Ovarian Cancer Audit Comparative Annual Report 01/01/ /12/2009

Transcription

1 SE Scotland Cancer Network SCAN AUDIT Ovarian Cancer Audit Comparative Annual Report 01/01/ /12/2009 S E Scotland Cancer Network (SCAN) (Excluding Dumfries and Galloway) NHS Borders NHS Fife NHS Lothian Board Borders Lead Clinicians for Ovarian Cancer Audit Dr Queenie Menezes Audit Staff Alistair Meikle Cancer Audit Facilitator Borders Fife Lothian Dr Jane Macnab Dr Graeme Walker Dr Melanie Mackean (SCAN Group Chair) Jackie Stevenson Cancer Audit Facilitator Fife Dr Lorna Bruce SCAN Cancer Audit Facilitator SA Ov03/10 _W Prepared by Dr Lorna Bruce SCAN Audit Office, Western General Hospital, Crewe Road, Edinburgh EH4 2XU T: W: alison.allen@luht.scot.nhs.uk

2 Contents Document History...3 Commentary...3 Change in practice in Action points...6 SCAN Ovarian Cancer Audit Overview...7 Data summary table...8 Attainment of Standards Patient Data Summary Estimated Case ascertainment Specialties into which patients were initially referred Time from referral to first treatment Time from seeing gynaecologist to date of surgery Time from first seeing gynaecologist or gynae-oncologist Time from definitive surgery to start of chemotherapy Investigations Preoperative Preparations Surgical Treatment CSBS standard 11a a SIGN : Fertility Preserving Surgery Patients undergoing appropriate surgical procedures Surgical Incision Washings / ascitic fluid sampling Primary cytoreductive surgery All patients having hysterectomy Patients having unilateral or bilateral oophorectomy Omentectomy / omental biopsy Record of Residual disease Surgical Assessment FIGO Post operative management: Pathology Type/Sub-Type Grade of Disease Final FIGO on pathology report Chemotherapy management Clinical Trials Outcomes Thirty Day Mortality a Post Operative Deaths b Post Chemotherapy Deaths c Post Treatment deaths Residual Disease Survival: Multidisciplinary Meeting...44 Ovarian Cancer Glossary of Terms...45 SCAN Audit Office, Western General Hospital, Crewe Road, Edinburgh EH4 2XU T: W: alison.allen@luht.scot.nhs.uk

3 Document History v Date Events Actions /10/10 First draft circulated to SCAN gynae Group After discussion at sub-group of SCAN Gynae, initial amendments were made, and agreement to remove D&G data on the grounds that it was not sufficiently complete /11/10 Amended draft incorporating outlier comments from each board sent to SCAN Gynae Chair for commentary. Commentary and final comments incorporated /12/10 Final draft recirculated to SCAN Gynae group Typo removed, and minor rewording /12/10 Final version signed off. Report number incorporated. Web 13/06/11 Final version checked for disclosive data Adjustments were made to two tables to avoid the risk of communicating personally-identifiable and possibly sensitive information about a data subject. Commentary Since 2008 this report has included outcome data on women with ovarian cancer including survival figures, mortality from treatment, and residual disease after surgery. Such figures need to be interpreted with caution due to small numbers each year and inevitably variation from year to year in the stage and type of ovarian cancer diagnosed in these women. However it will be useful to compare these at a national level in the future. Due to problems with audit resources in Dumfries and Galloway it has not been possible to include the data from this region in All the numbers for SCAN will therefore be approximately 10% lower than previous years. In other data that has been collected over years we see a trend to improvement which is encouraging. There is still more to be done in terms - 3 -

4 of waiting times for surgery but the data is slightly skewed in that we have not recorded the date at which the women are told they need surgery, only the date they first see a gynaecologist. There may be a significant time between these two dates in reality as investigations to confirm the presumed diagnosis are undertaken. Ovarian cancer can be difficult to diagnose preoperatively. Only 1 in 3 solitary ovarian cysts will be malignant, the others are benign. RMI (Risk of Malignancy Index) is used to try and identify patients with likely malignancy preoperatively but is not 100% accurate. Specialist resources are limited and therefore not all simple benign ovarian cysts should be operated upon by a gynaecology oncology specialist. Inevitably this means some ovarian cancers with a low RMI preoperatively may require a second full operation when cancer is unexpectedly diagnosed. This audit shows a low number of these cases. Some of the highlighted low percentages regionally are due to lack of recording rather than lack of something being done. Clinical recording processes need to be improved so that data can be captured efficiently. A new operation form has been developed for Lothian with this in mind. Other percentages are also prone to variation due to small numbers e.g. ref % compliance in BGH is due to 2 emergency cases and one low RMI case being operated (correctly) open by non specialists. Overall this data is encouraging, although sadly many women present with very advanced disease and a balance needs to be carefully taken between treatment and quality of life at all times. I am very grateful to all the hard work from my colleagues in preparing this report, and keen, as always, for any comments for areas for improvement. Dr Melanie Mackean Chair of the SCAN gynae group December

5 Change in practice in Neoadjuvant chemotherapy (NACT) and delayed primary surgery. Prior to 2009 it was routine for advanced ovarian cancer (stage IIIC and IV) to be treated with an initial operation and then 6 cycles of chemotherapy. Some patients have very advanced disease and surgery can be risky as well as unsuccessful. There have been studies to see if it is better to have chemotherapy first to shrink the cancer (NACT) then surgery after 3 cycles of chemotherapy ( interval debulking or delayed primary surgery ) followed by 3 further cycles of chemotherapy. The EORTC/NCIC trial randomly assigned people with advanced ovarian cancer to either of these approaches (surgery first or surgery after chemotherapy-nact). They showed no difference in overall survival to either approach but a reduction in surgical problems in the group receiving chemotherapy first (NACT). There has been a move throughout the UK to offer neoadjuvant chemotherapy then surgery in advanced ovarian cancer. In September 2009 a subgroup of the SCAN gynae group met and formalised a protocol to offer neoadjuvant chemotherapy and delayed primary surgery. This means many more patients are having chemotherapy before surgery in 2009 in SCAN. The SCAN ovarian cancer protocol has been updated in 2010 accordingly. This will have some effects on some of the criteria being examined in this audit. It is now likely that less fit patients will receive chemotherapy rather than surgery as their first treatment. This is likely to increase the post chemotherapy mortality and reduce the post surgical mortality rates. This is seen in the 2009 audit (11.1b). However the overall mortality within 30 days of decision to treat remains the same (around 7%) over the years (11.1c). Encouragingly there has been an improvement of the percentage of patients optimally debulked with this new approach in 2009 (63% ). A separate SCAN wide audit is ongoing of patients undergoing NACT and delayed primary surgery. Ovarian cancer patient pathway 2009 Patient diagnosis Biopsy Ca125 / cytology / scan Decision for therapy Follow up only Best supportive care Staging laparotomy Neoadjuvant chemotherapy Delayed primary surgery Palliative primary chemotherapy Adjuvant chemotherapy x6 Adjuvant chemotherapy x3-5 -

6 Action points from this Audit Report Section Possible area for improvement Proposed action Which clinical standard will this meet? 3.3 Time from seeing gynaecologist to date of surgical treatment Ongoing BACiL working group on gynae surgical Services in Lothian. Better Cancer 31 day target from decision to treat to therapy 3.4 Time from seeing gynaecologist to first non-surgical treatment Better links between general surgery and gynaecology/oncology Better Cancer 31 day target from decision to treat to therapy 3.4 Time from surgery to chemotherapy (Fife) Better links between general surgery and gynaecology SIGN guideline Recording of DVT prophylaxis (Lothian) New operation note form being implemented CSBS Standard Recording of antibiotic prophylaxis (Lothian) New operation note form being implemented CSBS Standard Record of residual disease is made at surgery (Lothian) New operation note form being implemented CSBS Standard 11c7 6.9 Surgical pathological stage is recorded in case notes (Lothian) New operation note form being implemented CSBS Standard 11c9-6 -

7 SCAN: OVARIAN CANCER AUDIT Report on patients diagnosed 01/01/ /12/2009 SCAN Ovarian Cancer Audit Overview This report relates to patients diagnosed with ovarian cancer (including primary peritoneal and Borderline tumours) between 1 st January 2009 and 31 st December 2009 within the SCAN region of NHS Borders, Fife and Lothian. Due to problems with data completeness there is no data from Dumfries and Galloway for Audit Process Identification of patients for audit, plus capture of some data items, is primarily from the regional Multi-disciplinary Meeting held at the Western General Hospital, Edinburgh. Other data is collected from the clinical record (casenotes and electronic systems), GRO (death) lists and pathology lists. Data Capture Data is recorded on Access databases by Audit Facilitators. Datasets and Definitions The Minimum Core Data Set (published September 2001) developed by the Scottish Cancer Therapy Network under the direction of the Scottish Programme for Clinical Effectiveness in Reproductive Health continues to be collected. SIGN Guidelines (75) for Epithelial ovarian cancer were published in October Nationally agreed general fields for waiting times were added from 1st January Measures, Analysis and Reporting Data has been analysed in line with national standards set by the Clinical Standards Board for Scotland (CSBS) now NHS Quality Improvement Scotland (NHS QIS) and by the Scottish Government Health Department, and also in line with aspects of the SIGN Guidelines. Clinical Effectiveness Measures are as agreed by Lead Clinicians and approved by the SCAN Gynaecology Group. Actual figures for graphs are available by contacting: Lorna Bruce, SCAN Cancer Audit Facilitator SCAN Audit Office, Western General Hospital Tel: lorna.bruce@luht.scot.nhs.uk. Data and Reporting Quality Clinical Sign-Off: This report compares data from reports prepared for individual health board areas and signed off as accurate following review by the lead clinicians from each service. Additionally, the collated SCAN results are reviewed jointly at a meeting of lead clinicians to assess variances and provide comments on results. External Quality Assurance of data is carried out by ISD. The dataset on which this report is based is the subject of a current QA process the results of which will be reported in December Case ascertainment for the current reporting period is compared with the latest Scottish Cancer Registration 5 year average

8 Data summary table Total patients recorded in SCAN Audit: 130 Mode of Diagnosis Initial Surgical Assessment First Treatment Surgery Laparotomy Surgery Percutaneous biopsy Laparoscopy Chemotherapy Presumptive No surgery Patient declined Total Patient declined No active treatment Total Hormone therapy Includes patients diagnosed clinically by imaging / CA125 only. Also includes patients diagnosed through cytology Died before treatment whether or not they subsequently had surgery. Total Imaging Chest Imaging CA 125 Performed Performed Tested Not performed Not performed Not tested Not recorded Not recorded Not Recorded Total Total Total Washings/ Ascites Chemotherapy (Pre-/ post-op) Lothian Fife BGH SCAN Subsequent Surgery Sampled Performed Delayed primary surgery Not sampled Not performed Post-chemo surgery Inapplicable Total Not performed Not recorded Inapplicable* Total Total *No chemo. Includes both fully debulked at primary operation, and not surgically resectable at any stage - 8 -

9 Data summary table (cont.) Total patients with surgery as first treatment: 68 Type of List Incision Hysterectomy Elective Midline Total (TAH) Emergency Paramedian Subtotal Not recorded Low transverse No hysterectomy Total Transverse muscle cutting Fertility preserving Laparoscopy only No uterus pre-op Not recorded Total Total Oophorectomy Omentectomy Fluid sampled Unilateral Omentectomy Positive Bilateral Omental biopsy Negative Biopsy only Not performed Not sent Not performed Not recorded Not recorded Not recorded Total Total Total Residual Disease Residual Disease Size Recorded None Not recorded <1cm Total cm >5cm Not recorded Total

10 Surgical Assessment FIGO Stage Data summary table (cont.) Surgically assessed patients: 89 Final pathology report FIGO Stage IA IA IB IB IC IC IIA IIA IIB IIB IIC IIC IIIA IIIA IIIB IIIB IIIC IIIC IV IV Not recorded Not Recorded Total Total

11 Data summary table (cont.) Histopathological Type Differentiation Epithelial Borderline Well Differentiated Epithelial cancer - Serous Moderately Differentiated Epithelial cancer - Mucinous Poorly Differentiated Epithelial cancer Endometrioid Borderline Epithelial cancer Clear Cell Not recorded Epithelial cancer Undifferentiated Inapplicable* Epithelial cancer Mixed Total Epithelial cancer Unspecified Sex cord Granulosa *Insufficient tissue to grade/ Inapplicable to grade (e.g. cytology sample)/ no histology Sex cord Stromal tumour Germ Cell (Dysgerminoma) Germ Cell (Teratoma) Germ Cell (mixed) Mixed mullerian Sertoli leydig sex cord Other (inc Mixed Mesodermal) Inapplicable (No pathology available) Not recorded Total

12 Attainment of Standards Percent Attained Ref Standard SIGN 75 Guideline 5.2 : Chemotherapy should be started no later than eight weeks after surgery CSBS Standard 2: Minimum investigation: CA125 level to be organised CSBS Standard 2: Minimum investigation: abdominal and pelvic ultrasound and/or CT scan CSBS Standard 10: Appropriate pre-op preparation: Chest x-ray CSBS Standard 10: Appropriate pre-op preparation: DVT prophylaxis CSBS Standard 10: Appropriate pre-op preparation: Antibiotic prophylaxis a 6.2 CSBS standard 11a: All patients with suspected ovarian cancer to be operated on only by a designated gynaecological surgeon or referred to a gynaecological oncologist. (NB: All patients diagnosed with ovarian cancer) SIGN : All patients with (FIGO) stage 3 disease should be operated on by a gynaecological oncologist rather than a general gynaecologist or general surgeon. CSBS standard 11b: In young women, the possibility of germ cell tumours is considered. Fertility preserving surgery to be performed in most cases. If germ cell tumour is confirmed, patient to be referred to regional oncology centre N/A CSBS standard 11c3: Vertical incision is made Less than 75% 75 to 95% Over 95% Small numbers in Borders cause a disproportionate skew in percentages. For details, see later in report

13 Percent Attained Ref Standard 6.5 CSBS standard 11c4: Washings or ascitic fluid should be sent for cytology CSBS standard 11c 5: Primary cytoreductive surgery to be attempted and to include a total or subtotal hysterectomy CSBS standard 11c 5: Primary cytoreductive surgery to be attempted and to include a bilateral salpingo-oophorectomy CSBS standard 11c 6: Omentectomy and/or omental biopsy performed CSBS standard 11c 7: Record of residual disease to be made CSBS standard 11c 9: Surgical pathological stage is recorded in case notes CSBS: Essential criterion: Type, sub-type and grade of disease are recorded SIGN 75: 5.5.1A: First line chemotherapy of epithelial ovarian cancer should include a platinum agent either in combination or as a single agent, unless specifically contraindicated. CSBS Standard 3d stipulates that the management of patients with cancer should be multidisciplinary. Less than 75% 75 to 95% Over 95% note - Small numbers in Borders cause a disproportionate skew in percentages. For details, see later in report. 6.6 note - CSBS standard 11c 5: - This standard does not take into account recent data on offering neoadjuvant chemotherapy before surgery

14 SCAN: OVARIAN CANCER AUDIT Report on patients diagnosed 01/01/ /12/ Patient Data Summary Summary of numbers of patients, and patient data in all categories: see data summary table Age of patients at diagnosis: n = 129. All patients Patient age < > Total

15 2. Estimated Case ascertainment Cancer Registration data for the seven years from 2001 to 2007 indicates an annual average of (range ) new ovarian cancers diagnosed in SCAN. This compares to 141 patients (84.2%) recorded in audit during this analysis period. Scottish Cancer Registry Average Lothian Fife BGH SCAN** (Source: Scottish Cancer Registry, ISD) SCAN Audit registrations 2004* Average 2009 % of Cancer registry average Lothian Fife Borders SCAN *Figures for financial year (April - March) Cancer Registration figures include patients diagnosed though post mortem only, and are based on the date the patient first attends hospital, rather than the date of definitive diagnosis. 2 patients with pseudo myxoma peritonei were excluded from SCAN 2009 audit as these cancers are now thought to all arise from the GI tract

16 3. Referral Process 3.1 Specialties into which patients were initially referred. Graph showing the various specialties to which the patients were initially referred SCAN % 2% Gynaecology 23% 3% 66% General Surgery General Medicine Gastroenterology Respiratory Medicine Cardiology Geriatric Medicine Medical Oncology Palliative Medicine

17 3.2 Time from referral to first treatment: All Referrals n = 120. All patients, excluding 4 that declined treatment and 5 that died before treatment Time from referral to treatment 100% 90% 80% % patients 70% 60% 50% 40% 30% 20% 10% Lothian Fife BGH SCAN 0% >62 Time (days) n Median (days) Range Waiting time results for patients diagnosed with ovarian cancer for this cohort were reported through ISD, circulated to the Scottish Executive National Waiting Times Unit and were published on a quarterly basis. These figures differ as the ISD reports are split by urgency of referral, and do not include patients whose pathway was delayed through comorbidities, patient-induced delays, or for other clinical reasons. SCAN data n Median (days) 42* 36* Range *Excluding BGH data, which are not available

18 3.3 Time from seeing gynaecologist to date of surgery CSBS Standard 9. Essential criteria: 10 working day maximum between patient being informed she requires surgery and date of surgery. SCAN agreed 14 day maximum wait between decision to perform laparotomy and day of procedure. Scottish Government 31 day target: 31 day maximum from decision to treat to first definitive treatment (Better Cancer Care 2008). The national dataset does not include a field for date of decision to treat. Date of decision to perform laparotomy is assumed to be the date first seen by the gynaecologist. However, patients may see a gynaecologist several times with numerous investigations prior to a decision for laparotomy being made. n = 64. All patients seen by gynaecologist who went on to have surgery as first treatment, excluding 1 Lothian patient operated on by a general surgeon, and 3 Fife patients operated on by general surgeons 100% 90% Time from first seeing gynaecologist to laparotomy CSBS 10 working day target day target % patients 80% 70% 60% 50% 40% 30% 20% 10% Lothian Fife BGH SCAN 0% >56 Time (days) 2009 n Median (days) Range % compliance % <31 days SCAN data n Median (days) Range % compliance CSBS

19 3.4 Time from first seeing gynaecologist or gynae-oncologist to non-surgical treatment, as first line therapy Scottish Government 31 day target: 31 day maximum from decision to treat to first definitive treatment (Better Cancer Care 2008). Patients may see a gynaecologist or gynae oncologist several times with numerous investigations prior to a decision for non-surgical treatment being made. n = 52. All patients having non surgical treatment as first line therapy (includes no active treatment). Time from first seeing gynaecologist or gynae-oncologist to non-surgical treatment 100% 90% QIS 31 day target 80% 70% 60% 50% 40% 30% Lothian Fife BGH SCAN 20% 10% 0% >56 n Median (days) Range % < 31 days A review of the Lothian patients with waiting times for referral to treatment over 62 days was undertaken. In the 13 such patients who saw an oncologist for non-surgical treatment the mean time from seeing an oncologist (i.e. the date of the patient being told of the possible treatment) and the date of that treatment (usually chemotherapy ) was a median of 11 days (range 2-23 days). This implies any delay was prior to being seen or decision to treat. This target is not exactly measurable in the absence of a national dataset field to record date of decision to treat. The analysis above does not allow for any exclusions on grounds of e.g. patient choice or clinical complexity

20 3.5 Time from definitive surgery to start of chemotherapy SIGN 75 Guideline 5.2 : Chemotherapy should be started no later than eight weeks after surgery Time from definitive surgery to start of chemotherapy n =31. All patients who had surgery followed by chemotherapy Time from surgery to chemotherapy 100% 90% 80% % patients 70% 60% 50% 40% 30% 20% 10% Lothian Fife BGH SCAN 0% >56 Time (days) n Median (days) Range % compliance Lothian: Of the 5 patients who did not meet the 8 week guideline. 1 was delayed through comorbidities, 1 was delayed through referral from general surgery, 3 had completion surgery before chemo (2 had low risk of malignancy (RMI) prior to their first operation and the third wished to try fertility preserving surgery but due to stage of tumour then decided against this). Fife: 1 patient had a laparotomy performed by a general surgeon prior to being seen by a gynaecologist, following which there was a patient induced delay prior to chemotherapy. SCAN data n Median (days) Range % Compliance

21 4. Investigations CSBS Standard 2: The following are to be organised as a minimum: CA125 level; abdominal and pelvic ultrasound and/or CT scan n = 129. All patients CA 125 Performed Not performed Not recorded Total Lothian: Both Lothian patients had CA125 done but not within the correct time frame to be used as a baseline for future reference. % Performed in previous years Year Lothian Fife BGH DGRI SCAN Imaging (US/ CT /MRI) Performed Not performed Not recorded Total BGH: 1 patient with low RMI was not suspected preoperatively, 1 patient had no imaging as per protocol. % Performed in previous years Year Lothian Fife BGH DGRI SCAN

22 5. Preoperative Preparations 5.1 CSBS Standard 10: All patients considered suitable for surgery will have appropriate pre-operative preparation. Preparation to include: Chest x-ray, DVT prophylaxis, antibiotic prophylaxis, bowel preparation if disease likely to be extensive. n = 68. All patients undergoing surgery as first treatment Chest Imaging Performed Not performed Not recorded Total Lothian: Of the 5 with no chest imaging, 3 were low RMI and found to be Borderline, and 2 had no chest imaging as per protocol. Fife: Of the 4 patients with no chest imaging, 1 patient had surgery performed by a general surgeon. 3 patients had a low RMI and were found to be Borderline (not requiring imaging) Borders: 1 patient with low RMI was not suspected preoperatively, 1 patient had no chest imaging as per protocol. In total 4 patients out of 68 failed to have chest imaging performed as per protocol in SCAN. % Performed in previous years Year Lothian Fife BGH DGRI SCAN

23 DVT prophylaxis Performed Not performed Not recorded Total Lothian: 1 patient had no DVT prophylaxis during laparoscopic removal of cyst, later found to be Borderline. Antibiotic prophylaxis Performed Not performed Not recorded Total Data for DVT and antibiotic prophylaxis are not available from 2006 / 2007 for comparison. Lothian: 2 patients had no antibiotic prophylaxis (as per protocol), both had hysterectomy, BSO and omentectomy

24 6. Surgical Treatment 6.1 CSBS standard 11a: All patients with suspected ovarian cancer to be operated on only by a designated gynaecological surgeon or referred to a gynaecological oncologist. In 2009 SCAN had 4 trained sub-specialty consultant gynaecological oncologists and 3 gynaecologists with special interest in oncology. n = 68. All patients having surgery as first treatment Clinician Sub-specialty trained Gynaecology surgeon with special interest Gynaecologist General surgeon Total % of patients in SCAN were operated on by sub-specialty consultant gynaecological oncologists or a gynaecologist with special interest in oncology. Lothian: The 2 patients operated on by gynaecologists were not suspected cancer cases pre-op (i.e. low Risk Of Malignancy Index). Both the cases done by general surgery were emergency cases. Fife: Of the 3 patients operated on by general surgeons, 2 were emergencies, and one was a converted diagnostic laparoscopy involving the bowel. BGH: Of the 3 patients operated on by gynaecologists, 2 were emergencies and one had a low RMI where ovarian cancer was not suspected pre-op. % Operated on by sub-specialty trained or special interest gynaecologists in previous years Year Lothian Fife BGH DGRI SCAN

25 6.1a SIGN : All patients with (FIGO) stage 3 disease should be operated on by a gynaecological oncologist rather than a general gynaecologist or general surgeon. n = 14. All patients having surgery as first treatment with FIGO stage 3 Sub-specialty trained gynaecologist Stage I Stage II Stage III Stage IV Not recorded Total Clinician n % n % Dr Busby - Earle Dr Farquharson Dr Martin Dr Walker Special Dr Macnab interest Dr Pinion gynaecologist Court General gynaecologist Abdel-All Kallat McCullough Milne Rodger Gen Surgeon General Surgeon Totals Total sub specialty trained / special interest surgical patients in SCAN were staged with FIGO IIIA, IIIB or IIIC 78.6% of those were operated on by a sub-specialty trained gynaecologist. 14.3% were operated on by a gynaecologist with special interest in oncology. 7.1% were operated on by general gynaecologists or general surgeons

26 6.2 Fertility Preserving Surgery CSBS standard 11b: In young women, the possibility of germ cell tumours is considered. Fertility preserving surgery to be performed in most cases. If germ cell tumour is confirmed, patient to be referred to regional oncology centre. n =2. All women under 30 at diagnosis Fertility preserving surgery in women under 30 at diagnosis Lothian % Fife % BGH % SCAN % Performed Not performed Total under % Performed in previous years Year Lothian Fife BGH DGRI SCAN n/a n/a n/a n/a n/a Patients undergoing appropriate surgical procedures CSBS Standard 11c2: All patients considered suitable for surgery to have appropriate surgical procedure carried out. Not all patients will be appropriate for surgery as first treatment. n = 89. All patients having surgical procedures 89 patients were surgically assessed: 71 patients had laparotomy, 65 of which were first treatment. 18 patients had laparoscopies, 3 of which were first treatment (all of the patients treated laparoscopically had normal RMI, and had oophorectomies only. 2 were Borderline and 1 was sex cord that went on to completion surgery) 68 patients had surgery as first treatment

27 6.4 Surgical Incision CSBS standard 11c3: Vertical incision is made. This is to ensure a good exposure of the upper abdomen to assess the full peritoneal cavity. n = 68. All patients having surgery as first treatment Incision Midline (vertical) Paramedian (vertical) Low transverse Transverse muscle cutting Laparoscopy only Not recorded Total Lothian: One patient had a transverse incision where cancer was not suspected prior to laparotomy, FIGO 1C. BGH: 2 patients had transverse incisions: 1 was a Borderline tumour FIGO 1a which was not suspected pre-operatively, the other was a sex cord tumour FIGO 1C. % Vertical incisions performed in previous years Year Lothian Fife BGH DGRI SCAN 2006 NA NA 2007 NA NA Lothian figures for 2006 and 2007 are not available for comparison

28 6.5 Washings / ascitic fluid sampling CSBS standard 11c4: Washings or ascitic fluid should be sent for cytology n = 68. All patients with surgery as first treatment (laparotomy / laparoscopy) Washings/ Ascites Fluid Sampled Not Sampled Total Washings/ Ascites Result Positive Negative Total Lothian: Of the 6 cases with peritoneal washings not sent, 2 had a normal RMI preoperatively (i.e. cancer was not suspected); 2 were operated on by colorectal surgeons as an emergency. 2 should have had washings sent as routine but did not. Fife: All 3 with no peritoneal washings sent were operated on by general surgeons. % Performed in previous years Year Lothian Fife BGH DGRI SCAN

29 6.6 Primary cytoreductive surgery CSBS standard 11c5: Primary cytoreductive surgery to be attempted and to include a total or subtotal hysterectomy and bilateral salpingo-oophorectomy All patients having hysterectomy n = 68. All patients having surgery as first treatment No uterus present preoperatively Uterus present preoperatively Total surgical patients Total hysterectomy Sub total hysterectomy Fertility preserving surgery No hysterectomy Total with uterus recorded as present preoperatively Lothian: Of the 9 patients with no hysterectomy performed 3 had low RMI (i.e. cancer not suspected preoperatively), one was very frail, 4 were inoperable and one was considering fertility issues but then went on to completion surgery later. Fife: Of the 5 patients with no hysterectomy, 3 patients had surgery performed by a general surgeon, 1 patient was thought to be benign and 1 patient was inoperable % Performed in previous years (total + sub-total hysterectomy) Year Lothian Fife BGH DGRI SCAN

30 6.6.2 Patients having unilateral or bilateral oophorectomy n = 68. All patients with ovaries recorded as present pre-operatively Unilateral Bilateral Ovarian biopsy only (intention to treat) No oophorectomy Not recorded Total with ovaries recorded as present pre-op Lothian: One patient had no oophorectomy as the ovaries were not resectable. Fife: One patient had no oophorectomy was operated on by a general surgeon, and the ovary was not resectable. % Performed in previous years (bilateral + unilateral) Year Lothian Fife BGH DGRI SCAN

31 6.7 Omentectomy / omental biopsy CSBS standard 11c6: Omentectomy and/or omental biopsy performed n= 68. All surgical patients having surgery as first treatment Omentectomy Omental biopsy No omental tissue taken Total surgical patients Lothian: All 5 cases with no omental tissue taken had low RMI prior to surgery (i.e. cancer was not suspected) Fife: Both patients had surgery performed by a general surgeon. % Performed in previous years (omentectomy + omental biopsy) Year Lothian Fife BGH DGRI SCAN

32 6.8 Record of Residual disease CSBS standard 11c7: Record of residual disease to be made n= 68. All patients having surgery as first treatment Residual disease Recorded Not recorded Total surgical patients Lothian: Of the 10 cases with no record of residual disease, 4 were not suspected cancer preoperatively (normal RMI), 2 were operated on by general surgeons as emergencies. There were 4 cases where a record should have been made by gynaecologists. % Recorded in previous years Year Lothian Fife BGH DGRI SCAN Surgical Assessment FIGO CSBS standard 11c9: Surgical pathological stage is recorded in case notes n = 89. All surgically assessed patients, includes open and shut cases FIGO Recorded Not recorded Total patients Lothian: Measures are now being put in place to capture this data on new operation notes. % Recorded in previous years Year Lothian Fife BGH DGRI SCAN

33 7. Post operative management: Pathology CSBS: Essential criterion: Type, sub-type and grade of disease are recorded. 7.1 Type/Sub-Type n = 117. All patients with histology, includes cytology samples Recorded Not recorded Total patients with histology % Recorded in previous years Year Lothian Fife BGH DGRI SCAN , Grade of Disease n = 90. All patients with histological samples where grading is applicable Total with histology Grading inapplicable* *Not applicable to grade, or not possible to grade (e.g., cytology) Recorded Not recorded Total patients with histology applicable to grade Lothian: Both cases where grade was not recorded were reported by pathologists specialising in bowel pathology. % Recorded in previous years Year Lothian Fife BGH DGRI SCAN ,

34 7.3 Final FIGO on pathology report - Surgical patients n = 89. All patients having surgical assessment, includes open and shut cases Recorded Not recorded Total surgically assessed Lothian: Of the 5 cases with no final FIGO documented, 4 had very advanced inoperable disease and the 5 th was not fully staged due to fertility issues. BGH: One patient with no final FIGO documented had initial laparotomy where resection was not possible and no surgical FIGO was noted, the final FIGO was not documented after the delayed primary surgery. % Recorded in previous years Year Lothian Fife BGH DGRI SCAN

35 8. Chemotherapy management SIGN 75: 5.5.1A: First line chemotherapy of epithelial ovarian cancer should include a platinum agent either in combination or as a single agent, unless specifically contraindicated. Exclude: Patients with no histological sample taken, patients with Borderline tumours and patients who declined chemotherapy. n = 66. All patients with epithelial ovarian cancer that received chemotherapy, excluding 3 patients that declined all treatment, and 2 patients that died before treatment. Platinum based Platinum alone Platinum + taxane Total Reasons for no chemotherapy Died post surgery/biopsy 0 Early stage tumour 15 Too frail / comorbidities 4 Declined chemotherapy 0 Not recorded 1 Total 20 % Performed in previous years (platinum ± taxane) Year Lothian Fife BGH DGRI SCAN

36 9.0 Post Chemo surgery / Delayed primary surgery n = 129. All patients, includes patients with neoadjuvant and adjuvant chemo. Subsequent Surgery Interval debulking / Delayed primary surgery Post chemo surgery Not performed* Inapplicable (no chemo) Total * Includes patients with previous complete surgery, and those that were inoperable post chemotherapy. Lothian: 2 patients had post chemo surgery, both had neoadjuvant chemo as first treatment. 1 patient had surgery as first treatment and went on to interval debulking surgery. Fife: All of the delayed primary surgery patients had neoadjuvant chemo as first treatment. BGH: All of the delayed primary surgery patients had neoadjuvant chemo as first treatment

37 10. Clinical Trials CSBS Essential Criteria: Patients being offered clinical trials is recorded. Clinical trial entry is recorded. n = 129. All patients Clinical trials DNA Methylation study Entered in trial Not entered in trial % Entered in trial Total patients Accrual figures for Surgical and Clinical Trials (offered and accepted) are regularly reported to the Scottish Executive by Scottish Cancer Research Network (SCRN)

38 11. Outcomes 11.1 Thirty Day Mortality Surgical mortality within 30 days is subject to automatic review. Following the NCEPOD report on chemotherapy 30 days mortality (2009) from chemotherapy is also now subject to close review and scrutiny. 11.1a Post Operative Deaths (30 days or less from date of primary surgery) n = 68. All patients undergoing surgery Number of post op deaths Total surgical patients % Post op deaths in previous years Year Lothian Fife BGH DGRI SCAN

39 11.1b Post Chemotherapy Deaths (30 days or less from start date of chemotherapy) NB: National dataset currently only includes start date of chemotherapy, not date of any chemotherapy. n =73. All patients undergoing chemotherapy Number of post chemo deaths Total no patients undergoing chemotherapy patients died within 30 days of chemotherapy. Lothian: All 5 had locally advanced stage IIIC and IV ovarian cancer where surgery had not been successful (1) or felt likely to be unsuccessful (4). All died in the Edinburgh Cancer Centre after their first dose of chemotherapy with carboplatin as inpatients. Three patients died of progressive cancer on days 21, 22 and 25 post chemotherapy. One patient died of a sudden pulmonary embolus and another of an acute myocardial infarct 19 and 21 days chemotherapy respectively. Both chemotherapy and advanced cancer are known to increase the risk of clots and both were on prophylactic doses of blood thinning. None of the five patients had evidence of neutropenic sepsis. Fife: One patient died 13 days post 1st cycle of chemotherapy for stage IV disease. She had a poor performance status and there was clear discussion of risks of chemotherapy with patient and family. The patient died of thromboembolic disease and progression of cancer. There was no evidence of neutropenic sepsis. Reports prior to 2008 included deaths within 60 days of 1 st cycle of chemo % Post chemo deaths in previous years NB: 60 days or less from start date of chemo Year Lothian Fife BGH DGRI SCAN % Post chemo deaths (30 days or less from start date of chemo)

40 11.1c Post Treatment deaths (Within 30 days of first treatment date) (Treatment includes surgery, chemotherapy, no active treatment) n = 120. All patients undergoing treatment No of post treatment deaths Total no patients that received treatment % Post Treatment deaths in previous years (30 days or less from date of first treatment, or decision not to treat) Year Lothian Fife BGH DGRI SCAN

41 11.2 Residual Disease Survival in ovarian cancer is directly related to residual disease i.e. the amount of cancer left behind at the end of surgery. The less disease (under 1cm) the more likely 5 year survival without relapse. This is a indicator of the quality of surgery, but also dependent upon the amount of disease at the start of the operation. n =68. All patients undergoing surgery as first treatment No residual disease < 1 cm cm > 5 cm Residual disease size not recorded Total surgical patients Lothian: Of the 10 patients with no residual disease size recorded, 2 were operated on by general surgeons, 4 had normal RMI, a further 2 were not suspected to have cancer pre-operatively, 2 had no record of residual disease size. Fife: The patient that had no residual disease size recorded was operated on by a general surgeon. % No residual disease or <1cm in previous years. Year Lothian Fife BGH DGRI SCAN

42 11.3 Survival: CSBS: Desirable criteria: 1, 2, and 5-year survival rates are audited. Regular reporting of case mix and outcome. Survival figures are given below. They will vary from year to year given the small number of patients and the case mix (stage of disease at presentation). Cause of death is taken from the GRO data (death certificate). Over 93% of these are due to advanced ovarian cancer rather than other disease Patients diagnosed Patients with no known death date checked against dates last seen alive. Patients diagnosed in 2006 (excluding 24 Borderline tumours, 2 patients that died before treatment, and 5 that declined treatment) SCAN Total At 6 months At 1 year At 2 years At 3 years 2006 patients Dead Alive % survival Dead Alive % survival Dead Alive % survival Dead Alive % survival Stage I - II Stage III No stage* Totals Patients diagnosed in 2007 (excluding 26 Borderline tumours, 4 patients that died before treatment, and 2 that declined treatment) SCAN Total At 6 months At 1 year At 2 years 2007 patients Dead Alive % survival Dead Alive % survival Dead Alive % survival Stage I - II Stage III No stage* Totals Patients diagnosed in 2008 (excluding 25 Borderline tumours, 5 patients that died before treatment, and 3 that declined treatment) SCAN Total At 6 months At 1 year 2008 patients Dead Alive % survival Dead Alive % survival Stage I - II Stage III No stage* Totals

43 Patients diagnosed in 2009 (excluding 25 Borderline tumours, 5 patients that died before treatment, and 3 that declined treatment) SCAN Total At 6 months 2009 patients Dead Alive % survival Stage I - II Stage III No stage* Totals *Presumptive diagnoses, or inadequate information to assign FIGO stage (checked against trials database)

44 12. Multidisciplinary Meeting CSBS Standard 3d stipulates that the management of patients with cancer should be multidisciplinary. Discussed at MDM Not discussed at MDM Not recorded Total

45 Ovarian Cancer Glossary of Terms Adenocarcinoma A malignant growth of glandular tissue, adenocarcinoma can develop in any gynaecological organ. Adjuvant treatment Treatment used in addition to main treatment, usually chemotherapy given after surgery. Adnexal mass Mass of tissue on or in a structure associated with the uterus such as an ovary, fallopian tube, or uterine ligament. Ascites An accumulation of fluid in the abdominal (peritoneal) cavity. Audit A method by which those involved in providing services assess the quality of care. Results of a process or intervention are assessed, compared with a pre-existing standard, changed where necessary, then reassessed. Biopsy Removal of a sample of tissue or cells from the body to assist in diagnosis of a disease. Borderline Tumour Tumours of low malignant potential based on the microscopic appearance of the cancer. They are expected to behave as very low grade cancers, i.e., to be very slow growing Carcinoma A cancerous growth. CA125 A substance which may be found in the blood of women who have ovarian cancer, used as a biochemical marker for the disease. Chemotherapy The use of drugs that kill cancer cells, or prevent or slow their growth. Cytology The study of the appearance of individual cells under a microscope. Cytotoxic Toxic to cells. This term is used to describe drugs which kill cancer cells or slow their growth.3 Debulking Removal by surgery of a substantial proportion of cancer tissue. Optimal debulking refers to the removal of the largest possible amount of cancer while limiting damage to normal tissue; interval debulking refers to surgical removal of tumour after chemotherapy aimed at further reducing its bulk. Differentiation The degree of morphological resemblance between cancer tissue and the tissue from which the cancer developed. Exenterative surgery Removal of the pelvic organs including the uterus, ovaries and associated organs and the bladder and/or large bowel. FIGO International Federation of Gynaecology and Obstetrics. FIGO defines staging in gynaecological cancer and collates information about treatment and survival from a group of collaborating European centres (including some in the UK)