In Oncology clinical research, Overall Treatment Utility (OTU) is a composite clinical outcome measure designed to quantify the effect of palliative treatments on individuals with a diagnosis of advanced or incurable cancer.

OTU attempts to capture the balance of benefits and harms from cancer treatments. It combines clinical and radiological response, toxicity, adverse events, quality of life and patient-reported acceptability of treatment.

As a concept, the measure may be regarded as asking the treating clinician: “With the benefit of hindsight, are you glad you gave this treatment?” and asking the patient: “With the benefit of hindsight, are you glad you received it?.”

Overall Treatment Utility may be considered a more patient centred intermediate endpoint as a response to criticism leveled at the increasing reliance on surrogate endpoints by drug regulators.^[1] The inclusion of Overall Treatment Utility as a pre-defined endpoint has now been seen in a variety of clinical trials in the United Kingdom, including FOCUS2^[2], 321GO^[3], GO2^[4] and the ROSELEE study.

It is common to report OTU after 9 or 12 weeks of treatment.

For more information about OTU or if you are considering using it in a study please get in touch.

Validation

As an outcome measure, Overall Treatment Utility has been validated as a better predictor of both Progression Free Survival and survival rate compared with tumor response alone as measured by the gold standard Response Evaluation Criteria in Solid Tumors (RECIST).^[5] 

Overall Treatment Utility was first developed within within the FOCUS2 clinical trial in elderly patients treated with chemotherapy for advanced colorectal cancer.^[2] A variety of baseline clinical characteristics were shown to predict for benefit or harm as measured by Overall Treatment Utility using an ordered logit model. Validation and further development took place in the context of the 321GO clinical trial that looked at chemotherapy intensity in the palliative treatment of patients with advanced gastric and oesophageal cancer.^[3] 

As a clinical outcome measure, Overall Treatment Utility needs further development and validation. If you would like to help please get in touch.

License

Presenting OTU results

Scoring method

To score Overall Treatment Utility, a patient is assessed at a pre-defined time-point from commencement of treatment. Overall Treatment Utility is scored as good, intermediate or poor, corresponding to “yes”, “uncertain” or “no” replies to these questions.

Scoring uses the following criteria:

 

1. Clinical benefit?

Score 1 if all of:

No evidence of radiological progression

No cancer-related clinical deterioration , as assessed by treating physician

No deterioration in patient reported outcomes

Score 0 if any of:

Radiological progression

Clinical deterioration, as assessed by treating consultant

Deterioration in patient reported quality of life

2. Tolerable and acceptable?

Score 1 if all of the following:

No Serious Adverse Reaction (SAR) or Suspected Unexpected Serious Adverse Reaction (SUSAR) attributed to treatment

Patient response to question “How much has your treatment interfered with your normal daily activities?” is not “Very much” or “quite a bit”

Patient response to question (“How worthwhile do you think your treatment has been?”) is not “Not at all”

Score 0 if any of the following:

SAR or SUSAR attributed to treatment

Patient response to question “How much has your treatment interfered with your normal daily activities?”) is “Very much” or “quite a bit”

Patient response to question “How worthwhile do you think your treatment has been?” is “Not at all”

Scoring:

Good OTU:

•  Patient is alive and scores 2

Intermediate OTU:

• Patient is alive and scores 1

Poor OTU:

Patient is alive and scores 0, or patient is dead

References