How Effective is Recombinant Zoster Vaccine Against Herpes in the Real World?
BACKGROUND AND PURPOSE:
- In clinical trial, 2 doses of a recombinant zoster vaccine (RZV) was 97% effective against herpes zoster (HZ)
- Zerbo et al. (Ann Intern Med, 2024) assessed the real world vaccine effectiveness of the RZV against HZ
METHODS:
- Prospective cohort study
- Participants
- ≥50 years in the Vaccine Safety Datalink
- Exposure
- RZV vaccination
- Time since last RZV
- Corticosteroid use
- Study design
- Cox regression was used to estimate the hazard
- Vaccine effectiveness (VE) was calculated as 1 minus the adjusted hazard ratio
- Primary outcome
- Incident HZ, defined by diagnosis with antiviral prescription
RESULTS:
- 2.0 million individuals | 7.6 million person-years of follow-up
- VE of 1 dose: 64%
- VE of 2 doses: 76%
- After one dose, VE was
- During first year: 70%
- During second year: 45%
- After third year: 48%
- After two doses, VE was
- During first year: 79%
- During second year: 75%
- During third and fourth years: 73%
- VE in individuals who received corticosteroids before vaccination: 65% | VE in individuals who did not receive corticosteroids: 77%
CONCLUSION:
- Real world VE of the RZV was 76% after two doses and VE remained stable even after four years
- The authors state
In conclusion, 2 doses of RZV showed high effectiveness that waned very little over 4 years
Our finding of substantial VE among corticosteroid recipients underscores the value of vaccination for these persons, who are at increased risk for HZ
Our finding that the effectiveness of 1 dose decreased after a year further supports the current recommendation for a second dose
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Effectiveness of Recombinant Zoster Vaccine Against Herpes Zoster in a Real-World Setting
RCT Results: Do AHA Optimal Positioning Guidelines for BP Measurements Significantly Impact Readings?
BACKGROUND AND PURPOSE:
- The AHA has published guidance on how to properly obtain BP measurements, including having both of the patient’s feet on the floor, back supported and arm at heart level
- In routine care, there may be barriers to implementing these guidelines
- Alpert et al. (eClinicalMedicine, 2023) compared BP readings using AHA guidelines vs typical routine clinical care
METHODS:
- Prospective, randomized, 3-group cohort study
- Modified cross-over design
- Participants
- Arm circumference ≥18 cm and ≤42 cm
- Did not have a renal dialysis shunt
- No previous or current diagnosis of atrial fibrillation
- Exposures
- Group A
- BP readings taken on a fixed-height exam table followed by readings taken in an exam chair with adjustable positioning options
- Group B
- Readings taken in the reverse order, chair then table
- Group C
- Both sets of readings taken in the exam chair
- Group A
- Study design
- A rest period occurred before each set of readings
- Group C was included for the purpose of obtaining an independent estimate of the order effect
- Primary outcome
RESULTS:
- Group A: 48 participants | Group B: 49 participants | Group C: 53 participants
- The mean systolic/diastolic BP of readings taken on the table vs chair were significantly higher
- Mean Difference increase 7.0/4.5 mm Hg P<0.0001
- In group C, the mean SBP/DBP of the first set of readings taken on the chair were 1.6/0.6 mmHg higher than for the second set of readings when including all 3 readings
- There was no difference in SBP/DBP when including only the 2nd and 3rd set of readings
CONCLUSION:
- The positioning recommended by the AHA resulted in significantly lower BP readings than when patients were improperly positioned
- The authors state
This result demonstrates that when BPs are taken in the recommended position, the readings are lower and that simply following proper protocol could reduce the misdiagnosis of HTN for millions of patients, avoiding unnecessary medication or more intense follow-up
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RCT Results: Can Low Back Pain Recurrence Be Prevented by Walking?
BACKGROUND AND PURPOSE:
- Pocovi et al. (The Lancet, 2024) investigated the clinical effectiveness and cost-effectiveness of a simple individualized walking program to prevent the recurrence of low back pain
METHODS:
- Randomized controlled trial
- WalkBack trial
- intervention delivered by 25 private Australian physiotherapy clinics
- Participants
- ≥18 years
- Recently recovered from an episode of non-specific low back pain
- No specific diagnosis
- Lasted for at ≥24 hours
- Interventions
- Individualized, progressive walking and education intervention | 6 sessions with a physiotherapist across 6 months
- No treatment control
- Study design
- Goal: Walk 5 times per week for ≥30 min daily by 6 months
- Individualization as appropriate
- Participants were followed for ≥12 months for a maximum of 36 months
- Cost-effectiveness was evaluated from the societal perspective and expressed as incremental cost per quality-adjusted life-year (QALY) gained
- Goal: Walk 5 times per week for ≥30 min daily by 6 months
- Primary outcome
- Days to the first recurrence of an activity-limiting episode of low back pain
RESULTS:
- Intervention: 351 individuals | No treatment control: 350 individuals
- The intervention was effective at preventing an episode of activity-limiting low back pain
- Hazard ratio (HR) 0.72 (95% CI, 0.60 to 0.85) | P=0.0002
- Median days to a recurrence
- Intervention: 208 (95% CI, 149 to 295) days
- Control: 112 (95% CI, 89 to 140) days
- The incremental cost per QALY gained was AU$7802
- There was a 94% probability that the intervention was cost-effective at a willingness-to-pay threshold of $28,000
- The total number of participants experiencing at least one adverse event over 12 months was similar between the intervention and control groups
- Intervention: 52% | Control: 54% | P=0.60
- Adverse events
- Overall adverse events were similar between groups, including serious adverse events
- There was a greater number of adverse events related to the lower extremities in the intervention group than in the control group
CONCLUSION:
- Low back pain recurrence was prevented with an individualized, progressive walking and education intervention program
- The program was also considered cost effective
- The authors state
By encouraging active self-management using health coaching principles, the WalkBack intervention might be able to reduce the prevalence of recurrent low back pain and associated burden on health-care systems
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Is Semaglutide Associated with a Higher Risk of Optic Neuropathy?
BACKGROUND AND PURPOSE:
- There are anecdotal reports that associate semaglutide, a glucagon-like peptide 1 receptor agonist (GLP-1 RA), with nonarteritic anterior ischemic optic neuropathy (NAION)
- Hathaway et al. (JAMA Ophthalmology, 2024) investigated whether there is an association between semaglutide and risk of NAION
METHODS:
- Retrospective matched cohort study
- Population
- Patients with type 2 diabetes (T2D) or overweight/obesity
- No history of NAION
- Exposures
- Semaglutide
- Non-GLP-1 RA medications
- Study design
- Participants using semaglutide were propensity score-matched to those who did not use semaglutideCovariates that were addressed
- Sex | Age | Systemic hypertension | T2D | Obstructive sleep apnea | Obesity | Hyperlipidemia | Coronary artery disease | Contraindications for use of semaglutide
- The cumulative incidence of NAION was determined with the Kaplan-Meier method and a Cox proportional hazards regression model adjusted for potential confounding comorbidities
- Participants using semaglutide were propensity score-matched to those who did not use semaglutideCovariates that were addressed
- Primary outcomes
- Cumulative incidence and hazard ratio (HR) of NAION
RESULTS:
- 16,827 patients
- With T2D: 710
- Semaglutide: 194 | Non-GLP-1 RA medication: 516
- Median age: 59 (IQR, 49 to 68) | 52% female
- With overweight or obesity: 979
- Semaglutide: 361 | Non-GLP-1 RA medication: 618
- Median age: 47 (IQR, 32 to 59) | 72% female
- With T2D: 710
In the T2D Population
- Cumulative incidence of NAION
- Semaglutide: 8.9% (95% CI, 4.5 to 13.1)
- Non-GLP-1 RA medication: 1.8% (95% CI, 0 to 3.5)
- There was a higher risk of NAION in patients receiving semaglutide
- HR 4.28 (95% CI, 1.62 to 11.29) | P<0.001
In the Overweight/Obesity Population
- Cumulative incidence of NAION
- Semaglutide: 6.7% (95% CI, 3.6 to 9.7)
- Non-GLP-1 RA medication: 0.8% (95% CI, 0 to 1.8)
- There was a higher risk of NAION in patients receiving semaglutide in this population as well
- HR 7.64 (95% CI, 2.21 to 26.36) | P<0.001
CONCLUSION:
- Semaglutide is associated with a higher risk of NAION
- The authors state
This study is the first, to our knowledge, to report an association between semaglutide and NAION, although the design of our study did not enable query into a causal relationship between the two
The best approaches to confirm, refute, or refine our findings would be to conduct a much larger, retrospective, multicenter population-based cohort study; a prospective, randomized clinical study; or a postmarket analysis of all GLP-1 RA drugs
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Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide
ESPIRIT Trial: Does Lowering Systolic BP Targets to 120 mm Hg Reduce Risk for Cardiovascular Events Among Hypertensive Patients?
BACKGROUND AND PURPOSE:
- Liu et al. (The Lancet, 2024) compared the efficacy and safety of intensive blood pressure lowering treatment targeting systolic BP of <120 mm Hg among participants with high cardiovascular risk and with or without diabetes or previous stroke
METHODS:
- Open-label, blinded-outcome, randomized controlled trial
- Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing Risk of Vascular Events (ESPRIT) trial
- 116 hospitals or communities in China
- Participants
- ≥50 years
- High cardiovascular risk: Established cardiovascular disease or ≥2 major cardiovascular risk factors
- Interventions
- Intensive treatment: Systolic BP <120 mm Hg
- Standard treatment: Systolic BP <140 mm Hg
- Study design
- Follow up: Months 1, 2, and 3 and then every 3 months
- Medications based on standard office BP measurement
- Free medications were made available to improve adherence
- Analysis was by intention-to-treat
- Primary outcome
- Composite of major vascular events
- Myocardial infarction | Revascularization | Hospitalization for heart failure | Stroke | Death from cardiovascular causes
- Composite of major vascular events
RESULTS:
- Intensive treatment: 5624 | Standard treatment: 5631
- Patients with diabetes: 4359 | Patients with previous stroke: 3022
- Median follow-up: 3.4 years
- Mean systolic BP through follow-up
- Intensive: 119.1 (SD, 11.1) mm Hg
- Standard: 134.8 (SD, 10.5) mm Hg
- Over the follow-up period, the primary outcome occurred in fewer patients in the intensive treatment group
- Intensive: 9.7% | Standard: 11.11%
- Hazard ratio (HR) 0.88 (95% CI, 0.78 to 0.99) | P=0.028
- There was no heterogeneity of effects due to
- Diabetes status | Duration of diabetes | History of stroke
- Syncope occurred more frequently in the intensive treatment group
- Intensive: 0.4% | Standard: 0.1%
- HR 3.00 (95% CI, 1.35 to 6.68)
- There was no significant between-group difference in other serious adverse events
- Hypotension | Electrolyte abnormality | Injurious fall | Acute kidney injury
- Intention-to-treat analysis
- To prevent a primary outcome event: 75 patients need to be treated
- To prevent a cardiovascular death: 148 patients need to be treated
CONCLUSION:
- A target systolic BP of 120 mm Hg vs 140 mm Hg reduced adverse cardiovascular events among high-risk hypertensive patients with a slight increase in syncope risk
- Other adverse events did not differ between the groups
- The authors state
Our findings provide new evidence about the benefit and harm of treatment targeting systolic blood pressure of less than 120 mm Hg
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RCT Results: Does Intermittent Fasting Improve Weight Loss for Those with Overweight or Obesity?
BACKGROUND AND PURPOSE:
- Intermittent fasting refers to eating windows separated by defined periods of fasting
- Evidence related to risk and benefits remains limited
- Lowe et al. (JAMA Intern Med, 2020) sought to determine the effect of 16:8-hour time-restricted eating on weight loss for individuals who are overweight or obese
METHODS:
- 12 week randomized controlled trial
- Participants
- Men and women aged 18 to 64 years
- BMI: 27 to 43
- Interventions
- Consistent meal timing group (CMT)
- 3 structured meals per day
- Time-restricted eating group (TRE)
- Eat ad libitum from 12:00 pm until 8:00 pm
- Completely abstain from caloric intake from 8:00 pm until 12:00 pm the following day
- Consistent meal timing group (CMT)
- Study design
- Use of mobile application and a Bluetooth scale
- A subset of participants underwent in-person testing
- Use of mobile application and a Bluetooth scale
- Primary outcome
- Weight loss
- Secondary outcomes (in-person cohort)
- Changes in the following: Weight | Fat and lean mass | Fasting insulin and glucose | Hemoglobin A1c levels | Estimated energy intake | Total energy expenditure | Resting energy expenditure
RESULTS:
- 116 participants | In-person cohort: n = 25 TRE, n = 25 CMT
- Mean age: 46.5 years | 60.3% men
- While those in the TRE group had a significant decrease in weight, there was no significant change between groups (P = 0.63)
- Between groups: −0.26 kg (95% CI, −1.30 to 0.78)
- Agreement was strong between in-person weight measurements and at-home weight measurements
- Aside from appendicular lean mass which was significantly lower in the TRE group (low appendicular lean mass is associated with weakness and disability), there were no significant changes in any of the other secondary outcomes within or between groups
- There were no differences in estimated energy intake between groups or other metabolic markers
CONCLUSION:
- Time-restricted eating alone, without other interventions, is no more effective for weight loss vs eating throughout the day
- The authors conclude
Together, the results of this study do not support the efficacy of TRE for weight loss
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RCT Results: Does Intermittent Fasting Improve Weight Loss for Those with Overweight or Obesity?
BACKGROUND AND PURPOSE:
- Intermittent fasting refers to eating windows separated by defined periods of fasting
- Evidence related to risk and benefits remains limited
- Lowe et al. (JAMA Intern Med, 2020) sought to determine the effect of 16:8-hour time-restricted eating on weight loss for individuals who are overweight or obese
METHODS:
- 12 week randomized controlled trial
- Participants
- Men and women aged 18 to 64 years
- BMI: 27 to 43
- Interventions
- Consistent meal timing group (CMT)
- 3 structured meals per day
- Time-restricted eating group (TRE)
- Eat ad libitum from 12:00 pm until 8:00 pm
- Completely abstain from caloric intake from 8:00 pm until 12:00 pm the following day
- Consistent meal timing group (CMT)
- Study design
- Use of mobile application and a Bluetooth scale
- A subset of participants underwent in-person testing
- Use of mobile application and a Bluetooth scale
- Primary outcome
- Weight loss
- Secondary outcomes (in-person cohort)
- Changes in the following: Weight | Fat and lean mass | Fasting insulin and glucose | Hemoglobin A1c levels | Estimated energy intake | Total energy expenditure | Resting energy expenditure
RESULTS:
- 116 participants | In-person cohort: n = 25 TRE, n = 25 CMT
- Mean age: 46.5 years | 60.3% men
- While those in the TRE group had a significant decrease in weight, there was no significant change between groups (P = 0.63)
- Between groups: −0.26 kg (95% CI, −1.30 to 0.78)
- Agreement was strong between in-person weight measurements and at-home weight measurements
- Aside from appendicular lean mass which was significantly lower in the TRE group (low appendicular lean mass is associated with weakness and disability), there were no significant changes in any of the other secondary outcomes within or between groups
- There were no differences in estimated energy intake between groups or other metabolic markers
CONCLUSION:
- Time-restricted eating alone, without other interventions, is no more effective for weight loss vs eating throughout the day
- The authors conclude
Together, the results of this study do not support the efficacy of TRE for weight loss
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Which Factors Have Contributed Most to the Decline in Breast Cancer Mortality Over the Past 45 Years?
BACKGROUND AND PURPOSE:
- Breast cancer mortality has declined in the US since 1975
- It’s not clear whether this decline is due to improved treatment of metastatic breast cancer or some other factor
- Caswell-Jin et al. (JAMA, 2024), estimated the impact of various factors, including newer breast cancer treatments, on the reduction in breast cancer mortality
METHODS:
- Cancer Intervention and Surveillance Modeling Network (CISNET) models
- Based on aggregated observational and clinical trial data
- From 1975 to 2019
- Simulated population
- Women aged 30 to 79
- Exposures
- Screening mammography | Treatment of stage I to III breast cancer | Treatment of metastatic breast cancer
- Study design
- The authors simulated death due to breast cancer, overall and by estrogen receptor and ERBB2 (formerly HER2) status
- Primary outcome
- Model-estimated age-adjusted breast cancer mortality rate associated with exposures
- Model-estimated median survival after breast cancer metastatic recurrence
RESULTS:
- Age-adjusted breast cancer mortality rate in the US
- 1975: 48 per 100,000 women
- 2019: 27 per 100,000 women
- Reduction in breast cancer mortality in 2019: 58% (model range, 55 to 61)
- Reduction associated with treatment of metastatic breast cancer: 29% (range 19 to 33)
- Reduction associated with treatment of stage I to III breast cancer: 47% (range, 35 to 60)
- Reduction associated with mammography screening: 25% (range, 21 to 33)
- The greatest change in survival after metastatic recurrence occurred between 2000 and 2019
- 2000: 1.9 years (range, 1.0 to 2.7)
- 2019: 3.2 years (range, 2.0 to 4.9)
- Median survival for estrogen receptor (ER)–positive/ERBB2-positive breast cancer improved by 2.5 years (range, 2.0 to 3.4)
- Median survival for ER−/ERBB2− breast cancer improved by 0.5 years (range, 0.3 to 0.8)
CONCLUSION:
- By 2019, model simulations suggest that breast cancer mortality is down 58% from 1975 mortality rates in association with newer treatments and screening guidelines
- Treatment for stage I to III breast cancer was associated with 47% of this reduction
- Treatment of metastatic cancer accounted for 29% of this reduction, and mammography screening for 25%
- The authors state
Breast cancer screening accounts for an increasingly smaller proportion of breast cancer mortality reduction as improvements in stage I to III therapy continue
However, the absolute contribution of screening to mortality reduction remained consistent in the models, emphasizing that cancers diagnosed in the absence of screening were associated with poorer outcomes that cannot be overcome with modern treatments
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Analysis of Breast Cancer Mortality in the US—1975 to 2019
How Has Cervical Cancer Incidence Changed Over the Past 10 Years in the US?
BACKGROUND AND PURPOSE:
- Incidence of cervical cancer may have plateaued between 2012 and 2017
- A decline in cancer screening uptake has been reported, particularly among younger women
- Shahmoradi et al. (JAMA, 2022) evaluated calendar trends in cervical cancer incidence by age at diagnosis
METHODS:
- Time series data analysis
- Data
- National Program of Cancer Registries (NPCR) and Surveillance, Epidemiology, and End Results (SEER) from 2001 to 2019
- Population
- Cervical cancer cases
- Study design
- Hysterectomy-corrected incidence trends were assessed by removing the proportion of women with hysterectomy from the denominator
- For age groups with increasing incidence, trends were examined by race and ethnicity, stage, and histology
- Primary outcome
- Incidence rates of cervical cancer
- Trends in cases
- Annual percentage changes (APCs) by 5-year age group
RESULTS:
- 227,062 reported cervical cancer cases
- Overall, hysterectomy-corrected cervical cancer incidence declined
- 2001: 12.39 per 100,000
- 2019: 9.80 per 100,000
- APC −1.2% (95% CI, −1.6 to −0.9)
- Among women aged 30 to 34 years, after an initial decline from 2001 to 2012, incidence increased after 2012
- 2001: 12.77 per 100,000
- 2012: 10.14 per 100,000
- 2019: 11.60 per 100,000
- 2001 to 2012: APC −2.3% (95% CI, −2.8 to −1.7)
- 2012 to 2019: APC 2.5% (95% CI, 1.4 to 3.6)
- Among this age group, hysterectomy-corrected cervical cancer incidence increased significantly for
- Hispanic
- APC 3.0% (95% CI, 0.3 to 5.7)
- Non-Hispanic White
- APC 2.8% (95% CI, 0.6 to 5.0)
- Other racial and ethnic groups
- APC 5.0% (95% CI, 2.7 to 7.4)
- Hispanic
- The APC for Black women was relatively stable from 2012 to 2019
- APC −0.8% (95% CI, −2.8 to 1.2)
- Increases occurred for
- Localized stage cervical cancer
- APC 2.8% (95% CI, 1.3 to 4.3)
- Regional stage cervical cancer
- APC 1.9% (95% CI, 0.7 to 3.1)
- Squamous cell carcinoma
- APC 2.6% (95% CI, 1.0 to 4.2)
- Adenocarcinoma
- APC 3.0% (95% CI, 0.9 to 5.1)
- Localized stage cervical cancer
CONCLUSION:
- Cervical cancer rates declined or were stable from 2012 to 2019, except among women aged 30 to 34
- Among this age group the incidence increased by 2.5% per year after 2012
Possible Explanations for the Increased Incidence Include Guideline Changes in 2012
- Co-testing (HPV and cytology): Could lead to increased detection of early-stage cancers
- Increased screening interval: The authors state
In 2012, the US Preventive Services Task Force recommended an increase in screening interval in 21- to 65-year-old women with cytology every 3 years or in 30- to 65-year-old women with a combination of cytology and human papillomavirus testing every 5 years
Beginning in 2013, declines in screening participation among 21- to 29-year-old women were observed
Future studies are needed to assess factors that underlie the increase in cervical cancer incidence among 30- to 34-year-old women
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Cervical Cancer Incidence Among US Women, 2001-2019
Are Fertility-Sparing Procedures for Cervical Cancer Associated with a Greater Risk of Recurrence?
BACKGROUND AND PURPOSE:
- Nonradical procedures have become more common for patients with cervical cancer who want to become pregnant
- Slama et al. (AJOG, 2023) analyzed oncological outcomes after fertility-sparing treatment in patients with cervical cancer including prognostic risk factors
METHODS:
- Retrospective observational study
- Population
- 18 to 40 years
- Stage IA1 with positive lymphovascular space invasion or ≥IA2 cervical cancer
- Underwent any type of fertility-sparing procedure
- Exposures
- Disease-related characteristics
- Treatment-related characteristics
- Study design
- Inclusion criteria
- Conization (any technique) | Simple vaginal trachelectomy | Vaginal or abdominal radical trachelectomy
- Any surgical approach (laparotomy vs minimally invasive)
- Exclusion
- Hysterectomy as part of primary treatment
- Inclusion criteria
- Primary outcome
- Risk of recurrence
RESULTS:
- 733 patients across 13 countries
- Mean age: 32.2 years
- Stage IB1 cervical cancer: 49%
- Nulliparous: 66%
- Median follow-up: 72 months
- Recurrence: 7%
- Cervical cancer related deaths: 2.6%
- The most common sites of recurrence
- Cervix: 53% | Pelvic nodes: 22%
- The risk of recurrence was 3 times higher in patients with tumors >2 cm in size than in patients with smaller tumors, irrespective of the
- Tumors >2 cm: 19.4% | Smaller tumors: 5.7%
- Hazard ratio (HR) 2.982 (95% CI, 1.383 to 6.431) | P=0.005
- Results did not differ based on treatment radicality
- The recurrence risk in patients with tumors ≤2 cm in size (P=0.957)
- Did not differ between patients who underwent radical trachelectomy and patients who underwent nonradical procedures such as conization and simple trachelectomy
- Results did not differ based on tumor size subcategory or lymphovascular space invasion
CONCLUSION:
- For patients with tumors ≤2 cm, nonradical fertility-sparing cervical cancer procedures did not increase the risk of cancer recurrence vs radical procedures
- Patients with tumors >2 cm had significantly higher risk of recurrence with nonradical procedures
- The authors state
Nonradical fertility-sparing procedures represent a safe treatment option for patients with cervical cancer with HPV-associated tumors of ≤2 cm in size and negative regional LNs
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Impact of Disparities on Uptake of USPSTF Cancer Screening Recommendations
BACKGROUND AND PURPOSE:
- Social determinates of health (SDoH) influence the rate at which certain populations uptake recommended cancer screenings, but little is known about how this plays out at the county level
- The social vulnerability index (SVI) is one SDoH measure that can be used to identify populations with fewest resources and least access to health care
- Bauer et al. (JAMA Network Open, 2022) examined the geographic variation of USPSTF breast, cervical, and colorectal cancer screening rates and the association between county-level SVI and the 3 screening rates
METHODS:
- Population-based cross-sectional study
- Data
- County-level information from the CDC PLACES and SVI data sets
- From 2018
- Exposures
- SVI score categorized in quintiles
- Study design
- Odds ratios were calculated for each cancer screening by SVI quintile as
- Unadjusted odds ratio (OR): Only accounting for eligible population per county
- Adjusted odds ratio (aOR): Urban-rural status | Percentage of uninsured adults | Primary care physician rate per 100,000 residents
- Odds ratios were calculated for each cancer screening by SVI quintile as
- Primary outcome
- County-level rates of USPSTF guideline concordant, up-to-date breast, cervical, and colorectal screenings
RESULTS:
- 3141 counties
- County-level cancer screening rates showed regional disparities that ranged from
- Breast cancer screening: 54.0% to 81.8%
- Cervical cancer screening: 69.9% to 89.7%
- Colorectal cancer screening: 39.8% to 74.4%
- Higher SVI was significantly associated with lower odds of cancer screening
- Lowest odds of screening occurred in the highest SVI quintile
- Comparing the highest quintile of SVI (SVI-Q5) with the lowest quintile of SVI (SVI-Q1), unadjusted and adjusted odds of cancer screenings were significantly lower
- Breast cancer screening
- OR 0.86 (95% Credible Interval [CrI], 0.84 to 0.87)
- aOR 0.92 (95% CrI, 0.90 to 0.93)
- Cervical cancer screening
- OR 0.80 (95% CrI, 0.79 to 0.81)
- aOR 0.87 (95% CrI, 0.86 to 0.88)
- Colorectal cancer screening
- OR 0.72 (95% CrI, 0.71 to 0.73)
- aOR 0.86 (95% CrI, 0.85 to 0.88)
- Breast cancer screening
CONCLUSION:
- There were county-level disparities in recommended cancer screening
- Counties with higher social vulnerability had lower rates of USPSTF recommended cancer screenings
- The authors state
Assessing area-level social vulnerability encompassing various SDoH allows us to capture conditions that affect all individuals living in the same area, either from compositional or contextual effects
Further research on assessing the optimal interventions to reduce disparities and improve uptake in cervical cancer screening is crucial to reverse this increasing incidence trend in less affluent areas and overall declining screening rates
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How Have Distant Stage Cervical Cancer Trends in the US Changed Over the Past 18 Years?
BACKGROUND AND PURPOSE:
- Stage IVA-B (distant stage) cervical cancer has poor long-term outcomes and related trends are generally not well studied
- Francoeur et al. (International Journal of Gynecologic Cancer, 2022) sought to determine the trends for distant stage cervical cancer in the US and identify possible related factors
METHODS:
- Population cohort study
- Population
- US Cancer Statistics program from 2001 to 2018
- Study design
- Rates of cervical cancer screening and vaccination were evaluated using the Behavioral Risk Factor Surveillance System and TeenVax data
- Regression analysis was used to calculate incidence trends
- Primary outcome
- Trends of distant stage cervical cancer rates over the last 18 years
RESULTS:
- 31 million cancer cases during the study period
- Diagnoses of distant stage cervical cancer: 29,715 women
- Black vs White women have disproportionately higher rates of distant stage diagnoses (P<0.001)
- Black women: 1.55 per 100,000 cases
- White women: 0.92 per 100,000 cases
- There has been an annual increase in distant stage cervical cancer
- Increase of 1.03% per years (P<0.001)
- The largest increase is seen in cervical adenocarcinoma
- Average annual percent change: 2.9% (P<0.001)
- When performing an intersection analysis of race, region and age
- White women in the South, 40 to 44 years of age, had the highest rise in distant cervical cancer
- Annual increase: 4.5% (P<0.001)
- White vs Black women have a nearly two-fold higher rate of missed or lack of guideline screening
- White women: 26.6%
- Black women: 13.8%
- White teenagers (13 to 17 years) have the lowest HPV vaccination rate vs other groups
- White teenagers: 66.1%
- Others: 75.3%
CONCLUSION:
- Over the past 18 years, Black women experienced the highest incidence of distant stage cervical cancer
- However, White women experienced the greatest annual increase in distant stage diagnoses, especially in adenocarcinomas
- White women also had lower rates of screening adherence, and HPV vaccination, compared to Black women
- The authors state
While rates of early-stage cervical cancer have fallen, distant stage cancer is on the rise in White and Black women, a finding most pronounced in adenocarcinoma subtypes. Even with screening and vaccination, there is not one racial/ethnic group, region in the USA, or age group where distant stage cervical cancer has been decreasing over the last 18 years
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The increasing incidence of stage IV cervical cancer in the USA: what factors are related?
The HPV Vaccine Leads to a Reduction in Cervical Precancers in Young Women in the U.S.
BACKGROUND AND PURPOSE:
- High-grade cervical lesions (CIN2+) are used to monitor HPV vaccine impact, since they develop much more quickly after infection
- McClung et al. (MMWR, 2019) used data from the Human Papillomavirus Vaccine Impact Monitoring Project (HPV-IMPACT) to assess the impact of the HPV vaccination program
- The following is the first estimate of the number of CIN2+ cases in the U.S. based on population since introduction of the HPV vaccine
METHODS:
- Data review and analysis (2008 to 2016)
- Data set: HPV-IMPACT
- A population-based CIN2+ surveillance system
- Data analysis
- Age-specific rates applied to U.S. population data to estimate the total number of CIN2+ cases
RESULTS:
- An estimated 76% of CIN2+ cases were attributable to HPV types targeted by the vaccine currently used in the US (9-valent HPV vaccine)
- The number of CIN2+ cases diagnosed in women aged 18–29 years decreased from 2008 to 2016
- 2008: ~216,000 (95% CI, 194,000–241,000)
- 2016: ~196,000 (95% CI, 176,000–221,000)
- From 2008 to 2016, the rate of CIN2+ per 100,000 women in the US
- Declined significantly in women aged 18–19 years and 20–24 years
- Increased significantly in women aged 40–64 years
CONCLUSION:
- Rates of cervical precancers have declined in younger women since the introduction of the vaccine
- A majority of CIN2+ cases diagnosed are attributable to HPV types that the vaccine targets
- These changes are likely due to updated cervical cancer screening and management recommendations, and primary prevention through HPV vaccination
- Increasing coverage of the vaccine in females at the routine age of 11-12 years and catch-up vaccination through women 26 years of age will likely contribute to a further reduction in cervical precancers
Learn More – Primary Sources:
Why Have Cervical Cancer Screening Rates Decreased Over the Past Decade in the US?
BACKGROUND AND PURPOSE:
- Individuals in the US receive cervical cancer screening at suboptimal rates but reasons remain unclear
- Suk et al. (JAMA Network Open, 2022) estimated changes in USPSTF guideline–concordant cervical cancer screening over time and assessed the reasons women do not receive up-to-date screening by sociodemographic factors
METHODS:
- Pooled population-based cross-sectional study
- Population
- Women aged 21 to 65 years without previous hysterectomy
- Data came from the US National Health Interview Survey from 2005 and 2019
- Exposures
- Age
- Race and ethnicity
- Sexual orientation
- Rurality of residence
- Health insurance type
- Study design
- USPSTF screening definitions
- For 2005: Screening every 3 years for women aged 21 to 65 years
- For 2019: Screening every 3 years with a Papanicolaou test alone for women aged 21 to 29 years | Screening every 3 years with a Papanicolaou test alone or every 5 years with high-risk HPV testing or cotesting for women aged 30 to 65 years
- Outcomes were compared across sociodemographic factors in 2019
- Outcomes in 2005 were compared with 2019 by age group, race and ethnicity, and insurance type
- Comparisons were not available for sexual orientation and rurality of residence because of the lack of data from 2005
- USPSTF screening definitions
- Primary outcomes
- USPSTF guideline–concordant cervical cancer screening rates
- Self-reported primary reasons for not receiving up-to-date screening
RESULTS:
- 20,557 women (weighted, 113.1 million women)
- Aged 30 to 65 years: 76.3%
- Had private insurance: 67.0%
- Race/ethnicity
- Asian: 6.1%
- Hispanic: 17.2%
- Non-Hispanic Black: 13.1%
- Non-Hispanic White: 61.0%
- Other races/ethnicities: 2.7%
- In 2019, women aged 21 to 29 years had a significantly higher rate of overdue screening compared to women who were older (P<0.001)
- 21 to 29 years old: 29.1%
- 30 to 65 years old: 21.2%
- Significantly higher rates of overdue screening were found among
- Those of Asian vs non-Hispanic White race and ethnicity (P=0.01)
- Asian: 31.4%
- Non-Hispanic White: 20.1%
- Those identifying as LGBQ+ vs heterosexual (P<0.001)
- LGBT+: 32.0%
- Heterosexual: 22.2%
- Those living in rural vs urban areas (P=0.04)
- Rural: 26.2%
- Urban: 22.6%
- Those without insurance vs those with private insurance (P<0.001)
- Without insurance: 41.7%
- Private insurance: 18.1%
- Those of Asian vs non-Hispanic White race and ethnicity (P=0.01)
- The most common reason for not receiving timely screening across all groups was lack of knowledge
- In women identifying as LGBT+: 47.2% cited as a reason
- In women with Hispanic ethnicity: 64.4%
- Previous receipt of HPV vaccine was not a primary reason for not having up-to-date screening (<1% of responses)
- From 2005 to 2019, among women aged 30 to 65 years, lack of access decreased significantly as a primary reason for not receiving screening
- 2005: 21.8%
- 2019: 9.7%
- Reasons for not receiving screening that increased significantly over the study period included
- Lack of knowledge
- 2005: 45.2%
- 2019: 54.8%
- Not receiving recommendations from health care professionals
- 2005: 5.9%
- 2019: 12.0%
- Lack of knowledge
CONCLUSION:
- Cervical cancer screening rates in the U.S. decreased from 2005 to 2019, and vary widely based on demographic factors
- The biggest reported barrier to screening was lack of knowledge and fewer recommendations from health care professionals
- Findings regarding populations that were overdue for screening were not unexpected
- Previous research suggests that changing guidelines put higher risk individuals, such as marginalized populations, at even greater risk for underscreening, supporting the findings in this study
- The authors state
…findings also revealed that barriers to screening significantly varied by sociodemographic factors, suggesting cultural adaptation of interventions will be an important factor in the success of efforts to increase cervical cancer screening uptake among priority populations in the US, including women of Asian race and Hispanic ethnicity, women without insurance, women living in rural areas, and/or women identifying as LGBQ+
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RCT Results: Can a Monoclonal Antibody Therapy Increase Survival in Patients with Persistent, Recurrent or Metastatic Cervical Cancer?
BACKGROUND AND PURPOSE:
- Pembrolizumab (brand name Keytruda), is an anti-programmed death 1 (PD-1) monoclonal antibody
- PD-1 on lymphocytes normally prevents immune system from attacking other normal cells in the body (immune checkpoint) by binding to PD ligands (PD-L1) and deactivating cell-mediated immune response
- Cancer cells can make PD-L1 and block person’s immune system from destroying the malignant cells
- Colombo et al. (NEJM, 2021) assessed the relative benefit of adding pembrolizumab to chemotherapy for persistent, recurrent or metastatic cervical cancer
METHODS:
- Double-blind, phase 3 trial
- Participants
- Persistent, recurrent, or metastatic cervical cancer
- Adenocarcinoma, adenosquamous carcinoma, or squamous-cell carcinoma
- Not been treated with systemic chemotherapy
- Not amenable to curative treatment
- Interventions
- Pembrolizumab (200 mg) every 3 weeks, for up to 35 cycles, plus platinum-based chemotherapy and, per investigator discretion, bevacizumab (anti-VEGF monoclonal antibody)
- Placebo and platinum-base chemotherapy
- Study design
- 1:1 randomization
- Stratified by metastatic disease at diagnosis, planned bevacizumab and programmed death ligand-1 (PD-L1) combined positive score (reflects likelihood of response to pembrolizumab)
- Primary outcome
- Progression-free survival
- Overall survival
RESULTS:
- 548 patients with a PD-L1 combined score of ≥1 or more
- Median progression-free survival was significantly higher in patients in the pembrolizumab group, compared to the placebo group
- Pembrolizumab: 10.4 months
- Placebo: 8.2 months
- Hazard ratio (HR) for disease progression or death 0.62 (95% CI, 0.50 to 0.77); P<0.001
- Overall survival at 24 months was higher in the pembrolizumab group
- Pembrolizumab: 53.0%
- Placebo: 41.7%
- HR for death 0.64 (95% CI, 0.50 to 0.81); P<0.001
- Median progression-free survival was significantly higher in patients in the pembrolizumab group, compared to the placebo group
- 617 patients in the intention to treat population
- Median progression-free survival was significantly higher in patients in the pembrolizumab group, compared to the placebo group
- Pembrolizumab: 10.4 months
- Placebo: 8.2 months
- HR 0.65 (95% CI, 0.53 to 0.79); P<0.001
- Overall survival at 24 months was higher in the pembrolizumab
- Pembrolizumab: 50.4%
- Placebo: 40.4%
- Hazard ratio 0.67 (95% CI, 0.54 to 0.84); P<0.001
- Median progression-free survival was significantly higher in patients in the pembrolizumab group, compared to the placebo group
- 317 patients in the PD-L1 combined positive score of ≥10
- Median progression-free survival was significantly higher in patients in the pembrolizumab group, compared to the placebo group
- Pembrolizumab: 10.4 months
- Placebo: 8.1 months
- Hazard ratio 0.58 (95% CI, 0.44 to 0.77); P<0.001
- Overall survival at 24 months was higher in the pembrolizumab group
- Pembrolizumab: 54.4%
- Placebo: 44.6%
- Hazard ratio 0.61 (95% CI, 0.44 to 0.84); P=0.001
- Median progression-free survival was significantly higher in patients in the pembrolizumab group, compared to the placebo group
- Adverse events
- Anemia
- Pembrolizumab: 30.3%
- Placebo: 26.9%
- Neutropenia
- Pembrolizumab: 12.4%
- Placebo: 9.7%
- Anemia
CONCLUSION:
- When combined with chemotherapy, patients with persistent, recurrent, or metastatic cervical cancer in the pembrolizumab group experienced a median progression-free and overall survival that was significantly longer than those in the placebo group
- The authors conclude
We found that adding pembrolizumab reduced the hazard of disease progression, as assessed by investigator review, or death by 38% in patients with a PD-L1 combined positive score of 1 or more, by 35% in the intention-to-treat population, and by 42% in patients with a PD-L1 combined positive score of 10 or more; the hazard of death was reduced by 36%, 33%, and 39%, respectively
Learn More – Primary Sources:
Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer
How Many Women Over 65 Meet Criteria for Cervical Cancer Screening Exit?
BACKGROUND AND PURPOSE:
- Guidelines from a number of professional groups suggest discontinuation of cervical cancer screening for women who are >65 years old, if they meet the following criteria
- Average risk | Adequate negative screening prior to discontinuation
- However, recent data suggests that women >65 constitute approximately 20% of new cervical cancer cases
- Mills et al. (Gynecologic Oncology, 2021) explored the real-world applicability of screening exit criteria
METHODS:
- Cross-sectional study
- Populations
- Cohort 1: Women aged 64 | Employer-sponsored insurance enrolled in a national database between 2016 and 2018
- Cohort 2: Women aged 64 to 66 years receiving primary care at a safety net health center in 2019
- Study design
- Patients were evaluated for exit eligibility by current guidelines
- Exit due to hysterectomy
- Exit due to screening
- Criteria for screening exit include
- 2 consecutive negative HPV tests or HPV plus Pap co-tests, or 3 consecutive negative Pap tests within the prior 10 years
- No diagnosis of a precancerous lesion in the past 25 years
- Patients were evaluated for exit eligibility by current guidelines
RESULTS:
- 590,901 women in the national claims database (cohort 1)
- Eligible for exit: 22.25%
- Due to hysterectomy: 1.6%
- Due to negative screening: 20.6%
- Eligible for exit: 22.25%
- 1544 women in the safety net health center (cohort 2)
- Eligible for exit: 34.2%
- Due to hysterectomy: 9.3%
- Due to negative screening: 24.9%
- Eligible for exit: 34.2%
- Most women did not have sufficient data available to fulfill exit criteria
- National database: 64.7%
- Safety net hospital system: 56.7%
- Even among women with 10 years of insurance claims data, only 41.5% qualified to discontinue screening
CONCLUSION:
- Approximately two-thirds of women ≥64 years did not qualify for cervical cancer screening exit
- Cervical cancers in women >65 may be prevented with adequate screening performed between 55 and 65 years
Learn More – Primary Sources:
Eligibility for cervical cancer screening exit: Comparison of a national and safety net cohort
Does Changing the Frequency of Recommended Cervical Cancer Testing Lead to a Decrease in STI Screening?
BACKGROUND AND PURPOSE:
- The province of Ontario (Canada) changed their cervical cancer screening guidelines in 2012
- Annual Pap within 3 years of sexual activity was changed to every 3 years for women ≥21 years of age
- Zur et al. (Journal of Obstetrics and Gynecology Canada, 2020) sought to determine if changing Pap guidelines from 1 to 3 years impacted STI screening rates in younger women
METHODS:
- Retrospective cohort study
- Participants
- Women aged 19 to 25
- Care provided by family health team
- Exposures
- Annual Pap test: women who presented between May 1, 2009 and April 30, 2012
- Triennial Pap test: women who presented between Nov 1, 2012 and Oct 31, 2015
- Power analysis
- >90% power and an alpha of <0.05
- Pre-guideline testing rate of 90%
- 175 patients in each group required to detect a 15% difference
- Primary outcome
- Proportion of patients screened for CT/GC at any point during the 3-year study period
- Secondary outcomes
- Number of patient visits that included any STI screening
- Number of screening tests for GC, CT, syphilis, hepatitis B, hepatitis C, HIV
- Positive STI results
- Method of screening used (cervical swab, urine nucleic acid amplification test [NAAT], serum [HIV, hepatitis B, hepatitis C, and VDRL])
RESULTS:
- 600 women
- There were no statistically significant differences in the two groups for the following
- Age | Number of physician appointments | History of STIs
- There was a significant decrease in the number of visits (mean) at which STI screening was performed after the recommendations were changed in 2012 (P=0.001)
- Annual Pap test group: 1.21 visits/patient
- Triennial Pap test group: 0.82 visits/patient
- There was a decrease in the proportion of patient screened for STIs over 3 years (P=0.007)
- Annual Pap test group: 66.8%
- Triennial Pap test group: 52.8%
- For STI screening methods, there was a
- Significant decrease in the use of endocervical culture (P<0.001)
- Annual Pap test group: 1.06 tests/patient
- Triennial Pap test group: 0.57 tests/patient
- Nonsignificant increase in the use of urine NAAT (P=0.07)
- Annual Pap test group: 0.09 tests/patient
- Triennial Pap test group: 0.17 tests/patient
- Nonsignificant increase in the use of serum STI screening (P=0.16)
- Annual Pap test group: 0.37 tests/patient
- Triennial Pap test group: 0.47 tests/patient
- Significant decrease in the use of endocervical culture (P<0.001)
CONCLUSION:
- A change in cervical cancer screening guidelines, from once annually to once every three years, was associated with a decrease in STI screening in younger women
- The authors conclude
…we observed a decrease in STI screening even though there was no difference in number of physician visits over 3 years
This implies that it is not the frequency of physician visits but rather the nature of the visit that matters
This may be due to the ease with which a sensitive topic such as sexual health can be broached or the additional time and resources needed to perform an STI assessment when a pelvic examination is not otherwise indicated
