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. 2020 Feb 26;8(1):e000146. doi: 10.1136/jitc-2019-000146

Table 3.

Concordance in best overall response achieved prior to use of non-protocol-specified anticancer therapy per iRECIST and RECIST V.1.1 in the anti-PD-1/PD-L1 antibody-treated population

CR PR SD PD NE/baseline Total
iCR 258 13 0 5 0 276 (5.8%)
iPR 0 1178 11 32 0 1221 (25.7%)
iSD 0 0 1110 59 0 1169 (24.6%)
iCPD 0 0 0 405 0 405 (8.5%)
iUPD 0 0 0 1192 0 1192 (25.1%)
NE/baseline 0 0 0 0 488* 488 (10.3%)
Total 258 1191 1121 1693 488 4751

The bold values identify the 48 patients with response per iRECIST but only progression or stable disease per RECIST v.1.1

*Includes 355 patients with no postbaseline tumor assessment; 78 patients receiving non-protocol-specified anticancer therapy prior to first postbaseline tumor assessment, 29 patients in whom not all target tumors were assessed in postbaseline evaluations and 26 patients whose assessment of iSD was conducted too early to be considered durable and who had no further assessment or received non-protocol therapy.

iCPD, confirmed progression of disease; iCR/CR, complete response; iPR/PR, partial response; iSD/SD, stable disease; iUPD, unconfirmed progression of disease; NE, not evaluable; PD, progression of disease; RECIST, Response Evaluation Criteria in Solid Tumours.