Renal Cancer Clinical Quality Performance Indicators: Engagement Document

Patients with renal cancer should have cross sectional imaging for staging of Renal Cell Carcinoma ( RCC).

Proportion of patients with RCC who undergo pre-treatment cross-sectional imaging of the chest, abdomen +/- pelvis.

Although definitive diagnosis of renal cell carcinoma requires pathological assessment, radiology suggests the diagnosis in almost all cases and is the first line of investigation.

Patients with renal cell carcinoma should undergo CT with contrast to assess the extent of local and distant metastatic disease ^[5] . MRI is also an alternative option for patients who require further imaging, or have allergies to intravenous CT contrast media ^[6] .

Numerator:

Number of patients receiving active treatment ^[1] with a diagnosis of RCC who undergo cross-sectional imaging ( CT or MRI) of the chest, abdomen +/- pelvis (with contrast) before first treatment.

Denominator:

All patients receiving active treatment ^[1] with a diagnosis of RCC.

Exclusions:

• No exclusions

95%

The tolerance within this target is to account for those patients with contraindications due to renal impairment, allergies to contrast media, and also where renal cancer is an incidental finding following surgery.

Patients with renal cancer not undergoing surgery should have a histological diagnosis prior to commencing treatment.

Proportion of patients with RCC where surgery is not the primary treatment who have a histological diagnosis before treatment, via biopsy.

Please note: the specifications of this QPI are separated to ensure clear measurement of patients undergoing the following treatments:

(i) Cryotherapy / Radiofrequency ablation

(ii) Systemic Anti-Cancer Therapy ( SACT)

With alternative minimally invasive therapies such as radio frequency ablation ( RFA) and cryotherapy where the primary tumour is not resected, it is essential to make a histological or cytological diagnosis of renal carcinoma prior to treatment to avoid treating a non-malignant lesion ^[5,7] .

In patients who are being considered for expensive medical anti-cancer therapy, histological confirmation of the diagnosis is essential as other cell types will not benefit from this treatment ^[8] .

Numerator:

Number of patients with RCC undergoing cryotherapy or radiofrequency ablation as their first treatment who have a histological diagnosis (confirmed by biopsy) before commencing treatment.

Denominator:

All patients with RCC undergoing cryotherapy or radiofrequency ablation as their first treatment.

Exclusions:

• Histology not assessable.

90%

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

Numerator:

Number of patients with RCC undergoing SACT as their first treatment who have a histological diagnosis (confirmed by biopsy) before commencing treatment.

Denominator:

All patients with RCC undergoing SACT as their first treatment.

Exclusions:

• Histology not assessable.

90%

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

The TNM staging system should be used to stage patients with Renal Cell Carcinoma ( RCC).

Proportion of patients whose RCC is staged pre-treatment using the TNM staging system.

The TNM stage of disease will aid in determining prognosis, choice of therapy and follow up ^[9] .

The TNM staging system is widely recommended for staging of renal cell carcinoma as it ^[6,9] .

Numerator:

Number of patients diagnosed with RCC who were clinically staged using TNM staging system before first treatment.

Denominator:

All patients diagnosed with RCC.

Exclusions:

• No exclusions

Please Note:

For a patient to be recorded as having been clinically staged using the TNM staging system, cT, cN and cM all require to be recorded.

100%

Patients with renal cell carcinoma should be discussed by a multidisciplinary team prior to definitive treatment.

Proportion of patients with renal cell carcinoma who are discussed at MDT meeting before definitive treatment.

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 ^[8] .

Discussion prior to definitive treatment decisions being made provides reassurance that patients are being managed appropriately.

Numerator:

Number of patients with renal cell carcinoma discussed at the MDT before definitive treatment.

Denominator:

All patients with renal cell carcinoma.

Exclusions:

• Patients who died before first treatment.

95%

The tolerance within this target is designed to account for situations where patients require treatment urgently or where renal cancer has been an incidental finding following surgery.

Patients with T1a renal cancer should receive Nephron Sparing Surgery ( NSS).

Proportion of patients with T1aN ₀M ₀ RCC who undergo NSS (laparoscopic partial nephrectomy or open partial nephrectomy).

When compared with radical nephrectomy, NSS can achieve preserved renal function, decreased overall mortality, reduced frequency of cardiovascular events and increased quality of life for patients. Patients should be informed of these potential advantages of nephron sparing surgery ^[5] .

Surgical resection is the gold standard of care for curative treatment of RCC. Patients with T1a tumours should undergo nephron sparing surgery where appropriate, as clinical trials have shown that long term survival rates are comparable to those following radical surgery ^[5,7,9] .

Numerator:

Number of patients with T1a N ₀M ₀ RCC undergoing NSS (laparoscopic partial nephrectomy or open procedure partial nephrectomy).

Denominator:

All patients with T1a N ₀M ₀ RCC.

Exclusions:

• Patients who refuse treatment.
• Patients who receive RFA/Cryotherapy

• Patients receiving supportive care only (not for active treatment).
• Patients receiving active surveillance (no active treatment).
• Patients who died before treatment

40%

This target reflects the fact that some patients opt for a laparoscopic radical nephrectomy ( LRN) rather than nephron sparing surgery ( NSS) due to factors such as shorter convalescence period and decreased complications associated with LRN compared to NSS.

Including this patient group in the exclusion criteria noted above would by default make the target meaningless as 100% would be achieved.

Patients with clear cell Renal Cell Carcinoma ( RCC) should be assigned a Leibovich score following surgical resection.

Proportion of patients with clear cell RCC who are assigned a Leibovich score following surgical resection.

Various prognostic scores exist to predict the likelihood of developing metastatic disease following surgery.

Evidence shows that the Leibovich score is an accurate model of prediction and assists clinicians and patients in making decisions regarding treatment plans, follow up and selection for clinical trials ^[10] .

Numerator:

Number of patients with clear cell RCC who undergo surgical resection assigned a Leibovich score following surgical resection.

Denominator:

All patients with clear cell RCC who undergo surgical resection.

Exclusions:

• Patients undergoing partial nephrectomy
• Patients with metastatic disease (TanyNanyM1)

100%

Renal resectional surgery should be performed in hospitals where there are an appropriate annual volume of such cases.

Number of renal surgical resections performed by a specialist centre, and surgeon, over a 1 year period.

A number of studies have demonstrated the relationship between the number of patients operated on at a particular hospital and the outcome of surgery.

The literature demonstrates that there is a relationship between increasing surgical volume and lower complication rates for surgeons undertaking partial nephrectomy for renal cell carcinoma ^[11] .

Number of renal surgical resections performed by each centre / surgeon in a given year.

Exclusions:

• No exclusions

Minimum 25 procedures per centre, with a minimum of 8 procedures per surgeon, in a 1 year period.

This is a minimum target level and is designed to ensure that all surgeons performing renal surgery perform a minimum of 8 procedures per year.

Please Note: Varying evidence exists regarding the most appropriate target level for surgical case volume. In order to ensure that the target level takes account of level 1 evidence and will drive continuous quality improvement as intended this performance indicator must be kept under regular review.

Trifecta Rate in Partial Nephrectomy T1a Renal Cell Carcinoma ( RCC) patients.

Proportion of patients with T1a RCC undergoing partial nephrectomy who achieve trifecta (warm ischaemic time less than 25 minutes, negative surgical margins and no complications*).

Trifecta is regarded as a surrogate measure of surgical quality.

The combination of achieving negative margins, minimal surgical complications and a reduced warm ischaemic time (associated with improved renal function) is associated with better outcomes for patients undergoing partial nephrectomy ^[12] .

*Length of stay is being used as a surrogate measure for the quality of surgery and post operative care including post operative complications.

Numerator:

Number of patients with T1a RCC undergoing partial nephrectomy who have warm ischaemic time less than 25 minutes, negative surgical margins and no complications (length of stay ≤7days).

Denominator:

All patients with T1A RCC undergoing partial nephrectomy.

Exclusions:

• No exclusions

60%

The tolerance within this target takes account of the fact that it is not always possible to achieve trifecta due to patient fitness, complex lesions and in solitary kidneys. It may also not always be safe or practical for patients to go home within 7 days of surgery.

30 and 90 Day Mortality following treatment for RCC.

Proportion of patients who die within 30 or 90 days of treatment for RCC.

Treatment related mortality is a marker of the quality and safety of the whole service provided by the Multi Disciplinary Team ( MDT). However, all causes of death have been used in this indicator as the recording of cause of death by the certifying medical practitioner is not always as specific as the recording of a cancer diagnosis.

"For clinicians to restore and retain public confidence, they need to show that effective mechanisms exist for assessing events such as death and to justify patients' faith in the delivery of care" ^[13] .

Numerator:

Number of patients with RCC who undergo minimally invasive ( RFA, cryotherapy, SACT) or operative treatment who die within 30 / 90 days of treatment.

Denominator:

All patients with RCC who undergo minimally invasive ( RFA, cryotherapy, SACT) or operative treatment.

Exclusions:

• Patients who undergo emergency surgery (nephrectomy).

Please Note:

This QPI will be reported separately as 30 day mortality and 90 day mortality as opposed to a single figure.

In addition, this QPI will be reported by treatment type as opposed to a single figure for all treatment options covered by the indicator (i.e. RFA, cryotherapy, SACT or surgery).

<5% for patients receiving SACT

<2% for patients receiving operative treatment, RFA and cryotherapy.

This target reflects the fact that death from any cause, rather than death from renal cancer is being measured by this indicator.

Patients with metastatic renal cell carcinoma ( RCC) should be assigned a valid prognostic score ^[2] prior to starting treatment.

Proportion of patients with metastatic RCC who are assigned a valid prognostic score ^[2] prior to starting treatment.

Various models exist to predict the survival and prognosis for patients with metastatic RCC. These are key in making decisions about the most appropriate treatment plan for patients, particularly with the use of targeted therapies ^[14] .

Numerator:

Number of patients with metastatic RCC who are assigned a valid prognostic score prior to starting treatment.

Denominator:

All patients diagnosed with metastatic RCC.

Exclusions:

• No exclusions

90%

The tolerance within this target is to account for situations where patients are deemed unfit to undergo active treatment.

Patients with advanced and/or metastatic renal cell carcinoma ( RCC) should receive systemic therapy between diagnosis and death.

Proportion of patients presenting with advanced and/or metastatic RCC who receive systemic anti-cancer therapy ( SACT) for RCC within 12 months of diagnosis.

Sunitinib is currently recommended for use in Scotland as a first-line treatment option for people with advanced and/or metastatic RCC who are suitable for immunotherapy and have an Eastern Cooperative Oncology Group ( ECOG) performance status of 0 or 1 ^[15] . Pazopanib is recommended by the Scottish Medicines Consortium ( SMC) as a first line treatment option for people with advanced RCC ^[16,17] Although the SMC advice does not restrict patients according to ECOG performance status, the clinical trial supporting its use was restricted to ECOG PS 0 or 1 patients.

Large randomised clinical trials have demonstrated clinical effectiveness of a variety of agents in this setting. Cost effectiveness analysis has demonstrated that sunitinib and pazopanib are considered cost effective in this setting within NHS Scotland.

In some cases it is reasonable to delay systemic therapy and the assumption is that 100% of suitable patients should receive systemic therapy between diagnosis and death. We estimate that at least 40% of these patients would be expected to die within 12 months of diagnosis in the absence of systemic treatment and therefore have chosen this time period as suitable for assessing this aspect of practice.

Numerator:

Number of patients with RCC which is advanced and / or metastatic at time of diagnosis ^[3] treatment with SACT, within 12 months of diagnosis where at least 12 months have elapsed since diagnosis irrespective of whether or not they have died who receive first treatment with SACT, within 12 months of diagnosis ^[4] .

Denominator:

All patients with RCC which is advanced and / or metastatic at time of diagnosis where at least 12 months have elapsed since diagnosis irrespective of whether or not they have died.

Exclusions:

• Patients documented to have performance status 2, 3 or 4 at time of diagnosis.
• Patients documented to have refused systemic treatment.
  Patients enrolled in clinical trials.

70%

The target reflects the following facts: i. some patients will decline very quickly and systemic therapy is inappropriate; ii. some will have very indolent disease and systemic therapy is not appropriate within 12 months of diagnosis; iii. some patients will die of unrelated causes within 12 months of diagnosis without the need for systemic anti-cancer therapy; iv. some patients will have specific medical contra-indications to systemic therapy; v. some patients with isolated metastatic disease may undergo surgical resection.