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SACT - Guidance for reporting regimen outcome summary (non-curative)

This document provides guidance to clinicians reporting regimen outcomes for non-curative treatments in the systemic anti-cancer therapy (SACT) data set.

Background and introduction

This document aims to provide guidance to clinicians reporting regimen outcomes for non-curative treatments in the systemic anti-cancer therapy (SACT) data set. This guidance was produced with the collaboration of clinicians to address potential differences in interpretation of ‘outcome data’, whilst being mindful of the practicalities of recording this in routine clinical practice.

We appreciate that non-curative treatment benefit assessment is a complex question and may be considered, to a certain extent, subjective. Each patient is unique and ultimately the appreciation of treatment benefit reported is with the clinical staff.

Note that this document focuses only on solid tumours.

The document is made of 3 parts:

  1. background and introduction
  2. considerations for assessing benefit
  3. patient examples

The SACT data set collects data in 4 main areas:

  • the patient and their tumour
  • where the patient was treated and who initiated their treatment
  • treatment details
  • clinical outcomes

Treatment outcomes are a key aspect of the SACT data set. The collection of SACT specific outcomes allows the team to design analyses to evaluate treatment effectiveness and identify variations in clinical practice. Additionally, regimen outcome data are reported as part of our work to support Cancer Drugs Fund (CDF) re-appraisals.

‘Treatment outcomes’ refer to the clinical outcomes which result from the administration of a treatment regimen in the SACT data set.

While collecting ‘benefit’ data will likely bring variability at individual level, it is reasonable to expect to see trends at a population level that will be relevant to clinicians, and other groups.

Relevant SACT fields

Intent of treatment

The intent of treatment itself is captured as a separate data item (dataset item 15) and includes curative or palliative options:

National Code

National code definition

1

Curative – aiming to permanently eradicate the disease

2

Palliative – aiming to extend life expectancy

3

Palliative – aiming to relieve and/or control malignancy related symptoms

4

Palliative – aiming to achieve remission

5

Palliative – aiming to delay tumour progression

98

Other

99

Not known

Note that multiple answer options can be selected for this item.

Treatment outcomes

The treatment outcomes are captured differently depending on treatment intent:

For curative treatments, (dataset items 57 and 58): clinicians should state whether the treatment was completed as planned (Yes/No). If the treatment was not completed as planned, then further details are required on the reason(s) why the treatment was not completed.

For non-curative treatments, clinicians are asked to specify whether the patient has ‘benefitted’ from receiving the treatment (Yes/No). No further information is required for these treatment outcomes at this stage (dataset item 60). This item is the focus of this guidance document.


Considerations for assessing benefit

We recommend assessing the presence or absence of treatment benefit in light of the original intent of the treatment reported in the dataset (see the table under 'Background and introduction' for 'palliative' options).

For example, if the treatment intent was ‘4. Palliative - aiming to achieve remission’, then the benefit recorded should reflect whether the treatment achieved the goal of remission.

If the original aim of the treatment has been met, this is evidence that the treatment has been beneficial, for example 'Yes' should be selected. If you have selected multiple aims for ‘treatment intent’, then we recommend that you consider an overall assessment of the success of the aims, alongside the considerations below.

Where it is not completely clear if the treatment intent has been met, or it has not been fully met, the following elements can also be considered:

  • response to treatment
  • impact on symptoms
  • impact on quality of life

To determine true benefit, any clinical benefit to the patient should always be weighed against any toxicities experienced as part of the treatment and their impact on the patient’s quality of life.

Below are some examples of what elements may contribute toward a potential benefit.

Tumour:

  • biochemical or radiological response
  • unaltered or decreased tumour size
  • reduction in tumour markers
  • prolongation of progression-free survival (PFS)

Patient:

  • improvement of malignancy related symptoms (as observed and self-reported)
  • manageable treatment-induced toxicities (as observed and self-reported)

We acknowledge that patients may gain varied levels of benefit from treatment over time. However, for routine reporting through the SACT dataset it is only assessed when the treatment regimen is complete. Therefore, the entire period of treatment administration must be evaluated to answer the ‘treatment benefit’ data set question.


Patient examples

The patient examples described in the next section illustrate common patient profiles encountered by oncologists. These are hypothetical and simplified for this exercise and aim to provide examples of treatment benefit in a real-life setting.

These are a snapshot of the patient’s medical situation when the assessment is being recorded. However, the assessment must be made considering the entirety of the treatment period.

Note that the focus of this document is on solid tumours only.


Breast patients

Patient Category

Breast patients Tumour type

Patient characteristics

Treatment intent (SACT item)

Response assessment

Toxicity

Outcome on completing treatment

Suggested outcome (SACT item #60)

Patient Α Chemotherapy

Breast with lung metastases

Patient well, PS1

Palliative - aiming to relieve and/or control malignancy related symptoms

Reduction in number and size of metastases on CT scan, 4-5 months of good symptom control prior to rapid disease progression after the 8th cycle of treatment

Neutropenic sepsis after course 4, successfully treated with antibiotics

Dies from disease progression 20 days after the 8th cycle of treatment

Benefit

Patient B Chemotherapy and drainage of fluid

Breast with lung metastases

Pleural effusion and very breathless, PS1

Palliative - aiming to relieve and/or control malignancy related symptoms and aiming to extend life expectancy

Reduction in symptoms

Not recorded

Not known

Benefit

Patient C 8 cycles of chemotherapy

Breast with brain metastases

PS1

?

Patient feels well – stable condition on CT scan

Manageable – well tolerated

Not known

Benefit

Patient D Chemotherapy

Breast with liver metastases

Unwell patient, PS2

Palliative - aiming to extend life expectancy

Small reduction in metastases size

Side effects lead to significant deterioration in QOL Hospitalised for infection – poorly tolerated

Not known

No benefit


Melanoma patients

Patient Category

Melanoma patients Tumour type

Patient characteristics

Treatment intent (SACT item)

Response assessment

Toxicity

Outcome on completing treatment

Suggested outcome (SACT item #60)

Patient Α - Anti-PD-1 antibody monotherapy

Melanoma with liver metastases

80 yo, hypertension, previous TIAs, 3 antihypertensives, otherwise mobile, independent, PS 1

Palliative – aiming to achieve remission

Stable disease after 3 months

No significant immune-related adverse events

Dies of stroke after 5 months of treatment

No benefit

Patient Β - Combination immunotherapy with antiPD-1+anti-CTLA-4 antibodies

Melanoma with low volume lung metastases

45 yo, BRAF wildtype, asymptomatic

Palliative – aiming to achieve remission

Almost complete response by 6 months, maintained over time

Grade 3 colitis after 2 cycles, admitted for 3 weeks, needed infliximab x 2, developed grade 3 hepatitis while in hospital, chronic steroids, discharged, developed grade 2 chronic polyarthropathy

Alive, continues to need treatment for erosive polyarthropathy

Benefit

Patient C - Combination immunotherapy with antiPD-1+anti-CTLA-4 antibodies plus stereotactic radiotherapy to the brain

Melanoma with brain mets

55yo, brain mets progressed on BRAF targeted therapy

Palliative – aiming to extend life expectancy and/or delay tumour progression

Disease progression

Hospitalised with CVA after cycle 1, discharged for EOL care

Death within 3 months of hospitalisation

No benefit


Pancreatic patients

Patient Category

Pancreatic patients Tumour type

Patient characteristics

Treatment intent (SACT item)

Response assessment

Toxicity

Outcome on completing treatment

Suggested outcome (SACT item #60)

Patient 1 - Chemotherapy (FOLFIRINOX)

Pancreatic cancer with liver metastases

65 yo, mild fatigue only, PS 1 at start of treatment but PS 2 at month 6

Palliative – extend life expectancy, delay tumour progression

Month 2: minor responseMonth 4: stable diseaseMonth 6: early signs of progression; treatment stopped by patient choice due to toxicities

Chemo-related toxicities: fatigue, altered bowel habits and loss of taste, weight loss

Patient does not return to clinic and dies 9 months from starting chemotherapy

Benefit

Patient 2 - Chemotherapy (Gemcitabine)

Pancreatic cancer with liver metastases

75 yo, mild fatigue, back pain, PS 2

Palliative –delay tumour progression and relieve/control symptoms

Minor increase in liver mets on CT at 3 months, but overall stable disease

Pain controlled, recurrent thrombocytopenia interrupting chemo delivery with each cycle.Multiple extra visits for rescheduled chemo plus admission for fever of unknown origin, leading to treatment stopping after 4 months

Death at 6 months

No Benefit (see note underneath table)

Note on Patient 2: - Chemotherapy (Gemcitabine) - No benefit: Rationale - the clinician feels that the symptoms have been controlled, and this was one of the identified treatment intents. However, there is no strong evidence of delayed tumour progression, which was the other goal of treatment. Multiple hospital visits and admissions are considered to have a significant negative impact on the patient’s quality of life.

Last edited: 16 January 2023 2:47 pm