Expanding Role of Bortezomib in Multiple Myeloma: Nursing Implications

Kathleen Colson, RN, BSN, BS; Deborah S. Doss, RN, OCN; Regina Swift, RN, BSN; Joseph Tariman, RN, APN, MN, BC, OCN

Disclosures

Cancer Nurs. 2008;31(3):239-249. 

In This Article

Bortezomib in Clinical Trials

Outcomes from numerous trials evaluating the safety and efficacy of bortezomib have been reported ( Table 1 ); clinicians and nurses continue to gain experience with bortezomib as new data become available. The largest trial to date is APEX, in which 669 patients with relapsed MM treated with 1 to 3 prior regimens were randomized to either bortezomib or high-dose dexamethasone.[8] Time to disease progression was significantly longer with bortezomib compared with dexamethasone (P <.001). Overall survival, 1-year survival,and response rates (complete response [CR] and partial response [PR]) were also significantly greater with bortezomib than with dexamethasone (P ≤.003). Outcomes were most favorable in patients who had received only 1 prior therapy.[8] Updated results after an extended follow-up (median: 22 months) show that bortezomib continued to provide significantly longer median overall survival (by 6 months) compared with dexamethasone, despite substantial crossover of dexamethasone-treated patients to the bortezomib arm.[9]

In APEX, bortezomib was administered alone. In 2 phase II studies of bortezomib in patients with relapsed and/or refractory MM, study of uncontrolled myeloma managed with proteasome inhibition therapy (SUMMIT)[10,11] and clinical response and efficacy study of bortezomib in the treatment of refractory myeloma (CREST),[12] dexamethasone therapy was added in patients with a suboptimal response to bortezomib alone. Using the European Group for Blood and Marrow Transplant criteria, response rates (CR + PR + minimal response) with bortezomib alone were 35% (bortezomib 1.3 mg/m2; 27% CR + PR) in SUMMIT and 33% (bortezomib 1.0 mg/m2; 30% CR + PR) and 50% (bortezomib, 1.3 mg/m2; 38% CR + PR) in CREST. The addition of dexamethasone led to an improved response in 13 (18%) of 74 evaluable patients receiving the combination in the SUMMIT study and 9 (33%) of 27 in the CREST study.[17]

In the relapsed setting, bortezomib also demonstrates synergistic or additive activity with manageable, nonoverlapping toxicity when combined with one or more conventional chemotherapeutic agents such as dexamethasone, doxorubicin, cyclophosphamide, melphalan, prednisone, or thalidomide.[18] Combinations involving other agents are also being investigated. Furthermore, preliminary results indicate that retreatment with bortezomib in patients who had previously received bortezomib alone or in combination has encouraging activity with manageable toxicity and may help achieve prolonged disease control.[19]

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