Journal of the National Cancer Institute. Monographs最新文献

Background: While recommending a human papillomavirus (HPV) single-dose vaccination schedule in 2022, the World Health Organization highlighted the need for long-term follow-up studies to monitor waning of protection. We report on vaccine efficacy against HPV infections in 1-, 2-, and 3-dose schedules and protection against cervical precancers at a median follow-up of 12 years postvaccination.

Methods: This randomized multicenter study in India was originally designed to vaccinate unmarried girls aged 10-18 years with either 2 or 3 doses of quadrivalent HPV vaccine. A ministerial decree to halt vaccination in trials resulted in the creation of cohorts receiving different doses, including just a single dose. Cohorts were assessed for incident and persistent infections by genotyping cervical samples collected yearly for 4 consecutive years after participants were married. Cervical screening with an HPV test was initiated at age 25 years for married participants. Age- and site-matched unvaccinated married women were recruited to be compared with vaccinated cohorts. Vaccine efficacy was assessed using proportional incidence ratios.

Results: The number of participants in the 1-, 2- (at 0 and 6 months), and 3-dose cohorts was 4949, 4980, and 4348, respectively. Of the recipients, 71%-82% in the different cohorts were eligible to provide samples for genotyping. Vaccine efficacy against persistent HPV 16 and 18 infection was 92.0% (95% confidence interval [CI] = 87.0% to 95.0%) in 3022 recipients of the single dose; and comparable with that observed in the 2-dose arm (94.8%, 95% CI = 90.0% to 97.3%) and the 3-dose arm (95.3%, 95% CI = 90.9% to 97.5%). No high-grade precancer associated with HPV 16 and 18 was detected among vaccinated participants compared with 8 precancers detected among the unvaccinated women.

Conclusion: This observational cohort study has established that a single dose of HPV vaccine provides high protective efficacy against persistent HPV 16 and 18 infections and associated neoplasia 15 years postvaccination.

Background: The World Health Organization has endorsed single-dose human papillomavirus (HPV) vaccination, but data on the impact on HPV prevalence in high HIV burden settings are limited.

Methods: A single-dose bivalent HPV vaccine was delivered to adolescent girls in grade 10 in a schools-based campaign in 1 district in South Africa. Impact on HPV 16 and 18 prevalence was evaluated using repeat cross-sectional surveys. A clinic-based survey in girls aged 17-18 years established HPV 16 and 18 prevalence in a prevaccine population (n = 506, including 157 living with HIV) in 2019 and was repeated in the same age group and sites in a single-dose eligible population in 2021 (n = 892, including 117 with HIV). HPV DNA was detected on self-collected vaginal swabs using the Seegene Anyplex II HPV 28. Population impact was estimated overall and by HIV status using prevalence ratios adjusted for differences in sexual behavior between surveys.

Results: Single-dose vaccination campaign coverage was 72% (4807 of 6673) of eligible girls attending high school (n = 66) in the district. HPV 16 and 18 prevalence was 35% lower in the postvaccine survey overall (adjusted prevalence ratio = 0.65, 95% confidence interval [CI] = 0.51 to 0.83; P < .001) and 37% lower in those living with HIV (adjusted prevalence ratio = 0.63, 95% CI = 0.41 to 0.95; P  = .026). No protective effect was seen for nonvaccine oncogenic HPV types 33, 35, 39, 51, 52, 56, 58, 59, or 68 overall (adjusted prevalence ratio = 1.14, 95% CI = 1.03 to 1.26; P = .011) or in those living with HIV (adjusted prevalence ratio = 1.00, 95% CI = 0.83 to 1.21. P = 0.99).

Conclusion: These data provide reassuring evidence of single-dose impact on population-level HPV 16 and 18 prevalence in a South African population, irrespective of HIV status.

Background: We simulated the impact of hypothetical waning scenarios of a 1-dose human papillomavirus (HPV) vaccination paired with switching to 2-dose mitigation strategies guided by empirical vaccine trial reporting timelines.

Methods: Using 2 independent mathematical models fitted to a high-burden setting, we projected the cumulative cervical cancer cases averted over 85 years for alternative HPV vaccination scenarios under 2 program adoption timelines: 1) de novo introduction of a 1-dose HPV vaccination and 2) a switch from an existing 2-dose HPV vaccination program to a 1-dose vaccination. We assumed 80% vaccination coverage with the bivalent vaccine and an average duration of a 1-dose HPV vaccine protection of either 30 or 25 years with 100% efficacy. We varied the eligible age group(s) at program introduction and the 2-dose mitigation (single-age cohort or multi-age cohort). If needed for mitigation, reintroduction of 2-dose vaccination was assumed to occur in 2036 (ie, 30 years after initiation of the Costa Rica Vaccine Trial).

Results: Under both vaccine adoption timelines, the models projected that countries could achieve the same level of health benefits by switching to 2 doses in 2036 using a multi-age cohort approach as with initiating a 2-dose or 1-dose vaccination program with no waning. With only a single-age cohort 2-dose mitigation approach, 98%-99% of cases would be prevented compared with the health benefits of 2 doses or a noninferior, durable 1 dose.

Conclusions: Countries hesitant to adopt a 1-dose HPV vaccination program may have opportunities to leverage the benefits and efficiency of a 1-dose schedule while awaiting longer-term reporting from 1-dose durability studies, including Costa Rica Vaccine Trial.

Human papillomavirus (HPV) vaccines received regulatory approval and were recommended for use in young girls nearly 2 decades ago. Uptake is mostly high in resource-rich settings. In resource-limited settings, where the burden of cervical cancer is disproportionately high, access to and uptake of HPV vaccines are nowhere near satisfactory, despite evidence that HPV vaccination is highly cost-effective and a significant value-for-money investment. The discovery that only a single dose of the HPV vaccines may be needed to confer adequate protection may make equitable access to HPV vaccines possible. Indeed, the recent World Health Organization recommendation allowing for 1 or 2 doses is already gaining traction. This monograph aims to update the state of the science related to single-dose HPV vaccine protection and includes both primary data and modeling efforts that address key gaps in the knowledge regarding 1) durability of protection of a single dose of the HPV vaccine, 2) single-dose HPV vaccine effectiveness in both high-income and low-income settings, 3) implementation of single-dose HPV vaccination, and 4) how to accelerate control of cervical cancer by integrating a 1-time screen for cervical disease. The content published in this monograph will continue to advance the science of HPV vaccination and will be vital as new countries make informed decisions about how best to use this remarkable vaccine.

Prescription opioids are used for managing pain in persons with cancer, however, there are socioeconomic and racial disparities in medication access. Cannabis is increasingly used for cancer symptom management and as an opioid alternative. Limited data are available about patterns of opioid and cannabis use among patients with cancer. We used survey data from 4 National Cancer Institute-designated cancer centers in 3 states (n = 1220) to assess perceptions, use of cannabis and opioids for pain, their substitution, and racial and ethnic differences in each outcome. Compared with White patients, Black patients were less likely to use opioids for pain (odds ratio [OR] = 0.66; P = .035) and more likely to report that cannabis was more effective than opioids (OR = 2.46; P = .03). Race effects were mitigated (P > .05) after controlling for socioeconomic factors. Further research is needed to understand cannabis and opioid use patterns and how overlapping social determinants of health create a disadvantage in cancer symptom management for Black patients.

Background: There has been limited study regarding patient-provider communication about medical cannabis for cancer symptom management. To address this gap, this study assesses the determinants and prevalence of patient-provider communication about the use of medical cannabis for cancer symptoms at a National Cancer Institute-designated Comprehensive Cancer Center.

Methods: Individuals who completed cancer treatment from July 2017 to December 2019 were invited to participate in a survey regarding medical cannabis. An electronic survey was administered in English and Spanish from August to November 2021 and completed by 1592 individuals (response rate = 17.6%).

Results: About one-third (33.5%) of participants reported discussing medical cannabis for cancer symptom management with a health-care provider. Controlling for other factors, individuals with malnutrition and/or cachexia had higher odds (odds ratio [OR] = 2.30, 95% confidence interval [CI] = 1.50 to 3.53) of reporting patient-provider discussions compared with individuals without malnutrition and/or cachexia. Similarly, individuals with nausea had higher odds (OR = 1.94, 95% CI = 1.44 to 2.61) of reporting patient-provider discussions compared with individuals without nausea. A smaller percentage (15.6%) of participants reported receiving a recommendation for medical cannabis for cancer symptom management. Among individuals who reported using cannabis, a little over one-third (36.1%) reported not receiving instructions from anyone on how to use cannabis or determine how much to take.

Conclusions: Overall, our study suggests that patient-provider communication about medical cannabis for cancer symptom management is limited. As interest and use of medical cannabis continues to grow among cancer patients, there is a need to ensure patients have access to high quality patient-provider communication.

Background: The benefits of cannabis in symptom management among cancer survivors are widely acknowledged; however, patterns of cannabis use by cancer stage at diagnosis are unknown.

Methods: Here, we examined the association between cancer stage at diagnosis and consideration of cannabis use since diagnosis. We analyzed cross-sectional survey data from 954 cancer survivors, weighted to be representative of a National Cancer Institute-Designated Comprehensive Cancer Center's patient population. We used survey-weighted multivariable logistic regression to examine the association between cancer stage at diagnosis (advanced [III/IV] versus non-advanced [I/II]) and consideration of cannabis use (yes versus no) since diagnosis.

Results: Sixty percent of the population was diagnosed with non-advanced stages of cancer, and 42% had considered using cannabis since diagnosis. The odds of consideration of cannabis use were 63% higher (odds ratio = 1.63, 95% confidence interval = 1.06 to 2.49) among cancer survivors diagnosed at stages III/IV than among those diagnosed at stages I/II.

Conclusion: Cancer stage may be a predictor of consideration of cannabis use after diagnosis.

Background: Patients with cancer report increasing rates of cannabis use, often to manage symptoms and toxicities. The efficacy and safety of cannabis, however, for some use cases remains unclear. To better understand characteristics of patients with cancer who report using cannabis, we examined data from a cannabis use survey of among patients with cancer seen at a National Cancer Institute-Designated Cancer Center.

Methods: In late 2021, patients with cancer (N = 1608) treated between July 2017 and December 2019 provided cannabis use data. Additional data were obtained from medical records data and routine patient-reported outcomes collected for clinical purposes. Univariable analyses and multivariable regression analyses were conducted to identify correlates of cannabis use at different stages in the cancer care trajectory.

Results: Rates of self-reported cannabis use by patients with cancer were 59% before cancer diagnosis and 47% after diagnosis. Longitudinal rates of cannabis use were 29% for no cannabis use, 23% before diagnosis, 12% after diagnosis, and 35% for both before and after diagnosis. Demographic factors associated with cannabis use included age, sex, race, and educational achievement. Tobacco use and binge drinking were associated with higher odds of cannabis use. Cannabis use was also associated with greater self-reported interference with physical functioning due to pain and interference with social functioning due to health problems.

Conclusions: We found high rates of cannabis use among patients with cancer, both before and after their cancer diagnosis. Future studies should further investigate psychosocial factors associated with cannabis use among patients with cancer as well as psychosocial outcomes among patients with cancer using cannabis.

Background: Many patients with cancer use cannabis to help alleviate untreated cancer symptoms and side effects.

Methods: We examined associations of perceived benefits and risks and postdiagnosis cannabis use in a weighted sample of adult cancer survivors through a 1-time survey. Fifteen perceived cannabis use benefits and 19 perceived risks were operationalized as both summary scores and report of any benefits or risks. Survey-weighted logistic regression provided covariate-adjusted odds of postdiagnosis cannabis use for each benefit-risk measure.

Results: Among the weighted population of 3785 survivors (mean [SD] age = 62.2 [13.5] years), one-third used cannabis after diagnosis. Perceiving any benefits increased the odds of postdiagnosis cannabis use more than 500%, and perceiving any risks lowered the odds by 59%. Each SD increase in endorsed benefits doubled the odds of postdiagnosis cannabis use, while each SD increase in endorsed risks reduced the odds by 36%.

Conclusion: An accurate understanding of benefits and risks is critical for informed decision making.

Background: We assessed patient costs associated with cannabis use during cancer treatment.

Methods: Adults treated for cancer at a large, comprehensive center completed an anonymous survey regarding their thoughts and experiences with cannabis and cancer. Bivariate and weighted multivariable logistic regression assessed clinical and sociodemographic factors associated with patient-reported out-of-pocket costs for cannabis products.

Results: Overall, 248 cannabis users provided data on cost and were analyzed. Median monthly out-of-pocket cost for cannabis was $80 (interquartile range = $25-$150). On regression analysis, male gender (odds ratio = 2.5, 95% confidence interval = 1.2 to 5.5, P = .026) and being 45 years of age or older (odds ratio = 7.5, 95% confidence interval = 1.9 to 30.0, P = .0042) were associated with spending $100 a month or more on cannabis. Of the 166 patients who stopped using cannabis early or used less than preferred, 28% attributed it to cost and 26% to lack of insurance coverage.

Conclusion: Cannabis use during cancer treatment may contribute to significant out-of-pocket costs, with men and younger patients more likely to pay higher costs.