If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Intensive Induction Therapy Followed by Stem-Cell Support and Consolidation Therapy Produces High Responses in Elderly With Multiple Myeloma: Presented at EHA By Emma Hitt, PhD COPENHAGEN, Denmark -- June 15, 2008 -- Nearly 90% of elderly patients with newly diagnosed multiple myeloma responded to an intensive sequential treatment regimen of induction therapy with bortezomib, pegylated-liposomal doxorubicin, and dexamethasone (PAD) followed by autologous stem-cell transplantation, and then consolidation with lenalidomide and prednisone (LP). However, the findings indicate that those patients aged 70 years and older are the least likely to benefit. Antonio Palumbo, MD, Division of Haematology, University of Torino, Turin, Italy, reported the findings here on June 14 at the 13th Congress of the European Haematology Association (EHA). Data in the current interim analysis were available for 86 patients (planned accrual, n = 105) aged 65 to 75 years (median: 67 years). The researchers sought to assess whether the addition of a third drug (pegylated-liposomal doxorubicin) was superior to standard induction therapy with bortezomib and dexamethasone. In addition, available data have not confirmed whether elderly patients aged 65 to 75 years can tolerate PAD followed by tandem melphalan 100 mg/m2 and stem-cell support (Mel-100) and whether LP is effective as consolidation therapy. "The major question here," said Dr. Palumbo, "is whether we can adopt an intensive sequential approach using a third drug for induction, followed by autologous transplant, followed by use of another drug, lenalidomide, for consolidation and maintenance in elderly patients." After 4 cycles of PAD (n = 86), the overall response rate (ORR) -- defined as complete response (CR) plus near CR (nCR) plus very good partial response (VGPR) -- was 59%. Following Mel-100 (n = 51), the ORR further increased to 88%, with a combined CR/nCR rate of 59%. The benefit of adding lenalidomide to consolidation with prednisone (n = 34) was observed by an increase in the CR/nCR rate to 70% and an ORR of 88%. The results in patients receiving PAD/Mel-100/LP (n = 34) were compared with a historical control of patients receiving dexamethasone, doxorubicin, and vincristine (DAV) followed by Mel-200 (n = 124). Among the historical controls, the ORR was 51%. The PAD/Mel-100/LP regimen also appeared to offer a survival advantage, at least with respect to progression-free survival (P = .01), when comparing data from these 2 trials. The 2-year overall survival rate was higher for PAD/Mel-100/LP versus the historical controls (92% vs 85%) but was not statistically significant. According to Dr. Palumbo, the age of 70 years might be the limit for use of an intensified treatment regimen such as this one, because these patients might experience a higher incidence of adverse events. Patients with poor prognostic factors, including age >=70 years, did not appear to derive additional benefit from the approach compared with the historical controls. The major adverse events were thrombocytopenia and peripheral neuropathy. "Infections were a concern," Dr. Palumbo said, "especially during the first 2 courses of treatment." "This is a comparison with a historical control, but the data look quite interesting," he noted. "We hope we can confirm these data." [Presentation title: Bortezomib, Pegylated-Lyposomal Doxorubicin and Dexamethasone as Induction Prior to Autologous Transplant, Followed by Lenalidomide as Maintenance in Elderly Newly Diagnosed Myeloma Patients. Abstract 438.]
|
