Predictive Factors of Survival After Thalidomide Therapy in Advanced Multiple Myeloma: Long-Term Follow-Up of a Prospective Multicenter Nonrandomized Phase II Study in 120 Patients

BackgroundThalidomide monotherapy has demonstrated consistent results in the treatment of advanced multiple myeloma.Patients and MethodsWe report the 9-year follow-up of a French multicenter, nonrandomized, phase II study that evaluated the effect of oral thalidomide in advanced multiple myeloma. Thalidomide was started at 200 mg/d and increased to 400 mg/d at day 15.ResultsOne hundred twenty patients were enrolled in 2 months at 33 centers. The overall response rate was 31.7% (38/120) on day 60. Overall survival rates were 47.5% (95% confidence interval [CI], 38.6-56.4), 25.0% (95% CI, 17.3-32.7), 11.7% (95% CI, 5.9-17.4), and 7.5% (95% CI, 2.8-12.2) at 1, 3, 6, and 9 years, respectively. Independent predictors of short survival at 1, 3, 6, and 9 years were multiple myeloma refractory to last therapy, performance status ≥ 2, serum β2-microglobulin level ≥ 3.5 mg/L, platelet count < 152 × 109/L, and nonresponse at day 60 (Cox proportional hazards regression model).ConclusionOur study identified 5 independent unfavorable prognostic factors associated with short survival. These prognostic factors were very robust, allowing the prediction of patient survival not only during the first year but also during 3, 6, and even 9 years after the beginning of treatment.