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 This is an original JGO publication from 2017. Please visit the JGO website to access the full article. 


Primary Prevention of Cervical Cancer: American Society of Clinical Oncology Resource-Stratified Clinical Practice Guideline

 Authors

Silvina Arrossi, Sarah Temin, Suzanne Garland, Linda O’Neal Eckert, Neerja Bhatla, Xavier Castellsagué†, Sharifa Ezat Alkaff, Tamika Felder, Doudja Hammouda, Ryo Konno, Gilberto Lopes, Emmanuel Mugisha, Rául Murillo, Isabel C. Scarinci, Margaret Stanley, Vivien Tsu, Cosette M. Wheeler, Isaac Folorunso Adewole, Silvia de Sanjosé

THE BOTTOM LINE

Primary Prevention of Cervical Cancer: ASCO Resource-Stratified Clinical Practice Guideline

Guideline Question

What is the optimal method for the primary prevention of cervical cancer?

Target Population

General population

Target Audience

Public health authorities, cancer control professionals, policymakers, obstetricians and gynecologists, pediatricians, other primary care providers, and lay public

Recommendations

Vaccination is the optimal strategy for primary prevention of infection by some types of human papillomavirus (HPV) that cause cervical cancer in the target population. There is no other preventive strategy for this cancer that can substitute for vaccination.

In maximal and enhanced resource settings:

For which cohorts is routine vaccination recommended in maximal and enhanced resource settings?

      • Recommendation A1a
        Public health authorities, ministries of health, and primary care providers should routinely vaccinate girls, with the target age range being as early as possible, starting at 9 through 14 years of age (Type of recommendation: evidence based; Evidence quality: high; Strength of recommendation: strong).
      • Recommendation A1b
        Public health authorities may set the upper end of the target population higher than 14 years of age, depending on local policies and resources (Type of recommendation: evidence based; Evidence quality: low; Strength of recommendation: moderate).

What numbers of doses and intervals are recommended in maximal and enhanced resource settings?

      • Recommendation A2a
        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).
      • Recommendation A2b
        The interval between two 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. 12 to 15 months: Type of recommendation: evidence based; Evidence quality: low; Strength of recommendation: weak).
      • Recommendation A2c
        Girls age ≥ 15 years at the time of the first dose or initiation (outside of target population) who receive vaccine should receive three doses (Type: informal consensus-based; Evidence quality: intermediate; Strength of recommendation: moderate).

Should catch-up for those outside the priority age groups for vaccination be offered for prevention of HPV infection in maximal and enhanced resource settings?

      • Recommendation A3
        For females who have received one dose and are age > 14 years, public health authorities may provide additional doses or complete the series up to 26 years of age (Type of recommendation: evidence based; Evidence quality: intermediate; Strength of recommendation: moderate).

Should HPV vaccination of boys be recommended to reduce HPV infection in maximal and enhanced resource settings?*

      • Recommendation A4
        For prevention of cervical cancer, if there is low vaccine coverage of the priority female target population (< 50%) in maximal or enhanced resource settings, vaccination may be extended to boys (Type of recommendation: evidence based; Evidence quality: intermediate; Strength of recommendation: moderate).
        For prevention of cervical cancer in maximal or enhanced resource settings where vaccine coverage of girls is ≥ 50%, vaccination of boys is not recommended (Type of recommendation: evidence based; Evidence quality: insufficient; Strength of recommendation: weak).

In limited resource settings:

For which cohorts is routine vaccination recommended in limited resource settings?

      • Recommendation B1a
        Public health authorities, ministries of health, and primary care providers should vaccinate girls as early as possible, starting at 9 through 14 years of age (Type of recommendation: evidence based; Evidence quality: high; Strength of recommendation: strong).

What numbers of doses and intervals are recommended in limited resource settings?

      • Recommendation B2a
        For girls starting at 9 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).
      • Recommendation B2b
        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; Evidencefor quality: high; Strength of recommendation: strong. 12 to 15 months: Type of recommendation: evidence based; Evidence quality: low; Strength of recommendation: moderate).

Should catch-up for those outside the priority age groups for vaccination be offered for prevention of HPV infection in limited resource settings?

      • Recommendation B3
        If there are sufficient resources remaining after vaccinating high-priority populations with an adequate target (minimum recommended coverage is 50% with two doses, with a target of 80%),53 for females who have received one dose and are age > 14 years, public health authorities may provide additional doses or complete the series up to 26 years of age (Type of recommendation: evidence based; Evidence quality: intermediate; Strength of recommendation: moderate).

Should HPV vaccination of boys be recommended to reduce HPV infection in limited resource settings?*

      • Recommendation B4
        For prevention of cervical cancer in limited resource settings where vaccine coverage of girls is 50%, vaccination of boys is not recommended.
        For prevention of cervical cancer, if there is low vaccine coverage of the priority female target population (< 50%) in limited resource settings, vaccination may be extended to boys (Type of recommendation: evidence based; Evidence quality: intermediate; Strength of recommendation: moderate).
        *Qualifying statement for A4 and B4. Extending vaccination to boys to prevent cervical cancer is not cost effective, unless there is low vaccine coverage of the priority female target population (< 50%). Vaccination may be extended to boys for other reasons, such to prevent other noncervical HPV-related cancers and diseases (eg, genital warts) and/or to reduce more rapidly circulating HPVs.

In basic resource settings:

For which cohorts is routine vaccination recommended in basic resource settings?

      • Recommendation C1
        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. Strength of recommendation: strong).

What numbers of doses and intervals are recommended in basic resource settings?

      • Recommendation C2a
        For girls starting at 9 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).
      • Recommendation C2b
        The interval between the doses should be at least 6 months and may be up to 12 to 15 (6 months: Type of recommendation: evidence based; Evidence quality: high; Strength of recommendation: strong. 12 to 15 months: Type of recommendation: evidence based; Evidence quality: low; Strength of recommendation: moderate).

Should catch-up for those outside the priority age groups for vaccination be offered for prevention of HPV infection in basic resource settings?

      • Recommendation C3
        High coverage of priority populations should be emphasized. Where coverage of the primary targeted group of females is high ( 50%) and resources allow, the age group may be expanded upward in catch-up efforts (Type of recommendation: evidence based; Evidence quality: high; Strength of recommendation: strong).

Should HPV vaccination of boys be recommended to reduce HPV infection in basic resource settings?†

      • Recommendation C4
        For prevention of cervical cancer in basic resource settings where vaccine coverage of girls is ≥ 50%, vaccination of boys is not recommended.
        For prevention of cervical cancer, if there is low vaccine coverage of the priority female target population (< 50%) in basic resource settings, vaccination may be extended to boys (Type of recommendation: evidence based; Evidence quality: intermediate; Strength of recommendation: moderate).
        †Qualifying statement for C4. Extending vaccination to boys to prevent cervical cancer is not cost effective, unless there is low vaccine coverage of the priority female target population (< 50%). However, if resources allow for efforts to reduce noncervical cancers and diseases and/or reduce more rapidly circulating HPVs, vaccination may be extended to boys.

In all resource settings:

What vaccination strategy is recommended for women who are HIV positive or immunosuppressed for other reasons (all resource settings)?

      • Recommendation D
        Females who are HIV positive or immunosuppressed for other reasons should follow the same age recommendations but should receive three doses (Type of recommendation: evidence based; Evidence quality: insufficient; Strength of recommendation: weak).

What vaccination strategy is recommended for women who are pregnant (all resource settings)?

      • Recommendation E
        HPV vaccination is not recommended for pregnant women (Type of recommendation: evidence based; Evidence quality: insufficient; Strength of recommendation: weak).

What vaccination strategy is recommended for women receiving treatment of cervical cancer precursor lesions (cervical intraepithelial neoplasia grade 2; eg, conization, loop electrosurgical excision process, or cryotherapy; all resource settings)?

      • Recommendation F
        No recommendation (insufficient data).

Qualifying Statements

Additional qualifying statements: If boys are vaccinated, use the same age-related recommendations as for girls, according to resource settings.Recommendations regarding boys do not apply to men who have sex with men, and readers are referred to Centers for Disease Control and Prevention, Australian, and other guidelines.

Additional Resources

More information, including a Data Supplement, a Methodology Supplement, slide sets, and clinical tools and resources, is available at www.asco.org/rs-cervical-cancer-primary-prev-guideline and www.asco.org/guidelineswiki. Patient information is available at www.cancer.net.

The American Society of Clinical Oncology believes that cancer and cancer prevention clinical trials are vital to inform medical decisions and improve cancer care and that all patients should have the opportunity to participate.

SUMMARY OF RECOMMENDATIONS

Clinical QuestionRecommendationEvidence Rating
Maximal and Enhanced
For which cohorts is routine vaccination recommended?Public health authorities, ministries of health, and primary care providers should routinely vaccinate girls with the target age range being as early as possible starting at 9 years through 14 years of age.

Type: evidence-based

Evidence quality: high

Strength of recommendation: strong

Public health authorities may set the upper end of the target population higher than 14 years of age, depending on local policies and resources.

Type: evidence-based

Evidence quality: low

Strength of recommendation: moderate

What number of doses and intervals are recommended?For girls 9 to 14 years of age who are immune competent, a two-dose regimen is recommended.

Type: evidence-based

Evidence quality: intermediate

Strength of recommendation: moderate

The interval between two doses should be at least 6 months and may be up to 12 to 15 months.

6 months:

Type: evidence-based

Evidence quality: high

Strength of recommendation: strong

12 to 15 months:

Type: evidence-based

Evidence quality: low

Strength of recommendation: weak

Girls 15 years of age or older at the time of the first dose/initiation (outside of target population) who receive vaccine should receive three doses.

Type: informal consensus-based

Evidence quality: intermediate

Strength of recommendation: moderate

Should catch-up to subjects outside the priority age groups for vaccination be offered for prevention of HPV infection?For females who have received one dose and are more than 14 years of age, public health authorities may provide additional doses/complete the series up to 26 years of age.

Type: evidence-based

Evidence quality: intermediate

Strength of recommendation: moderate

Should HPV vaccination of boys be recommended to reduce HPV infection?*For prevention of cervical cancer, if there is low vaccine coverage of the priority female target population (< 50%) in maximal or enhanced resource settings, then vaccination may be extended to boys.

Type: evidence-based

Evidence quality: intermediate

Strength of recommendation: moderate

For prevention of cervical cancer in maximal or enhanced resource settings where vaccine coverage of girls is ≥ 50%, there are insufficient data to recommend for or against vaccination of boys

Type: evidence-based

Evidence quality: insufficient

Strength of recommendation: weak

Limited
For which cohorts is routine vaccination recommended in limited resource settings?Public health authorities, ministries of health, and primary care providers should vaccinate girls as early as possible, starting at 9 years through 14 years of age.

Type: evidence-based

Evidence quality: high

Strength of recommendation: strong

What number of doses and intervals are recommended in limited resource settings?For girls starting at 9 years of age who are immune competent, a two dose regimen is recommended.

Type: evidence-based

Evidence quality: intermediate

Strength of recommendation: moderate

The interval between the doses should be at least 6 months and may be up to 12 to 15 months.

6 months:

Type: evidence-based

Evidence for quality: high

Strength of recommendation: strong

12 to 15 months:

Type: evidence-based

Evidence quality: low

Strength of recommendation: moderate

Should catch-up to subjects outside the priority age groups for vaccination be offered for prevention of HPV infection in limited resource settings?If there are sufficient resources remaining after vaccinating high-priority populations with an adequate target (minimum recommended coverage is ≥ 50% with two doses, with a target of 80%),1 for females who have received one dose and are more than 14 years of age, public health authorities may provide additional doses/complete the series up to 26 years of age.

Type: evidence-based

Evidence quality: intermediate

Strength of recommendation: moderate

Should HPV vaccination of boys be recommended to reduce HPV infection in limited resource settings?*For prevention of cervical cancer in limited resource settings where vaccine coverage of girls is ≥50%, vaccination of boys is not recommended.
For prevention of cervical cancer, if there is low vaccine coverage of the priority female target population (< 50%) in limited resource settings, then vaccination may be extended to boys.

Type: evidence-based

Evidence quality: intermediate

Strength of recommendation: moderate

*Qualifying Statement Extending vaccination to boys to prevent cervical cancer is not cost-effective, unless there is low vaccine coverage of the priority female target population (< 50%). Vaccination may be extended to boys for other reasons, such as to prevent other noncervical HPV-related cancers and diseases (eg, genital warts) and/or to reduce more rapidly circulating HPVs.
Basic
For which cohorts is routine vaccination recommended in basic resource settings?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: evidence-based

Evidence quality: high

Strength of recommendation: strong

What number of doses and intervals are recommended in basic resource settings?For girls starting at 9 years of age who are immune competent, a two-dose regimen is recommended.

Type: evidence-based

Evidence quality: intermediate

Strength of recommendation: moderate

The interval between the doses should be at least 6 months and may be up to 12 to 15.

6 months: Type: evidence-based

Evidence quality: high

Strength of recommendation: strong

12 to 15 months:

Type: evidence-based

Evidence quality: low

Strength of recommendation: moderate

Should catch-up to subjects outside the priority age groups for vaccination be offered for prevention of HPV infection in basic resource settings?High coverage of priority populations should be emphasized. Where coverage of the primary targeted group of females is high (≥50%) and resources allow, the age group may be expanded upward in catch-up efforts.

Type: evidence-based

Evidence quality: high

Strength of recommendation: strong

Should HPV vaccination of boys be recommended to reduce HPV infection in basic resource settings?**For prevention of cervical cancer in basic resource settings where vaccine coverage of girls is ≥50%, vaccination of boys is not recommended.
For prevention of cervical cancer, if there is low vaccine coverage of the priority female target population (< 50%) in basic resource settings, then vaccination may be extended to boys.

Type: evidence-based

Evidence quality: intermediate

Strength of recommendation: moderate

**Qualifying Statement Extending vaccination to boys to prevent cervical cancer is not cost-effective, unless there is low vaccine coverage of the priority female target population (<50%). However, if resources allow for efforts to reduce noncervical cancers and diseases and/or reduce more rapidly circulating HPVs, then vaccination may be extended to boys
What vaccination strategy is recommended for women who are HIV positive or women who are immunosuppressed for other reasons?Females who are HIV positive or immunosuppressed for other reasons should follow the same age recommendations, but should receive three doses.

Type: evidence-based

Evidence quality: insufficient

Strength of recommendation: weak

What vaccination strategy is recommended for women who are pregnant?HPV vaccination is not recommended for pregnant women

Type: evidence-based

Evidence quality: insufficient

Strength of recommendation: weak

What vaccination strategy is recommended for women receiving treatment for cervical cancer precursor lesions (CIN2+; eg, conization, loop electrosurgical excision process, cryotherapy)?No recommendationInsufficient Data
Additional Qualifying Statements: If boys are vaccinated, use the same age-related recommendations as for girls, according to resource settings. Recommendations regarding boys do not apply to men who have sex with men (MSM) and readers are referred to US CDC, Australian and other guidelines.

Reference

1. Drolet M, Benard E, Boily MC, et al: Population-level impact and herd effects following human papillomavirus vaccination programmes: a systematic review and meta-analysis. Lancet Infect Dis 15:565-80, 2015

ASCO Guideline Disclaimer: The clinical practice guidelines and other guidance published herein are provided by the American Society of Clinical Oncology, Inc. (“ASCO”) to assist practitioners in clinical decision making. The information therein should not be relied upon as being complete or accurate, nor should it be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. With the rapid development of scientific knowledge, new evidence may emerge between the time information is developed and when it is published or read. The information is not continually updated and may not reflect the most recent evidence. The information addresses only the topics specifically identified therein and is not applicable to other interventions, diseases, or stages of diseases. This information does not mandate any particular course of medical care. Further, the information is not intended to substitute for the independent professional judgment of the treating physician, as the information does not account for individual variation among patients. Recommendations reflect high, moderate or low confidence that the recommendation reflects the net effect of a given course of action.  The use of words like “must,” “must not,” “should,” and “should not” indicate that a course of action is recommended or not recommended for either most or many patients, but there is latitude for the treating physician to select other courses of action in individual cases. In all cases, the selected course of action should be considered by the treating physician in the context of treating the individual patient. Use of the information is voluntary.  ASCO provides this information on an “as is” basis, and makes no warranty, express or implied, regarding the information. ASCO specifically disclaims any warranties of merchantability or fitness for a particular use or purpose. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of this information or for any errors or omissions.


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