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Brief Summary

GUIDELINE TITLE

Management of cervical cancer.

BIBLIOGRAPHIC SOURCE(S)

  • Scottish Intercollegiate Guidelines Network (SIGN). Management of cervical cancer. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2008 Jan. 73 p. (SIGN publication; no. 99). [254 references]

GUIDELINE STATUS

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • July 31, 2008, Erythropoiesis Stimulating Agents (ESAs): Amgen and the U.S. Food and Drug Administration (FDA) informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs). The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated.
  • November 8, 2007 and January 3, 2008 Update, Erythropoiesis Stimulating Agents (ESAs): The U.S. Food and Drug Administration (FDA) notified healthcare professionals of revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs) stating serious adverse events, such as tumor growth and shortened survival in patients with advanced cancer and chronic kidney failure.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Note from the Scottish Intercollegiate Guidelines Network (SIGN) and National Guideline Clearinghouse (NGC): In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the full-text guideline document.

The grades of recommendations (A–D) and levels of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) are defined at the end of the "Major Recommendations" field.

Presentation and Referral

Signs and Symptoms

D - Pre-menopausal women presenting with abnormal vaginal bleeding should be tested for Chlamydia trachomatis.

D - Post-menopausal women presenting with abnormal vaginal bleeding should be referred for gynaecological investigation.

D - Chlamydia trachomatis testing should be done if appropriate.

Diagnosis and Staging

Diagnosis and Prognosis

Histopathological Reporting

D - Pathology reports of cervical tumours should include the following histological features:

  • Tumour type
  • Tumour size
  • Extent of tumour (e.g., involvement of the vaginal wall or parametrium)
  • Depth of invasion
  • Pattern of invasion (infiltrative or cohesive invasive front)
  • Lymphovascular space invasion (LVSI)
  • Status of resection margins (presence of tumour and distance from margin)
  • Status of lymph nodes (including site and number of nodes involved)
  • Presence of pre-invasive disease

Radiological Staging

Pelvic or Para-aortic Lymph Nodes

B - All patients with visible, biopsy proven cervical carcinoma (except those with International Federation of Gynecology and Obstetrics [FIGO] IV disease) should have an magnetic resonance imaging (MRI) scan.

C - The MRI scan should include:

  • Thin section T2 weighted images perpendicular to the cervix
  • Sequences to include urinary tract and para-aortic nodal areas

B - Post contrast spiral computed tomography (CT) should be considered as an alternative to MRI in patients who cannot have MRI.

B - Women who have clinically apparent FIGO stage IV disease should have post contrast spiral or multislice CT scans of chest abdomen and pelvis.

Positron Emission Tomography (PET)

C - Patients not suitable for surgery should be considered for a PET scan.

The Relative Benefit of Imaging Over Other Options in Pre-treatment Staging

C - Cystoscopy and sigmoidoscopy should not be routinely performed for staging purposes.

C - If imaging cannot exclude bladder or bowel involvement, cystoscopy and sigmoidoscopy should be used for staging.

C - Ultrasound, intravenous urography (IVU) and lymphangiography are not recommended for staging.

Surgery

Radical Hysterectomy

B - Radical surgery is recommended for FIGO IB1 disease if there are no contraindications to surgery.

Treatment of Cervical Cancer After Subtotal Hysterectomy

C - Cancer of the cervical stump should be managed in the same way as cervical cancer arising in an intact uterus.

Treatment of Early Stage Disease (FIGO IA1 and IA2)

Pelvic Node Metastases

D - Removal of pelvic lymph nodes is not recommended during treatment for FIGO IA1 disease.

D - Pelvic lymph nodes should be removed if FIGO IA2 disease is present.

Fertility Conservation Surgery

C - Women requesting fertility conservation should be offered radical trachelectomy and pelvic lymph node dissection, providing the tumour diameter is less than 2 cm and no lymphatic-vascular space invasion is present.

D - Women with early stage disease and no lymphovascular space invasion (LVSI) (FIGO IA2 and microscopic IB1) requesting fertility conservation may be offered cold knife conisation or large loop excision of the transformation zone (LLETZ) combined with pelvic lymph node dissection.

Laparoscopic-Vaginal Radical Hysterectomy

D - Laparoscopic-vaginal radical hysterectomy should not be offered to patients with tumour diameter greater than 2 cm.

D - Surgeons wishing to offer laparoscopic-vaginal radical hysterectomy should have appropriate training.

Non-surgical Treatment

Concurrent Chemoradiotherapy

A - Any patient with cervical cancer considered suitable for radical radiotherapy treatment should have concurrent chemoradiotherapy with a platinum based chemotherapy, if fit enough.

Adjuvant Chemoradiotherapy/Radiotherapy

Positive Lymph Nodes

B - Patients who have undergone surgery for cervical carcinoma and have positive nodes should be considered for adjuvant treatment with concurrent chemoradiotherapy with platinum based chemotherapy.

Negative Lymph Nodes

B - Patients who have undergone surgery for cervical carcinoma, have negative nodes and any two of the following risk factors should be considered for adjuvant treatment with radiotherapy, if fit enough:

  • Greater than a third stromal invasion
  • Lymphovascular space invasion
  • Tumour diameter of >4 cm

D - Concurrent chemoradiation should be considered in preference to radiation alone.

Brachytherapy

D - Brachytherapy should be considered an essential component of radical radiotherapy or chemoradiotherapy.

Treatment of Anemia

C - Patients with cervical carcinoma undergoing radiotherapy or chemoradiotherapy should have their haemoglobin level monitored and corrected if it falls below 12 g/dL.

B - Anaemia should be corrected with either blood transfusion or erythropoietin and iron products after consideration of the attendant costs, risks and benefits.

Treatment of Radiation Induced Complications

Rectum

B - Rectal or oral sucralfate is not recommended to reduce acute radiation induced proctitis.

D - Rectal sucralfate may be considered to reduce late radiation induced proctitis.

Hormone Replacement Therapy (HRT)

C - HRT is recommended for women who have lost ovarian function as a result of treatment for cervical cancer.

Treatment During Pregnancy

C - For pregnant women with cervical cancer, the choice of therapeutic modality should be decided in the same manner as for non-pregnant patients.

C - For pregnant women diagnosed with cervical cancer before 16 weeks of gestation, immediate treatment is recommended.

C - For pregnant women with early stage disease (FIGO IA1, IA2, IB) diagnosed after 16 weeks of gestation, treatment may be delayed to allow fetal maturity to occur.

C - For pregnant women with advanced disease (FIGO 1B2 or greater) diagnosed after 16 weeks of gestation, consideration for delay must be based on gestational age at time of diagnosis.

Sexual Morbidity

Physical Interventions

C - Women should be offered a vaginal stent or dilator to prevent post-radiotherapy vaginal complications.

Psychoeducational Interventions

B - Information about female sexual function should be offered to patients by a relevantly-trained healthcare professional using a model of care that involves addressing motivational issues and teaching behavioural skills.

C - Patients should be offered support sessions by a designated member of their care team, as soon as possible after treatment, which may include one or more of the following:

  • Relaxation
  • Personalised information about their disease and treatment
  • Emotional support and care

Lymphoedema

Risk Factors

D - Patients with lymphoedema, or at risk of lymphoedema, should have access to appropriate information.

Diagnosis

D - Patient review should include identification and recording of lower limb lymphoedema.

D - Patients with symptoms suggestive of lymphoedema should be referred early for assessment by a designated lymphoedema practitioner.

Treatment

D - Patients with severe or poorly controlled lymphoedema should be offered decongestive lymphatic therapy (DLT) with a specialist lymphoedema practitioner.

D - Early and appropriate use of antibiotic therapy is recommended for patients with cellulitis.

Patient Self Management

D - Patients with lymphoedema should be supported to self manage by a practitioner qualified in lymphoedema management.

Follow Up

Post-treatment Surveillance

D - History taking and clinical examination should be carried out during follow up of patients with cervical cancer to detect symptomatic and asymptomatic recurrence.

D - Cervical cytology or vault smears are not indicated to detect asymptomatic recurrence of cervical cancer.

Detection of Relapsed Disease

C - MRI or CT should be considered initially to assess potential clinical recurrence in symptomatic patients.

B - A whole body PET scan or PET-CT should be performed on all patients in whom recurrent or persistent disease has been demonstrated on MRI or CT and in whom salvage therapy (either pelvic exenteration or radiotherapy) is being considered.

Management of Recurrent Disease

Total Pelvic Exenteration

D - Pelvic exenteration should be reserved as salvage surgery for women with recurrent cervical cancer in the central pelvis whose chemoradiotherapy has failed.

C - MRI or CT should be considered initially to assess potential clinical recurrence in symptomatic patients.

B - A whole body PET scan or PET-CT should be performed on all patients in whom recurrent or persistent disease has been demonstrated on MRI or CT and in whom salvage therapy (either pelvic exenteration or radiotherapy) is being considered.

Chemotherapy

B - Palliative chemotherapy should be offered to women with FIGO stage IVB or recurrent cervical carcinoma, after discussion of the relative benefits and risks, with either:

  • Cisplatin 50 mg/m2 on day 1 plus topotecan 0.75 mg/m2 on days 1 to 3 every 3 weeks, or
  • Cisplatin 50 mg/m2 on day 1 plus paclitaxel 135 mg/m2 every 3 weeks

Management of Complications in Advanced Disease

Renal Failure

D - Retrograde ureteric stents should be changed according to the level of ureteric obstruction (ranging from 3 to 12 months).

D - If a retrograde stent is unsuccessful:

  • The stent should be changed more frequently
  • An alternative stent should be tried
  • Patients should be offered percutaneous nephrostomy (PCN) and/or antegrade stent.

D - Urinary diversion may be considered in suitable patients.

D - Patients should have careful follow up and access to counselling.

Thrombotic and Bleeding Problems

Deep Venous Thrombosis

C - Low molecular weight heparin should be considered for treatment of deep venous thrombosis (DVT) and prevention of recurrent thromboembolism.

D - Compression garments, in conjunction with low molecular weight heparin (LMWH) and early walking exercises should be considered in patients with DVT.

Treatment of Minor Haemorrhage

D - Treatment for minor haemorrhage may include:

  • Oral tranexamic acid or aminocaproic acid
  • Tranexamic acid applied topically to superficial fungating wound
  • Tranexamic acid by rectal or bladder instillation
  • A single fraction of radiotherapy

Psychosocial Care and Support for Patients and Carers

Support Needs

D - Patients with cervical cancer should be offered psychological support at the time of diagnosis and at intervals throughout their management.

D - Information about local support services should be made available to patients.

D - Carers, families and dependants should be made aware of support available including local and national organisations.

Information Needs

C - Patients should be offered information throughout their journey of care.

Communication Methods

B - Healthcare professionals in cancer care should be trained in listening and communication skills.

B - Healthcare professionals in cancer care should consider giving either written summaries or audiotapes of consultations to people who have expressed a preference for them.

Definitions:

Levels of Evidence

1++: High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias

1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias

1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias

2++: High quality systematic reviews of case control or cohort studies
High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal

2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal

2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal

3: Non-analytic studies (e.g., case reports, case series)

4: Expert opinion

Grades of Recommendation

Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation.

A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results

B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D: Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

Good Practice Points: Recommended best practice based on the clinical experience of the guideline development group

CLINICAL ALGORITHM(S)

Algorithms are available in the original guideline document for:

  • Investigation of Post-Coital Bleeding
  • Imaging to Detect Relapsed Disease
  • Management of Renal Failure in Patients with Cervical Cancer

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").

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • Scottish Intercollegiate Guidelines Network (SIGN). Management of cervical cancer. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2008 Jan. 73 p. (SIGN publication; no. 99). [254 references]

ADAPTATION

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

DATE RELEASED

2008 Jan

GUIDELINE DEVELOPER(S)

Scottish Intercollegiate Guidelines Network - National Government Agency [Non-U.S.]

SOURCE(S) OF FUNDING

Scottish Government Health Department

GUIDELINE COMMITTEE

Not stated

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Guideline Development Group: Dr Nadeem Siddiqui Consultant Gynaecological Oncologist, (Chair) Glasgow Royal Infirmary; Dr Mohamed Allam, Consultant Obstetrician and Gynaecologist, Monklands Hospital, Airdrie; Dr Gerry Beattie, Consultant Obstetrician and Gynaecologist, St John's Hospital, Livingston; Dr Rachel Connor, Consultant Radiologist, Victoria Infirmary, Glasgow; Dr Maggie Cruickshank, Senior Lecturer in Obstetrics and Gynaecology, Aberdeen Maternity Hospital; Dr Fiona Downs, Consultant in Palliative Medicine, Strathcarron Hospice, Stirlingshire; Ms Diane Florence, Patient Representative and Health Psychology Practitioner, Markinch; Ms Sarah Howlett, Oncology Pharmacist, Aberdeen Royal Infirmary, Sister Yvonne Hydes Ward, Sister in Gynaecological Oncology, Glasgow Royal Infirmary; Dr Jocelyn Imrie, Consultant Cytopathologist, Monklands Hospital, Airdrie; Dr Roberta James, Programme Manager, SIGN; Dr Carol MacGregor Macmillan, Consultant in Clinical Oncology, Raigmore Hospital, Inverness; Dr Rona McCarthy, Clinical Assistant in Genitourinary Medicine, Fife; Dr David Millan, Consultant Pathologist, Glasgow Royal Infirmary; Dr Kathryn Morton, Consultant Pathologist, Stirling Royal Infirmary; Dr Gordon Narayansingh, Consultant Gynaecological Oncologist, Aberdeen Royal Infirmary; Dr Nicholas Reed, Consultant Oncologist, Beatson Oncology Centre, Glasgow; Dr Azmat Sadozye, Consultant Oncologist, Beatson Oncology Centre, Glasgow; Mr Duncan, Service Senior Information Officer, SIGN; Mrs Rhona Scott, Clinical Nurse Specialist in Gynaecological Oncology, Crosshouse Hospital, Kilmarnock; Dr Emily Stenhouse, Consultant Paediatric Radiologist, Yorkhill Hospital for Sick Children, Glasgow; Mrs Allison Tait, Practice Nurse, Marchmont Surgery, Edinburgh; Ms Anne Williams, Cancer Nursing Research Fellow, Napier University, Edinburgh

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Declarations of interests were made by all members of the guideline development group. Further details are available from the Scottish Intercollegiate Guidelines Network (SIGN) Executive.

GUIDELINE STATUS

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Additional tools, including a minimum dataset proforma and a screening tool for measuring distress are available in the Annexes of the original guideline document.

PATIENT RESOURCES

None available

NGC STATUS

This summary was completed by ECRI Institute on April 10, 2008. The information was verified by the guideline developer on May 21, 2008. This summary was updated by ECRI Institute on August 15, 2008 following the U.S. Food and Drug Administration advisory on Erythropoiesis Stimulating Agents (ESAs).

COPYRIGHT STATEMENT

DISCLAIMER

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