The CDC adopted the GRADE methodology for critical appraisal of evidence in 2011 and first used it for its guidelines on HPV vaccination for males. European Medicines Agency Committee for Medicinal Products for Human Use (CHMP): Assessment report EMA/789820/2013: Cervarix. As a TMED student, something that really stood out to me was that despite the controversial nature of this topic, Dr. Carrier and his colleagues are still exploring the translational elements of this research. This guideline agrees with the International Papillomavirus Society policy statement on the safety of HPV vaccines. Is there a need to have a registration system (ie, enrollment, refusal, or surveillance of potential adverse effects) to evaluate the impact and coverage of the strategies?

HPV vaccination is not recommended during pregnancy, because of lack of sufficient evidence of safety; however, there is no evidence of harm.54,55 It is not necessary to perform a pregnancy test before vaccination or to terminate a pregnancy subsequent to vaccination. Furthermore, the information is not intended to substitute for the independent professional judgment of the treating provider, because the information does not account for individual variation among patients. High coverage of priority populations should be emphasized. Active surveillance is the implementation of systematic procedures to actively seek and identify clinically significant events that occur within a defined period and/or population and include large postlicensure studies sponsored by the manufacturer or national regulatory authorities. Archive

Providing catch-up vaccination should not be performed at the expense of achieving high coverage in the recommended priority cohort. ASCO believes that cancer and cancer prevention clinical trials are vital to inform medical decisions and improve cancer care. The Expert Panel was assembled in accordance with ASCO’s Conflict of Interest Policy Implementation for Clinical Practice Guidelines (“Policy,” found at http://www.asco.org/rwc). The rationale for screening and cancer registries is the need for data over time to track longer-term outcomes, especially cervical cancer outcomes, and the duration of immunity and protection. Among systematic reviews found was a 2013 review by Fesenfeld et al30 of CEAs specifically on vaccination and focusing on LMICs. Primary prevention involves strategies aimed at preventing healthy individuals from ever developing cancer, and can be implemented at any stage in the life. If there are more resources than are typically found in limited resource settings, the age group of females offered vaccines may be expanded. The 2016 Australian guideline population included males, females, MSM, and immunocompromised persons.

CEAs support the recommendations in this guideline for, at minimum, vaccination of girls age 9 to 14 years. The interval between the doses should be at least 6 months and may be up to 12 to 15 months (6 months: Type of recommendation: evidence based; Evidence quality: high; Strength of recommendation: strong.

As a result of these disparities, the American Society of Clinical Oncology (ASCO) Resource-Stratified Guidelines Advisory Group chose cervical cancer as a priority topic for guideline development.4,5. Public health authorities, ministries of health, and primary care providers should vaccinate girls in the priority target age group, starting as early as possible through 14 years of age (Type of recommendation: evidence based; Evidence quality: high. CH-1211 Geneva 27 Tobacco smoke has more than 7000 chemicals, at least 250 are known to be harmful and more than 50 are known to cause cancer. Risks increase when the exposure occurs at a young age and also when the exposure amount is higher. The 2014 recommendations on 4vHPV were based on four RCTs on efficacy and safety guidance from seven clinical trials. 611-634. Global burden of human papillomavirus and related diseases, HPV involvement in head and neck cancers: Comprehensive assessment of biomarkers in 3680 patients, Management and care of women with invasive cervical cancer: American Society of Clinical Oncology resource-stratified clinical practice guideline summary, Secondary prevention of cervical cancer: ASCO resource-stratified clinical practice guideline, Human papillomavirus (HPV) and related cancers in the Global Alliance for Vaccines and Immunization (GAVI) countries: A WHO/ICO HPV Information Centre report, Age-specific occurrence of HPV16- and HPV18-related cervical cancer, Human papillomavirus genotype attribution in invasive cervical cancer: A retrospective cross-sectional worldwide study, FDA licensure of bivalent human papillomavirus vaccine (HPV2, Cervarix) for use in females and updated HPV vaccination recommendations from the Advisory Committee on Immunization Practices (ACIP), Quadrivalent human papillomavirus vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP), Human papillomavirus vaccination: Recommendations of the Advisory Committee on Immunization Practices (ACIP), Recommendations on the use of quadrivalent human papillomavirus vaccine in males: Advisory Committee on Immunization Practices (ACIP), 2011, Use of 9-valent human papillomavirus (HPV) vaccine: Updated HPV vaccination recommendations of the advisory committee on immunization practices, Cross-protective efficacy of HPV-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by non-vaccine oncogenic HPV types: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial, A review of clinical trials of human papillomavirus prophylactic vaccines, Breast cancer in limited-resource countries: An overview of the Breast Health Global Initiative 2005 guidelines, Cancer in low- and middle-income countries: An economic overview, International Bank for Reconstruction and Development/World Bank, AGREE II: Advancing guideline development, reporting and evaluation in health care, Development of AMSTAR: A measurement tool to assess the methodological quality of systematic reviews, Building better guidelines with BRIDGE-Wiz: Development and evaluation of a software assistant to promote clarity, transparency, and implementability, Meeting of the strategic advisory group of experts on immunization, April 2014: Conclusions and recommendations, HPV catch-up vaccination of young women: A systematic review and meta-analysis, Vaccination against HPV-associated neoplasias: Recommendations from the current S3 guideline of the HPV management forum of the Paul-Ehrlich Society—AWMF guidelines, Registry No. For cervical cancer only, vaccinating both sexes resulted in $28,713 to $554,317 per QALY gained.29 Higher ICERs obtained for both sexes might still be acceptable if HPV-related diseases are prevalent in a country, whereby the burden of HPV-related disease management would definitely be higher than the cost of primary prevention achieved by vaccinating both sexes. All guidelines except the WHO and NACI guidelines presumed the target intervention included three doses of the vaccines. It has been estimated that outdoor air pollution contributed to 3.2 million premature deaths worldwide in 2012 including more than 200,000 lung cancer deaths. Readers Limited and basic settings: if sufficient resources remain after vaccinating girls age 9 to 14 years, girls who received one dose may receive additional doses between age 15 and 26 years.

In all cases, the selected course of action should be considered by the treating provider in the context of treating the individual patient. For girls 9 to 14 years of age who are immune competent, a two-dose regimen is recommended (Type of recommendation: evidence based; Evidence quality: intermediate; Strength of recommendation: moderate). Dr. Carrier’s Grand Rounds presentation focused on the primary prevention of cancer associated venous thromboembolism and highlighted recent evidence from two important clinical trials. Kiatpongsan et al78 published a CEA after Fesenfeld et al30 on two countries in east Africa. Ultraviolet (UV) radiation, and in particular solar radiation, is carcinogenic to humans, causing all major types of skin cancer, such as basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and melanoma. HPV vaccination is not recommended for pregnant women (Type of recommendation: evidence based; Evidence quality: insufficient; Strength of recommendation: weak).

The interval between the doses should be at least 6 months and may be up to 12 to15 (6 months: Type of recommendation: evidence based; Evidence quality: high; Strength of recommendation: strong. Adaptation of guidelines is considered by ASCO in selected circumstances, when one or more quality guidelines from other organizations already exist on the same topic. I would like to thank Dr. Carrier for his time speaking with the Translational Medicine Graduate Cohort after rounds and inspiring thoughtful discussion. In trial conditions, the 9vHPV vaccine showed ≥ 96% efficacy in the reduction of persistent infection and cervical, vaginal, and vulvar precursor or preneoplastic lesions for the five additional types included in the vaccine (ie, 31, 33, 45, 52, and 58).15 Protection from infection is improved with higher vaccination coverage. Visit www.asco.org/guidelineswiki to provide comments on the guideline or to submit new evidence. The following represents disclosure information provided by authors of this manuscript. Nearly 80% of the 1 billion smokers in the world live in low- and middle-income countries. Prevention offers the most cost-effective long-term strategy for the control of cancer. Adapted guideline manuscripts are reviewed and approved by the ASCO Clinical Practice Guideline Committee. As we discussed with Dr. Carrier, educating patients on the signs and symptoms of thrombosis is crucial to them seeking proper medical attention in a timely manner. The ASCO Panel and guidelines staff will work with co-chairs to keep abreast of any substantive updates to the guideline. International Agency for Research on Cancer: GLOBOCAN 2012 cervical cancer: Estimated incidence, mortality and prevalence worldwide in 2012.

Gastrointestinal Diseases Research Unit The likelihood of infection with HPV 16 or 18 increases with the severity of cervical abnormality, and the overall benefit of vaccination would decrease.