Quality standard

Quality statement 6: Tissue sampling

Quality statement 6: Tissue sampling

Quality statement

Adults with non-small-cell lung cancer stage III or IV who are having tissue sampling, have samples taken that are suitable for pathological diagnosis and assessment of predictive biomarkers. [2012, updated 2019]

Rationale

Drug treatments for non-small-cell lung cancer work best if they are targeted according to the histological sub‑type and predictive biomarkers of the tumour. Obtaining a pathological diagnosis and assessment of predictive biomarkers for a lung tumour in people with good performance status ensures that the most appropriate treatment regimen is offered. It is important that samples taken for diagnosis and staging yield enough material for pathology tests and immunohistochemical and/or genetic analysis. This will reduce delays to treatment by minimising the need for further sampling before making treatment decisions.

Quality measures

The following measures can be used to assess the quality of care or service provision specified in the statement. They are examples of how the statement can be measured, and can be adapted and used flexibly.

Structure

a) Evidence of the availability of radiologists and respiratory specialists experienced in performing lung biopsies for adults with lung cancer.

Data source: Local data collection, for example, workforce plans or staff rotas.

b) Evidence of local processes to ensure that adults with non-small-cell lung cancer stage III or IV who are having tissue sampling, have samples taken that are suitable for pathological diagnosis and assessment of predictive biomarkers.

Data source: Local data collection, for example, service protocols.

c) Evidence of audit of the local test performance of endobronchial ultrasound‑guided transbronchial needle aspiration (EBUS‑TBNA) and endoscopic ultrasound‑guided fine-needle aspiration (EUS‑FNA) for people with lung cancer.

Data source: Local data collection, for example, audit reports. Specific details of audit for EBUS‑TBNA are included in the British Thoracic Society quality standards for diagnostic flexible bronchoscopy in adults (statements 5a and b).

Process

a) Proportion of adults with non-small-cell lung cancer stage III or IV who have a second diagnostic test in order to determine histological sub‑type or predictive biomarkers.

Numerator – the number in the denominator who have a second diagnostic test in order to determine histological sub‑type or predictive biomarkers.

Denominator – the number of adults with non-small-cell lung cancer stage III or IV.

Data source: Local data collection, for example, audit of patient records. For measurement purposes, this measure aims to identify where suitable samples have not been taken, making it necessary for a second test to be carried out.

b) Proportion of adults with non-small-cell lung cancer stage III or IV for whom the reported tumour sub‑type is 'not otherwise specified'.

Numerator – the number in the denominator for whom the reported tumour sub‑type is 'not otherwise specified'.

Denominator – the number of adults with non-small-cell lung cancer stage III or IV.

Data source: National Cancer Registration and Analysis Service Cancer Outcomes and Services Dataset. For measurement purposes, this measure aims to identify where suitable samples have not been taken, resulting in a sub‑type 'not otherwise specified'.

c) Proportion of adults with non-small-cell lung cancer stage III or IV and performance status 0 to 2 who are successfully tested for all relevant biomarkers.

Numerator – the number in the denominator who are successfully tested for all relevant biomarkers.

Denominator – the number of adults with non-small-cell lung cancer stage III or IV and performance status 0 to 2.

Data source: National Cancer Registration and Analysis Service Cancer Outcomes and Services Dataset includes data on epidermal growth factor receptor mutational status, ALK fusion status, ROS1 Fusion status and PD‑L1 expression.

Outcome

a) Proportion of adults with non-small-cell lung cancer stage III or IV and performance status 0 to 2 who have a pathological diagnosis.

Numerator – the number in the denominator who have a pathological diagnosis.

Denominator – the number of adults with non-small-cell lung cancer stage III or IV and performance status 0 to 2.

Data source: National Cancer Registration and Analysis Service Cancer Outcomes and Services Dataset.

b) 1‑year survival rate for adults with non-small-cell lung cancer stage III or IV.

Data source: National Cancer Registration and Analysis Service Cancer Outcomes and Services Dataset.

What the quality statement means for different audiences

Service providers (such as secondary and tertiary care) ensure that adults with non-small-cell lung cancer stage III or IV who are having tissue sampling, have samples taken that are suitable for pathological diagnosis and assessment of predictive biomarkers. Providers ensure that lung cancer multidisciplinary teams include radiologists and respiratory specialists experienced in performing lung biopsies for adults with lung cancer. Providers also audit local test performance for EBUS‑TBNA and EUS‑FNA to assess the sensitivity of the procedures and the suitability of samples.

Healthcare professionals (such as respiratory specialists and radiologists) take tissue samples from adults with non-small-cell lung cancer stage III or IV that are suitable for pathological diagnosis and assessment of predictive biomarkers.

Commissioners (such as clinical commissioning groups) commission services that ensure that adults with non-small-cell lung cancer stage III or IV have tissue samples taken that are suitable for pathological diagnosis and assessment of predictive biomarkers.

Adults with advanced non-small-cell lung cancer have tissue samples taken that give enough information for a complete diagnosis and to guide treatment options.

Source guidance

Lung cancer: diagnosis and management. NICE guideline NG122 (2019), recommendation 1.3.11

Definitions of terms used in this quality statement

Samples suitable for pathological diagnosis and assessment of predictive biomarkers

Providing there is no risk to the person, tissue samples of sufficient size and quality should be taken to support pathological diagnosis, including tumour sub‑typing and assessment of predictive biomarkers. The samples should:

  • allow pathologists to classify non-small-cell lung cancer into squamous cell carcinoma or adenocarcinoma wherever possible

  • support stage‑appropriate immunohistochemical and/or genetic analysis to detect specific biomarkers that predict whether targeted treatments are likely to be effective, for example, epidermal growth factor receptor (EGFR) mutations, anaplastic lymphoma kinase (ALK) gene rearrangement, programmed death‑ligand 1 (PD‑L1) expression or ROS‑1 gene mutation.

[NICE's 2011 full guideline on lung cancer and expert opinion]