Table 10.
ISCL/USCLC/EORTC response in blood for MF and SS
| Response | Definition |
|---|---|
| CR | B0*,† |
| PR | >50% decrease in quantitative measurements of blood tumor burden from baseline in those with B2 classification*,†,‡ |
| SD | Fails to attain criteria for CR, PR, or PD |
| PD§ | • B0 to B2*,† or • >50% increase from baseline and ≥5000 neoplastic cells/μL‖ or • Loss of response in those with PR who were originally B2 at baseline, >50% increase from nadir and ≥5000 neoplastic cells/μL‖ |
Modified from Olsen et al.7
As determined by absolute numbers of neoplastic cells/μL by flow cytometry.
The absolute number of CD4+CD26− and/or CD4+CD7− lymphocytes may be used to assess blood involvement in clinical trials. In the case where more than one aberrant population of lymphocytes is recorded, the population with the highest absolute number at baseline should determine the B classification and the highest absolute number at each assessment should be used to determine the number of aberrant lymphocytes for response purposes.
There is no PR in those with B1 disease at baseline as the difference within the range of neoplastic cells that define B1 is not considered significant and should not affect determination of global objective response.
Whichever occurs first.
The determination of what constitutes a significantly high count of neoplastic cells above 1000 neoplastic cells/μL and what should be used here to help define PD in MF/SS blood involvement is at present arbitrary and based on expert opinion. We cede modification of this number to published data showing prognostic value for a different number of neoplastic cells per microliter than what is published here.