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. 2013 Jan 7;31(5):573–583. doi: 10.1200/JCO.2012.42.7211

Table 3.

Patient Characteristics at Baseline

Characteristic Relapsed FL(n = 42)*
 Relapsed DLBCL(n = 47)†
 Refractory NHL(n = 30)‡
 Total(N = 119)
No. % No. % No. % No. %
Age, years
    Median 64 72 63 65
    Range 29-82 33-85 20-79 20-85
    > 60 26 62 32 68 16 53 74 62
Sex
    Female 20 48 19 40 9 30 48 40
    Male 22 52 28 60 21 70 71 60
Baseline ECOG performance status§
    0 26 62 23 49 13 43 62 54
    1 15 36 15 32 13 43 43 38
    2 0 6 13 3 10 9 8
Baseline FLIPI/IPI score§
    0 3 7 2 4 1 3
    1 7 17 8 17 4 13
    2 15 36 19 40 7 23
    3 7 17 13 28 9 30
    4 9 21 3 6 4 13
    5 1 2 0 1 3
Disease stage III to IV 33 79 32 68 23 77 88 74
Bulky disease, cm
    > 7.5 7 17 7 15 9 30 23 19
    > 5.0 17 41 16 34 20 67 53 45
Increased LDH§ 13 31 16 35 18 62 47 40
Bone marrow involvement§ 13 31 8 17 6 20 27 23
Prior rituximab exposure 42 100 47 100 30 100 119 100
No. of prior regimens
    1 20 48 19 40 2 7 41 35
    2 20 48 24 51 9 30 53 45
    ≥ 3 2 5 4 9 19 63 25 21
Prior radiotherapy 6 14 14 30 12 40 32 27
Prior stem-cell transplantation 2 5 9 19 3 10 14 12
Response to most recent prior therapy
    Complete response 24 57 30 64 1 3 55 46
    Partial response 13 31 14 30 1 3 28 24
    Stable disease 2 5 2 4 4 13 8 7
    Disease progression 3 7 1 2 24 80 28 24

Abbreviations: DLBCL, diffuse large B-cell lymphoma; ECOG, Eastern Cooperative Oncology Group; FL, follicular lymphoma; FLIPI, Follicular Lymphoma International Prognostic Index; IPI, International Prognostic Index; LDH, lactate dehydrogenase; NHL, non-Hodgkin lymphoma.

*

Includes one patient who received 0.8 mg/m2 inotuzumab ozogamicin and two patients who received 1.3 mg/m2 inotuzumab ozogamicin during dose-escalation phase (part 1).

†

Includes four patients who received 0.8 mg/m2 inotuzumab ozogamicin and one patient who received 1.3 mg/m2 inotuzumab ozogamicin during dose-escalation phase (part 1).

‡

Consists of patients with DLBCL (n = 20), transformed FL (n = 5), and mantle cell lymphoma (n = 5).

§

Missing ECOG data (FL, n = 1; DLBCL, n = 3; refractory groups, n = 1), FLIPI/IPI data (DLBCL, n = 2; refractory groups, n = 4), LDH data (DLBCL, n = 1; refractory groups, n = 1), and bone marrow involvement data (FL, n = 2; DLBCL, n = 1; refractory groups, n = 1).

Includes nine patients with three prior therapies, seven patients with four prior therapies, and two patients with six prior therapies; one patient with Richter's transformation received nine prior therapies.