Table 3.
Bortezomib: relapsed or refractory regimens.
| Regimen/trial | Treatment scheme | Number of patients | Median age | Median follow-up (months) | Median number of prior lines | Prior ASCT | ORR | CR | PFS | OS | Reference |
|---|---|---|---|---|---|---|---|---|---|---|---|
| PINNACLE | Bortezomib 1.3 mg/m2 IV on days 1, 4, 8, and 11 in 21-day cycles (every 21 days until progression up to 17 cycles) |
155 | 65 | 32 | 1 | 37%* | 32% | 8% | 6.7 months | 23.5 months | Fisher et al. [2006]; Goy et al. [2009] |
| BVR | Bendamustine 90 mg/m2 IV on days 1 and 4 Bortezomib 1.3 mg/m2 IV on days 1, 4, 8, and 11 Rituximab 375 mg/m2 on day 1 (every 28 days up to six cycles) |
30 (total) 7 (MCL) |
64 | 24 | 4 | 20% (total) | 82% (total) 71% (MCL) |
51% (total) | 47% (total) 2 years |
UR | Friedberg et al. [2011] |
| CHOP versus V-CHOP | Cyclophosphamide 750 mg/m2 IV, doxorubicin 50 mg/m2 IV, vincristine 1·4 mg/m2 IV (to a maximum dose of 2 mg) and prednisolone 100 mg daily PO ×5 days on day 1 of each cycle with or without bortezomib 1·6 mg/m2 on days 1 and 8 (every 21 days up to a maximum of eight cycles) |
46 | 71 versus 69 | 34 | 1 | None | 48.8% versus 82.6% | 21.7% versus 34.8% | 8.1 versus 16.5 months | 11.8 versus 35.6 months | Furtado et al. [2015] |
| CALGB- (Alliance) 50501 |
Bortezomib, 1.3 mg/m2 IV on days 1, 4, 8, 11, and lenalidomide, 20 mg PO daily on days 1–14 (every 21 days up to a maximum of eight cycles) | 53 | 67 | 46 | 1 | 40% | 39.6% | 15.1% | 7 months | 26 months | Morrison et al. [2015] |
| R-HAD + B | Bortezomib 1.5 mg/m2 IV on days 1 and 4, cytarabine 2000 mg/m2 (⩽60 years) or 1000 mg/m2 (⩾60 years) as a 3 h IVCI on days 2 and 3, and dexamethasone 40 mg PO daily on days 1–4 ± rituximab 375 mg/m2 IV on day 0 (every 21 days given hematologic recovery) |
8 | 65 | UR | 4 | 25% | 50% | 25% | 5 months | 15.5 months | Weigert et al. [2009] |
| NCIC IND 172 |
Gemcitabine 1000 mg/m2 IV on days 1 and 8 and bortezomib 1.0 mg/m2 IV on days 1, 4, 8, and 11 (every 21 days given hematologic recovery up to a maximum of four cycles) |
26 | 62 | 15.9 | 1 | 15% | 60% | 8% | 11.4 months | UR | Kouroukis et al. [2011] |
ASCT, autologous stem cell transplantation; CALGB, Cancer and Leukemia Group B; CR, complete response rate; IV, intravenous; IVCI, intravenous continuous infusion; MCL, mantle cell lymphoma; NCIC, National Cancer Institute of Canada Clinical Trials Group; ORR, overall response rate; OS, overall survival; PO, orally; PFS, progression-free survival; UR, unreported.
*
Including all ‘high-intensity regimens’ with or without ASCT (Hyper-CVAD, ICE, ESHAP, or DHAP, all with or without rituximab [Fisher et al. 2006]).