Maintenance therapy with alternate-day prednisone improves survival in multiple myeloma patients

Abstract

The role of maintenance therapy in multiple myeloma is controversial. Recent studies have shown an improvement in both progression-free and overall survival for patients receiving maintenance treatment with a combination of interferon and glucocorticoids, compared with interferon alone. The role of glucocorticoids alone as maintenance therapy has not been previously addressed. We compared alternate-day, oral prednisone at 2 different dose levels (10 mg versus 50 mg) for remission maintenance among previously untreated myeloma patients following a response to induction with standard-dose vincristine, doxorubicin, and dexamethasone with prednisone (VAD-P) or VAD-P plus quinine (VAD-P/Q). There were 250 eligible patients registered on Southwest Oncology Group study 9210 and randomized to receive VAD-P or VAD-P/Q. There were 125 patients achieving at least a 25% tumor reduction following induction therapy who were randomized to either physiologic (10 mg) or pharmacologic (50 mg) doses of alternate-day, oral prednisone until disease progression. At the time of study entry, patient characteristics were similar in VAD-P and VAD-P/Q patients and in the 2 arms randomized to maintenance therapy. After a median follow-up of 53 months, there was no difference in either progression-free or overall survival between the 2 induction regimens. However, from the time of maintenance randomization, both progression-free (14 versus 5 months; P ‫؍‬ .003) and overall survival (37 versus 26 months; P ‫؍‬ .05) were significantly improved in patients receiving 50 mg as compared with 10 mg alternate-day prednisone. There was no difference in treatment-related adverse events between the groups. Thus, 50 mg, oral, alternateday prednisone is effective maintenance treatment for multiple myeloma patients who achieve a response to induction chemotherapy. (Blood. 2002;99:3163-3168)

Initial Therapy of Multiple Myeloma Patients Who Are Not Candidates for Stem Cell Transplantation

“…Berenson et al evaluated the use of prednisone at either 50 mg every other day or 10 mg every other day in patients who had responded to infusional vincristine, doxorubicin, and oral dexamethasone. 53 With a median followup of 53 months, no difference was noted in PFS or OS from the start of induction therapy, but from the time of randomization to the two prednisone arms both PFS and OS were significantly prolonged on the higher dose steroid arm, suggesting a benefit for prednisone. In contrast, dexamethasone was studied as a maintenance therapy in older patients after induction with either MP or MD, and compared with observation alone by Shustik et al 54 PFS was prolonged significantly with dexamethasone, but steroid maintenance did not result in an enhanced OS, casting doubt on this approach.…”

Thalidomide maintenance treatment increases progression-free but not overall survival in elderly patients with myeloma

“…3 Corticosteroids in high doses were shown to prolong the duration of the maintenance phase, but results concerning overall survival (OS) were controversial. 4,5 Interferon α-2b (IFN) exerts direct anti-myeloma activity 6 but yielded inconsistent results when tested as maintenance treatment. Two meta-analyses, one on individual patient data 7 and another on published results, 8 showed a marginal but statistically significant gain in both maintenance duration and overall survival.…”

Chemotherapy plus lenalidomide versus autologous transplantation, followed by lenalidomide plus prednisone versus lenalidomide maintenance, in patients with multiple myeloma: a randomised, multicentre, phase 3 trial

“…[13][14][15]17 A randomized trial showed a significant PFS benefit in patients receiving maintenance with pharmacologic (50 mg every other day) vs physiologic doses of prednisone. 19 Maintenance with thalidomide-prednisone prolonged PFS, with conflicting OS results. 20,21 This study aims to compare the efficacy and safety of consolidation with CRD versus MEL200-ASCT, followed by maintenance with lenalidomide-prednisone versus lenalidomide alone, in NDMM patients eligible for transplantation.…”