• Scottish Intercollegiate Guidelines Network (SIGN). Epithelial ovarian cancer. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2003 Oct. 36 p. (SIGN publication; no. 75). [182 references]

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 original guideline document.

The strength of recommendation grading (A-D) and level of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) are defined at the end of the "Major Recommendations" field.

Screening

D - Screening for ovarian cancer in high risk groups should only be offered in the context of a research study designed to gather data on:

• sensitivity and specificity of the screening tool
• The International Federation of Gynaecology and Obstetrics (FIGO) stages of cancers detected through screening
• residual risk of primary peritoneal cancer following prophylactic oophorectomy

D - Screening programmes for women at increased risk of ovarian cancer should include mechanisms for providing emotional and psychological support.

C - Women with genetic mutations of BRCA1 or BRCA2 genes should be counselled regarding prophylactic oophorectomy and removal of Fallopian tubes at a relevant time of their life.

Diagnosis

D - Women with a pelvic mass should be referred to gynaecology irrespective of the CA125 test result.

C - The risk of malignancy index (RMI) scoring system is the method of choice for predicting whether or not an ovarian mass is likely to be malignant.

C - Women with a risk of malignancy index score >200 should be referred to a centre with experience in ovarian cancer surgery.

Surgery

C - Preoperative bowel preparation in ovarian cancer patients should be undertaken where clinical findings and imaging reveal that advanced disease with bowel involvement is present.

B - Patients for whom preoperative bowel preparation is indicated should see a trained stoma nurse for counselling and potential stoma site marking.

D - Serum CA125 levels are useful in predicting disease bulk and should be assayed preoperatively in women with pelvic masses.

D - Routine preoperative carcinoembryonic antigen (CEA) estimation should not be performed in patients with ovarian cancer.

D - To minimise the need for a second operative staging procedure, intraoperative frozen section assessment can be used to diagnose malignancy and to exclude metastatic disease.

In Advanced Disease

C - If aggressive cytoreduction is not possible then optimal cytoreduction is the recommended surgical procedure if performance status allows this to take place.

D - Patients with stage III disease should be operated on by a gynaecological oncologist rather than a general gynaecologist or general surgeon.

C - Interval debulking surgery is recommended, if performance status allows, where there is evidence of response to chemotherapy as determined by CA125 and imaging.

Chemotherapy

B - Carboplatin can be offered to all early stage epithelial ovarian cancer patients.

In Advanced Disease

A - First line chemotherapy treatment of epithelial ovarian cancer should include a platinum agent either in combination or as a single agent, unless specifically contraindicated.

A - Carboplatin is the platinum drug of choice in both single and combination therapy.

A - Paclitaxel is recommended in combination therapy with platinum in the first line postsurgery treatment of epithelial ovarian cancer where the potential benefits justify the toxicity of the therapy.

A - Patients who choose less toxic therapy or who are unfit for taxanes should be offered single agent carboplatin.

A - Cyclophosphamide is not recommended in the first line chemotherapy treatment of epithelial ovarian cancer.

A - The use of anthracyclines in first line chemotherapy treatment of epithelial ovarian cancer is not recommended outside randomised controlled trials (RCTs).

In Relapsed Disease

B - Chemotherapy for recurrent ovarian cancer should be regarded as palliative in intent and should be reserved for symptomatic recurrence of disease.

B - Symptomatic platinum-sensitive cancer recurrence can be treated with further platinum and paclitaxel.

C - Tamoxifen should be considered in patients for whom chemotherapy is not appropriate.

B - If erythropoietin is used to treat anaemia it should only be when the haemoglobin concentration is <10 g/dL and the dose should not exceed 450 units/kg/week.

D - Staff should be experienced, trained in the safe administration of chemotherapy, and involved in ongoing continuing professional development (CPD) and reappraisal.

D – Hospital-based administration of chemotherapy should take place during the working day in designated areas equipped to deal with any medical emergencies.

D - Women should be given accurate information on their likely response to chemotherapy, including adverse effects, so that they can make an informed decision about whether or not to proceed with treatment.

D - The impact of chemotherapy toxicities on patients’ quality of life must be balanced against their anticipated response to treatment.

C - Clinical trials should have appropriate inclusion criteria and should incorporate recognised standard treatment.

Management of Malignant Bowel Obstruction

C - Surgery for malignant bowel obstruction in patients with advanced ovarian cancer must be justified on the basis of achieving a significant benefit.

C - Symptoms of bowel obstruction can be relieved by using the following drug categories either alone or in combination:

• antiemetic
• antisecretory
• analgesic
• corticosteroids

Specialist Palliative Care

B - Patients with advanced ovarian cancer require a coordinated, multiprofessional approach with access to a specialist palliative care team.

D - Patients with persistent poorly controlled symptoms should be referred to specialist palliative care.

Information for Patients

C - Patients should be offered verbal and written information throughout their journey of care and should be made aware of the support mechanisms that are in place and how to access them.

C - Structured emotional support should be available to all patients and carers.

Definitions:

Grades of Recommendation

A: At least one meta-analysis, systematic review of randomised 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+

Levels of Evidence

1++: High quality meta-analyses, systematic reviews of 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

None provided

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

• Scottish Intercollegiate Guidelines Network (SIGN). Epithelial ovarian cancer. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2003 Oct. 36 p. (SIGN publication; no. 75). [182 references]

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

2003 Oct

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

Scottish Executive Health Department

Not stated

Guideline Development Group: Dr Nadeem Siddiqui (Chairman), Consultant Gynaecologist and Oncologist, Stobhill Hospital, Glasgow; Dr Chris Hardwick (Secretary), Specialist Registrar in Obstetrics and Gynaecology, North Glasgow Hospitals National Health System (NHS) Trust; Dr Ian Aitken, General Practitioner, Glasgow; Mr Andrew Anderson, National Coordinator, Maggie’s Centres, Western General Hospital, Edinburgh; Mr Roger Black, Head, Scottish Cancer Intelligence Unit, Information and Statistics Division (ISD), Common Services Agency, Edinburgh; Ms Sandra Bredin, Clinical Nurse Specialist, Stobhill Hospital, Glasgow; Mrs Anne Coote, Patient Helpline Coordinator, Argyll and Clyde Health Council, Paisley; Mrs Inez Crow, District Nurse, Falkirk; Ms Linda Davidson, Staff Nurse, Crosshouse Hospital, Kilmarnock; Dr Heather Deans, Consultant Radiologist, Aberdeen Royal Infirmary; Dr Sonia Devereux, General Practitioner, Forfar; Mr Craig Eriksen, Consultant Colorectal Surgeon, Perth Royal Infirmary; Dr Marie Fallon, Senior Lecturer in Palliative Medicine, Western General Hospital, Edinburgh; Dr Hani Gabra, Consultant in Medical Oncology, Western General Hospital, Edinburgh; Professor David Hole, Professor of Epidemiology and biostatistics, West of Scotland Cancer Surveillance Unit, Department of Public Health, University of Glasgow; Dr Brian Magowan, Consultant Gynaecologist, Borders General Hospital, Melrose; Mrs Jean McAllister, Principal Biochemist, North Glasgow University Hospitals NHS Trust; Dr David W. M. Millan, Consultant in Pathology, Western Infirmary, Glasgow; Miss Kath Nattress, Macmillan Clinical Nurse Specialist, Western General Hospital, Edinburgh; Dr David Parkin, Consultant Gynaecological Oncologist, Aberdeen Royal Infirmary; Mr Mark Parsons, Principal Clinical Pharmacist, Ninewells Hospital, Dundee; Dr Denny Phillips, Consultant Gynaecologist, Perth Royal Infirmary; Dr Nicholas Reed, Clinical Director, Beatson Oncology Centre, Glasgow; Mr Duncan Service, Information Services, Scottish Intercollegiate Guidelines Network; Dr Sally Stearns, Health Economist, Health Economics Research Unit, University of Aberdeen; Professor Michael Steele, Professor in Medical Science, University of St. Andrews; Mrs Diane Stirling, Macmillan Clinical Nurse Specialist, Western General Hospital, Edinburgh; Ms Joanne Topalian, Programme Manager, SIGN; Dr Sara Twaddle, Health Economist, North Glasgow Hospital NHS Trust

All members of the Scottish Intercollegiate Guidelines Network (SIGN) guideline development groups are required to complete a declaration of interests, both personal and non-personal. A personal interest involves payment to the individual concerned (e.g., consultancies or other fee-paid work commissioned by or shareholdings in the pharmaceutical industry); a non-personal interest involves payment which benefits any group, unit or department for which the individual is responsible (e.g., endowed fellowships or other pharmaceutical industry support). Details of the declarations of interest of any guideline development group member(s) are available from the Scottish Intercollegiate Guidelines Network executive.

This NGC summary was completed by ECRI on May 3, 2004. The information was verified by the guideline developer on July 15, 2004. This summary was updated by ECRI on January 29, 2007, following the U.S. Food and Drug Administration advisory on erythropoiesis stimulating agents. This summary was updated by ECRI Institute on June 22, 2007 following the U.S. Food and Drug Administration (FDA) advisory on heparin sodium injection. This summary was updated by ECRI Institute on July 9, 2007, following the FDA advisory on erythropoiesis stimulating agents. This summary was updated by ECRI Institute on March 13, 2008 following the updated FDA advisory on heparin sodium injection. This summary was updated by ECRI Institute on March 21, 2008 following the FDA advisory on Erythropoiesis Stimulating Agents. 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).