Journal Of The National Cancer Institute. Monographs[JOURNAL]
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200 papers
Practical design considerations for cluster randomized controlled trials: lessons learned in community oncology research.
Dressler EV, Pugh SL, Gunn HJ … +3 more , Unger JM, Zahrieh DM, Snavely AC
J Natl Cancer Inst Monogr · 2025 Mar · PMID 39989035 · Full text
Cancer care delivery research trials conducted within the National Cancer Institute (NCI) Community Oncology Research Program (NCORP) routinely implement interventions at the practice or provider level, necessitating the...
Cancer care delivery research trials conducted within the National Cancer Institute (NCI) Community Oncology Research Program (NCORP) routinely implement interventions at the practice or provider level, necessitating the use of cluster randomized controlled trials (cRCTs). The intervention delivery requires cluster-level randomization instead of participant-level, affecting sample size calculation and statistical analyses to incorporate correlation between participants within a practice. Practical challenges exist in the conduct of these cRCTs due to unique trial network infrastructures, including the possibility of unequal participant accrual totals and rates and staggered study initiation by clusters, potentially with differences between randomized arms. Execution of cRCT designs can be complex, ie, if some clusters do not accrue participants, unintended cluster-level crossover occurs, how best to identify appropriate cluster-level stratification, timing of randomization, and multilevel eligibility criteria considerations. This article shares lessons learned with potential mitigation strategies from 3 NCORP cRCTs.
Impact of single-dose HPV vaccination on HPV 16 and 18 prevalence in South African adolescent girls with and without HIV.
Delany-Moretlwe S, Machalek DA, Travill D … +6 more , Petoumenos K, Nyemba DC, Mbulawa ZZA, Ndlovu N, Kaldor JM, Rees H
J Natl Cancer Inst Monogr · 2024 Nov · PMID 39529527 · Full text
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...
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.
Population-level impact of switching to 1-dose human papillomavirus vaccination in high-income countries: examining uncertainties using mathematical modeling.
Brisson M, Laprise JF, Drolet M … +8 more , Chamberland É, Bénard É, Burger EA, Jit M, Kim JJ, Markowitz LE, Sauvageau C, Sy S
J Natl Cancer Inst Monogr · 2024 Nov · PMID 39529531 · Full text
BACKGROUND: A concern in high-income countries is that switching to 1-dose human papillomavirus (HPV) vaccination could cause a rebound in HPV infection and cervical cancer if 1-dose efficacy or duration were inferior to...
BACKGROUND: A concern in high-income countries is that switching to 1-dose human papillomavirus (HPV) vaccination could cause a rebound in HPV infection and cervical cancer if 1-dose efficacy or duration were inferior to 2 doses. Using mathematical modeling and up-to-date trial-based data, we projected the population-level effectiveness of switching from 2-dose to 1-dose vaccination under different vaccine efficacy and duration assumptions in high-income countries. METHODS: We used HPV-ADVISE (Agent-based Dynamic model for VaccInation and Screening Evaluation), a transmission-dynamic model of HPV infection and cervical cancer, varying key model assumptions to identify those with the greatest impact on projections of HPV-16 and cervical cancer incidence over time: 1) 1-dose vaccine efficacy and vaccine duration, 2) mechanisms of vaccine efficacy and duration over time, 3) midadult (>30 years of age) sexual behavior, 4) progression to cervical cancer among midadults, and 5) vaccination coverage and programs. RESULTS: In high-income countries, 1-dose vaccination would cause no appreciable rebound in HPV-16 infection, except for a limited rebound under the most pessimistic assumptions of vaccine duration (average, 25 years), because 1) the switch would occur when HPV prevalence is low because of high 2-dose vaccination coverage and 2) individuals would be protected during their peak ages of sexual activity (<35 to 40 years of age). Our model projects a more limited rebound in cervical cancer because of a shift to older age at infection, resulting in fewer life-years left to potentially develop cancer. Projections were robust when varying key model assumptions. CONCLUSIONS: High protection during peak ages of sexual activity in high-income countries would likely mitigate any potential rebounds in HPV infection and cervical cancer under the most pessimistic assumptions of 1-dose efficacy and duration.
Population-level health impact of hypothetical waning 1-dose human papillomavirus vaccination and 2-dose mitigation strategies in a high cervical cancer burden setting.
Burger EA, Laprise JF, Portnoy A … +7 more , Spencer JC, Sy S, Regan MC, Bénard É, Drolet M, Brisson M, Kim JJ
J Natl Cancer Inst Monogr · 2024 Nov · PMID 39529530 · Full text
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 ti...
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.
HPV16/18 antibodies 16-years after single dose of bivalent HPV vaccination: Costa Rica HPV vaccine trial.
Porras C, Romero B, Kemp T … +13 more , Fantin R, Herrero R, Hildesheim A, Ocampo R, Sierra MS, Gail MH, Schussler J, Schiller JT, Lowy DR, Pinto LA, Liu D, Kreimer AR, Costa Rica HPV Vaccine Trial Study Group
J Natl Cancer Inst Monogr · 2024 Nov · PMID 39529529 · Full text
BACKGROUND: The Costa Rica HPV Vaccine Trial provided initial evidence that 1 dose of the bivalent human papillomavirus (HPV) vaccine induces stabilizing antibody levels that may provide extended protection against HPV-1...
BACKGROUND: The Costa Rica HPV Vaccine Trial provided initial evidence that 1 dose of the bivalent human papillomavirus (HPV) vaccine induces stabilizing antibody levels that may provide extended protection against HPV-16/18 infections. We report antibody seropositivity and stability 11 to 16 years after vaccination. METHODS: We invited a random subset of Costa Rica HPV Vaccine Trial participants (n = 398) who had received 3 doses and all women (n = 203) who had received 1 dose at 18 to 25 years of age to follow-up visits 11, 14, and 16 years after vaccination. We calculated HPV-16 and HPV-18 seropositivity and assessed change in enzyme-linked immunosorbent assay antibody levels 11 to 16 years after vaccination among 500 participants. RESULTS: By year 16, 99.4% (95% confidence interval [CI] = 96.8% to 100.0%) and 100.0% (95% CI = 98.9% to 100.0%) of 1-dose and 3-dose recipients, respectively, were HPV-16 seropositive and 98.8% (95% CI = 95.9% to 99.9%) and 100% (95% CI = 98.9% to 100.0%) of 1-dose and 3-dose recipients, respectively, were HPV-18 seropositive. Between years 11 and 16, women who had received 3 doses had a small but statistically significant decrease in the geometric mean concentration for HPV-16 of ‒12.4% (95% CI = ‒16.3% to ‒8.4%) and HPV-18 of ‒13.4% (95% CI = ‒17.2% to ‒9.4%). Among women who had received 1 dose, the decrease was statistically significant for HPV-16 at ‒8.9 (95% CI = ‒14.2% to ‒3.1%) but nonsignificant for HPV-18. Geometric mean concentration ratios of 3:1 dose (year 16) were 3.0 and 2.2 for HPV-16 and HPV-18, respectively. CONCLUSIONS: HPV-16/18 seropositivity remained exceedingly high 16 years after vaccination. Over 5 years, small declines in antibodies were observed. Women should have protection for at least 20 years and likely much longer at the observed rate of decline.
Leveraging single-dose human papillomavirus vaccination dose-efficiency to attain cervical cancer elimination in resource-constrained settings.
Man I, Georges D, Basu P … +1 more , Baussano I
J Natl Cancer Inst Monogr · 2024 Nov · PMID 39529528 · Full text
BACKGROUND: In low- and middle-income countries, resource constraints remain a critical factor limiting access to cervical cancer preventive measures. The option of single-dose immunization could help improve access to h...
BACKGROUND: In low- and middle-income countries, resource constraints remain a critical factor limiting access to cervical cancer preventive measures. The option of single-dose immunization could help improve access to human papillomavirus vaccination and attain cervical cancer elimination. METHODS: With simulation models adapted to country-specific data and scenarios for single-dose protection derived from International Agency for Research on Cancer India vaccine trial data, we estimated the expected impact of single-dose vaccination in India, Rwanda, and Brazil, three countries with varying profiles of cervical cancer risk and vaccination timelines. In combination with single-dose vaccination, we explored different resource reallocation strategies based on dose efficiency, elimination attainment, and cervical cancer cases prevented, with the existing 2-dose program as a comparator. RESULTS: Assuming lifelong single-dose protection, switching from 2-dose to 1-dose vaccination and reallocating resources to female catch-up could prevent 467-1336, 94-194, and 15-207 additional cervical cancer cases (per 100 000 women born) in cohorts aged 11-30 years in India, Rwanda, and Brazil, respectively. Resource reallocation to improve the current routine coverage could help eliminate cervical cancer in India and across all Brazilian states but not in Rwanda. For each country, we found a dose-efficient reallocation strategy (or a combination of strategies) together with 1-dose vaccination that could prevent more cervical cancers vs 2-dose vaccination, even in the worst-case scenario of single-dose protection. CONCLUSION: Adopting single-dose vaccination with resource reallocation is a resource-efficient approach to enhance progress toward cervical cancer elimination. The overall impact of vaccination can be maximized by fine-tuning resource reallocation to a country's needs.
Community intervention of a single-dose or 2-dose regimen of bivalent human papillomavirus vaccine in schoolgirls in Thailand: vaccine effectiveness 2 years and 4 years after vaccination.
Jiamsiri S, Rhee C, Ahn HS … +20 more , Seo HW, Klinsupa W, Park S, Lee J, Premsri N, Namwat C, Silaporn P, Excler JL, Kim DR, Chon Y, Sampson JN, Nilyanimit P, Vongpunsawad S, Poudyal N, Markowitz LE, Panicker G, Unger ER, Rerks-Ngarm S, Poovorawan Y, Lynch J
J Natl Cancer Inst Monogr · 2024 Nov · PMID 39529526 · Full text
BACKGROUND: With accumulating evidence of single-dose human papillomavirus (HPV) vaccine efficacy in young women, we conducted a community vaccine effectiveness study comparing HPV single-dose and 2-dose regimens (0 and...
BACKGROUND: With accumulating evidence of single-dose human papillomavirus (HPV) vaccine efficacy in young women, we conducted a community vaccine effectiveness study comparing HPV single-dose and 2-dose regimens (0 and 6 months) of a bivalent HPV vaccine among grade 8 schoolgirls (aged 13-14 years) in Thailand. METHODS: In 2018, eligible grade 8 schoolgirls in Udon Thani (single dose) and Buri Ram (2 doses) provinces were offered HPV vaccine per assigned dose regimen. Concurrently, a cross-sectional survey for measuring baseline HPV prevalence was conducted in grade 10 (n = 2600) and grade 12 unvaccinated schoolgirls (n = 2000) in each province. HPV infection was assessed in first-void urine samples, tested by DNA polymerase chain reaction on the cobas 4800 system (Roche Molecular Diagnostics, Pleasanton, CA). All samples positive on the cobas system and an equal number of negative samples were also tested by Anyplex II HPV28 Detection (Seegene, Seoul, South Korea). The surveys were repeated in 2020 and 2022, when vaccinated grade 8 schoolgirls reached grade 10, and then subsequently grade 12, respectively. Vaccine effectiveness was estimated by comparing the weighted prevalence of HPV-16 or HPV-18 between grade-matched unvaccinated schoolgirls on the baseline survey (2018) and vaccinated schoolgirls in the year-2 (2020) and year-4 (2022) surveys. Adjustment methods were used in the analysis to account for potential differences in sexual behavior due to the noncontemporaneous comparison. RESULTS: The prevalence of HPV-16 and HPV-18 on the baseline survey among unvaccinated grade 10/grade 12 schoolgirls was 2.90% (95% confidence interval [CI] = 2.54% to 3.31%)/3.98% (95% CI = 3.52% to 4.49%) for Udon Thani and 3.87% (95% CI = 3.46% to 4.34%)/6.13% (95% CI = 5.56% to 6.75%) for Buri Ram. On the year-2 survey, the prevalence among vaccinated grade 10 schoolgirls was 0.57% (95% CI = 0.42% to 0.77%) for Udon Thani and 0.31% (95% CI = 0.21% to 0.47%) for Buri Ram. The 2-year postvaccination crude vaccine effectiveness for the single-dose regimen was estimated at 80.4% (95% CI = 73.9% to 86.9%), and for the 2-dose regimen at 91.9% (95% CI = 88.5% to 95.4%). On the year-4 survey, the prevalence among vaccinated grade 12 schoolgirls was 0.37% (95% CI = 0.25% to 0.56%) for Udon Thani and 0.28% (95% CI = 0.18% to 0.45%) for Buri Ram. Four-year postvaccination crude vaccine effectiveness for the single-dose regimen was estimated at 90.6% (95% CI = 86.6% to 94.6%) and for the 2-dose regimen was estimated at 95.4% (95% CI = 93.2% to 97.6%). All adjustment methods minimally affected vaccine effectiveness for the single-dose and 2-dose regimens. At 4 years after vaccination, the difference in crude vaccine effectiveness between the single-dose and 2-dose regimens was ‒4.79% (95% CI = ‒9.32% to ‒0.25%), meeting the study's noninferiority criteria. CONCLUSIONS: Our study demonstrated that both single-dose and 2-dose HPV vaccination significantly decreased HPV-16/18 point prevalence 2 years and 4 years after vaccination. Crude vaccine effectiveness at 4 years after vaccination was greater than 90% for both the single-dose and 2-dose regimens; the single-dose regimen was not inferior to the 2-dose regimen. These data show that a single dose of HPV vaccine provides high levels of protection when administered to schoolgirls younger than 15 years of age.
A cervical cancer control strategy for lower-resource settings: interventions to complement one-dose HPV vaccination.
Campos NG, Lowy DR, de Sanjosé S … +1 more , Schiffman M
J Natl Cancer Inst Monogr · 2024 Nov · PMID 39529525 · Full text
One-dose prophylactic HPV vaccination of pre-adolescents may reduce cervical cancer deaths dramatically in lower-resource settings, but the benefits of achieving immediate high coverage among pre-adolescents would not be...
One-dose prophylactic HPV vaccination of pre-adolescents may reduce cervical cancer deaths dramatically in lower-resource settings, but the benefits of achieving immediate high coverage among pre-adolescents would not be realized for 20 to 40 years. Prophylactic vaccine efficacy is reduced after sexual debut, and current therapeutic intervention candidates designed to treat existing HPV infections or precancerous lesions have yielded insufficient evidence to warrant widespread use. However, we are developing a feasible, scalable, high-quality cervical screening approach that could prevent hundreds of thousands of deaths, while we work to achieve high coverage of one-dose vaccination for adolescent cohorts. A time-limited "one screen" campaign approach for lower-resource settings could complement parallel efforts to achieve high coverage with one-dose vaccination. This screen-triage-treat strategy would target the highest risk groups of screening age (ie, 25 to 49 years) for once-in-a-lifetime HPV testing of self-collected samples using a low-cost accurate HPV test; subsequent triage relying on extended genotyping and a validated deep-learning algorithm for automated visual evaluation (AVE) would stratify management based on risk to provide treatment for those most likely to develop cancer without overburdening health care systems. Early efficacy of this approach has been demonstrated in 9 countries within the HPV-AVE (PAVE) Study Consortium. We estimate that the cost per death averted of a screen-triage-treat campaign is of similar magnitude to prophylactic vaccination. We do not envision perpetual investment in ubiquitous brick-and-mortar screening programs if "one dose, one screen" is implemented with high coverage and targets the highest-risk populations. In collaboration with in-country stakeholders, efforts to ensure acceptability, risk communication, and cost-effectiveness are underway.
Acceptability of single-dose HPV vaccination schedule among health-care professionals in Kenya: a mixed-methods study.
Umutesi G, Weiner BJ, Oluoch L … +7 more , Bukusi E, Onono M, Njoroge B, Mecca L, Ngure K, Mugo NR, Barnabas RV
J Natl Cancer Inst Monogr · 2024 Nov · PMID 39529524 · Full text
BACKGROUND: The World Health Organization recommends a single-dose human papillomavirus (HPV) vaccination schedule for girls and boys to accelerate progress toward cervical cancer elimination. We applied the Theoretical...
BACKGROUND: The World Health Organization recommends a single-dose human papillomavirus (HPV) vaccination schedule for girls and boys to accelerate progress toward cervical cancer elimination. We applied the Theoretical Framework of Acceptability (TFA) within the context of HPV vaccination to assess the acceptability of a single-dose schedule among health-care professionals in Kenya. METHODS: A REDCap survey was developed using relevant Theoretical Framework of Acceptability domains and validated with health-care professionals. Descriptive analyses and multivariate Poisson regression were conducted to assess factors associated with increased acceptability. Free-text responses were analyzed using a rapid qualitative approach, and findings were presented using a joint display. RESULTS: Among 385 responses, 74.2% of health-care professionals were female and 48.6% were nurses. On average, respondents had been in their position for 60 months, and one-third (33.2%) were based at level-4 facilities. The majority (75.84%) thought that giving a single-dose of the HPV vaccine to adolescent girls and young women was either acceptable or very acceptable. Qualitative findings highlighted that lack of information was the underlying reason for health-care professionals who were resistant, and most clinicians thought that a singled-dose schedule was less burdensome to clinicians and patients. Hospital directors had a non-statistically significantly lower acceptability likelihood than nurses (incident rate ratio = 0.93, 95% confidence interval = 0.45 to 1.71) and health-care professionals at urban facilities had a non-statistically significantly lower acceptability likelihood than clinicians in rural facilities (incident rate ratio = 0.97, 95% confidence interval = 0.83 to 1.13). CONCLUSION: Although not statistically significant, predictors of increased acceptability provide information to tailor strategies to increase HPV vaccination coverage and accelerate progress toward cervical cancer elimination.
Evaluating potential program cost savings with a single-dose HPV vaccination schedule: a modeling study.
Slavkovsky R, Mvundura M, Debellut F … +1 more , Naddumba T
J Natl Cancer Inst Monogr · 2024 Nov · PMID 39529523 · Full text
BACKGROUND: There is limited evidence on the magnitude of the potential program cost savings associated with the World Health Organization-endorsed single-dose schedule for the human papillomavirus (HPV) vaccine. The obj...
BACKGROUND: There is limited evidence on the magnitude of the potential program cost savings associated with the World Health Organization-endorsed single-dose schedule for the human papillomavirus (HPV) vaccine. The objective of this analysis was to model the delivery and vaccine procurement cost implications of the new schedule. METHODS: The analysis leveraged primary data during a study evaluating the HPV vaccine delivery costs and operational context in 5 countries (Ethiopia, Guyana, Rwanda, Sri Lanka, and Uganda) implementing a two-dose schedule. To estimate the cost for the single-dose schedule, we adjusted the two-dose schedule cost estimates to account for differences in the frequency of activities, whether activities differed by HPV vaccine dose or session, and differences in relative quantity or storage volume of HPV vaccines delivered. We estimated the cost per dose and cost per adolescent receiving the full (single-dose or two-dose) vaccination schedule in 2019 US dollars from a health system perspective. RESULTS: Modeled results found that cost per dose would increase under a single-dose schedule, whereas cost per adolescent receiving the full schedule would decrease. The financial cost for vaccine procurement and delivery per adolescent receiving the full schedule ranged from $9.64 (Sri Lanka) to $23.43 (Guyana) under a two-dose schedule and decreased to $4.84 and $12.34, respectively, under a single-dose schedule, reflecting savings up to 50%. For economic costs, the range for a single-dose schedule was $7.86 (Rwanda) to $28.53 (Guyana). CONCLUSION: A single-dose HPV vaccination schedule could provide cost savings to immunization programs and enhance program affordability and sustainability.
Human papillomavirus prophylactic vaccines: update on new vaccine development and implications for single-dose policy.
Schuind AE, Balaji KA, Du A … +2 more , Yuan Y, Dull P
J Natl Cancer Inst Monogr · 2024 Nov · PMID 39529522 · Full text
Human papillomavirus (HPV) prophylactic vaccines were first licensed in 2006 with the primary goal of preventing HPV-related cancers, with cervical cancer accounting for the highest morbidity and mortality globally. Six...
Human papillomavirus (HPV) prophylactic vaccines were first licensed in 2006 with the primary goal of preventing HPV-related cancers, with cervical cancer accounting for the highest morbidity and mortality globally. Six HPV vaccines have been licensed; 4 of these have been prequalified by the World Health Organization, and additional products are in the pipeline. This article provides an overview of HPV vaccine coverage and current and anticipated vaccine supply vs expected demand. Given that the 2022 World Health Organization position paper on HPV vaccines includes a 1-dose regimen as an alternate schedule, we will discuss the evidence for using licensed vaccines in single-dose regimens and the approach to generating similar supportive data for other current and future vaccines. The broad adoption of a single-dose HPV vaccine regimen would expand access to vaccines by improving the supply-demand balance, increasing affordability, and simplifying logistics, which will ultimately impact HPV-related morbidity and mortality.
A prospective cohort study comparing efficacy of 1 dose of quadrivalent human papillomavirus vaccine to 2 and 3 doses at an average follow up of 12 years postvaccination.
Malvi SG, Esmy PO, Muwonge R … +26 more , Joshi S, Poli URR, Lucas E, Verma Y, Lucksom PG, Shah A, Patel B, Zomawia E, Pimple S, Jayant K, Hingmire S, Chiwate A, Divate U, Vashist S, Mishra G, Jadhav R, Siddiqi M, Sauvaget C, Sankaran S, Kannan TPRA, Shastri SS, Pillai MR, Anantharaman D, Bhatla N, Sankaranarayanan R, Basu P
J Natl Cancer Inst Monogr · 2024 Nov · PMID 39529521 · Full text
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...
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.
Single-dose human papillomavirus vaccination: an update.
Kreimer AR, Watson-Jones D, Kim JJ … +1 more , Dull P
J Natl Cancer Inst Monogr · 2024 Nov · PMID 39529520 · Full text
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...
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.
Perceptions, prevalence, and patterns of cannabis use among cancer patients treated at 12 NCI-Designated Cancer Centers.
Ellison GL, Helzlsouer KJ, Rosenfield SM … +19 more , Kim Y, Ashare RL, Blaes AH, Cullen J, Doran N, Ebbert JO, Egan KM, Heffner JL, Lee RT, McClure EA, McDaniels-Davidson C, Meghani SH, Newcomb PA, Nugent S, Hernandez-Ortega N, Salz T, Vidot DC, Worster B, Zylla DM
J Natl Cancer Inst Monogr · 2024 Aug · PMID 39108244 · Full text
BACKGROUND: The legal climate for cannabis use has dramatically changed with an increasing number of states passing legislation legalizing access for medical and recreational use. Among cancer patients, cannabis is often...
BACKGROUND: The legal climate for cannabis use has dramatically changed with an increasing number of states passing legislation legalizing access for medical and recreational use. Among cancer patients, cannabis is often used to ameliorate adverse effects of cancer treatment. Data are limited on the extent and type of use among cancer patients during treatment and the perceived benefits and harms. This multicenter survey was conducted to assess the use of cannabis among cancer patients residing in states with varied legal access to cannabis. METHODS: A total of 12 NCI-Designated Cancer Centers, across states with varied cannabis-access legal status, conducted surveys with a core questionnaire to assess cannabis use among recently diagnosed cancer patients. Data were collected between September 2021 and August 2023 and pooled across 12 cancer centers. Frequencies and 95% confidence intervals for core survey measures were calculated, and weighted estimates are presented for the 10 sites that drew probability samples. RESULTS: Overall reported cannabis use since cancer diagnosis among survey respondents was 32.9% (weighted), which varied slightly by state legalization status. The most common perceived benefits of use were for pain, sleep, stress and anxiety, and treatment side effects. Reported perceived risks were less common and included inability to drive, difficulty concentrating, lung damage, addiction, and impact on employment. A majority reported feeling comfortable speaking to health-care providers though, overall, only 21.5% reported having done so. Among those who used cannabis since diagnosis, the most common modes were eating in food, smoking, and pills or tinctures, and the most common reasons were for sleep disturbance, followed by pain and stress and anxiety with 60%-68% reporting improved symptoms with use. CONCLUSION: This geographically diverse survey demonstrates that patients use cannabis regardless of its legal status. Addressing knowledge gaps concerning benefits and harms of cannabis use during cancer treatment is critical to enhance patient-provider communication.
A survey of patients with cancer and oncology health-care professionals about cannabis use during treatment.
Lee RT, Kim E, Mendiratta P … +6 more , Farrell M, Finklea S, Huang L, Trapl E, Gerson S, Cullen J
J Natl Cancer Inst Monogr · 2024 Aug · PMID 39108243 · Full text
BACKGROUND: This study characterizes patient and health-care professional perspectives regarding medical cannabis use at a National Cancer Institute-Designated Cancer Center. Data evaluated included the prevalence and pa...
BACKGROUND: This study characterizes patient and health-care professional perspectives regarding medical cannabis use at a National Cancer Institute-Designated Cancer Center. Data evaluated included the prevalence and patterns of and reasons for cannabis use. METHODS: Patients with cancer undergoing treatment were recruited into a cross-sectional survey as part of a national National Cancer Institute-funded effort. Participants completed a survey about cannabis use, reasons for use, and types of cannabis. A health-care professional survey was also conducted to explore perspectives regarding patients' use of cannabis. RESULTS: A total of 313 patients with cancer (mean [SD] age = 60.7 [12.8] years) completed the survey (43% response rate) between 2021 and 2022. Of the respondents, 58% were female; identified as White (61%) and Black (23%); and had diverse cancer diagnoses. Nearly half of respondents (43%) had previously used cannabis, one-quarter (26%) had used cannabis since their cancer diagnosis, and almost 1 in 6 (17%) were actively using cannabis at the time of survey completion. The most common modes of ingestion were gummies (33%) and smoking (30%). The most commonly reported reasons for use were insomnia (46%), pain (41%), and mood (39%). For the 164 health-care professionals who completed the survey (25% response rate), the majority agreed that cannabis use (72%) is safe and beneficial for patients (57%). Four in 10 (39%) health-care professionals felt comfortable providing guidance to patients about cannabis use; however, only 1 in 8 (13%) felt knowledgeable about the topic of cannabis. CONCLUSIONS: Approximately one-sixth of patients with cancer receiving treatment actively use cannabis for management of various cancer symptoms. Perceptions about cannabis use and education varied widely among health-care professionals.
Tobacco-cannabis co-use among cancer patients and survivors: findings from 2 US cancer centers.
Smith DM, Kaye JT, Walters KJ … +7 more , Schlienz NJ, Hyland AJ, Ashare RL, Tomko RL, Dahne J, McRae-Clark AL, McClure EA
J Natl Cancer Inst Monogr · 2024 Aug · PMID 39108242 · Full text
BACKGROUND: Cannabis use is prevalent among cancer patients and survivors and may provide some therapeutic benefits for this population. However, benefits may be attenuated when cannabis is co-used with tobacco, which is...
BACKGROUND: Cannabis use is prevalent among cancer patients and survivors and may provide some therapeutic benefits for this population. However, benefits may be attenuated when cannabis is co-used with tobacco, which is associated with more severe tobacco and cannabis use and adverse outcomes in noncancer populations. We compared cannabis use, primary mode of use, and therapeutic and/or nontherapeutic use among 3 groups of patients and survivors based on cigarette smoking status. METHODS: Survey data was collected from patients and survivors with cancer (n = 1732) at 2 US National Cancer Institute-designated cancer centers in states with varying cannabis regulatory policy. Prevalence of cannabis use (prior to diagnosis, after diagnosis, before treatment, after treatment), primary mode of use, and therapeutic and/or nontherapeutic use were assessed by cigarette smoking status (current, former, never) within and across centers using weighted bivariate analyses and multivariable logistic regression, controlling for demographic and clinical variables. RESULTS: Current cigarette use was associated with greater rates of cannabis use prior to diagnosis, after diagnosis, during treatment, and after treatment within each center (all P < .001) and in pooled analyses across centers (all P < .001). Primary mode of use, knowledge of cannabis products, and therapeutic and/or nontherapeutic use also statistically differed by tobacco status and study site. CONCLUSIONS: Results illustrate the importance of conducting assessments for both tobacco and cannabis use among cancer patients during and after cancer treatment, regardless of the cannabis regulatory environment. Given previous data indicating harms from co-use and continued tobacco use during cancer treatment, this issue introduces new priorities for cancer care delivery and research.
Concurrent substance use among cancer patients with and without a history of cannabis use since cancer diagnosis at an NCI-Designated Cancer Center in Florida.
Islam JY, Nguyen OT, Turner K … +8 more , Martinez YC, Rodriguez OG, Rodriguez DI, Rajasekhara S, Chang YD, Gonzalez BD, Jim HSL, Egan KM
J Natl Cancer Inst Monogr · 2024 Aug · PMID 39108241 · Full text
BACKGROUND: Although substance use may have adverse impacts on cancer outcomes, little is known regarding patterns of concurrent substance use with cannabis among cancer patients. Our objective was to examine predictors...
BACKGROUND: Although substance use may have adverse impacts on cancer outcomes, little is known regarding patterns of concurrent substance use with cannabis among cancer patients. Our objective was to examine predictors of concurrent substance use with cannabis among cancer patients since their cancer diagnosis and explore perceptions of cannabis among these patients. METHODS: Patients treated at a National Cancer Institute-designated comprehensive cancer center were invited to participate in an electronic survey regarding medical cannabis from August to November 2021. Survey data were linked to internal data resources including electronic health records and patient intake forms to obtain history of substance use (defined as within at least 3 months of cancer diagnosis) of cigarettes, injection drugs, high levels of alcohol, or clinically unsupervised prescription drugs (total n = 1094). Concurrent substance users were defined as those with any reported substance use and cannabis use at the time of cancer diagnosis. We used descriptive statistics (χ2 or exact tests) to compare groups and estimated adjusted odds ratios (AORs) with 95% confidence intervals (CIs) to identify predictors of substance use among users and nonusers of cannabis. RESULTS: Approximately 45% (n = 489) of the sample reported cannabis use since their cancer diagnosis. Of patients who reported using cannabis, 20% self-reported concurrent polysubstance use, while 8% of cannabis nonusers reported substance use (P < .001). Among patients who use cannabis, those who reported 2 or more self-reported treatment-related symptoms (eg, pain, fatigue) were more likely to have self-reported concurrent substance use (AOR = 3.15, 95% CI = 1.07 to 9.27) compared with those without any symptoms. Among nonusers, those with lower educational background were more likely to have a history of concurrent substance use (AOR = 3.74, 95% CI = 1.57 to 8.92). Patients who use cannabis with concurrent substance use were more likely to report improved sleep (P = .04), increased appetite (P = .03), and treatment of additional medical conditions (P = .04) as perceived benefits of cannabis use. CONCLUSIONS: High symptom burden may be associated with concurrent substance use with cannabis among cancer patients.
Item response theory analysis of benefits and harms of cannabis use in cancer survivors.
Jones SMW, Ton M, Malen RC … +2 more , Newcomb PA, Heffner JL
J Natl Cancer Inst Monogr · 2024 Aug · PMID 39108240 · Full text
Medical cannabis with cancer as a qualifying condition has become legalized in more states, but currently there are no standardized measures of perceived benefits and harms of cannabis use in cancer. This study surveyed...
Medical cannabis with cancer as a qualifying condition has become legalized in more states, but currently there are no standardized measures of perceived benefits and harms of cannabis use in cancer. This study surveyed a population-based sample of cancer survivors (n = 1539) with various types of cancer including breast (25%), prostate (17%), and gastrointestinal (11%) cancers. Item response theory analyses were used to evaluate the items for measuring perceived benefits and harms. Item response theory evaluates survey items by estimating the accuracy (analogous to reliability) and severity reflected by each item. Item response theory analyses showed all the items were accurate (reliable) measures of perceived benefits or harms. The perceived benefits items assessed beliefs well from low to high levels of perceived benefits. The perceived harms items assessed beliefs from moderate to high levels of perceived harms. The items can be used in future studies to standardize measurement while allowing some customization.
The association of perceived cannabis risks and benefits with cannabis use since cancer diagnosis.
McDaniels-Davidson C, Parada H, Kasiri N … +3 more , Patel SP, Strong D, Doran N
J Natl Cancer Inst Monogr · 2024 Aug · PMID 39108239 · Full text
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 weigh...
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.
Patient out-of-pocket costs for cannabis use during cancer treatment.
Lapen K, Mishra Meza A, Dee EC … +8 more , Mao JJ, Raghunathan NJ, Jinna S, Brens J, Korenstein D, Furberg-Barnes H, Salz T, Chino F
J Natl Cancer Inst Monogr · 2024 Aug · PMID 39108238 · Full text
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 e...
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.
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