Table 4.
Disease response at end of treatment by PET/CT
| Arm A: VEN + R-CHOP, n/N (%) | VEN 200 mg, | VEN 400 mg, | VEN 600 mg, | VEN 800 mg, | Total | |
|---|---|---|---|---|---|---|
| Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | |||
| Responders | 6/7 (85.7) | 3/3 (100) | 7/8 (87.5) | 5/6 (83.3) | 21/24 (87.5) | |
| CR | ||||||
| Overall | 6/7 (85.7) | 2/3 (66.7) | 6/8 (75.0) | 5/6 (83.3) | 19/24 (79.2) | |
| DLBCL | 3/3 (100) | 0/0 | 1/2 (50.0) | 4/5 (80.0) | 8/10 (80.0) | |
| FL | 2/3 (66.7) | 1/1 (100) | 5/6 (83.3) | 0/0 | 7/10 (70.0) | |
| Other* | 1/1 (100) | 1/2 (50.0) | 0/0 | 1/1 (100) | 3/4 (75.0) | |
| PR | ||||||
| Overall | 0/7 | 1/3 (33.3) | 1/8 (12.5) | 0/6 | 2/24 (8.3) | |
| DLBCL | 0/3 | 0/0 | 0/2 | 0/5 | 0/10 | |
| FL | 0/3 | 0/1 | 1/6 (16.7)† | 0/0 | 1/10 (10.0) | |
| Other* | 0/1 | 1/2 | 0/0 | 0/1 | 1/4 (25.0) | |
| PD | ||||||
| Overall | 0/7 | 0/3 | 1/8 (12.5) | 1/6 (16.7) | 2/24 (8.3) | |
| DLBCL | 0/3 | 0/0 | 1/2 (50.0) | 1/5 (20.0) | 2/10 (20.0) | |
| FL | 0/3 | 0/1 | 0/6 | 0/0 | 0/10 | |
| Other* | 0/1 | 0/2 | 0/0 | 0/1 | 0/4 | |
| Missing | ||||||
| Overall | 1/7 (14.3) | 0/3 | 0/8 | 0/6 | 1/24 (12.5) | |
| DLBCL | 0/3 | 0/0 | 0/2 | 0/5 | 0/10 | |
| FL | 1/3 (33.3) | 0/1 | 0/6 | 0/0 | 1/10 (10.0) | |
| Other* | 0/1 | 0/2 | 0/0 | 0/1 | 0/4 | |
| Arm B: VEN + G-CHOP, n/N (%) | VEN 200 mg, | VEN 400 mg, | VEN 600 mg, | VEN 800 mg (10 d), | VEN 800 mg (5 d), | Total |
|---|---|---|---|---|---|---|
| Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4A | Cohort 4B | ||
| Responders | 5/7 (71.4) | 6/7 (85.7) | 5/6 (83.3) | 6/6 (100) | 6/6 (100) | 28/32 (87.5) |
| CR | ||||||
| Overall | 3/7 (42.9) | 6/7 (85.7) | 4/6 (66.7) | 6/6 (100) | 6/6 (100) | 25/32 (78.1) |
| DLBCL | 0/0 | 1/1 (100) | 2/2 (100) | 2/2 (100) | 3/3 (100) | 8/8 (100) |
| FL | 2/3 (66.7) | 3/3 (100) | 2/4 (50.0) | 3/3 (100) | 2/2 (100) | 12/15 (80.0) |
| Other* | 1/4 (25.0) | 2/3 (66.7) | 0/1 | 1/1 (100) | 1/1 (100) | 5/10 (50.0) |
| PR | ||||||
| Overall | 2/7 (28.6) | 0/7 | 1/6 (16.7) | 0/6 | 0/6 | 3/32 (9.4) |
| DLBCL | 0/0 | 0/1 | 0/2 | 0/2 | 0/3 | 0/8 |
| FL | 0/3 | 0/3 | 1/3 (33.3) | 0/3 | 0/2 | 1/14 (7.1) |
| Other* | 2/4 (50.0)† | 0/3 | 0/1 | 0/1 | 0/1 | 2/10 (20.0) |
| Missing | ||||||
| Overall | 2/7 (28.6) | 1/7 (14.3) | 1/6 (16.7) | 0/6 | 0/6 | 4/32 (12.5) |
| DLBCL | 0/0 | 0/1 | 0/2 | 0/2 | 0/3 | 0/8 |
| FL | 1/3 (33.3) | 0/3 | 0/2 | 0/3 | 0/2 | 1/13 (7.7) |
| Other* | 1/4 (25.0) | 1/3 (33.3) | 1/1 (100) | 0/1 | 0/1 | 3/10 (30.0) |
If no PET-CT was performed at end of treatment, available CT results were included instead. Responses were assessed by the investigators and central review based on imaging studies and BM examinations using a modified version of the Lugano Classification described by Cheson et al28 with the following modifications: (1) For CR, if the BM was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat BM biopsy or aspirate; (2) For PET-CT–based PR, CT criteria for PR (or CR) must also be met. Nonmissing end-of-treatment (EOT) CT response was used if EOT PET response was missing. Five (8.9%) patients discontinued early due to toxicity (3 in cohort 1) and have missing EOT response assessments (2 discontinued in cycle 5 and responded in cycle 4; 1 discontinued in cycle 1 and responded during follow-up).
Transformed lymphoma, marginal zone lymphoma, composite lymphoma, and Waldenström macroglobulinemia.
Three patients (1 in arm A, 2 in arm B) with BM involvement at baseline who achieved radiologic CR were classified as having PR due to missing BM data at EOT with all other evidence of CR. Percentages within bars were calculated per cohort; those above bars were calculated per arm.