Clinical outcomes according to baseline characteristics
| Patient subgroups . | CR rates . | P . | ||
|---|---|---|---|---|
| Vorinostat-EPOCH +/− R (%) . | EPOCH +/− R (%) . | Total (%) . | ||
| All patients, n (% [95% CI])* | 30/44 (8 [54-82]) | 31/42 (74 [61-87]) | 61/86 (71 [61-81]) | .72† |
| DLBCL | 21/30 (70) | 24/31 (77) | 45/61 (74) | .57 |
| GCB type | 10/15 (67) | 15/19 (79) | 25/34 (74) | .46 |
| Non-GCB type | 11/14 (79) | 9/12 (75) | 20/26 (77) | .99 |
| Unclassified DLBCL | 0/1 (0) | — | 0/1 (0) | — |
| PBL | 5/8 (63) | 5/7 (71) | 10/15 (67) | .99 |
| PEL | 3/5 (60) | 2/2 (100) | 5/7 (71) | .99 |
| BL | — | 0/1 (0) | 0/1 (0) | — |
| BCL-U, with features b/w DLBCL and BL | 1/1 (100) | 0/1 (0) | 1/2 (50) | .99 |
| EBV status | ||||
| All NHL types | ||||
| Positive | 13/18 (72) | 12/16 (75) | 25/34 (74) | .99 |
| Negative | 12/18 (67) | 16/22 (73) | 28/40 (70) | .74 |
| Inconclusive or ND | 5/8 (62) | 3/4 (75) | 8/12 (67) | .99 |
| Bcl-2 protein | ||||
| All NHL types | ||||
| Positive | 13/18 (72) | 16/21 (76) | 29/39 (74) | .99 |
| Negative | 6/11 (55) | 10/14 (71) | 16/25 (64) | .43 |
| Inconclusive or ND | 11/15 (73) | 5/7 (71) | 16/22 (72) | .99 |
| DLBCL | ||||
| Positive | 10/15 (67) | 14/17 (82) | 24/32 (75) | .42 |
| Negative | 5/7 (71) | 9/12 (75) | 14/19 (74) | .99 |
| Inconclusive or ND | 6/8 (75) | 1/2 (50) | 7/10 (70) | .99 |
| Myc protein | ||||
| All NHL types | ||||
| Positive | 9/14 (64) | 10/16 (63) | 19/30 (63) | .99 |
| Negative | 10/13 (77) | 6/8 (75) | 16/21 (76) | .99 |
| Inconclusive or ND | 11/17 (65) | 15/18 (83) | 26/35 (74) | .26 |
| DLBCL | ||||
| Positive | 5/8 (63) | 7/10 (70) | 12/18 (67) | .99 |
| Negative | 9/11 (82) | 5/7 (71) | 14/18 (78) | .99 |
| Inconclusive or ND | 7/11 (64) | 12/14 (86) | 19/25 (76) | .35 |
| Absolute CD4 count (cells/mm3) | ||||
| <100 | 2/5 (40) | 3/6 (50) | 5/11(45) | .99 |
| 100-199 | 12/19 (63) | 10/16 (63) | 22/35 (63) | .99 |
| >200 (range, 224-1137) | 16/20 (80) | 18/20 (90) | 34/40 (85) | .66 |
| Preprotocol chemotherapy | ||||
| 1 cycle | 9/16 (56) | 13/19 (68) | 22/35 (63) | .50 |
| None | 21/28 (75) | 18/23 (78) | 39/51 (76) | .99 |
| DTI | ||||
| <15 d | 15/25 (60) | 10/19 (53) | 25/44 (57) | .76 |
| ≥15 d | 15/19 (79) | 21/23 (91) | 36/42 (86) | .38 |
| Time from enrollment | EFS (standard error) | P | ||
| 12 mo | 70 (6.9) | 74 (6.8) | 72 (4.8) | .32 |
| 24 mo | 63 (7.4) | 71 (7.0) | 67 (5.1) | |
| 36 mo | 63 (7.4) | 69 (7.2) | 66 (5.2) | |
| Time from enrollment | OS (standard error) | P | ||
| 12 mo | 77 (6.4) | 85 (5.5) | 81 (4.3) | .39 |
| 24 mo | 70 (7.1) | 83 (5.9) | 76 (4.7) | |
| 36 mo | 70 (7.1) | 77 (6.8) | 73 (5.0) | |
| Patient subgroups . | CR rates . | P . | ||
|---|---|---|---|---|
| Vorinostat-EPOCH +/− R (%) . | EPOCH +/− R (%) . | Total (%) . | ||
| All patients, n (% [95% CI])* | 30/44 (8 [54-82]) | 31/42 (74 [61-87]) | 61/86 (71 [61-81]) | .72† |
| DLBCL | 21/30 (70) | 24/31 (77) | 45/61 (74) | .57 |
| GCB type | 10/15 (67) | 15/19 (79) | 25/34 (74) | .46 |
| Non-GCB type | 11/14 (79) | 9/12 (75) | 20/26 (77) | .99 |
| Unclassified DLBCL | 0/1 (0) | — | 0/1 (0) | — |
| PBL | 5/8 (63) | 5/7 (71) | 10/15 (67) | .99 |
| PEL | 3/5 (60) | 2/2 (100) | 5/7 (71) | .99 |
| BL | — | 0/1 (0) | 0/1 (0) | — |
| BCL-U, with features b/w DLBCL and BL | 1/1 (100) | 0/1 (0) | 1/2 (50) | .99 |
| EBV status | ||||
| All NHL types | ||||
| Positive | 13/18 (72) | 12/16 (75) | 25/34 (74) | .99 |
| Negative | 12/18 (67) | 16/22 (73) | 28/40 (70) | .74 |
| Inconclusive or ND | 5/8 (62) | 3/4 (75) | 8/12 (67) | .99 |
| Bcl-2 protein | ||||
| All NHL types | ||||
| Positive | 13/18 (72) | 16/21 (76) | 29/39 (74) | .99 |
| Negative | 6/11 (55) | 10/14 (71) | 16/25 (64) | .43 |
| Inconclusive or ND | 11/15 (73) | 5/7 (71) | 16/22 (72) | .99 |
| DLBCL | ||||
| Positive | 10/15 (67) | 14/17 (82) | 24/32 (75) | .42 |
| Negative | 5/7 (71) | 9/12 (75) | 14/19 (74) | .99 |
| Inconclusive or ND | 6/8 (75) | 1/2 (50) | 7/10 (70) | .99 |
| Myc protein | ||||
| All NHL types | ||||
| Positive | 9/14 (64) | 10/16 (63) | 19/30 (63) | .99 |
| Negative | 10/13 (77) | 6/8 (75) | 16/21 (76) | .99 |
| Inconclusive or ND | 11/17 (65) | 15/18 (83) | 26/35 (74) | .26 |
| DLBCL | ||||
| Positive | 5/8 (63) | 7/10 (70) | 12/18 (67) | .99 |
| Negative | 9/11 (82) | 5/7 (71) | 14/18 (78) | .99 |
| Inconclusive or ND | 7/11 (64) | 12/14 (86) | 19/25 (76) | .35 |
| Absolute CD4 count (cells/mm3) | ||||
| <100 | 2/5 (40) | 3/6 (50) | 5/11(45) | .99 |
| 100-199 | 12/19 (63) | 10/16 (63) | 22/35 (63) | .99 |
| >200 (range, 224-1137) | 16/20 (80) | 18/20 (90) | 34/40 (85) | .66 |
| Preprotocol chemotherapy | ||||
| 1 cycle | 9/16 (56) | 13/19 (68) | 22/35 (63) | .50 |
| None | 21/28 (75) | 18/23 (78) | 39/51 (76) | .99 |
| DTI | ||||
| <15 d | 15/25 (60) | 10/19 (53) | 25/44 (57) | .76 |
| ≥15 d | 15/19 (79) | 21/23 (91) | 36/42 (86) | .38 |
| Time from enrollment | EFS (standard error) | P | ||
| 12 mo | 70 (6.9) | 74 (6.8) | 72 (4.8) | .32 |
| 24 mo | 63 (7.4) | 71 (7.0) | 67 (5.1) | |
| 36 mo | 63 (7.4) | 69 (7.2) | 66 (5.2) | |
| Time from enrollment | OS (standard error) | P | ||
| 12 mo | 77 (6.4) | 85 (5.5) | 81 (4.3) | .39 |
| 24 mo | 70 (7.1) | 83 (5.9) | 76 (4.7) | |
| 36 mo | 70 (7.1) | 77 (6.8) | 73 (5.0) | |
Unless otherwise stated, data are number of patients/total patients analyzed (% of total analyzed). Shown are CR and EFS and OS rates after intention to treat according to NHL subtypes, EBV status, Bcl-2 and Myc protein expression, absolute CD4 counts, preprotocol therapy, and DTI.
ND, not done.
95% confidence interval on CR rate. Data are in percentage units.
P value from a 1-sided z-test to detect increase on the VOR-EPOCH arm. All other P-values are from 2-sided tests that used Fisher’s exact test for CR rates and the log-rank test for EFS and OS.