The BOR calculation is a very common analysis in oncology trials for solid tumor, so it's necessary to create a function. Maybe it can be used as a supplement code or for internal analysis.
[x] BOR of confirmation or not confirmation following RECIST guideline (version 1.1).
[x] Consider the days between responses.
[x] Consider SD duration.
[x] Maybe also need to consider if we should cut the response before first PD.
The following is the conversion to programming logic:
Best Overall Response without confirmation
Using investigator/IRC assessed responses after the first treatment date/randomized and up to the earliest of the first 'PD', and the start of non-protocol anti-cancer therapy (anti-cancer therapy including radiotherapy, surgery, etc.).
Set to 'CR' if there exists an observation of 'CR'
Else set to 'PR' if there exists an observation of 'PR'
Else set to 'SD' if there exists an observation of 'SD' after study protocol specified time (6 weeks from first treatment date (for non-randomized study)/randomized date).
Else set to 'PD' if there exists an observation of AVALC='PD'
Else set to 'NE' if there exists an observation of AVALC= 'NE' or if the subject has only 'SD' before the study protocol specified time (6 weeks from first treatment date (for non-randomized study) or randomized date).
Else set to ‘NA’ if the subject did not have any responses (none of the above 1–5 criteria is fulfilled) or has no post-baseline record.
Use the order CR>PR>SD>PD>NE
Best Overall Response when confirmation of response is required
Using investigator/IRC assessed responses on or after the first treatment date and up to the earliest of the first 'PD', the start of non-protocol anti-cancer therapy, and the study-specific cutoff
Set to 'CR' if patient had CR on each of two tumor assessments which are >=28 days apart with either
(i) no other tumor assessments in between or
(ii) the tumor response between these two assessments can only be CR or NE;
Else set to 'PR' if subject had two tumor assessments >=28 days apart with the first being PR and the second being PR or CR with either
(i) no other tumor assessments in between or
(ii) the tumor response between these two assessments can be PR or NE.
Else set to 'PR' if patient had a "CR” following a "PR" and there is >=4 weeks apart between the two tumor assessments.
Else set to 'SD' if there is at least one response assessment of 'CR', 'PR' or 'SD', and minimum of 6 weeks after first treatment date without any PD in between.
Else set to 'PD' if
(i) If a "PR" is after a "CR", and the assessment date of the "PR" is within 6*7 days from first treatment date. The “PR” should be PD. Same for “SD” following CR.
(ii) If a patient does not meet the criteria of CR/PR/SD and at least one response assessment is PD
Else set to 'NE' if the subject only had NE (Not Evaluable) or CR, PR, SD and did not meet any of the above criteria.
Else set to ‘NA’ if the subject did not have any responses (none of the above 1-6 criteria is fulfilled) or has no post-baseline record.
The BOR calculation is a very common analysis in oncology trials for solid tumor, so it's necessary to create a function. Maybe it can be used as a supplement code or for internal analysis.
Related documents are shown below. https://www.pharmasug.org/proceedings/2023/QT/PharmaSUG-2023-QT-047.pdf
And
The following is the conversion to programming logic:
Best Overall Response without confirmation
Best Overall Response when confirmation of response is required
(ii) If a patient does not meet the criteria of CR/PR/SD and at least one response assessment is PD