Table 4.

Major clinical trials of bortezomib-based therapies in follicular lymphoma.

Ref.	Prior therapies	Treatment regimen	Bortezomib dose and schedule	Phase	No. of patients	Results
[100]	At least 1	Rituximab (375 mg/m2 on days 1, 8, 15, 22 of cycle 1 and day 1 of cycles 2 – 5) ± bortezomib	1.6 mg/m2 on days 1, 8, 15, 22, every 35 days × 5	III	676 (340 in rituximab group + 336 in combination group)	Median PFS 11 months in rituximab group and 12.8 months in combination group (p = 0.039)
[99]	Median 2	Bortezomib, rituximab (375 mg/m2 on days 1, 8, 15, 22 of cycle 1 and day 1 of cycles 2 – 5) and bendamustine (50, 70 or 90 mg/m2 on days 1 and 2)	1.6 mg/m2 on days 1, 8, 15, 22, every 35 days × 5	II	73 (63 received 90 mg/m2 of bendamustine)	88% ORR, 53% CRs, median DOR 11.7 months and PFS 14.9 months
[97]	Median 3 in biweekly arm, 3.8 in weekly arm	Monotherapy (comparison of two schedules)	1.5 mg/m2 on days 1, 4, 8, 11, every 21 days up to 8 cycles versus 1.6 mg/m2 on days 1, 8, 15, 22, every 35 days up to 6 cycles. Two additional cycles allowed in both arms in responders	II	87 (50 in biweekly arm + 37 in weekly arm	ITT ORR 30% in biweekly arm versus 22% in weekly arm (evaluable ORR 32 vs 23%); median DOR 16 and 15 months, and PFS 7 and 6 months, respectively, at median f/u of 36 and 38 months, respectively
[98]	None	BR-CVP for up to 8 cycles	1.3 mg/m2 on days 1 and 8 of a 21-day cycle	II	94	83% ORR, 49% CR/ CRu rate (ITT)

BR-CVP: Bortezomib, rituximab, cyclophosphamide, vincristine, prednisone; CR: Complete response; CRu: Unconfirmed complete response; DOR: Duration of response; f/u: Follow up; ITT: Intention to treat; ORR: Overall response rate; PFS: Progression-free survival.