Table III.
Trials evaluating bortezomib therapy in malignant lymphoma
| Trial | Treatment and patients | na | orrb(%) | cr(%) | pr(%) | Median remission (months) |
|---|---|---|---|---|---|---|
| Phase ii, nonrandomized | ||||||
| O’Connor 200413 (multicentre) | Bortezomib 1.5 mg/m2 Relapsed, refractory, or untreated indolent nhl and mcl | 51 (100%)c | 55 | nr | nr | nr |
| fl: 19 | 60 | 5 | 5d | Not yet reached | ||
| mcl: 23 | 56 | nr | nr | 6–19 | ||
| sll/cll: 5 | 20 | 0 | 20 | nr | ||
| mzl: 4 | 100 | 0 | 100 | nr | ||
| Goy 200214 (abstract) | Bortezomib 1.5 mg/m2 Relapsed/refractory lymphoma; median age 63 years; median of 4 prior treatments; entry: ≤ grade 1 sensory neuropathy | 24/30 (80%) | 38 | 13 | 25 | nr |
| sll: 1 | 0 | |||||
| fl: 2 | 0 | |||||
| mcl: 15/18 | 53 | 20 | 33 | |||
| dlbcl: 6/8 | 17 | 0 | 17 | 2–7e | ||
| tfl: 0/1 | ne | |||||
| Strauss 200415 (abstract) | Bortezomib 1.3 mg/m2 Relapsed/refractory lymphoma subset; median of 3.5 prior treatments | 32/32 (100%) | 19f | 3 | 16 | nr |
| mcl: 11 | 36 | 9 | 27 | |||
| fl: 10 | 0g | Not assessable | Not assessable | |||
| wm: 4 | 50 | 0 | 50 | |||
| ll: 1 | 0 | na | na | |||
| dlbcl: 1 | 0 | na | na | |||
| atl: 1 | 0 | na | na | |||
| dfcl: 1 | 0 | na | na | |||
| hd: 3 | 0 | na | na | |||
| Belch 200416 (abstract) | Bortezomib 1.3 mg/m2 Mantle cell lymphoma; advanced stage previously untreated or ≤2 prior chemotherapy regimens; median age 67 years; stage iii/iv disease in all cases | 24/30 (80%) | 33h | 0 | 33h | nr |
| pt: 14 | 36h | 0 | 36 | |||
| ut: 10 | 30 | 0 | 30 | |||
| Phase i/ii | ||||||
| Dunleavy 200417 (abstract) | Bortezomib 1.3 mg/m2 | With chemotherapy: 25/26 (96%) | 24 | 8 | 16 | nr |
| Relapsed/refractory aggressive B-cell lymphoma (activated B-cell dlbcl); median age 54 years; median of 4 prior therapies | Alone: 15/16 (94%) | 7 | 0 | 7 | nr | |
Subgroups indicated by italic font.
Sum of all measured response rates: for example, compete response rate + near-complete response rate + partial response rate + minimal response rate.
One patient was untreated.
Unconfirmed complete response rate/partial response rate not reported.
Lower end represents 1 patient with autologous stem-cell transplantation; 2–7 refers to complete remission; for partial remission, value was 3 months.
Plus a 6% “late response” rate.
“Late response” was recorded by authors in 2 patients (7%).
Unconfirmed complete response rate + partial response rate.
orr = overall response rate; cr = complete response rate; pr = partial response rate; nr = not reported; nhl = non-Hodgkin lymphoma; mcl = mantle cell lymphoma; fl = follicular lymphoma; sll = small lymphocytic lymphoma; cll = chronic lymphocytic leukemia; mzl = marginal zone lymphoma; dlbcl = diffuse large B-cell lymphoma; tfl =transformed fl; ne = not evaluable; wm = Waldenström macroglobulinemia; ll = lymphoplasmacytic lymphoma; na = not applicable; atl = adult T-cell leukemia/lymphoma; dfcl = diffuse follicle centre lymphoma; hd = Hodgkin disease; pt = previously treated; ut = untreated.