Combined pegylated liposomal doxorubicin plus bortezomib is highly effective in patients with relapsed or refractory multiple myeloma

Objective: To investigate the efficacy and adverse events of bortezomib in combination with pegylated liposomal doxorubicin (PLD) in 8 patients with relapsed or refractory multiple myeloma and to evaluate the safety of this regimen in the patients concurrently with renal impairment. Methods: From January 2006 to December 2007 in the Department of Medical Oncology, Henan Cancer Hospital, 8 patients with relapse or refractory multiple myeloma received bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 in combination with PLD 20 mg/m~2 on day 4, followed by a 10-day rest period regimen. The regimen was repeated for 2- 4 cycles. The European Group for Blood and Marrow Transplant (EMBT) response criteria was used to assess the response. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE, version 3.0). Results: During the follow-up duration with a median of 12 months, 87.5% (7/8) patients responded to the treatment, including nearly complete response in 3 (37.5%) patients, partial response in 4 (50%) patients and no response in 1 (12.5%) patient. The median time of disease progression (TTP) was 10 months (95% CI, 6.54-13.46). The response rates of the patients with and without renal impairment were similar (100% vs.75%, P0.05), and the renal function in the patients with renal impairment was improved during chemotherapy. The most common adverse events (grade Ⅰ-Ⅱ) included peripheral neuropathy (8/8, 100%), fatigue (7/8, 87.5%), diarrhea (5/ 8, 62.5%), neutropenia (6/8, 75%), and thrombocytopenia (6/8, 75%), while Ⅲ-Ⅳ adverse events included mainly fatigue (1/ 8, 12.5%), neutropenia (2/8, 25%), and thrombocytopenia (2/8, 25%). All these adverse events could be relieved by symptomatic treatment or by delaying chemotherapy. Conclusion: Bortezomib in combination with PLD, given on a 21-day sched- ule, is an effective, new, and safe salvage therapy with manageable toxicity in patients with relapsed or refractory multiple myeloma. The adverse events can be tolerated in most patients, and this regimen is also safe in the patients with renal im- pairment.