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Table 2 Clinical trial experience with bortezomib in lymphoma

From: Targeted therapy in lymphoma

Reference

Study

Evaluable Patients

ORR (CR + PR)

Treatment-naïve MCL

Kahl et al 2008 [20]

Phase II, single-arm, VcR-CVAD followed by maintenance rituximab therapy

N = 30

90%

Relapsed/refractory MCL (and other lymphomas)

O'Connor et al 2005 [21]

Phase II, single-arm, monotherapy (1.5 mg/m2 days 1, 4, 8, 11 every 21 days)

N = 24: MCL (n = 10), follicular lymphoma (n = 9), small lymphocytic lymphoma or CLL (n = 3), marginal zone lymphoma (n = 2)

MCL 50%

Follicular lymphoma 78%

Small lymphocytic lymphoma or CLL 0%

Marginal zone lymphoma 100%

Gerecitano et al 2009 [22]

Extension of O'Connor et al 2005 trial: continuing patients switched to weekly bortezomib 1.8 mg/m2

N = 22: MCL (n = 8), follicular lymphoma (n = 14)

MCL 25%

Follicular lymphoma 14%

Goy et al 2005 [23]

Phase II, single-arm, monotherapy (1.5 mg/m2 days 1, 4, 8, 11 every 21 days)

N = 50: MCL (n = 29), other B-cell lymphomas (n = 21)

MCL 41%

Other B-cell lymphomas 19%

Strauss et al 2006 [24]

Phase II, single-arm, monotherapy (1.3 mg/m2 days 1, 4, 8, 11 every 21 days)

N = 48: MCL (n = 24), follicular lymphoma (n = 11), other lymphomas (n = 13)

MCL 29%

Follicular lymphoma 18%

Others 23%

Relapsed/refractory MCL

PINNACLE, Fisher et al 2006 [25]

Phase II, single-arm, monotherapy (1.3 mg/m2 days 1, 4, 8, 11 every 21 days)

N = 141

33%

Updated PINNACLE,a Goy et al 2009 [26]

Phase II, single-arm, monotherapy (1.3 mg/m2 days 1, 4, 8, 11 every 21 days)

N = 55

29%

Belch et al 2007 [27]

Phase II, single-arm, monotherapy (1.3 mg/m2 days 1, 4, 8, 11 every 21 days)

N = 28

46%

O'Connor et al 2009 [28]

Phase II, single-arm monotherapy (1.5 mg/m2 days 1, 4, 8, 11 every 21 days)

N = 36b

47%

Weigert et al 2009 [29]

Multicenter observational study of R-HAD+B salvage regimen:

- bortezomib (1.5 mg/m2 days 1, 4)

- cytarabine (2,000 mg/m2 days 2, 3c)

- dexamethasone (40 mg days 1-4)

- Rituximab (375 mg/m2 on day 0 for patients not refractory to prior rituximab-containing regimens)

N = 8

50%

DLBCL

Dunleavy et al 2009 [30]

Phase I/II, 2-part study of bortezomib monotherapy (part A) followed by bortezomib plus DA-EPOCH (part B)

N = 47 (n = 23 part A, n = 44 part B)

Part A 4%

Part B 34%

Relapsed/refractory Hodgkin lymphoma

Trelle et al 2007 [31]

Phase II, bortezomib (1.3 mg/m2) plus dexamethasone (20 mg) on days 1, 4, 8, 11 every 21 days

N = 12

0% (17% SD, 83% PD)

Blum et al 2007 [32]

Phase II, single-arm, monotherapy (1.3 mg/m2 on days 1, 4, 8, 11 every 21 days)

N = 29

0% (30% SD, 70% PD)

Mendler et al 2008 [33]

Phase II, single-arm bortezomib (1 mg/m2 on days 1, 4, 8, 11) and gemcitabine (800 mg/m2 on days 1, 8) every 21 days

N = 18

22%

  1. Abbreviations: MCL - mantle-cell lymphoma, ORR - overall response rate, CR - complete response, PR - partial response, CLL - chronic lymphocytic leukemia, DLBCL - diffuse large B-cell lymphoma, DA-EPOCH - doxorubicin-based chemotherapy (etoposide, vincristine, doxorubicin, with cyclophosphamide and prednisone), R-HAD+B - bortezomib, high-dose cytarabine, dexamethasone, SD - stable disease, PD - progressive disease; VcR-CVAD - bortezomib, rituximab, cyclophosphamide, doxorubicin, vincristine and dexamethasone.
  2. aOriginal PINNACLE publication reported data from median follow-up period of 13.4 months [25]; updated publication described data from median follow-up of 26.4 months [26]
  3. bThe 36 evaluable patients included 11 patients whose outcome was reported by O'Connor et al 2005 [21, 28]
  4. cPatients ≥60 years of age were treated with 1,000 mg/m2 [29]
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Journal of Hematology & Oncology

ISSN: 1756-8722

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