Bortezomib-Based Induction Therapy Followed by High-Dose Chemotherapy and Autologous Stem Cell transplantation in Newly-Diagnosed Myeloma: Initial Report From a Chinese Multiple-Center Study

Abstract 4557

Bortezomib-based induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT) is considered as standard treatment for patients with newly-diagnosed myeloma. Though front-line treatment of Bortezomib containing regimen is widely used in China, first-line treatment of high-dose chemotherapy with ASCT is not widely accepted for Chinese patients. There is also no prospective study in Chinese population to evaluate the efficacy, safety and feasibility of such treatment strategy. This is a prospective study in young Chinese population (18–65 year old) with newly-diagnosed myeloma (NCT00984828). All patients will receive 4 cycles of Bortezomib and Dexamethasone as frontline therapy. After that, patients will receive either a single ASCT conditioning with melphalan 200mg/m2 (mel 200) or ASCT with mel 200 + bortezomib conditioning and another 3 cycles of Bortezomib monotherapy as consolidation after ASCT. From Jan 2010, a total of 37 patients (median age 54, 31∼64) were enrolled in this study. There were 2 patients died of treatment toxicity 1 and 3 months after entering study. In the remaining 35 patients, 17 already finished ASCT and other 18 patients declined the ASCT. In 23 evaluable patients, 11 achieved CR (n=10) and VGPR (n=1), 9 with PR, 2 with SD and 1 PD. At the last follow-up at May 2012, a total of 6 patients experienced disease progression and no patients died of disease or treatment associated toxicity. As a whole group, with a median follow-up of 10 months (1∼33 months), the estimated 2-year OS and PFS were 94.3±4% and 66.2±12.3% respectively. Though further analysis was impossible with limited number of patient enrolled in the study with short follow-up, overall, the treatment was safe particularly no significant treatment associated toxicity or treatment mortality documented during and after ASCT procedure. The overall 43% CR rate was comparable to most previous reports. The early analysis of the study demonstrated that Bortezomib-Dexa followed by ASCT can be safely performed in Chinese population and further enrolled and follow-up may provide evidence of long-term efficacy of such strategy in Chinese population.