomized phase 2/phase 3 trial to examine whether radiotherapy with concurrent and adjuvant durvalumab would improve outcomes compared to radiotherapy with cetuximab among eligible patients with stage III to IVB p16-negative HNSCC or unfavorable stage I to III p16-positive oropharyngeal or unknown primary carcinoma with a contraindication to cisplatin.
The researchers of the phase 2 trial randomly assigned 186 patients: 123 to durvalumab and 63 to cetuximab. Following an interim futility analysis, phase 2 accrual was suspended and then permanently closed. The phase 3 part of the trial was not performed. The researchers found that at a median follow-up of 2.3 years, two-year progression-free survival was 50.6 and 63.7 percent in the durvalumab and cetuximab groups, respectively (hazard ratio, 1.33; 95 percent confidence interval, 0.84 to 2.12). The groups had similar adverse events.
"The final phase 2 results did not show a statistically significant signal of efficacy of durvalumab and radiotherapy," the authors write. "These findings are consistent with the results of other trials indicating a lack of benefit of immune checkpoint inhibitors compared with cetuximab in patients with HNSCC who are ineligible for cisplatin."
Several authors disclosed ties to biopharmaceutical companies, including AstraZeneca, which manufactures durvalumab and partially funded the study.
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Men Aged >16 to <55 Years Have Increased AKI Risk During Hospitalization
Boys and men aged >16 to <55 years have an increased risk for acute kidney injury (AKI) during hospitalization, according to a study published online Oct. 22 in the American Journal of Kidney Disease.
Noting that female sex hormones have been suggested to play a protective role in kidney disease, Ladan Golestaneh, M.D., from the Yale University School of Medicine in New Haven, Connecticut, and colleagues conducted a prospective cohort study to examine the strength of the association between sex and AKI incidence in hormonally distinct age groups across the life span. Data were included for all patients hospitalized in the Montefiore Health System between Oct. 15, 2015, and Jan. 1, 2019, except those with kidney failure or obstetrics diagnoses.
Overall, 132,667 individuals had 235,629 hospitalizations (55 percent of hospitalizations for women). The researchers found that 30.5 and 10.3 percent of hospitalizations occurred among Black and Hispanic patients, respectively. Overall, AKI occurred in 22.9 percent of hospitalizations. A significant interaction was seen between age and sex in adjusted models. Across all age groups, boys and men had a higher risk for AKI, with the association more pronounced for those aged >16 to <55 years, which had an odds ratio for 1.7 for men. Across prespecified types of hospitalizations, the age-based pattern persisted. A sensitivity analysis revealed that women older than 55 years who received prescriptions for estrogen had lower odds of AKI than those without prescriptions.
"Our study shows that the protection afforded by female sex is highest among menstruating women, is absent in prepubertal females and declines with the onset of menopause," Golestaneh said in a statement.
Authors disclosed ties to Axon Therapies, Horizon Therapeutics, and AstraZeneca.
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Risk for Most Cardiovascular Events Reduced After COVID-19 Vaccination
COVID-19 vaccination is associated with a reduced risk for most cardiovascular events, but with slightly increased risks of extrasystoles and transient ischemic attack, as well as myocarditis and pericarditis after mRNA vaccination, according to a study published online Sept. 30 in the European Heart Journal.
Yiyi Xu, Ph.D., from the University of Gothenburg in Sweden, and colleagues examined the risks for several cardiovascular and cerebrovascular events in a nationwide register-based cohort (8,070,674 Swedish adults). The postvaccination risk for myocarditis/pericarditis, dysrhythmias, heart failure, myocardial infarction, and cerebrovascular events (transient ischemic attack and stroke) was examined in several risk windows after each vaccine dose.
The researchers found reduced risks for cardiovascular events postvaccination for most of the studied outcomes, especially after dose 3 (hazard ratios ranging from 0.69 to 0.81), while the risks for myocarditis and pericarditis were increased one to two weeks after COVID-19 mRNA vaccination. Across vaccines, similar slightly increased risks were seen for extrasystoles (hazard ratios, 1.17 and 1.22 for doses 1 and 2, respectively, which were stronger in the elderly and males), but not for arrhythmias, and for transient ischemic attack (hazard ratio, 1.13, mainly in elderly), but not for stroke.
"We found decreased risks of several serious cardiovascular outcomes after COVID-19 vaccination, likely related to the protection of vaccination against severe COVID-19," the authors write. "Overall, our results clearly underscore the protective benefits of complete vaccination, especially for elderlies."
Several authors disclosed ties to pharmaceutical companies, including AstraZeneca and Pfizer.
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2008 to 2022 Saw Rise in Industry-Sponsored Adult Cancer Clinical Trials
In the United States, there is a growing reliance on industry to conduct cancer clinical research, according to a study published online Sept. 27 in the Journal of Clinical Oncology.
Joseph M. Unger, Ph.D., from the Fred Hutchinson Cancer Center in Seattle, and colleagues evaluated cancer trial enrollment patterns from 2008 to 2022 using ClinicalTrials.gov data to estimate the ratio of enrollments attributable to industry versus federal sponsors.
The researchers identified 26,080 studies and determined the estimated enrollment ratio from 2018 to 2022 for all industry-sponsored versus federally sponsored trials was 8.1. The ratio increased from 4.8 during 2008 to 2012 to 9.6 during 2018 to 2022 for adult trials, while the ratio increased for trials in children from 0.7 to 2.3. Enrollment counts for federally sponsored trials were flat during the study period, despite increasing cancer incidence.
"We recognized that industry was playing an increasing role in cancer clinical research compared to decades ago. But we didn't realize the difference was this dramatic," Unger said in a statement. "Industry investment in cancer clinical research has accelerated precision oncology and cancer immunotherapy tremendously. However, with increased federal investment in cancer research as well, we could see even greater strides in treatment options for patients with cancer."
One author disclosed ties to AstraZeneca and Loxo/Lilly; another author disclosed ties to Agios.
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Adjuvant Durvalumab Extends Survival in Small Cell Lung Cancer
For patients with limited-stage small cell lung cancer, adjuvant therapy with durvalumab leads to significantly longer overall and progression-free survival, according to a study published online Sept. 13 in the New England Journal of Medicine to coincide with the annual meeting of the European Society for Medical Oncology, held from Sept. 13 to 17 in Barcelona, Spain.
Ying Cheng, M.D., from Jilin Cancer Hospital in Changchun, China, and colleagues conducted a phase 3 trial involving patients with limited-stage small cell lung cancer who did not have disease progression after standard concurrent platinum-based chemoradiotherapy. Participants were randomly allocated to receive durvalumab 1,500 mg (264 patients), durvalumab 1,500 mg plus tremelimumab 75 mg (four doses only; 200 patients), or placebo (266 patients) every four weeks for up to 24 months. The first planned interim analysis compared overall and progression-free survival for durvalumab versus placebo.
The researchers observed significantly longer overall survival with durvalumab therapy versus placebo (median, 55.9 versus 33.4 months; hazard ratio for death, 0.73); in addition, significantly longer progression-free survival was seen (median, 16.6 versus 9.2 months; hazard ratio for progression or death, 0.76). The incidence of adverse events with a maximum grade of 3 or 4 was 24.4 and 24.2 percent among patients receiving durvalumab and placebo, respectively; adverse events led to discontinuation in 16.4 and 10.6 percent, respectively, and to death in 2.7 and 1.9 percent, respectively.
"The incorporation of adjuvant durvalumab therapy led to significantly longer overall survival and progression-free survival among patients with limited-stage small cell lung cancer after definitive concurrent chemoradiotherapy," the authors write.
Several authors disclosed ties to biopharmaceutical companies, including AstraZeneca, which manufactures durvalumab and funded the study.
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Olaparib Monotherapy Yields Good PSA Response Rates in Prostate Cancer
For men with high-risk biochemically recurrent prostate cancer, olaparib monotherapy yields good prostate-specific antigen (PSA) response rates, especially among those with BRCA2, according to a study published online Aug. 22 in JAMA Oncology.
Catherine H. Marshall, M.D., from the Johns Hopkins University School of Medicine in Baltimore, and colleagues examined the activity of olaparib monotherapy among patients with high-risk biochemically recurrent prostate cancer after radical prostatectomy in a phase 2, single-arm nonrandomized controlled trial. A total of 51 male patients were enrolled and received treatment with olaparib twice daily until doubling of baseline PSA, clinical or radiographic progression, or unacceptable side effects.
The researchers found 13 participants (26 percent) had a 50 percent or higher decline in PSA from baseline (PSA50); all were within the homologous recombination repair-positive group (13 of 27; 48 percent). A PSA50 response occurred in all 11 participants with BRCA2 alterations. Fatigue, nausea, and leukopenia were common adverse events (63, 55, and 43 percent, respectively), which were consistent with known adverse effects of olaparib.
"Molecularly targeted therapies in select patient populations may be a reasonable treatment strategy for some patients with recurrent prostate cancer, even in the absence of androgen deprivation therapy," the authors write.
Several authors disclosed ties to pharmaceutical companies, including AstraZeneca, which provided olaparib and financial support for the study.
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Incidence of Mental Illness Up After COVID-19 in Unvaccinated People
For unvaccinated people, the incidence of mental illness is elevated after diagnosis of COVID-19, according to a study published online Aug. 21 in JAMA Psychiatry.
Venexia M. Walker, Ph.D., from the University of Bristol in the United Kingdom, and colleagues examined whether mental illness is associated with diagnosed COVID-19 by vaccination status in a study conducted in three cohorts: before vaccine availability (January 2020 to June 2021; 18,648,606 people) and vaccinated (14,035,286 individuals) and unvaccinated (3,242,215 individuals) cohorts during June to December 2021.
The researchers found that in each cohort, the incidence of most mental illness outcomes was elevated during weeks 1 through 4 after COVID-19 diagnosis compared with before or without COVID-19. Compared with the pre-vaccine availability cohort and the unvaccinated cohort, the vaccinated cohort had a lower incidence of mental illnesses, specifically depression and serious mental illness during weeks 1 through 4 after COVID-19 (adjusted hazard ratios, 1.16 and 0.91, respectively, in the vaccinated cohort; 1.93 and 1.49, respectively, in the pre-vaccine availability cohort; and 1.79 and 1.45, respectively, in the unvaccinated cohort). After hospitalization for COVID-19, the elevation in incidence was higher and persisted longer.
"This has important implications for public health and mental health service provision, as serious mental illnesses are associated with more intensive health care needs and longer-term health and other adverse effects," the authors write.
One author disclosed ties to AstraZeneca.
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COVID-19 Vaccination May Increase Risk for Urinary Tract Symptoms
COVID-19 vaccination seems to have some side effects on the lower urinary tract and overactive bladder in younger adults, according to a study published online June 24 in Frontiers in Medicine.
Marta de-la-Plaza-San-Frutos, from Universidad Europea de Madrid in Spain, and colleagues examined potential side effects of COVID-19 vaccination on the urinary tract among 1,563 individuals (74.7 percent women and 27.3 percent men), aged 18 to 45 years, who completed an online survey.
The researchers found that the Pfizer-BioNTech vaccine was the most frequently administered vaccine type (42.2 percent), and most individuals received three doses. The proportion of individuals who received the AstraZeneca vaccine and did not need to urinate in the night was significantly higher for women than men (59.1 versus 33.3 percent). Compared with those who received three vaccine doses, a higher proportion of those who received a single dose urinate five or more times during the night (2.2 versus 0.1 percent).
"Based on the results obtained in this study, monitoring and addressing urinary tract side effects of COVID-19 vaccination are important for vaccination programs to include the systematic collection of urinary tract side effect data, which will allow for ongoing evaluation of vaccine safety and efficacy," the authors write. "Health care professionals should be alert to the possibility of patients experiencing urinary tract symptoms following COVID-19 vaccination."
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