The RSSTRESC codelist was initially published to cover the needs of solid tumor responses as per the RECIST 1.0
and 1.1 criteria. The published definitions were kept deliberately generic in order to facilitate re-use of these terms
across multiple tumor types, imaging modalities, therapeutic agents, and published criterion papers. We continued
to uphold this philosophy when constructing the definitions for the new response values presented for public
review with P23. It is expected that clinicians should use the precise criterion definitions outlined in the individual
papers to assign response values. As per the SDTM Oncology domains, the published criterion used to assign the
responses can be put into the RSCAT variable.
FDA, CDISC, NCI-EVS and select academic experts came to consensus that the words Response (used in solid
tumors) and Remission (used in non-solid tumors) were functionally synonymous and so two distinct terms were
not required to be added to the RSSTRESC codelist. Instead ‘Remission’ has been added as a synonym in all
instances where ‘Response’ is used in a CDISC submission value, for those response values that are used in both
solid and non-solid tumors. FDA is expecting a single CDISC submission value to be submitted for both solid and
non-solid tumor response terms.
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