The Addition of Thalidomide in Any Line of Treatment of Multiple Myeloma, Improves Overall Survival: Single Center Experience in 246 Patients.

Thalidomide is effective for the treatment of either newly diagnosed or relapsed/refractory multiple myeloma (MM) patients. However, the contribution of Thalidomide to the overall survival in MM has not yet been clarified. The aim of this study was to examine, if the incorporation of Thalidomide either in first or in any line regimens, positively influences overall survival, in a large cohort of MM patients, with a long follow up. Two hundred forty-six newly diagnosed symptomatic MM patients, 139 males and 107 females, with a median age of 67 years (range 29–90) were studied. One hundred ninghty-two patients (group 1A) received regimens not containing Thalidomide as first line treatment (129 received Vincristine /Adriamycin /Dexamethasone, 58 received Melphalan /Prednisone and 5 received Dexamethasone). Fifty-four patients (group 2A) received regimens containing Thalidomide as first line treatment (32 patients received Vincristine /Adriamycin /Dexamethasone /Thalidomide 14 patients Dexamethasone /Thalidomide and 8 patients Melphalan /Prednisone /Thalidomide). One hundred-ninety patients received second or more than second line therapy. One hundred twenty-three patients received standard regimens not containing Thalidomide (group 1B) and 77, regimens containing Thalidomide (group 2B). The standard regimens in group 1B and 2B were similar to first line regimens. Totally, 100 patients received regimens containing Thalidomide at any time of the disease. Twenty and 8 patients in group 1A+1B and 2A+2B, respectively, received high dose therapy. The evaluated parameters, for predicting overall survival were: age, ISS score, creatinine, B2 microglobulin, LDH, Thalidomide-containing regimens in first line (group 2A) and in any line of treatment (group 2, A and B), time to response to first line treatment and quality of response (CR+PR versus less than PR). Cox regression was used for the univariate and multivariate analysis and Mann Whitney-U test and Pearson’s chi square test, for comparisons of patients’ characteristics. The median follow up was 31 months (range 1–231). Patients in both groups were well-balanced concerning age, sex, ISS score, B2-micriglobulin, creatinine and LDH (p<0.05). There was no statistical difference concerning the number of patients who proceeded to high dose therapy in both groups at any time of treatment (P>0.05). The univariate analysis showed that, age, ISS score, creatinine, B2 microglobulin, LDH, Thalidomide-containing regimens either in first or in any line of treatment and time to response to first line treatment, predicted for survival. The multivariate analysis demonstrated that age, ISS score and regimens containing Thalidomide in any line of treatment (group 2, A and B), independently predicted for overall survival (p<0.05). The median survival in the group 1 and 2 was 28mo (SD=35mo) and 34mo (SD=26mo), respectively (p=0.04). This study showed that, the incorporation of Thalidomide in any line of treatment, improves overall survival. Considering that the type of the standard regimens applied, either including or not Thalidomide, were similar and there was no statistical difference in the percentage of patients who underwent high dose therapy, between the two groups, these results produced by the analysis of a large cohort of newly diagnosed MM patients, with a long follow up offer important information about the impact of Thalidomide on the overall survival.