Immunogenicity and safety of the human papillomavirus vaccine in young survivors of cancer in the USA: a single-arm, open-label, phase 2, non-inferiority trial.

BACKGROUND: Young survivors of cancer are at increased risk for cancers that are related to human papillomavirus (HPV), primarily caused by oncogenic HPV types 16 and 18. We aimed to examine the immunogenicity and safety of the three-dose series of HPV vaccine in young survivors of cancer. METHODS: We conducted an investigator-initiated, phase 2, single-arm, open-label, non-inferiority trial at five National Cancer Institute-designated comprehensive cancer centres in the USA. Eligible participants were survivors of cancer who were HPV vaccine-naive, were aged 9-26 years, in remission, and had completed cancer therapy between 1 and 5 years previously. Participants received three intramuscular doses of either quadrivalent HPV vaccine (HPV4; enrolments on or before March 1, 2016) or nonavalent HPV vaccine (HPV9; enrolments after March 1, 2016) over 6 months (on day 1, at month 2, and at month 6). We also obtained data from published clinical trials assessing safety and immunogenicity of HPV4 and HPV9 in 9-26-year-olds from the general population, as a comparator group. The primary endpoint was antibody response against HPV types 16 and 18 at month 7 in the per-protocol population. A response was deemed non-inferior if the lower bound of the multiplicity-adjusted 95% CI was greater than 0·5 for the ratio of anti-HPV-16 and anti-HPV-18 geometric mean titres (GMTs) in survivors of cancer versus the general population. Responses were examined separately in male and female participants by age group (ie, 9-15 years and 16-26 years). Safety was assessed in all participants who received at least one vaccine dose and for whom safety data were available. This study is registered with ClinicalTrials.gov, NCT01492582. This trial is now completed. FINDINGS: Between Feb 18, 2013, and June 22, 2018, we enrolled 453 survivors of cancer, of whom 436 received one or more vaccine doses: 203 (47%) participants had survived leukaemia, 185 (42%) were female, and 280 (64%) were non-Hispanic white. Mean age at first dose was 15·6 years (SD 4·6). 378 (83%) of 453 participants had evaluable immunogenicity data; main reasons for exclusion from per-protocol analysis were to loss to follow-up, patient reasons, and medical reasons. Data were also obtained from 26 486 general population controls. The ratio of mean GMT for anti-HPV types 16 and 18 in survivors of cancer versus the general population was more than 1 for all subgroups (ie, aged 9-15 years, aged 16-26 years, male, and female groups) in both vaccine cohorts (ranging from 1·64 [95% CI 1·12-2·18] for anti-HPV type 16 in female participants aged 9-15 years who received HPV9, to 4·77 [2·48-7·18] for anti-HPV type 18 in male participants aged 16-26 years who received HPV4). Non-inferiority criteria were met within each age and sex subgroup, except against HPV type 18 in female participants aged 16-26 years receiving HPV9 (4·30 [0·00-9·05]). Adverse events were reported by 237 (54%) of 435 participants; injection site pain was most common (174 [40%] participants). One serious adverse event (ie, erythema nodosum) was possibly related to vaccine (HPV9; 16-26 year female cohort). INTERPRETATION: Immunogenicity and safety of HPV vaccine three-dose series in survivors of cancer is similar to that in the general population, providing evidence for use in this clinically vulnerable population. FUNDING: US National Cancer Institute, Merck, Sharp & Dohme, and American Lebanese Syrian Associated Charities.

Sexual behaviors and human papillomavirus vaccine non-initiation among young adult cancer survivors.

BACKGROUND: Young adult cancer survivors are at risk for subsequent human papillomavirus (HPV)-related malignancies. High-risk sexual behavior increases risk for HPV acquisition; HPV vaccination protects against infection. We aimed to determine the prevalence of sexual behaviors, factors related to high-risk sexual behaviors, and the relationship between sexual behaviors and HPV vaccine non-initiation among survivors. METHODS: Survivors at comprehensive cancer centers, aged 18-26 years and 1-5 years post-treatment, reported sexual behaviors and HPV vaccine initiation (i.e., ≥ 1 dose). Multivariable logistic regression was performed to calculate odds ratios (OR) and 95% confidence intervals (95%CI) for factors associated with high-risk sexual behaviors (age at first intercourse < 16 years, ≥ 3 lifetime sexual partners, or condom use ≤ 50% of the time) and to explore the relationship between sexual behaviors and vaccine non-initiation. RESULTS: Of the 312 participants (48.1% female, median age at cancer diagnosis 17.2 years and at survey 20.9 years), sexual intercourse was reported by 63.1%. Of those reporting intercourse, 74.6% reported high-risk sexual behavior. Factors related to high-risk sexual behavior included currently dating/partnered (OR = 4.39, 95%CI 2.5-7.7, P < 0.001) and perceived susceptibility to HPV (OR = 1.76, 95%CI 1.3-2.5, P < 0.001). Most survivors (75.3%) reported HPV vaccine non-initiation; sexual behaviors were not associated with vaccine non-initiation (P = 0.4). CONCLUSIONS: Many survivors participate in high-risk sexual behaviors, yet HPV vaccine initiation rates are low. Factors related to high-risk sexual behaviors can inform interventions to reduce risk for HPV acquisition among survivors. IMPLICATIONS FOR CANCER SURVIVORS: Cancer survivors participate in sexual behaviors that increase risk for HPV acquisition and would benefit from vaccination.

Coping strategies used by caregivers of children with newly diagnosed brain tumors.

In BriefThe authors interviewed families whose children had recently been hospitalized with a new brain tumor. From these interviews, they identified parents' coping strategies for handling the stress of having a child with a newly diagnosed tumor. Some strategies are considered "adaptive" and help parents deal with the stress better. Others are "maladaptive," leading to worse outcomes. Parents of children with brain tumors are at risk for maladaptive coping. Efforts to teach parents how to cope effectively with the stress of a sick child have the potential to improve outcomes.

Adherence to oral chemotherapy in childhood acute lymphoblastic leukemia: an evolutionary concept analysis.

PURPOSE/OBJECTIVES: To clarify the concept of adherence to daily oral chemotherapy in children with acute lymphoblastic leukemia (ALL), to examine its implications for clinical practice, and to provide a foundation for further research and knowledge development. DATA SOURCES: Published literature identified through the MEDLINE®, CINAHL®, PsycINFO, and ERIC databases. DATA SYNTHESIS: Identified attributes of adherence to oral chemotherapy in childhood ALL included motivation, persistence, collaboration, mindfulness, cognitive capacity, flexibility, active participation, and identification of key participants in the process. Identified antecedents included a diagnosis of leukemia, the perceived value of adherence, and patient, family, and healthcare system-related factors. Identified consequences included the potential for maintaining optimal drug levels and improving disease outcome, as well as increased patient and caregiver esteem through active participation in the process. Adherence in the context of childhood ALL is defined as the active self-care behavior of taking (or having the responsibility for administering) daily oral chemotherapy, in collaboration with and according to the instructions of the healthcare provider over a defined, prolonged treatment period. CONCLUSIONS: Adherence to oral chemotherapy in childhood ALL is a complex, multidimensional behavior that involves not only a willingness to follow the prescribed regimen over a prolonged period, but also the cognitive capacity and psychomotor skills to carry out the process. IMPLICATIONS FOR NURSING: Nurses should recognize the importance of clear communication of medication instructions, reinforcement of adherence-related behaviors, and assistance with common issues such as pill-swallowing skills and reminder systems in caring for children with ALL.

Use of complementary and alternative medical interventions for the management of procedure-related pain, anxiety, and distress in pediatric oncology: an integrative review.

This integrative review aims to identify evidence in four electronic databases (MEDLINE, CINAHL, PsyINFO, and COCHRANE) regarding the effectiveness of complementary and alternative medical interventions, either alone or as an adjunct to pharmacological therapy, in alleviating procedure-related pain, anxiety, and distress in children and adolescents with cancer. A total of 32 articles met inclusion criteria. Results suggest that mind-body interventions, including hypnosis, distraction, and imagery, may be effective, alone or as adjuncts to pharmacological interventions, in managing procedure-related pain, anxiety, and distress in pediatric oncology.