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 This is an original JGO publication from 2016. Please visit the JGO website to access the full article. 


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


 Authors

Jose Jeronimo, Philip E. Castle, Sarah Temin, Lynette Denny, Vandana Gupta, Jane J. Kim, Silvana Luciani, Daniel Murokora, Twalib Ngoma, Youlin Qiao, Michael Quinn, Rengaswamy Sankaranarayanan. Peter Sasieni, Kathleen M. Schmeler, Surendra S. Shastri

THE BOTTOM LINE

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

Guideline Question

What are the optimal method(s) for cervical cancer screening and the management of women with abnormal screening results for each resource level (ie, basic, limited, enhanced, maximal)?

Target Population

Women who are asymptomatic for cervical cancer precursors or invasive cervical cancer

Target Audience

Public health authorities, cancer control professionals, policymakers, obstetricians/gynecologists, primary care providers, lay public

Methods

A multinational, multidisciplinary Expert Panel was convened to develop clinical practice guideline recommendations on the basis of a systematic review of existing guidelines and/or an expert consensus process.

Authors’ note: It is the view of ASCO that health care providers and health care system decision makers should be guided by the recommendations for the highest stratum of resources available. The guidelines are intended to complement, but not replace, local guidelines.

Key Recommendations

Primary Screening

  • Human papillomavirus (HPV) DNA testing is recommended in all resource settings.
  • Visual inspection with acetic acid may be used in basic settings.
  • The recommended age ranges and frequencies in each setting are as follows:
      • Maximal: 25-65 years, every 5 years
      • Enhanced: 30-65 years, if two consecutive negative tests at 5-years intervals, then every 10 years
      • Limited: 30-49 years, every 10 years
      • Basic: 30-49 years, one to three times per lifetime

Exiting Screening

  • Maximal and enhanced: > 65 years with consistently negative results during past > 15 years
  • Limited and basic: < 49 years, resource-dependent; see specific recommendations

Triage

  • In basic settings, visual assessment for treatment may be used after positive HPV DNA testing results.
      • If visual inspection with acetic acid was used as primary screening with abnormal results, women should receive treatment.
  • For other settings, HPV genotyping and/or cytology may be used.

After Triage

  • Women with negative triage results should receive follow-up in 12 months.
  • In basic settings, women should be treated if there are abnormal or positive triage results.
  • In limited settings, women with abnormal results from triage should receive colposcopy, if available, or visual assessment for treatment, if colposcopy is not available.
  • In maximal and enhanced settings, women with abnormal or positive results from triage should receive colposcopy.

Treatment of Women With Precursor Lesions

  • In basic settings, treatment options are cryotherapy or loop electrosurgical excision procedure (LEEP).
  • In other settings, LEEP (if high level of quality assurance) or ablation (if medical contraindication to LEEP) is recommended.
  • Twelve-month post-treatment follow-up is recommended for all settings.

Special Populations

  • Women who are HIV positive or immunosuppressed for other reasons should be screened with HPV as soon as diagnosed and screened twice as many times in a lifetime as the general population.
  • The management of abnormal screening results for women with HIV and positive results of triage is the same as in the general population
  • Women should be offered primary screening 6 weeks postpartum in basic settings and 6 months postpartum in other settings.
  • Screening may be discontinued in women who have received a total hysterectomy for benign causes with no history of cervical dysplasia or HPV. Women who have received a subtotal hysterectomy (with an intact cervix) should continue receiving routine screening.

Qualifying Statement

In basic settings without current mass screening, infrastructure for HPV testing, diagnosis, and treatment should be developed.

Additional Resources

More information, including a Data Supplement, a Methodology Supplement with information about evidence quality and strength of recommendations, slide sets, and clinical tools and resources, is available at www.asco.org/rs-cervical-cancer-secondary-prev-guideline and www.asco.org/guidelineswiki. Patient information is available at www.cancer.net .

ASCO 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

RecommendationEvidence Rating
Maximal
In maximal resource settings, cervical cancer screening with HPV DNA testing should be offered every 5 years from ages 25 to 65 years. On an individual basis, women may elect to receive screening until 70 years of age.

Type: evidence-based for test, interval and age [25-65]

Type: formal consensus-based [until age 70]

Evidence quality: high

Strength of recommendation: strong

Women who are ≥ 65 years of age who have had consistently negative screening results during past ≥ 15 years may cease screening. Women who are 65 years of age and have a positive result after age 60 should be reinvited to undergo screening 2, 5, and 10 years after the last positive result. If women have received no or irregular screening, they should undergo screening once at 65 years of age, and if the result is negative, exit screening.

Type: evidence-based

Evidence quality: intermediate

Strength of recommendation: moderate

If the results of the HPV DNA test are positive, clinicians should then perform triage with reflex genotyping for HPV 16/18 (with or without HPV 45) and/or cytology as soon as HPV test results are known.

Type: evidence-based

Evidence quality: high

Strength of recommendation: strong

If triage results are abnormal (ie, ≥ ASC-US or positive for HPV 16/18 [with or without HPV 45]), women should be referred to colposcopy, during which biopsies of any acetowhite (or suggestive of cancer) areas should be taken, even if the acetowhite lesion might appear insignificant. If triage results are negative (eg, primary HPV positive and cytology triage negative), then repeat HPV testing at the 12-month follow-up.

Type: evidence-based

Evidence quality: intermediate

Strength of recommendation: strong

If HPV test results are positive at the repeat 12 month follow-up, refer women to colposcopy. If HPV test results are negative at the 12- and 24-month follow-up or negative at any consecutive HPV test 12 months apart, then women should return to routine screening

Type: evidence-based

Evidence quality: high

Strength of recommendation: strong

Women who have received HPV and cytology co-testing triage and have HPV-positive results and abnormal cytology should be referred for colposcopy and biopsy. If results are HPV positive and cytology normal, repeat co-testing at 12 months. If at repeat testing HPV is still positive, patients should be referred for colposcopy and biopsy, regardless of cytology results.

Type: formal consensus-based

Evidence quality: intermediate

Strength of recommendation: strong

If the results of the biopsy indicate that women have precusor lesions (CIN2+), then clinicians should offer loop electrosurgical excision procedure (LEEP; if there is a high level of quality assurance [QA])1 or, where LEEP is contraindicated, ablative treatments may be offered.

Type: evidence-based

Evidence quality: high

Strength of recommendation: strong

After women receive treatment for precursor lesions, follow-up should consist of HPV DNA testing at 12 months. If 12-month results are positive, continue annual screening; if not, return to routine screening.

Type: formal consensus-based

Evidence quality: intermediate

Strength of recommendation: moderate

Enhanced
In enhanced resource settings, cervical cancer screening with HPV DNA testing should be offered to women 30 to 65 years of age, every 5 years (i.e. second screen five years from the first).

Type: evidence-based

Evidence quality: high

Strength of recommendation: strong

If there are two consecutive negative screening test results, subsequent screening should be extended to every 10 years.

Type: formal consensus-based

Evidence quality: intermediate-low

Strength of recommendation: moderate

Women who are ≥ 65 years of age who have had consistently negative screening results during past ≥ 15 years may cease screening. Women who are 65 years of age and have a positive result after age 60 should be reinvited to undergo screening 2, 5, and 10 years after the last positive result. If women have received no or irregular screening, they should undergo screening once at 65 years of age, and if the result is negative, exit screening.

Type: formal consensus-based

Evidence quality: low

Strength of recommendation: weak

If the results of the HPV DNA test are positive, clinicians should then perform triage with HPV genotyping for HPV 16/18 (with or without HPV 45) and/or reflex cytology.

Type: evidence-based

Evidence quality: high

Strength of recommendation: strong

If triage results are abnormal (ie, ≥ASC-US or positive for HPV 16/18 [with or without HPV 45]), women should be referred to colposcopy, during which biopsies of any acetowhite (or suggestive of cancer) areas should be taken, even if the acetowhite lesion might appear insignificant. If triage results are negative (eg, primary HPV positive and cytology triage negative), then repeat HPV testing at the 12 month follow-up.

Type: evidence-based

Evidence quality: intermediate

Strength of recommendation: strong

If HPV test results are positive at the repeat 12 month follow-up, refer women to colposcopy. If HPV test results are negative at the 12- and 24-month follow-up or negative at any consecutive HPV test 12 months apart, then women should return to routine screening.

Type: evidence-based

Evidence quality: high

Strength of recommendation: strong

If the results of colposcopy and biopsy indicate that women have precusor lesions (CIN2+), then clinicians should offer LEEP (if there is a high level of QA) or, where LEEP is contradicted, ablative treatments may be offered.

Type: evidence-based

Evidence quality: high

Strength of recommendation: strong

After women receive treatment for precursor lesions, follow-up should consist of HPV DNA testing at 12 months. If 12-month results are positive, continue annual screening; if not, return to routine screening.

Type: formal consensus-based

Evidence quality: intermediate

Strength of recommendation: moderate

Limited
Cervical cancer screening with HPV DNA testing should be offered to women 30 to 49 years of age every 10 years, corresponding to two to three times per lifetime.

Type: evidence-based [age range]

Type: formal consensus-based [interval]

Evidence quality: intermediate

Strength of recommendation: moderate

If the results of the HPV DNA test are positive, clinicians should then perform triage with reflex cytology (quality assured) and/or HPV genotyping for HPV 16/18 (with or without HPV 45) or with visual assessment for treatment (VAT).

For cytology and genotyping

Type: evidence-based

Evidence quality: high

Strength of recommendation: strong

For VAT

Type: formal consensus-based

Evidence quality: low

Strength of recommendation: weak

If cytology triage results are abnormal (i.e. ≥ASC-US), women should be referred to quality assured colposcopy (the first choice, if available and accessible), during which biopsies of any acetowhite (or suggestive of cancer) areas should be taken, even if the acetowhite lesion might appear insignificant. If colposcopy is not available, then perform VAT.

Type: evidence-based

Evidence quality: intermediate

Strength of recommendation: moderate

If HPV genotyping or VAT triage results are positive, then women should be treated. If the results from both of these forms of triage are negative, then repeat HPV testing at the 12-month follow-up.

Type: evidence-based

Evidence quality: high

Strength of recommendation: strong

If test results are positive at the repeat 12 month follow-up, then women should be treated.

Type: formal consensus-based

Evidence quality: intermediate

Strength of recommendation: moderate

For treatment, clinicians should offer ablation if the criteria are satisfied; if not and resources available, then offer LEEP.

Type: evidence-based

Evidence quality: high

Strength of recommendation: strong

After women receive treatment for precursor lesions, follow-up should consist of the same testing at 12 months.

Type: formal consensus-based

Evidence quality: intermediate

Strength of recommendation: moderate

Basic
If HPV DNA testing for cervical cancer screening is not available, then VIA should be offered with the goal of developing health systems and moving to population-based screening with HPV testing at the earliest opportunity. Screening should be offered to women 30 to 49 years of age, at least once per lifetime, but not more than three times per lifetime.

Type: evidence-based

Evidence quality: intermediate

Strength of recommendation: strong

If the results of available HPV testing are positive, clinicians should then perform VAT followed by treatment with cryotherapy and/or LEEP, depending on the size and location of the lesion.

Type: formal consensus-based

Evidence quality: low

Strength of recommendation: moderate

If primary screening is VIA and results are positive, then treatment should be offered with cryotherapy and/or LEEP, depending on the size and location of the lesion.

Type: evidence-based

Evidence quality: intermediate2

Strength of recommendation: moderate

After women receive treatment for precursor lesions, then follow up with the available test at 12 months. If the result is negative, then women return to routine screening.

Type: formal consensus-based

Evidence quality: intermediate

Strength of recommendation: moderate

References

1. Jhpiego Corporation: Loop Electrosurgical Excision Procedure (LEEP) Services: A Reference Manual for Providers. Baltimore, MD, 2015

2. World Health Organization: WHO Guidelines for Screening and Treatment of Precancerous Lesions for Cervical Cancer Prevention. WHO Guidelines Approved by the Guidelines Review Committee. Geneva, Switzerland, World Health Organization, 2013



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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