Cancer care - ovarian cancer quality performance indicators review: consultation

6. Quality Performance Indicators for Ovarian Cancer

QPI 2 - Extent of disease assessed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) prior to treatment

• Revision(s): QPI Archived – target met or exceeded for all regions over the previous 3 years. Data will still be collected at the current time and available for local analysis if required.

QPI 3 - Treatment planned and reviewed at a multi-disciplinary team meeting

QPI Title:

Patients with epithelial ovarian cancer should be managed through a regional multidisciplinary team (MDT) process prior to definitive treatment.

Description:

Proportion of patients with epithelial ovarian cancer who are managed through a regional MDT process before definitive treatment.

Rationale and Evidence:

Evidence suggests that patients with cancer managed by a multi-disciplinary team have a better outcome. There is also evidence that the multidisciplinary management of patients increases their overall satisfaction with their care.

Discussion prior to definitive treatment decisions being made provides reassurance that patients are being managed appropriately. A streamlined pathway approach will be suitable for some patients whereby a standard protocol can be used to guide management and treatment decisions. These patients will therefore not require discussion, however this will be documented and agreed by the MDT.

Specifications:

• Numerator:
  • Number of patients with epithelial ovarian cancer managed through a regional MDT process before definitive treatment.
• Denominator:
  • All patients with epithelial ovarian cancer.
• Exclusions:
  • Patients who died before first treatment.
  • Patients with Risk of Malignancy Index <200
• Target: 95%

The tolerance within this target accounts for situations where patients require treatment urgently.

• Revision(s): QPI wording changed to patients ‘who are managed through a regional MDT process’ rather than ‘discussed’. This will incorporate all patients including those suitable for protocolised treatment who are registered at MDT but do not require discussion.

QPI 4 - Patients with early stage disease have an adequate staging operation

• Revision(s): QPI Archived – quality measures for surgery are all now incorporated in the new QPI 15.

QPI 6 - Histopathology reports are complete and support clinical decision- making

QPI Title:

Histopathology reports relating to pelvic clearance surgery for patients with epithelial ovarian cancer contain all necessary information to inform treatment decision making.

Description:

Proportion of patients with epithelial ovarian cancer undergoing pelvic clearance surgery having a complete pathology report as defined by the Royal College of Pathologists.

Rationale and Evidence:

Histopathological reporting provides prognostic indicators which inform treatment planning for women diagnosed with epithelial ovarian cancer.

Using a standardised data set to report pathology specimens promotes completeness and the Royal College of Pathologists has agreed a minimum data set for reporting ovarian cancer.

Specifications:

• Numerator:
  • Number of patients with epithelial ovarian cancer undergoing definitive cytoreductive surgery who have a complete pathology report that contains all data items as defined by the Royal College of Pathologists
• Denominator:
  • All patients with epithelial ovarian cancer undergoing definitive cytoreductive surgery.
• Exclusions: No exclusions.
• Target: 95%

The tolerance within this target reflects situations where it is not possible to report all components of the data set due to poor quality of specimen.

• Revision(s): No change to QPI

QPI 7 - Histological diagnosis prior to starting chemotherapy

QPI Title:

Patients with epithelial ovarian cancer should have a histological diagnosis of their cancer prior to starting chemotherapy.

Description:

Proportion of patients with epithelial ovarian cancer having a histological diagnosis obtained by percutaneous image-guided biopsy or laparoscopy prior to starting chemotherapy.

Rationale and Evidence:

Before commencing cytotoxic chemotherapy, women with suspected advanced ovarian cancer should have their diagnosis confirmed by histology or by cytology if histology is not appropriate.

Where patients are being treated with chemotherapy prior to surgery, histology rather than cytology should be used to confirm the diagnosis where possible.

Specifications:

• Numerator:
  • Number of patients who have a diagnosis of epithelial ovarian cancer confirmed by histology prior to starting chemotherapy.
• Denominator:
  • All patients with epithelial ovarian cancer undergoing chemotherapy.
• Exclusions:
  • No exclusions.
• Target: 90%

The tolerance allowed by the target reflects that not all patients are suitable for histological confirmation of disease, e.g. where no targetable lesion identified on imaging and patient unsuitable for general anaesthetic/laparoscopy.

• Revsions: No change to QPI

QPI 9 - First-line chemotherapy

QPI Title:

Patients with epithelial ovarian cancer should receive chemotherapy treatment where clinically appropriate.

Description:

Proportion of patients with epithelial ovarian cancer who receive chemotherapy treatment.

Rationale and Evidence:

Chemotherapy is an important aspect of management in patients with epithelial ovarian cancer and should be offered where fitness allows.

Where possible, first line chemotherapy treatment of epithelial ovarian cancer should include a platinum agent, either in combination or as a single agent. Carboplatin is the platinum drug of choice in both single and combination therapy and paclitaxel is recommended in combination where the potential benefits justify the toxicity of the therapy.

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

Specifications:

• Numerator
  • Number of patients with epithelial ovarian cancer who receive chemotherapy treatment.
• Denominator:
  • All patients with epithelial ovarian cancer.
• Exclusions:
  • Stage 1-IV Low grade serous ovarian carcinomas
  • Stage 1A-1C3 G1/G2 Endometrioid ovarian carcinomas
  • Stage 1A-1C1 clear cell ovarian carcinomas
  • Mucinous Stage 1A Grade 1/2
  • Mucinous Stage 1B-1C3 Grade 1/2
  • Patients who decline chemotherapy treatment.
• Target: 90%

The tolerance allowed by the target recognises that there are a number of patients who are not fit enough to undergo chemotherapy.

• Revisions: Removed reference to ‘platinum based compond’ and changed to focus on patients receiving any chemotherapy.

Please note:

Additional information on the time from diagnosis to neoadjuvant chemotherapy to surgery, and diagnosis to surgery to adjuvant chemotherapy will be reported across NHS Boards alongside this QPI. This information will be reviewed to ensure there is no impact on the quality of care due to delays in patient pathways.

QPI 10 - Surgery for advanced disease

• Revisions: QPI Archived – surgical quality measures for all stages of ovarian cancer are now incorporated in the new QPI 15.

QPI 11 - Genetic testing in non-mucinous epithelial ovarian cancer

QPI Title:

All patients with a confirmed diagnosis of non-mucinous epithelial ovarian cancer should be offered genetic testing.

Description:

Proportion of patients with epithelial ovarian cancer who undergo germline (blood) testing and somatic (tumour) testing.

Please note: The specifications of this QPI are separated to ensure clear measurement of the following:

1. Patients with a diagnosis of non- mucinous epithelial ovarian cancer who undergo germline testing;

2. Patients with a histological diagnosis of high grade epithelial ovarian carcinoma who undergo HRD testing; and

3. Patients with a histological diagnosis of endometrioid or clear cell ovarian carcinoma who undergo mismatch repair immunohistochemistry.

Rationale and Evidence:

Germline testing:

Germline testing should be performed in patients with ovarian cancer. where the combined risk of BRCA1 and BRCA2 mutation is ≥10%.

All patients with non-mucinous ovarian cancer should be offered germline mutation testing for a panel of markers including BRCA1 and BRCA2.

Various prediction models exist to assess the likelihood of a BRCA1 or BRCA2 mutation in a family. All patients with non-mucinous ovarian cancer (any age) would be predicted to have mutation detection rate of between 6.2% and 17.5%.

Somatic (tumour) testing:

Genetic testing of ovarian tumours is recommended by a number of international guidelines such as ESMO for both prognostic and predictive information. Specifically, in high grade serous carcinoma, assessment for BRCA1 and BRCA2 mutations and for Homologous Recombination Deficiency (HRD) are important predictors of benefit from PARP inhibitor maintenance therapy. They can be combined in the HRD test or BRCA testing can be performed independently.

Mismatch Repair Deficiency (MMR) testing is also valuable in predicting response to immune checkpoint inhibitors in ovarian endometrioid and clear cell carcinomas. It is likely that the extent of available clinically important somatic testing will increase in the coming years.

Specifications:

Specification 1:

• Numerator:
  • Number of patients with a diagnosis of non- mucinous epithelial ovarian cancer who undergo germline testing.
• Denominator:
  • All patients with non-mucinous epithelial ovarian cancer.
• Exclusions:
  • Patients with low grade serous ovarian cancer.
• Target: 90%

Specification 2:

• Numerator:
  • Number of patients with a histological diagnosis of high grade epithelial ovarian cancer who undergo HRD testing.
• Denominator:
  • All patients with high grade epithelial ovarian cancer.
• Exclusions:
  • No exclusions.
• Target: 90%

Specification 3:

• Numerator:
  • Number of patients with a histological diagnosis of endometrioid or clear cell ovarian carcinoma who undergo mismatch repair immunohistochemistry.
• Denominator:
  • All patients with endometrioid or clear cell ovarian carcinoma.
• Exclusions:
  • No exclusions.
• Target: 90%

The tolerance level within this target is designed to account for situations where there is insufficient tissue for tumour testing or patients who decline germline testing.

• Revisions: QPI has been revised to be more specific in terms of the testing required.

QPI 12 - 30 day mortality after first line treatment for ovarian cancer

QPI Title:

30 day mortality following surgery for ovarian cancer.

Description:

Proportion of patients who die within 30 days of surgery for ovarian cancer.

Rationale and Evidence:

Treatment related mortality is a marker of the quality and safety of the whole service provided by the Multi Disciplinary Team (MDT).

Outcomes of treatment, including treatment related morbidity and mortality should be regularly assessed.

Treatment should only be undertaken in individuals that may benefit from that treatment, that is, treatments should not be undertaken in futile situations. This QPI is intended to ensure treatment is given appropriately, and the outcome reported on and reviewed.

Specifications:

• Numerator:
  • Number of patients with epithelial ovarian cancer who undergo surgery that die within 30 days of treatment.
• Denominator:
  • All patients with epithelial ovarian cancer who undergo surgery.
• Exclusions:
  • No exclusions.
• Target: <5%
• Revisions: No changes to QPI.

QPI 13 - Clinical trials and research study access

• Revisions: This QPI has now been removed from the individual tumour specific QPI documents and will be replaced by trials activity measures reported via the Scottish Cancer Research Network.

QPI 14 - 30 day mortality following Systemic Anti-Cancer Therapy (SACT)

• Revisions: This QPI has now been removed from the QPI process and is reported by Public Health Scotland using national SACT data which has been checked and validated across Scotland.

QPI 15 - Surgical Management in Ovarian Cancer

QPI Title:

Patients with epithelial ovarian cancer should undergo primary or delayed surgery with the aim to achieve complete cytoreduction.

Description:

Proportion of patients with epithelial ovarian cancer undergoing surgery where complete cytoreduction is achieved following surgical resection.

Please note: The specifications of this QPI have been separated to allow clear measurement of the following:

1. Patients with stage 1 –3A^[1] who undergo primary surgery;

2. Patients with stage 1 –3A¹ who undergo primary surgery and achieve complete cytoreduction;

3. Patients with stage 3B and above¹ who undergo surgery (primary or delayed); and

4. Patients with stage 3B and above¹ who undergo surgery (primary or delayed) and achieve complete cytoreduction.

Rationale and Evidence:

Evidence shows that most women with ovarian cancer present with advanced disease. Surgery along with chemotherapy remains the optimal treatment for women with advanced ovarian cancer.

The objective of performing surgery on women with epithelial ovarian cancer, whether before chemotherapy or after chemotherapy, is complete resection of all macroscopic disease. This is not always possible in patients with advanced disease because of widespread involvement of peritoneal surfaces, bowel mesentery and serosa of the bowel.

Improved patient outcomes are observed in patients with no visible residual disease following surgical resection.

Patients with stage 1-3A epithelial ovarian cancer have either disease confined to the pelvis or microscopic abdominal disease therefore complete cytoreduction at primary surgery is feasible in most case. A small number of patients are not fit for surgery or require total pelvic exenteration to clear the disease and the tolerance allowed within the target reflects this.

Specifications:

Specification 1:

• Numerator:
  • Number of patients with stage 1-3A epithelial ovarian cancer who undergo primary surgery.
• Denominator:
  • All patients with stage 1–3A epithelial ovarian cancer.
• Exclusions:
  • No exlusions
• Target: 90%

The tolerance within this target accounts for the fact that not all patients are suitable for surgery due to fitness levels / co-morbidities or disease requiring primary total pelvic exenteration.

Specification 2:

• Numerator:
  • Number of patients with stage 1-3A epithelial ovarian cancer who undergo primary surgery and achieve complete cytoreduction.
• Denominator:
  • All patients with stage 1–3A epithelial ovarian cancer who undergo primary surgery.
• Exclusions:
  • No exclusions
• Target: 95%

The tolerance within this target accounts for situations where complete cytoreduction may not be possible due to underestimated extent of disease or where the surgical approach requires modification due to co-morbidities or interaoperatiove events.

Specification 3:

• Numerator:
  • Number of patients with stage 3B and above epithelial ovarian cancer who undergo surgery (primary or delayed).
• Denominator:
  • All patients with stage 3B and above epithelial ovarian cancer.
• Exclusions:
  • No exclusions.
• Target: 70%

The tolerance in the target reflects patients who may not be fit for radical cytoreduction, progress while on chemotherapy, or die during treatment with neoadjuvant chemotherapy. Some patients will also not proceed to surgery due to the presence of clearly inoperable disease involving the root of the bowel mesentery or porta hepatis.

Specification 4:

• Numerator:
  • Number of patients with stage 3B and above epithelial ovarian cancer who undergo surgery (primary or delayed) and achieve complete cytoreduction.
• Denominator:
  • All patients with stage 3B and above epithelial ovarian cancer who undergo surgery (primary or delayed).
• Exclusions:
  • No exclusions.
• QPI 15 - Surgical Management in Ovarian Cancer continued
• Target: 65%

The tolerance within this target accounts for the fact that due to widespread involvement of peritoneal surfaces, bowel mesentery, bowel serosa or porta hepatis, it is frequently not possible to resect all visible disease.

• Revisions: NEW QPI - This QPI is a revised version of previous QPI 10 and has been changed to account for appropriate surgical management for all stages of epithelial ovarian cancer.

QPI 16 – Maintenance Treatment for Advanced Stage High Grade Epithelial Tubo-Ovarian Cancer

QPI Title:

Patients with advanced stage high grade epithelial (non-mucinous) tubo-ovarian cancer should be offered maintenance treatment.

Description:

Proportion of patients with high grade epithelial (non-mucinous) stage 3 and 4 tubo-ovarian cancer who have completed^[2] primary chemotherapy (with a platinum based agent) who undergo maintenance treatment.

Rationale and Evidence:

There is evidence to support maintenance PARP inhibitor, maintenance PARP inhibitor and bevacuzimab combination and single agent bevacuzumab maintenance in advanced ovarian cancer with an improvement demonstrated in PFS and overall survival (OS).

Rather than focussing on any specific agents, the QPI Review Group agreed to use the term 'maintenance treatment' in order to account for any further treatments which may become available in the future as futher evidence evolves.

Specifications:

• Numerator:
  • Number of patients with high grade epithelial (non-mucinous) stage 3 and 4 tubo-ovarian cancer who have completed primary chemotherapy (with a platinum based agent) and undergo maintenance treatment.
• Denominator:
  • All patients with high grade epithelial (non-mucinous) stage 3 and 4 tubo-ovarian cancer who have completed primary chemotherapy (with a platinum based agent).
• Exclusions:
  • Patients with clear cell ovarian cancer.
  • Patients who decline maintenance treatment.
• Target: 65%

QPI 16 – Maintenance Treatment for Advanced Stage High Grade Epithelial Tubo-Ovarian Cancer Continued

The tolerance within this target accounts for situations where disease may progress during chemotherapy or for those patients with co-morbidities that preclude maintenance treatment.

Please note: varying evidence exists regarding the most appropriate target level therefore this may need redefined in the future, to take account of new evidence or as further data becomes available.

• Revisions: New QPI

QPI 17: MDT Review of Patients with Advanced Epithelial Cancer Following 3 Cycles of Chemotherapy

QPI Title:

Patients with Stage 3 and above epithelial ovarian cancer undergoing chemotherapy should be reviewed at MDT to inform decisions on surgical management.

Description:

Patients with Stage 3 and above epithelial ovarian cancer undergoing neoadjuvant chemotherapy who are discussed at a regional MDT following 3 cycles of treatment.

Rationale and Evidence:

Patients should be discussed at MDT with CT for consideration of interval debulking surgery (IDS) or continuation of chemotherapy with a view to delayed debulking surgery (DDS).

This will provide a platform for a strict pathway to be followed so that all patients following 3 cycles of chemotherapy have had reflex CT CAP with discussion at the MDT for consideration of IDS or DDS. Often the window of opportunity to perform IDS is lost due to CT not being arranged after 3 cycles.

Performing CT after 3 cycles of chemotherapy also gives an opportunity to explore the option of DDS if IDS with complete cyto-reduction is not possible. Delaying IDS, however, harbours the risk of losing the opportunity for debulking surgery.

Although there is no strong evidence to suggest an increase in improved disease free survival (DFS) and overall survival (OS) for patients undergoing IDS following 3-4 cycles of chemotherapy in comparison with after 5-6 cycles, there is evidence from cohort studies to show improved OS and DFS following complete cytoreduction (either after 3-4 or 5-6 cycles).

Specifications:

• Numerator:
  • Number of patients with Stage 3 and above epithelial ovarian cancer undergoing neoadjuvant chemotherapy who are discussed at a regional MDT following 3 cycles of treatment.
• QPI 17: MDT Review of Patients with Advanced Epithelial Cancer Following 3 Cycles of Chemotherapy Continued
• Denominator:
  • All patients with Stage 3 and above epithelial ovarian cancer undergoing neoadjuvant chemotherapy.
• Exclusions:
  • Patients who died during treatment
• Target: 95%

The tolerance within this target accounts for those patients who may not complete 3 cycles of chemotherapy treatment due to factors of fitness and co-morbidities.

• Revisions: New QPI