Long-term survival of stage I multiple myeloma given chemotherapy just after diagnosis or at progression of the disease: a multicentre randomized study

We conducted a randomized trial to evaluate whether melphalan-prednisone (M PH-P) treatment administered just after diagnosis improves survival of stag e I multiple myeloma (MM). Between January 1987 and March 1993, 145 consecu tive previously untreated patients with stage I MM were randomized between treatment with MPH-P (administered for 4 days every 6 weeks) just after dia gnosis and treatment only at disease progression. Survival was not influenc ed by MPH-P treatment either administered just alter diagnosis or at diseas e progression (64 vs 71 months respectively). Comparing the first with the second group the odds ratio of death is 1.17 (95% confidence interval 0.57- 2.42; P = 0.64). Disease progression occurred within a year in about 50% of patients who were initially untreated. Response rate was similar in both g roups, but duration of response was shorter in patients who were treated at disease progression (48 vs 79 months, P = 0.044). Patients actually treate d at disease progression (34/70) survived shorter than those who had neithe r disease progression nor treatment (56 vs > 92 months; P = 0.005). Startin g MPH-P just after diagnosis does not improve survival and response rate in stage I MM, with respect to deferring therapy until disease progression. H owever, patients with stage I MM randomized to have treatment delayed and w ho actually progressed and were treated had shorter survival than those wit h stable disease and no treatment. Biologic or other disease features could identify these subgroups of patients. (C) 2000 Cancer Research Campaign.