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| |  Melphalan, Prednisone, and Thalidomide Combo Improves Progression-Free Survival but Not Overall Survival in Older Patients With Multiple Myeloma: Presented at EHA By Emma Hitt, PhD COPENHAGEN, Denmark -- June 17, 2008 -- Melphalan, prednisone, and thalidomide (MPT) improves progression-free survival (PFS) compared with melphalan plus prednisone (MP) in patients 65 years or older with previously untreated multiple myeloma. However, no overall survival benefit was observed with the addition of thalidomide to MP, according to findings presented here on June 15 at the 13th Congress of the European Hematology Association (EHA). In their study, Antonio Palumbo, MD, Division of Haematology, University of Torino, Turin, Italy, and colleagues enrolled 331 patients with untreated multiple myeloma who were 65 years or older. Younger patients were also enrolled if they had been excluded from undergoing stem cell transplantation. Approximately 60% of the patients in each arm were older than 70 years. Patients who were randomised to MP (n = 164) received six 4-week cycles of oral melphalan 4 mg/m2 given on days 1 to 7 and prednisone 40 mg/m2 on days 1 to 7. Patients assigned to treatment with MPT (n = 167) also received thalidomide 100 mg/day until relapse. Enoxaparin was used as anticoagulant prophylaxis. Response rate was higher with MPT than with MP (P < .001). For MPT overall response was 69% versus 48% with MP. Over a median follow-up of 38 months, time to progression was 24.7 months with MPT and 15 months with MP (P < .0001). A PFS benefit was observed for MPT in all subgroups evaluated. By contrast, median overall survival was not significantly different between treatment arms (45 vs 47.6 months, respectively, P = .79). "More patients on MP received new treatments, including bortezomib- or thalidomide-based therapy, at relapse (41% vs 22%) and this crossover could have cancelled the overall survival benefit that may have otherwise been seen with MPT," Dr. Palumbo explained during the presentation. MPT also seemed to negate the overall prognostic effect of high beta-2 microglobulin. Beta-2 microglobulin was prognostic for survival in patients receiving MP (<= 3.5 mg/L vs > 3.5 mg/L, P = .0002) but not in patients receiving MPT. The incidences of grade 3/4 thrombosis (P = .0002), neurological complications (P = .0001), infection (P = .03), and cardiac (P = .009) and dermatologic (P = .008) complications were significantly higher among patients treated with MPT, and 72% of patients receiving MPT required some form of dose modification. Speaking at a press session on multiple myeloma, Jesus San-Miguel, MD, Hospital Universitario de Salamanca, Salamanca, Spain, noted that the outcome for patients with multiple myeloma has improved significantly over the last decade, and "this is mainly due to the efficacy of novel drugs such as thalidomide, lenalidomide, and bortezomib. Nevertheless, most patients relapse and eventually become refractory to all available treatments," he said. "Unfortunately, the expectations raised by some of these agents have not so far been confirmed in clinical experience."
[Presentation title: Oral Melphalan, Prednisone and Thalidomide in Elderly Multiple Myeloma Patients: Updated Results of a Randomized Controlled Trial. Abstract 916]
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