Table 4.
Response Rate and PFS for Patients With Relapsed FL or Relapsed/Refractory DLBCL Enrolled to Receive MTD Treatment, by Prognostic Factors
| Variable | Response Rate |
PFS |
|||
|---|---|---|---|---|---|
| No. | ORR (%)* | CR/CRu (%) | 1-Year PFS rate (%) | Median (months) | |
| Relapsed FL (n = 39)† | |||||
| Response to prior therapy | |||||
| CR/CRu | 23 | 87 | 65.2 | 87 | N/R |
| PR/SD | 14 | 86 | 50 | 86 | N/R |
| PD | 2 | 100 | 100 | 100 | 30.8 |
| Time to progression with prior therapy, months | |||||
| > 12 | 27 | 85 | 67 | 92 | N/R |
| < 12 | 12 | 92 | 50 | 75 | 30.8 |
| FLIPI score | |||||
| Low risk (< 2) | 10 | 100 | 90 | 100 | N/R |
| Intermediate risk 2 | 12 | 92 | 83 | 100 | N/R |
| High risk (> 2) | 17 | 77 | 29 | 69 | 30.8 |
| Bulky disease, cm | |||||
| < 5.0 | 23 | 87 | 78 | 91 | N/R |
| 5.0-7.5 | 10 | 90 | 50 | 79 | N/R |
| ≥ 7.5 | 6 | 83 | 17 | 83 | N/R |
| Relapsed/refractory DLBCL (n = 67)‡ | |||||
| Response to prior therapy§ | |||||
| CR/CRu | 28 | 82 | 61 | 61 | 18.7 |
| PR/SD | 17 | 47 | 24 | 34 | 7.8 |
| PD | 21 | 19 | 0 | 10 | 1.7 |
| Time to progression with prior therapy, months | |||||
| > 12 | 27 | 74 | 59 | 56 | 17.1 |
| < 12 | 40 | 40 | 15 | 25 | 4.1 |
| IPI§ | |||||
| Low risk (< 2) | 13 | 69 | 54 | 51 | 15.1 |
| Low-intermediate risk 2 | 24 | 58 | 38 | 49 | 9.6 |
| Intermediate-high/high risk (> 2) | 26 | 42 | 15 | 19 | 3.7 |
| Bulky disease, cm | |||||
| < 5.0 | 35 | 69 | 51 | 50 | 10.3 |
| 5.0-7.5 | 18 | 39 | 17 | 28 | 4.0 |
| ≥ 7.5 | 14 | 36 | 7 | 15 | 3.4 |
Abbreviations: DLBCL, diffuse large B-cell lymphoma; CR, complete response; CRu, unconfirmed CR; FL, follicular lymphoma; FLIPI, Follicular Lymphoma International Prognostic Index; IPI, International Prognostic Index; MTD, maximum-tolerated dose; N/R, not reached; ORR, objective response rate; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease.
ORR includes CR, CRu, and PR.
All patients with FL enrolled to receive MTD treatment (five enrolled in part 1; 34 enrolled in part 2).
All patients with relapsed or refractory DLBCL who were enrolled to receive MTD treatment (42 relapsed DLBCL [two patients enrolled in part 1; 40 enrolled in part 2, group 2], 20 refractory DLBCL [part 2, group 3], and five refractory transformed FL [part 2, group 3]). One patient enrolled in part 2, group 2 did not receive study treatment.
Prior response not reported for one patient; IPI score not reported for four patients.