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. Author manuscript; available in PMC: 2021 Jun 2.
Published in final edited form as: Clin Cancer Res. 2017 Apr 5;23(15):4127–4137. doi: 10.1158/1078-0432.CCR-16-2818

Table 2.

Response rate based on IRAC assessment (IWRC 1999)a (mITT Population)

Immunohistochemistry
Gene expression profiling
Overall
GCB
Non-GCB
GCB
ABC
Len n = 51 IC n = 51 Len n = 23 IC n = 25 Len n = 28 IC n = 26 Len n = 14 IC n = 16 Len n = 11 IC n = 16

ORR, n (%) 14 (27.5) 6 (11.8) 6 (26.1) 3 (12.0) 8 (28.6) 3 (11.5) 3 (21.4) 2 (12.5) 5 (45.5) 3 (18.8)
 [95% CI]b [15.9–41.7] [4.4–23.9] [10.2–48.4] [2.5–31.2] [13.2–48.7] [2.4–30.2] [4.7–50.8] [1.6–38.3] [16.7–76.6] [4.0–45.6]
P valuec 0.079 0.279 0.179 0.642 0.206
CRd, n (%) 5 (9.8) 1 (2.0) 1 (4.3) 0 (0.0) 4 (14.3) 1 (3.8) 1 (7.1) 0 (0.0) 3 (27.3) 1 (6.3)
PR, n (%) 9 (17.6) 5 (9.8) 5 (21.7) 3 (12.0) 4 (14.3) 2 (7.7) 2 (14.3) 2 (12.5) 2 (18.2) 2 (12.5)
SD, n (%) 13 (25.5) 11 (21.6) 5 (21.7) 7 (28.0) 8 (28.6) 4 (15.4) 4 (28.6) 3 (18.8) 2 (18.2) 3 (18.8)
PD/death, n (%) 24 (47.1) 33 (64.7) 12 (52.2) 14 (56.0) 12 (42.9) 19 (73.1) 7 (50.0) 11 (68.8) 4 (36.4) 10 (62.5)
Unknown, n (%) 0 (0.0) 1 (2.0) 0 (0.0) 1 (4.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
PFS, weeks 13.6 7.9 10.1 9.0 15.1 7.1 13.2 7.1 82.0 6.2
 HR (95% CI) 0.64 (0.41-0.99) 0.82 (0.43–1.57) 0.50 (0.27-0.92) 0.77 (0.35–1.68) 0.44 (0.15–1.23)
P value 0.041 0.550 0.021 0.506 0.105
OS, weeks 31.0 24.6 30.0 24.9 32.3 20.4 30.0 20.1 108.4 18.6
 HR (95% CI) 0.91 (0.59–1.41) 1.23 (0.65–2.34) 0.70 (0.38–1.30) 1.12 (0.52–2.42) 0.47 (0.17–1.33)
P value 0.673 0.526 0.253 0.767 0.144
a

mITT population; defined as all randomized patients who had confirmed DLBCL and GCB or non-GCB subtype diagnosis and received ≥1 dose of study drug.

b

Exact CI based on binomial distribution.

c

P value derived from the Fisher exact test.

d

No CR unconfirmed observed.

Abbreviation: Len, lenalidomide