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Table 4

Clinical activity of single-agent bortezomib

Tumor typeDose schedule (intravenous bolus)Activity
Relapsed, refractory multiple myeloma (108) 1.3 mg/m2 twice weekly every 3 weeks for up to 8 cycles 35% overall response rate (complete response + partial response + minimal response) by European Blood and Marrow Transplantation criteria (110); 18% clinical remission rate by Southwest Oncology Group criteria 
Malignant lymphoma (111, 112) 1.5 mg/m2 twice weekly every 3 weeks Promising activity, particularly in mantle cell lymphoma, in patients with relapsed disease (studies are ongoing) 
Metastatic renal cell carcinoma 1.3–1.5 mg/m2 twice weekly every 3 weeks 3 durable partial responses among 32 treated patients in an ongoing trial (113); 1 partial response in 21 evaluable patients (114) 
Non-small cell lung carcinoma 1.5 mg/m2 twice weekly every 3 weeks (115) 1 partial response and 2 patients with stable disease among 8 evaluable patients (115); 1 partial response in 8 patients enrolled in a dose-escalation study (19) 
Metastatic androgen-independent prostate cancer 0.13–2.0 mg/m2 weekly ×4 wks q 5 wks 2 radiographic partial responses in lymph nodes and 3 PSA partial responses among 48 treated patients (17). All responses occurred at doses resulting in average 1-h post-bortezomib whole-blood 20S proteasome inhibition ≥70%, which was also associated with a decline in serum interleukin 6 levels 
Tumor typeDose schedule (intravenous bolus)Activity
Relapsed, refractory multiple myeloma (108) 1.3 mg/m2 twice weekly every 3 weeks for up to 8 cycles 35% overall response rate (complete response + partial response + minimal response) by European Blood and Marrow Transplantation criteria (110); 18% clinical remission rate by Southwest Oncology Group criteria 
Malignant lymphoma (111, 112) 1.5 mg/m2 twice weekly every 3 weeks Promising activity, particularly in mantle cell lymphoma, in patients with relapsed disease (studies are ongoing) 
Metastatic renal cell carcinoma 1.3–1.5 mg/m2 twice weekly every 3 weeks 3 durable partial responses among 32 treated patients in an ongoing trial (113); 1 partial response in 21 evaluable patients (114) 
Non-small cell lung carcinoma 1.5 mg/m2 twice weekly every 3 weeks (115) 1 partial response and 2 patients with stable disease among 8 evaluable patients (115); 1 partial response in 8 patients enrolled in a dose-escalation study (19) 
Metastatic androgen-independent prostate cancer 0.13–2.0 mg/m2 weekly ×4 wks q 5 wks 2 radiographic partial responses in lymph nodes and 3 PSA partial responses among 48 treated patients (17). All responses occurred at doses resulting in average 1-h post-bortezomib whole-blood 20S proteasome inhibition ≥70%, which was also associated with a decline in serum interleukin 6 levels 
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