7512 Background: Bortezomib (VELCADE, Vc), a novel proteasome inhibitor, is approved in relapsed multiple myeloma and has shown activity in MCL in phase 2 NHL studies. Methods: Patients (pts) with relapsed or refractory MCL with a maximum of 2 prior therapies received Vc 1.3mg/m2 i.v. on d 1, 4, 8, and 11 of a 21-d cycle for up to 1y. Full accrual (155 pts) was completed in this multicenter, phase 2 study. Primary endpoint was TTP, secondary endpoints included RR and duration of response (DOR). Response (International Workshop Criteria) was assessed by the investigators and separately by the sponsor using central radiology review. Results: Data are available for 154 pts. Baseline characteristics included median age 65y, 81% male, 28% KPS <90%, 35% LDH > normal, 43% IPI ≥3, 74% stage IV MCL. 90% of pts had prior intensive therapy (e.g. Hyper CVAD, CHOP, EPOCH), 96% had prior rituximab, and 14% had prior stem cell transplant. Median duration of Vc treatment was 4 cycles. 138 pts were evaluable for response. By investigator assessment, RR was 35% (CR + CRu = 8%) and median DOR was 9.2 mo. Median TTP was 5.5 mo (all patients, n = 154). Using central radiology review RR was 31% (CR + CRu = 7%), median DOR was 4.6 mo and median TTP was 4.1 mo. With median follow-up of 10 mo, median survival has not been reached. The most common non-hematologic AEs were fatigue (14% ≥grade 3), GI events (≥grade 3 diarrhea, abdominal pain, and nausea/vomiting in 5%, 4%, and 3%, respectively), and peripheral neuropathies (7% ≥grade 3). Hematologic toxicities were minimal except for transient thrombocytopenia (10% ≥grade 3), as previously seen with Vc. Conclusions: This study confirms the activity of Vc in relapsed/refractory MCL in a multicenter international setting and supports its rapid development as a new treatment for relapsed MCL. Vc is also being studied in the first-line setting in combination with standard chemotherapy. [Table: see text]
Supplementary material to "The Fifth International Workshop on Ice Nucleation phase 2 (FIN-02): Laboratory intercomparison of ice nucleation measurements"
