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Complete Summary

GUIDELINE TITLE

Management of squamous cell cancer of the vulva.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

COMPLETE SUMMARY CONTENT

 
SCOPE
 METHODOLOGY - including Rating Scheme and Cost Analysis
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS
 QUALIFYING STATEMENTS
 IMPLEMENTATION OF THE GUIDELINE
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

SCOPE

DISEASE/CONDITION(S)

Squamous cell cancer of the vulva

GUIDELINE CATEGORY

Management

CLINICAL SPECIALTY

Obstetrics and Gynecology
Oncology
Radiation Oncology
Radiology
Surgery

INTENDED USERS

Physicians

GUIDELINE OBJECTIVE(S)

To review and make recommendations regarding the management of early and advanced squamous cell cancer of the vulva

TARGET POPULATION

Women diagnosed with squamous cell cancer of the vulva

INTERVENTIONS AND PRACTICES CONSIDERED

  1. Radical wide local excision (deep partial vulvectomy) without inguinofemoral lymphadenectomy
  2. Radical local excisions with inguinofemoral node dissection
  3. Radical vulvectomy and bilateral inguinofemoral lymphadenectomy
  4. Multimodality approach: primary radiation and concomitant chemotherapy, followed by surgical resection

MAJOR OUTCOMES CONSIDERED

  • Risk of inguinal lymph node metastases
  • Risk of tumor recurrence
  • Patient morbidity
  • Patient mortality

METHODOLOGY

METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

NUMBER OF SOURCE DOCUMENTS

Not stated

METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Quality of Evidence Assessment*

I: Evidence obtained from at least one properly designed randomized controlled trial.

II-1: Evidence obtained from well-designed controlled trials without randomization.

II-2: Evidence obtained from well-designed cohort (prospective or retrospective) or case-control studies, preferably from more than one centre or research group.

II-3: Evidence obtained from comparisons between times or places with or without the intervention. Dramatic results from uncontrolled experiments (such as the results of treatment with penicillin in the 1940s) could also be included in this category.

III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

*Adapted from the Evaluation of Evidence criteria described in the Canadian Task Force on the Periodic Health Exam.

METHODS USED TO ANALYZE THE EVIDENCE

Review

DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Classification of Recommendations*

  1. There is good evidence to support the recommendation that the condition be specifically considered in a periodic health examination.
  2. There is fair evidence to support the recommendation that the condition be specifically considered in a periodic health examination.
  3. There is poor evidence regarding the inclusion or exclusion of the condition in a periodic health examination.
  4. There is fair evidence to support the recommendation that the condition not be considered in a periodic health examination.
  5. There is good evidence to support the recommendation that the condition be excluded from consideration in a periodic health examination.

*Adapted from the Classification of Recommendations criteria described in the Canadian Task Force on the Periodic Health Exam.

COST ANALYSIS

A formal cost analysis was not performed and published cost analyses were not reviewed.

METHOD OF GUIDELINE VALIDATION

Internal Peer Review

DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

This guideline has been reviewed by the Society of Obstetricians and Gynaecologists of Canada/Society of Gynecologic Oncologists of Canada/Society of Canadian Colposcopists (SOGC/GOC/SCC) Policy and Practice Guidelines Committee and approved by the Executive and Council of the Society of Obstetricians and Gynaecologists of Canada.

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

The quality of evidence (I-III) and classification of recommendations (A-E) are defined at the end of the "Major Recommendations."

Microinvasive Vulvar Cancer

  1. Stage 1A lesions (≤2 cm diameter and ≤1 mm stromal invasion) can be managed by radical wide local tumor excision without inguinofemoral node dissection. (II-2B)

Early Vulvar Cancer (Stage I)

  1. Stage IB unilateral lesion (<2 cm diameter, >1 mm stromal invasion, and >1 cm from the midline) is treated by radical wide local excision completed by an ipsilateral inguinofemoral node dissection; a central lesion (within 1 cm from the midline) requires bilateral inguinofemoral node dissection. (II-2B)

Clinical Stage II or III

  1. Patients with three or more micrometastases in the groin, with node size >10 mm, with extracapsular spread, or with bilateral microscopic metastases, should receive postoperative bilateral groin and pelvic radiation. (II-2B)

Advanced Vulvar Cancer

  1. Advanced cancer of the vulva should be treated with primary radiation and concomitant chemotherapy, followed by consideration of surgical resection. (II-2B)

Definitions:

Quality of Evidence Assessment*

I: Evidence obtained from at least one properly designed randomized controlled trial.

II-1: Evidence obtained from well-designed controlled trials without randomization.

II-2: Evidence obtained from well-designed cohort (prospective or retrospective) or case-control studies, preferably from more than one centre or research group.

II-3: Evidence obtained from comparisons between times or places with or without the intervention. Dramatic results from uncontrolled experiments (such as the results of treatment with penicillin in the 1940s) could also be included in this category.

III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

Classification of Recommendations**

  1. There is good evidence to support the recommendation that the condition be specifically considered in a periodic health examination.
  2. There is fair evidence to support the recommendation that the condition be specifically considered in a periodic health examination.
  3. There is poor evidence regarding the inclusion or exclusion of the condition in a periodic health examination.
  4. There is fair evidence to support the recommendation that the condition not be considered in a periodic health examination.
  5. There is good evidence to support the recommendation that the condition be excluded from consideration in a periodic health examination.

*The quality of evidence reported in these guidelines has been adapted from the Evaluation of Evidence criteria described in the Canadian Task Force on the Periodic Health Exam.

**Recommendations included in these guidelines have been adapted from the Classification of Recommendations criteria described in the Canadian Task Force on the Periodic Health Exam.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

POTENTIAL BENEFITS

  • Early detection and treatment of cancer of the vulva is managed by less radical surgery.
  • Appropriate management of squamous cell cancer of the vulva based on clinical and pathological findings and tailored to the individual patient result in increased survival rates.

POTENTIAL HARMS

En bloc radical vulvectomy and bilateral inguinofemoral lymphadenectomy improved survival, but also resulted in significant morbidity including wound breakdown, cellulites, chronic lymphedema, and physical and psychological sequelae. Moreover, the impact, on both body image and on sexual function, was profound.

QUALIFYING STATEMENTS

QUALIFYING STATEMENTS

This guideline reflects emerging clinical and scientific advances as of the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed. Local institutions can dictate amendments to these opinions. They should be well documented if modified at the local level. None of these contents may be reproduced in any form without prior written permission of the Society of Obstetricians and Gynaecologists of Canada (SOGC).

IMPLEMENTATION OF THE GUIDELINE

DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

IOM CARE NEED

Getting Better
Living with Illness

IOM DOMAIN

Effectiveness

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2006 Jul

GUIDELINE DEVELOPER(S)

Society of Canadian Colposcopists - Professional Association
Society of Gynecologic Oncologists of Canada - Disease Specific Society
Society of Obstetricians and Gynaecologists of Canada - Medical Specialty Society

SOURCE(S) OF FUNDING

Society of Obstetricians and Gynaecologists of Canada

GUIDELINE COMMITTEE

SOGC/GOC/SCC Policy and Practice Guidelines Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Principal Author: Wylam Faught, MD, FRCSC, Edmonton AB

Committee Members: John Jeffrey, (Chair), MD, FRCSC, Kingston ON; Peter Bryson, MD, FRCSC, Kingston ON; Lesa Dawson, MD, FRCSC, St. John's NL; Wylam Faught, MD, FRCSC, Edmonton AB; Michael Helewa, MD, FRCSC, Winnipeg MB; Janice Kwon, MD, FRCSC, London ON; Susie Lau, MD, FRCSC, Montreal QC; Robert Lotocki, MD, FRCSC, Winnipeg MB; Diane Provencher, MD, FRCSC, Montreal QC

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the Society of Obstetricians and Gynaecologists of Canada Web site.

Print copies: Available from the Society of Obstetricians and Gynaecologists of Canada, La société des obstétriciens et gynécologues du Canada (SOGC) 780 promenade Echo Drive Ottawa, ON K1S 5R7 (Canada); Phone: 1-800-561-2416

AVAILABILITY OF COMPANION DOCUMENTS

None available

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI Institute on March 11, 2009. The information was verified by the guideline developer on March 25, 2009.

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

DISCLAIMER

NGC DISCLAIMER

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