North of Scotland Cancer Network Clinical Management Guideline for Cancer of the Ovary
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1 North of Scotland Cancer Network Cancer of the Ovary Based on WOSCAN CMG with further extensive consultation within NOSCAN UNCONTROLLED WHEN PRINTED DOCUMENT CONTROL Prepared by NOSCAN Gynaecology Cancer MCN Approved by NOT APPROVED Issue date June 2016 Review date September 2016 Version V 1.3 ( ) Page 1 of 7
2 Initial Diagnosis and Staging General Principles: The following information should only be used to guide the management of adult patients with cancer of the ovary and who have not been entered into a clinical trial only All patients (including those who decline, or are considered clinically not suitable for active treatment) should be registered with the North of Scotland regional Gynaecological cancer MDT in order to ensure accurate data capture and an opportunity for peer review. In advance of any patient being discussed at the above specialist weekly MDT, it is important to have locally taken steps earliest to establish i) a cancer of the ovary diagnosis, as well as ii) an indication of FIGO* clinical staging (available on page 8) Where available clinical trials should always be considered the preferred option for all eligible patients Clinical judgement should ultimately determine which diagnostic tests require performed for each patient. However, as a general rule: Initial ALL PATIENTS investigations: Full Medical History Physical Examination (including examination of the pelvis) Routine Blood Screen: ie Full Blood Count (FBC), Biochemistry (U&E s) CEA, CAI25 Further SUSPICION OF CANCER OF THE OVARY investigations: Other considerations Chest X-Ray (and CT of chest if indicated) Fertility expectations should be discussed Paracentisis CT of Abdomen and Pelvis CT guided biopsy of omental cake Laparascopy if indicated Calculate RMI* Score CT (if RMI >200) [See separate MCN Guideline s for further advice on Imaging of Gynaecological Malignancy] *RMI - The RMI is a product of the ultrasound scan score, the menopausal status and the serum CA125 level (IU/ml). Ie U x M x CA125 In addition to above, all patients should be referred or made aware earliest to the service identified Clinical Nurse Specialist for assessment and ongoing specialist advice education, support and co-ordination of care for both the patient and their relatives throughout the treatment pathway: this is in addition to any other specialist referrals that may also be clinically warranted depending on individual patient circumstances. V1.3 ( ) Page 2 of 7
3 Staging and primary treatment Evaluation Primary Treatment Follow-up Adjuvant treatment Confirmed Diagnosis of Ovarian Cancer (See page 2) Discuss At MDT Staging Laparotomy and Radical/ Primary debulking surgery (TAH/ BSO/ Omentectomy and pelvic washings) yes Immediately Operable Disease no SACT Notes: MDT Multidisciplinary Team Meeting SACT Systemic Anti Cancer Therapy IDS Interval Debulking Siurgery GO - Gynaecology Oncologist TAH Total Abdominal Hysterectomy BSO Bilateral Salpingo Oopherectomy Image guided biopsy +/- laparoscopy + biospy Stage 1 Disease Stage 2-4 Disease Re- Discuss At MDT Appropriate for Primary/Secondary Surgery no yes Stage IA (grade 1) Stage IA (grade 2/3) Stage IB (grade 1/2/3) Stage IC (grade 1/2) Stage IC grade 3) Stage II Stage III Stage IV Surgery by GO +/- additional surgical team as appropriate SACT Not Routinely required Consider SACT Consider SACT Consider IDS if initial surgery suboptimal Continue with SACT Follow up for 3 years Imaging as clinically indicated (see page 6) If available, clinical trials should always be considered the preferred option for eligible patients V1.3 ( ) Page 3 of 7
4 Treatment of relapsed disease At all stages in this flow chart, consider patient performance status and participation in clinical trials Evaluation 1 st Relapse 2 nd Line 3 rd Line 4th Line Platinum resistant (TFI <6 months) Non-platinum regime - consider IND clinical trial Pegylated liposomal Doxorubicin Hydrochloride (Caelyx) Weekly Carboplatin/Paclitaxel Topotecan Cisplatin/Etoposide Weekly Carbo/Paclitaxel Partially Platinum sensitive (TFI 6-12 months) Consider non-platinum to delay platinum free interval Consider Clinical Trial Consider IND Clinical Trial PLDH Topotecan Platinum sensitive (TFI >12 months) Notes: TFI Treatment Free Interval IND PLDH - Re-challenge with Carboplatin/Paclitaxel OR Carboplatin + Gemcitabine (if neuropathy) 1 Carbo AUC 4 & Gemcitabine Cisplatin/Etoposide Others including: Tamoxifen, Treosulfan, Cyclophosphamide, Oral Etoposide ¹Carboplatin/PLDH currently non-formulary for this patient group If available, clinical trials should always be considered the preferred option for eligible patients V1.3 ( ) Page 4 of 7
5 Systemic Anti Cancer Therapy NOSCAN Gynaecological Cancer MCN has identified the following regimens, together with the maximum starting doses and treatment durations indicated, suitable for the management of Ovarian cancer in the NoS: patient individualised dose reductions are permitted etc Cisplatin + Etoposide Cisplatin *??mg/m 2 IV infusion (? Duration) on Day 1 Etoposide?? mg/m 2 IV infusion (? Duration) on Day 1 Repeat every 3 weeks/21 days *Note: Where Cisplatin contraindicated, replace with Carboplatin [AUC 5] Carboplatin + Paclitaxel Carboplatin [AUC 5] IV infusion (? Duration) on Day 1 Paclitaxel 175mg/m 2 IV infusion (? Duration) on Day 1 Repeat every 3-weeks/21 days Carboplatin + Gemcitabine Carboplatin [AUC 5] IV infusion (? Duration) on Day 1 Gemcitabine??mg/m 2 IV infusion (? Duration) on Day 1 Repeat every 3-weeks/21 days Cyclophosphamide Cyclophosphamide??mg/m 2 IV infusion (? Duration) on Day 1 Repeat every 3 weeks/21 days Or PEGYLATED LYPOSOMAL DOXORUBICIN HYHROCHLORIDE (PGLH) Tamoxifen Topetecan Treosulfan If available, clinical trials should always be considered the preferred option for eligible patients V1.3 ( ) Page 5 of 7
6 Follow up and aftercare General principles: Any patients enrolled in clinical trial should be followed up according to study protocol CA125 should not be performed routinely excepting if symptoms/signs of recurrent disease Year Year 1 Year 2 Year 3 Ovarian Cancer [Stage I-IV] Every 3 months: physical GO Clinic + any imaging as clinically indicated Every 6 months: physical GO Clinic Every 4 months: physical GO Clinic + any imaging as clinically indicated. Discharge at 36 months if no evidence of disease recurrence* NOTE: All cases of Borderline Ovarian tumours must have been discussed (with review of surgical staging and pathology) at the NoS Gynaecology Cancer MDT, where definitive follow up regime will be determined Year Year 1-2 Year 3-5 Borderline Ovarian Cancer: [Note: The following is a guide to MDT only] Stage I Stage II IV No follow-up required (regardless of whether the other ovary remains in-situ) As below Every 3 months: physical GO Clinic + any imaging as clinically indicated Every 6 months: physical GO Clinic + any imaging as clinically indicated. Discharge at 60 months if no evidence of disease recurrence* * If there is any recurrence of disease, restart from Year 1 V1.3 ( ) Page 6 of 7
7 Ovarian Cancer: FIGO* Staging [Effective Jan 2014] Staging IA IB Tumour limited to 1 ovary, capsule intact, no tumour on surface, negative washings. Tumour involves both ovaries otherwise like IA. [Tumour limited to 1 or both ovaries] IC IIA IIB IIIA IIIA2 IIIB IIIC IVA IVB ICi ICii Surgical spill Capsule rupture before surgery or tumour on ovarian surface ICiii Malignant cells in the ascites or peritoneal washings Extension and/or implant on uterus and/or Fallopian tubes Extension to other pelvic intraperitoneal tissues [ Positive retroperitoneal lymph nodes and /or microscopic metastasis beyond the pelvis] Positive retroperitoneal lymph nodes only IIIA1 IIIA1(i) Metastasis 10 mm IIIA1(ii) Metastasis > 10 mm Microscopic, extrapelvic (above the brim) peritoneal involvement ± positive retroperitoneal lymph nodes Macroscopic, extrapelvic, peritoneal metastasis 2 cm ± positive retroperitoneal lymph nodes. Includes extension to capsule of liver/spleen Macroscopic, extrapelvic, peritoneal metastasis > 2 cm ± positive retroperitoneal lymph nodes. Includes extension to capsule of liver/spleen. Pleural effusion with positive cytology Hepatic and/or splenic parenchymal metastasis, metastasis to extra-abdominal organs (including inguinal lymph nodes and lymph nodes outside of the abdominal cavity) *FIGO The International Federation of Gynecology and Obstetrics V1.3 ( ) Page 7 of 7
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