Thalidomide‐dexamethasone versus Interferon‐alpha‐dexamethasone as maintenance treatment after ThaDD induction for multiple myeloma: a prospective, multicentre, randomised study

Abstract

SummaryMaintenance therapy was explored in multiple myeloma (MM) patients after conventional thalidomide, dexamethasone and pegylated liposomal doxorubicin (ThaDD). Patients with newly or relapsed MM obtaining at least minor response after 6 ThaDD courses, were randomised to receive a-interferon (IFN) 3 MU 3 times a week or thalidomide 100 mg daily until relapse. Both groups also received pulsed dexamethasone 20 mg 4 d a month. Fifty-one patients were randomized in the IFN-dexamethasone (ID) arm and 52 in the thalidomide-dexamethasone (TD) arm. The characteristics of two groups were similar. A significantly better 2-years progression-free survival (PFS; 63% vs. 32%; P = 0AE024) and overall survival (84% vs. 68%; P = 0AE030) was observed in the thalidomide arm. In high-risk patients and in those achieving less than very good partial response after induction, TD fared better in term of PFS. Main side effects were peripheral neuropathy and constipation in TD group, fatigue, anorexia and haematological toxicity in ID arm. There was a 21% probability of discontinuation at 3 years in the thalidomide arm and 44% in the IFN arm (P = 0AE014). Low-dose thalidomide plus pulsed low-dose dexamethasone after conventional thalidomide combination-based therapy was also feasible in the long term, enabling significantly better residual disease control if compared with a standard maintenance therapy.

Cyclophosphamide, thalidomide, and dexamethasone (CTD) as initial therapy for patients with multiple myeloma unsuitable for autologous transplantation

“…Importantly, our data indicate that patient cytogenetics continue to influence survival outcomes among patients who achieved a CR, underscoring the need for FISH cytogenetic profiling at the time of diagnosis. The influence of cytogenetics on survival outcomes has been noted previously in other studies of thalidomide-based therapy, 22,23 where it was shown that patients with a favorable cytogenetic profile had improved PFS or event-free survival after treatment with thalidomide.…”

Evolving Role of Novel Agents for Maintenance Therapy in Myeloma

“…11 After a median follow-up of 30 months, 60% of patients in ID arm relapsed versus 33% of patients who received TD (P ϭ 0.024) with a 2-years PFS of 32% and 63%, respectively. The advantage was evident both in newly diagnosed and in relapsed MM.…”

“…11 An Australian study compared maintenance with alternate day prednisolone alone versus alternate day prednisolone plus thalidomide (TP) given after ASCT. 9 Thalidomide induced a highly significant improvement in term of response (63% versus 40% at 1 year from the beginning of maintenance therapy) and an evident prolonged PFS and OS (Table 1).…”

Advances in the treatment of hematological malignancies: current treatment approaches in multiple myeloma

“…A limitation of this study is the crossover of patients to thalidomide who primarily were not scheduled to be treated with this substance. An Italian trial [38] compared two maintenance regimens, namely thalidomide (100 mg daily) plus dexamethasone (20 mg q week) and interferon plus dexamethasone, in patients receiving prior Thal-Dex-pegylated doxorubicin therapy. Thal-Dex was superior to interferon-dexamethasone with a response rate of 17 versus 13%.…”