OVARIAN CANCER 2011 COMPARATIVE AUDIT REPORT

Transcription

1 SOUTH EAST SCOTLAND CANCER NETWORK PROSPECTIVE CANCER AUDIT OVARIAN CANCER 2011 COMPARATIVE AUDIT REPORT Dr Melanie Mackean, NHS Lothian SCAN Lead Ovarian Cancer Clinician Dr Jane Macnab, NHS Fife Dr Scott Fegan, NHS Fife & NHS Lothian Dr Adrian McCullough, NHS Dumfries and Galloway Dr Queenie Menezes, NHS Borders Dr Graeme Walker, NHS Lothian Dr Lorna Bruce, NHS Lothian SCAN Ovarian Cancer Audit Facilitator Martin Keith, Cancer Audit Facilitator, NHS Dumfries and Galloway Alistair Meikle, Cancer Audit NHS Facilitator, Borders Jackie Stevenson, Cancer Audit Facilitator, NHS Fife SA Ov01/13W SCAN Audit Office, c/o Department of Clinical Oncology, Western General Hospital, Crewe Road, Edinburgh, EH4 2XU T: F: W:

2 Contents Document History...3 SCAN Chair Commentary...4 Change in practice...5 Action points from 2010 Audit...6 Action points from 2011 Audit...7 Attainment of Standards...8 Introduction and Methods Estimated Case ascertainment Referral Process Specialties into which patients were initially referred in SCAN Time from referral to first treatment Time from decision to treat to date of surgery Time from decision to treat to non-surgical treatment Time from definitive surgery to start of chemotherapy Investigations Preoperative Preparations Surgical Treatment NHS QIS 6a 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 Final FIGO All Patients Chemotherapy management Post Chemo surgery / Delayed primary surgery Clinical Trials Outcomes Thirty Day Mortality a Post Operative Deaths b Post Chemotherapy Deaths c Post Treatment deaths Residual Disease Survival: Multidisciplinary Meeting...39 Ovarian Cancer Glossary of Terms...45

3 Document History v Date Events Actions 1 25/10/12 First draft circulated to SCAN Gynae Group Some Fife data revisions. Typo for referral to treatment ranges corrected. 2 05/11/12 Circulated to Lead clinicians prior to meeting. Changes from meeting made, including typos and additional graphs. SCAN chair comments added 3 20/12/12 Final draft circulated to SCAN gynae group Minor typos corrected 4 24/12/12 Final report circulated to the Health Board Clinical Governance Groups and to the RCPG. Also numbered and lodged on audit report index. 5 June 2013 Checked for disclosive material Published on the SCAN Website SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 3

4 SCAN Chair Commentary There is again much to commend in this report, in particular the improvements in patients having any bulk tumour (over 1cm) left after surgery. My thanks to all the staff involved in this report and the hard work that goes on to collect all this data and in the analysis involved. Work is currently ongoing on the new ovary QPI (Quality Performance Indicators) and we have removed the data on preoperative outcomes as this has been very high compliance for many years. More focus in the future will be on patient outcomes rather than on recording of data, however there is still recording of residual disease at operation that could be improved. Residual disease has very important prognostic implications for the patients. Over 30% of patients in 2011 continue to present through non gynaecology, emergency routes and the work of the Early Cancer Diagnosis group in Scotland and NICE guidelines on early diagnosis of ovarian cancer in 2011 will hopefully begin to have some impact on this figure in the future. One change in this audit has been the increase in patients not presented for discussion at the MDM and contact has already been made with geriatrics in particular to see how we can improve ease of referral to the MDM. There is an ongoing issue of patients not having full staging procedures at their operation but this is in large part due to the problem of diagnosing ovarian cancer versus benign disease preoperatively and is discussed below. RMI (Risk of Malignancy Index) and the difficulties to diagnose ovarian cancer on this index Every effort is made to diagnose ovarian cancer before an operation, however roughly only one in every 3 ovarian cysts will be cancer; the other 2 will be benign disease. To avoid overburdening cancer services with benign disease gynaecologists will calculate the RMI, using a combination of ultrasound and CA125 blood level. This again is not perfect but helps identify most patients very likely or very unlikely to have ovarian cancer. This tool is discussed well in the NICE guidelines on early detection of ovarian cancer published in 2011: The evidence for this topic comprised one good quality systematic review of diagnostic studies (Geomini et al., 2009) in which the reviewers appraised 109 studies of eighty-three validated risk of malignancy models. By pooling data appropriately the authors concluded that the RMI I proposed by Jacobs et al., (1990) was superior in terms of sensitivity and specificity to the other comparators. With a cut-off score of 200, sensitivity = 78% [95%CI: 71-85%] and specificity = 87% [95%CI: 83-91%] and with a cut-off score of 50, sensitivity = 91% [95%CI: 85-97%] and specificity = 74% [95%CI: 69-80%]. A sensitivity of 78% means, using a cut off RMI score of greater than 200, 78% of women with ovarian cancer will be identified. Sadly it means 22% of ovary cancer patients will have a RMI score less than 200 and not be identified preoperatively. In keeping with this we see in our audit 22 out of 158 patients with ovarian cancer despite a low RMI who were not identified preoperatively and therefore some did not have full surgical procedures. SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 4

5 Change in practice - 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 was 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. A separate SCAN wide audit of patients undergoing NACT and delayed primary surgery has been performed. Current ovarian cancer patient pathway 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 SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 5

6 Action points from 2010 Audit Report Section Possible area for improvement Proposed action Progress on Action p13 NHS QIS standard 6c5 Better recording of incisions and residual disease Mandatory op note for Lothian patients having delayed primary surgery Operation Pro Forma has been circulated to all four Gynaecology Oncology Consultant surgeons. If adopted this will result in clear recording of residual disease, incisions and surgical FIGO NHS QIS standard 2a5 Referral to first treatment times NHS QIS standard 2a5 Time to laparotomy New gynae-oncology consultant appointment for 2012 Improved theatre times and links with colorectal service for joint procedures Dedicated theatre time to be allocated in advance Scott Fegan was appointed as a consultant gynaecology oncology consultant to Fife / Edinburgh as a joint post at the beginning of July However Fife remains short staffed. David Anderson in discussion as clinical director of general surgery regarding joint operating lists at the WGH, results of decision awaited. 5.1 NHS QIS 5a1 Chest imaging to be carried out prior to surgery Review all patients with no pre-op chest imaging Out-dated standard. Reporting on this measure can now be dropped a NHS QIS 5a1 Recording DVT and Antibiotic prophylaxis (Lothian) SIGN NHS QIS 6a.2 All patients with stage 3 disease should be operated on by a gynaecological oncologist Data to be obtained from theatres electronic system Review all patients with stage 3 or 4 disease not operated on by gynaecological oncologist Monthly extracts from ORSOS (theatre system) now provide this data. Reporting on this measure can now be dropped. Data on 4/21 (19%) Stage III patients not operated on by a gynaecological oncologist was reviewed and it was found that one was an emergency, two were not suspected cancer preoperatively, and one was treated urgently due to symptoms. SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 6

7 Action points from 2011 Audit Report Section 6.8 & 6.9 Possible area for improvement Action brought forward from Recording of residual disease / Recording of surgical FIGO Proposed action Standardised op note throughout SCAN. Fife template to be considered. Operation notes to be available on TRAK Which clinical standard will this meet? NHS QIS 6c5 NHS QIS 6c7 3.2 Action brought forward from Time to laparotomy Improved theatre times and links with colorectal service for joint procedures Dedicated theatre time to be allocated in advance David Anderson in discussion as clinical director of general surgery regarding joint operating lists at the WGH, results of decision awaited. NHS QIS standard 2a5 6.5 Fluid should be sent for cytology Review RMI calculations NHS QIS 6c2 6.7 Omental biopsy should be performed Review RMI calculations NHS QIS 6c5 12 All patients with ovarian cancer should be discussed at the MDM Review patients not discussed at MDM, and feedback to clinicians in charge of care. NHS QIS 3a4 SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 7

8 Attainment of Standards Ref Standard SIGN 75 Guideline 5.2 : Chemotherapy should be started no later than eight weeks after surgery NHS QIS 2a1 Minimum investigation: CA125 level to be organised NHS QIS 2a1 Minimum investigation: abdominal and pelvic ultrasound and/or CT scan a 6.2 NHS QIS 6a: All patients with a suspected diagnosis of ovarian cancer are operated on by a designated and trained gynaecological surgeon SIGN : All patients with (FIGO) stage 3 disease should be operated on by a gynaecological oncologist rather than a general gynaecologist or general surgeon. (Surgery as first treatment, excluding delayed primary surgery patients) NHS QIS 6b3: In young women, aged 30 or less, the possibility of germ cell tumours is considered. Fertility conserving surgery is planned and performed at laparotomy NA NHS QIS 6c1: Vertical incision is made Less than 75% 75 to 95% Over 95% SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 8

9 Attainment of Standards Ref Standard 6.5 NHS QIS 6c2: Washings or ascitic fluid should be sent for cytology NHS QIS 6c3: Primary cytoreductive surgery to be attempted and to include a total or subtotal hysterectomy NHS QIS 6c3: Primary cytoreductive surgery to be attempted and to include salpingo-oophorectomy NHS QIS 6c4: Omentectomy and/or omental biopsy performed NHS QIS 6c5: Record of residual disease to be made NHS QIS 6c7: FIGO surgical stage is recorded in case notes NHS QIS 8a3: Histological type, sub-type and grade of disease are recorded NHS QIS 6c8: Final FIGO surgical pathological stage is 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. NHS QIS 3a4: All patients confirmed to have ovarian cancer after surgery are discussed at the MDT meeting and follow up treatment organised. Less than 75% 75 to 95% Over 95% SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 9

10 Introduction and Methods SCAN Ovarian Cancer Audit Overview This report relates to patients diagnosed with ovarian cancer (including primary peritoneal and Borderline tumours) between 1st January 2011 and 31st December 2011 within the SCAN region of NHS Borders, Fife, D&G and Lothian. 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 NHS Quality Improvement Scotland (NHS QIS) in 2008, and by the Scottish Government Health Department, and is 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: 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 and was performed on the 2010 data with the following percent accuracies recorded: Lothian 95.8%, Fife 97.3%, Borders 86.6% and Dumfries 90.5%. Case ascertainment for the current reporting period is compared with the latest Scottish Cancer Registration 5 year average. Actions for Improvement After final sign off, the process is for the report to be sent to the Clinical Governance groups within the four health boards and to the Regional Cancer Planning Group. Action plans and progress with plans will be highlighted to the groups. The report will be placed on the SCAN website once it has been fully signed-off and checked for any disclosive material. Action points for 2011: as part of clinical sign-off areas for improvement are highlighted in the Action Plan 2011 on page 6. Action points from 2010 results: information is provided on progress with Action Plans for SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13 W 10

11 1. Estimated Case ascertainment Cancer Registration data for the 5 years from 2006 to 2010 indicates an annual average of 172 (range ) new ovarian cancers diagnosed in SCAN. This compares to 158 patients (91.9%) recorded in audit during 2011 Scottish Cancer Registry Average Lothian Fife BGH D&G SCAN Source: Scottish Cancer Registry, ISD (19/09/2012) Cancer Registration figures are based on the date the patient first attends hospital, rather than the date of definitive diagnosis and include patients diagnosed though post mortem only. SCAN Audit registrations Average Lothian Fife BGH D&G SCAN SCAN Audit figures for 2011 compared with 5 year Cancer Registry average from % Estimated Case Ascertainment. Lothian 104 Fife 70 BGH 54 D&G 100 SCAN 92 The lower case ascertainment in Fife and Borders has been reviewed and no cause was found other than variation due to small numbers. SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13 W 11

12 2. Age at Diagnosis Age of patients at diagnosis: n = 158 All patients Patient age > Total Median age: 69 Range: (23-91) SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13 W 12

13 3. Referral Process 3.1 Specialties into which patients were initially referred in SCAN Gynaecology (51%) General Surgery (14%) Accident & Emergency (10%) General Medicine (6%) Gastroenterology (6%) Geriatric Medicine (4%) Diagnostic Radiology (3%) Respiratory Medicine (3%) Medical Oncology (2%) Urology (1%) Over half of patients were referred through gynaecology, but over 30% came via gastroenterology, A& E and general medicine. This is in keeping with data from England on ovarian cancer. Routes to diagnosis for ovarian cancer, England (2007) Ovarian cancer patients (n = 5012) % Two Week Wait 26 GP referral 22 Other outpatient 15 Inpatient elective 1 Emergency presentation 29 Death Certificate Only 1 Unknown 6 Total 100 This concern about ovarian cancer presenting late and to emergency departments has led to the NICE guideline, Ovarian cancer: the recognition and initial management of ovarian cancer being published in 2011 with several key recommendations. There has been a Scottish wide initiative to Detect cancer early. As part of this initiative a new tumour markers bookmark has been developed in early 2012 for all GPs including guidance on CA125 testing. This is being disseminated through work in the Scottish Primary Care Cancer Group. In SCAN gynae group a protocol and pathway for raised CA125 has been developed for GPs in Lothian to aid in this initiative. Work is underway to disseminate this in SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13 W 13

14 3.2 Time from referral to first treatment: All Referrals NHS QIS 2a5: Assessment, investigations, treatment planning and first treatment are completed within 62 days of first referral in accordance with Scottish Government Health Department guidelines. n = 154. All patients, excluding 2 that declined treatment and 2 that died before treatment 100% Ovarian Cancer Patients - SCAN 2011 Time from referral to treatment % patients 90% 80% 70% 60% 50% 40% 30% 20% 10% Lothian Fife BGH DGRI SCAN 0% >62 Time (days) 2011 n Median (days) Range SCAN data 2007* n Median (days) 36* Range *Excluding BGH data, which are not available SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13 W 14

15 3.3 Time from decision to treat to date of surgery Scottish Government 31 day target: 31 day maximum from decision to treat to first definitive treatment (Better Cancer Care 2008). Decision to treat date is not part of the National dataset and is taken from waiting times tracking data where possible. These times do not take waiting times adjustments into account. n = 62. All patients who had surgery as first treatment. Ovarian Cancer Patients - SCAN 2011 Time from decision to treat to laparotomy 100% 90% 80% % patients 70% 60% 50% 40% 30% 20% 10% Lothian Fife BGH DGRI SCAN 0% >56 Time (days) 2011 n Median (days) Range % 31 day target compliance SCAN data n Median (days) Range % compliance 31d target Data for previous years is unavailable as waiting times decision to treat date has only been audited since SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13 W 15

16 3.4 Time from Decision to Treat 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). Decision to treat date is not part of the National dataset and is taken from waiting times tracking data where possible. These times do not take waiting times adjustments into account. n = 92. All patients having non surgical treatment as first line therapy (includes no active treatment). 61 patients had chemotherapy, 10 had hormone therapy and 21 had no active treatment. Ovarian Cancer Patients - SCAN 2011 Time from decision to treat to non-surgical treatment 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% >56 Lothian Fife BGH DGRI SCAN n Median (days) Range % 31 day target compliance patients were outwith the 31 day target. One due to patient illness, one due to a complex presentation and pathway of their cancer and two due to the decision changed from surgery to non surgical treatment SCAN data n Median (days) Range % 31 day target compliance Data for previous years is unavailable as waiting times decision to treat date has only been collected since SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13 W 16

17 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 = 25. All patients who had surgery followed by chemotherapy Ovarian Cancer Patients - SCAN 2011 Time from surgery to chemotherapy 100% 90% 80% % patients 70% 60% 50% 40% 30% 20% 10% 0% >56 Time (days) Lothian Fife BGH DGRI SCAN 2011 n Median (days) Range NA % SIGN guideline compliance Lothian: 2 out of 13 patients waited longer than 8 weeks: 1 required completion surgery before chemotherapy and one was initially thought to be a benign pathology. SCAN data n Median (days) Range % Compliance SIGN SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13 W 17

18 4. Investigations NHS QIS 2a1: The following basic investigations are to be organised once ovarian cancer is suspected or a mass detected: CA125 level; abdominal and pelvic ultrasound and/or CT scan. n = 158. All patients CA 125 Performed Not performed Not recorded Total Lothian: 5 patients without CA125 tested were not initially suspected ovarian cancers. D&G: 1 patient had CA125 measured prior to GP referral % Performed in previous years Year No data n = 158. All patients, excluding 20 patients with stage 1 Borderline tumours Imaging Performed Not performed Not recorded Total % Performed in previous years (All patients excl. stage 1 borderline after 2009) Year SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13 W 18

19 Patients with Stage 1 Borderline (n = 20) Imaging Performed Not performed Not recorded Total Preoperative Preparations 5.1 NHS QIS 5a1: All patients considered suitable for surgery will have appropriate pre-operative preparation. Preparation to include: Chest x-ray, DVT prophylaxis and antibiotic prophylaxis. Bowel preparation and Pre-op chest imaging are no longer current practice, so are not documented. DVT and antibiotic prophylaxis are standard practice and results are now routinely documented. SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13 W 19

20 6. Surgical Treatment 6.1 NHS QIS 6a: All patients with suspected ovarian cancer to be operated on only by a designated gynaecological surgeon or referred to a gynaecological oncologist. In 2011 SCAN had 4 trained sub-specialty consultant gynaecological oncologists and 3 gynaecologists with special interest in oncology. n = 40. All patients with suspected ovarian cancer having surgery as first treatment Surgical patients with suspected ovarian cancer Clinician Sub-specialty trained Gynaecology surgeon with special interest Total % of suspected ovarian cancer patients in SCAN were operated on by sub-specialty consultant gynaecological oncologists or a gynaecologist with special interest in oncology. n = 62. All patients having surgery as first treatment (includes 22 patients where cancer was not suspected pre-op) All surgical patients Clinician Sub-specialty trained Gynaecology surgeon with special interest Gynaecologist Urologist Total % Operated on by sub-specialty trained or special interest gynaecologists in previous years for all patients (suspected & unsuspected) Year No data SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 20

21 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 = 12. All patients having surgery as first treatment with FIGO stage 3 disease. Sub-specialty trained gynaecologist Special interest gynaecologist General gynaecologist Stage I Stage II Stage III Stage IV Total Clinician Dr Busby - Earle Dr Farquharson Dr Martin Dr Walker Dr Macnab Dr McCullough Dr Pinion Brady McKinley Mensah Stanczuk Other specialty Urologist Totals Total sub-specialty trained / special interest patients with surgery as first treatment in SCAN were staged with FIGO IIIA, IIIB or IIIC 66.7% of those were operated on by a sub-specialty trained gynaecologist. 25% were operated on by a gynaecologist with special interest in oncology. 1 patient was operated on by a general gynaecologist and was an incidental finding at laparotomy for another condition. SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 21

22 6.2 Fertility Preserving Surgery NHS QIS 6b3: 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 = 4. All women under 30 at diagnosis Fertility preserving surgery in women under 30 at diagnosis Lothian % Fife % BGH % D&G % SCAN % Performed NA Not performed Total under NA NA % Performed in previous years Year n/a n/a n/a n/a n/a 100 No data 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 = 84. All patients having surgical procedures 84 patients were surgically assessed: 64 patients had laparotomy, 54 of which were first treatment. 20 patients had laparoscopies, 8 of which were first treatment 62 patients had surgery as first treatment. SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 22

23 6.4 Surgical Incision NHS QIS 6c1: Vertical incision is made. This is to ensure a good exposure of the upper abdomen to assess the full peritoneal cavity. n = 54. All patients having surgery as first treatment, excluding 8 patients with laparoscopic surgery. Incision n % n % n % n % Midline (vertical) Paramedian (vertical) Low transverse Transverse muscle cutting Not recorded Total patients had a vertical incision, 94.4 % compliance with the CSBS standard. Lothian: 2 patients had transverse incisions both were stage 1 disease neither was suspected cancer Fife: 1 patient had a transverse incision for suspected endometrial cancer % Vertical incisions performed in previous years Year 2006 NA NA 2007 NA NA No data Lothian figures for 2006 and 2007 are not available for comparison SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 23

24 6.5 Washings / ascitic fluid sampling NHS QIS 6c2: Washings or ascitic fluid should be sent for cytology n = 62. 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 12 patients without washings 3 were technically not possible (cyst drainage/ rupture on entry/ bleeding) 9 were not suspected cancer pre-op with low RMI (one of whom was operated on by urologists). D&G: 2 patients with no washings had low RMI and were not suspected cancer preop, and one with a prior history of another cancer had an initial diagnostic laparoscopy followed by completion surgery. % Performed in previous years Year No data SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 24

25 6.6 Primary cytoreductive surgery NHS QIS 6c3: Primary cytoreductive surgery to be attempted and to include a total or subtotal hysterectomy and bilateral salpingo-oophorectomy All patients having hysterectomy n = 62. All patients having surgery as first treatment No uterus present preoperatively Uterus present pre-operatively Total surgical patients Total hysterectomy Sub total hysterectomy No hysterectomy Fertility preserving surgery Total with uterus recorded as present preoperatively Lothian: 6 patients had no hysterectomy, none were suspected cancers. 3 had completion surgery later, 1 had fertility conservation (patient was over 30yrs), and 2 were low grade or borderline stage 1 tumours. D&G: 2 patients had no hysterectomy, neither were suspected cancers both were stage 1, one was a borderline tumour. % Performed in previous years (total + sub-total hysterectomy) Year No data SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 25

26 6.6.2 Patients having unilateral or bilateral oophorectomy n = 62. All patients with ovaries recorded as present pre-operatively Unilateral Bilateral No oophorectomy Not recorded Total with ovaries recorded as present pre-op % Performed in previous years (bilateral + unilateral) Year No data Omentectomy / omental biopsy NHS QIS 6c4: Omentectomy and/or omental biopsy performed n = 62. All surgical patients having surgery as first treatment Omentectomy Omental biopsy No omental tissue taken Total surgical patients Lothian: Of the 8 patients, none were suspected cancers. Fife: 1 patient had no omental tissue taken at laparotomy for suspected endometrial cancer D&G: 3 patients had no omental tissue taken, 2 had low RMI and were not suspected cancers and one with a prior history of another cancer had an initial diagnostic laparoscopy followed by completion surgery. 80.6% of patients in SCAN had omental tissue taken at initial surgery. % Performed in previous years (omentectomy + omental biopsy) Year No data SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 26

27 6.8 Record of Residual disease NHS QIS 6c5: Record of residual disease to be made n= 62. All patients having surgery as first treatment Residual disease Recorded Not recorded Total surgical patients Lothian: Of the 13 cases with no record of residual disease, 12 were not suspected cancer preoperatively, one of which was found at an operation for another condition. There was 1 case where a record of residual disease status should have been made by gynaecologists. D&G: Of the 4 cases all 4 were operated on in D&G. 1 was not suspected cancer preop. There were 3 cases where a record of residual disease status should have been made by gynaecologists % Recorded in previous years Year No data Surgical Assessment FIGO NHS QIS 6c7: Surgical pathological stage is recorded in case notes n = 84. All surgically assessed patients, includes laparoscopy, and laparotomy where treatment was not possible. FIGO Recorded Not recorded Total patients Lothian: In the 23 patients 2 had diagnostic laparoscopy only and 5 were biopsy only at laparotomy. 11 were not suspected cancers preoperatively. There were 5 patients where recording of surgical pathological stage was expected and was missing. D&G: 9 patients had no surgical FIGO recorded, 3 were not suspected preoperatively 6 should have had surgical pathological stage recorded (2 Lothian operations 4 operated on in D&G) % Recorded in previous years Year No data SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 27

28 7. Post operative management: Pathology NHS QIS 8a3: Type, sub-type and grade of disease are recorded. 7.1 Type/Sub-Type n = 148. All patients with histology, or cytology samples Recorded Not recorded Total % Recorded in previous years Year No data Grade of Disease n = 148. All patients with histology / cytology samples, where grading is applicable Grading applicable Grading inapplicable* Total *Not applicable to grade (e.g. germ cell tumours), or not possible to grade (e.g., cytology) Recorded Not recorded Total with histology / cytology applicable to grade % Recorded in previous years Year No data SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 28

29 7.3 Final FIGO on pathology report - Surgical patients NHS QIS 6c8: Final surgical pathological stage is recorded n = 84. All patients having surgical assessment, includes laparoscopy, and laparotomy where treatment was not possible. Recorded Not recorded Total surgically assessed Lothian: 1 patient had a frozen pelvis recorded at laparotomy, later referred to as stage 3, but had no definite FIGO recorded. % Recorded in previous years Year No data Final FIGO All Patients n = 158. All patients (including presumptive diagnoses) Recorded Not recorded Total Data not recorded prior to 2010 (Not National dataset). Year SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 29

30 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. n =108. All patients with epithelial ovarian cancer that received chemotherapy, excluding 25 patients with Borderline tumours, 23 patients with non-epithelial tumours or no histology, and 2 patients with epithelial tumours that died before treatment. Platinum based Platinum alone Platinum + taxane Other Chemo No chemo required Total Reasons for no chemotherapy Died post surgery / biopsy Early stage and low grade tumour Too frail / comorbidities Declined chemotherapy Total Of the 20 with more advanced disease, 1 died post surgery and 12 were seen by oncology to discuss their options. Reasons for no chemotherapy in SCAN in previous years 100% % 4 80% % Not recorded 60% Declined chemotherapy 13 Too frail / comorbidities 50% 2 40% 30% 5 Died post surgery/biopsy 15 Early stage tumour 2 20% 8 10% 5 7 0% SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 30

31 9. Post Chemo surgery / Delayed primary surgery n = 158. All patients, includes patients with neoadjuvant and adjuvant chemo. Subsequent Surgery 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. SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 31

32 10. Clinical Trials CSBS Essential Criteria: Patients being offered clinical trials is recorded. Clinical trial entry is recorded. n = 158. All patients Clinical trials Lothian Fife BGH DGRI SCAN meoc PETROC Total in Trials No trial Total patients 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). SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 32

33 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 = 62. All patients undergoing surgery Number of post op deaths Total surgical patients % Post op deaths in previous years Year No data Post operative deaths have decreased since the introduction of neoadjuvant chemotherapy and delayed primary surgery in b Post Chemotherapy Deaths (30 days or less from start date of chemotherapy) NB: National dataset currently only includes start date of first chemotherapy, not date of any chemotherapy e.g., second cycle. n = 85. All patients undergoing chemotherapy Number of post chemo deaths Total no patients undergoing chemotherapy Reports prior to 2008 included deaths within 60 days of 1 st cycle of chemo % Post chemo deaths (30 days or less from start date of chemo) SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 33

34 11.1c Post Treatment deaths (Within 30 days of first treatment date) (Treatment includes surgery, chemotherapy, no active treatment) n = 154. All patients undergoing treatment No of post treatment deaths Total no patients that received treatment Lothian: Of the 13 deaths, 11 patients died within 30 days of decision for best supportive care and no active intervention. 2 patients died within 30 days of surgery, one had advanced ovarian cancer and was too frail for palliative chemo, and one developed multiple organ failure and ARDS post-op. Fife: 1 patient died within 30 days of decision for best supportive care and no active intervention D&G: 1 patient died within 30 days of decision for best supportive care and no active intervention % Post Treatment deaths in previous years (30 days or less from date of first treatment, or decision not to treat) Year No data SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 34

35 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 an indicator of the quality of surgery, but also dependent upon the amount of disease at the start of the operation. n = 62. 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 13 cases with no record of residual disease, 12 were not suspected cancer preoperatively, one of which was found at an operation for another condition. There was 1 case where a record of residual disease status should have been made by gynaecologists. D&G: 4 patients had no record of residual disease, 1 was not suspected cancer preop. There were 3 cases where a record of residual disease status should have been made by gynaecologists. % No residual disease or <1cm in previous years. Year No data SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 35

36 Since 2009 practice has changed towards patients receiving neoadjuvant chemotherapy followed by delayed primary surgery (see page 5 for details). Residual disease after delayed primary surgery is shown below. n = 38. All patients undergoing delayed primary surgery (DPS) No residual disease < 1 cm cm > 5 cm Residual disease size not recorded Total surgical patients Fife: 1 patient had no record of residual disease size recorded. D&G: 2 patients had no record of residual disease size, both had residual disease noted to be present but the size was not estimated. % No residual disease or <1cm in previous years for DPS patients (data only available since Year SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W 36

37 11.3 Survival: NHS QIS 4a2: 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. D&G data is not available for Exclusions: Patients with Borderline tumours, patients that declined treatment and patients that died before treatment. SCAN 2006 Total Percentage Survival Patients 1yr 2yrs 3yrs 4yrs 5yrs Stage I - II Stage III - IV No stage* Totals SCAN 2009 Total Percentage survival Patients 1yr 2yrs Stage I - II Stage III - IV No stage* Totals SCAN 2007 Total Percentage Survival Patients 1yr 2yrs 3yrs 4yrs Stage I - II Stage III - IV No stage* Totals SCAN 2010 Total Percentage Survival Patients 1yr Stage I - II Stage III - IV No stage* Totals SCAN 2008 Total Percentage Survival Patients 1yr 2yrs 3yrs Stage I - II Stage III - IV No stage* Totals *Presumptive diagnoses, or inadequate information to assign FIGO stage (checked against trials database) SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W

38 % Survival in Stage 1-2 ovarian cancer patients (SCAN) % Survival in Stage 3-4 ovarian cancer (SCAN) 100% 100% 90% 90% 80% 80% 70% 60% 50% 70% 60% 50% Key % 40% % 30% 20% 20% 10% 10% 0% 1yr 2yr 3yr 4yr 5yr 0% 1yr 2yr 3yr 4yr 5yr SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W -38 -

39 12. Multidisciplinary Meeting NHS QIS 3a4: All patients confirmed to have ovarian cancer after surgery are discussed at the MDT meeting and follow up treatment organised. Discussed at MDM Not discussed at MDM Not recorded Total Lothian: 11 patients were not discussed at the multidisciplinary meeting. 8 were diagnosed in medicine of the elderly or general medicine wards, and received palliative care. 1 was an incidental finding by urologists and was discussed at the urology MDM. 1 died shortly after surgery and was not registered at the gynae MDM. Of the 37 surgical patients 35 were discussed at the MDM (94.6%) D&G: 1 patient was diagnosed in a medicine of the elderly ward, received palliative care and was not referred to the gynae MDM. Of the 11 surgical patients 100% were discussed at the MDM Comment: Unusually this year 12 patients with ovarian cancer were not discussed at the regional MDM. Although still relatively small this is very high number compared to previous years. Median age of these patients was 81.5 (range 75 to 91 years). Two patients came through specialist gynaecology at RIE and sadly died very quickly. 7 patients came through geriatrics speciality and 6 died within 60 days of diagnosis. Of the remaining three, 2 came through acute general medicine and died rapidly. The remaining patient came through urology with advanced bladder cancer but had an incidental finding of an early ovarian cancer requiring no further therapy. More work needs to be undertaken to understand the difficulties for geriatrics to refer patients, even deceased, for review and audit. ACTION to liaise with geriatrics to understand barriers to refer to MDM and reminder to general team to refer even sadly after death. SCAN Comparative Ovarian Cancer Report 2011 SA Ov01/13W