Interferon alfa‐2b versus no maintenance therapy during the plateau phase in multiple myeloma: a randomized study

Abstract

This clinical trial was designed to investigate if maintenance therapy with alfa-interferon could prolong the plateau phase in patients with multiple myeloma. In addition, the tolerability of interferon treatment and its effect on survival were evaluated. From September 1987 to September 1989 a total of 314 patients were accrued to a multi-institutional randomized clinical trial. All patients entered into the protocol received standard melphalan-prednisone (MP) induction therapy. Response was noted in 184 (59%) and a plateau phase achieved in 155 (49%). From the latter group, 125 eligible patients were randomized to either interferon alfa-2b or no maintenance. The patients were followed for an average of 51 months (minimum 36 months) from the time of randomization. The plateau phase was significantly prolonged in the group of patients treated with interferon (median 13.9 v 5.7 months from the time of randomization; P < 0.0001). The interferon therapy was tolerated fairly well, moderate granulocytopenia and a chronic fatigue syndrome being the most frequent side-effects (22% v 18% W.H.O. grade 3 toxicity). The median survival from randomization was almost identical in both groups (36 v 35 months). The study shows that interferon maintenance therapy given to multiple myeloma patients who have achieved a response to initial treatment with MP prolongs the plateau phase duration with tolerable toxicity. The clinical value of this finding should be interpreted with caution, because survival was not prolonged. Further studies are required to clarify the role of interferon in the treatment of multiple myeloma.

Maintenance treatment with interferon alpha-2b in multiple myeloma: a prospective randomized study from PETHEMA (Program for the Study and Treatment of Hematological Malignancies, Spanish Society of Hematology)

“…This finding is in agreement with most studies on IFN maintenance in MM. [20][21][22][23] However, it is worth mentioning that in our study the median response duration was prolonged for only 6 months in the IFN arm compared with the observation group and that the statistical significance is borderline. In this regard, the prolongation of response in studies showing a significant benefit from IFN maintenance has also been modest, with differences in median response duration ranging from 5 to 12 months.…”

“…In this regard, the prolongation of response in studies showing a significant benefit from IFN maintenance has also been modest, with differences in median response duration ranging from 5 to 12 months. [20][21][22][23] In contrast to these observations, other trials have failed to show a significant advantage in response duration for IFN maintenance. 8,[24][25][26] Regarding overall survival, most available data, including our own study, suggest that there are no significant differences in survival from the time of randomization in patients maintained with IFN as compared to the observation group.…”

“…8,[24][25][26] Regarding overall survival, most available data, including our own study, suggest that there are no significant differences in survival from the time of randomization in patients maintained with IFN as compared to the observation group. 8,21,24,25 However, two studies have shown a significant survival prolongation in favor of IFN maintenance in patients achieving an objective response to inducation therapy and maintained with IFN. 20,22 In addition, a third study showed a survival benefit of borderline significance (P = 0.049) from IFN maintenance when the statistical analysis was done after adjusting for chance imbalances in baseline prognostic factors.…”

“…[20][21][22][23][24][25][26] In our series, IFN had to be discontinued at some time in 20% of the patients. However, about 75% of our patients were able to receive at least 3 MU of IFN three times per week for all the planned period.…”

Pilot study of 13cis-retinoic acid+dexamethasone+alpha interferon as maintenance therapy following high-dose chemotherapy and autologous stem cell transplant for multiple myeloma

“…Following conventional chemotherapy, randomized studies indicate that IFNa prolongs remission duration by 5-12 months. 14,[17][18][19] These trials also found a minimal or no survival advantage in the IFNa-treated patients. Plateau phase duration in those patients treated with IFNa ranged from 14 to 16 months.…”