EFFECTS OF POLYETHYLENE GLYCOL-CONJUGATED RECOMBINANT HUMAN MEGAKARYOCYTE GROWTH AND DEVELOPMENT FACTOR ON PLATELET COUNTS AFTER CHEMOTHERAPY FOR LUNG-CANCER

Background Polyethylene glycol (PEG)-conjugated recombinant human mega karyocyte growth and development factor (MGDF, also known as PEG-rHuMG DF), a recombinant molecule related to thrombopoietin, specifically st imulates megakaryopoiesis and platelet production and reduces the seve rity of thrombocytopenia in animals receiving myelosuppressive chemoth erapy. Methods We conducted a randomized, double-blind, placebo-contro lled dose-escalation study of MGDF in 53 patients with lung cancer who were treated with carboplatin and paclitaxel. The patients were rando mly assigned in blocks of 4 in a 1:3 ratio to receive either placebo o r MGDF (0.03, 0.1, 0.3, 1.0, 3.0, or 5.0 mu g per kilogram of body wei ght per day), injected subcutaneously. No other marrow-active cytokine s were given. Results In the 38 patients who received MGDF after chemo therapy, the median nadir platelet count was 188,000 per cubic millime ter (range, 68,000 to 373,000), as compared with 111,000 per cubic mil limeter (range, 21,000 to 307,000) in 12 patients receiving placebo (P =0.013). The platelet count recovered to base-line levels in 14 days i n the treated patients as compared with more than 21 days in those rec eiving placebo (P<0.001). Among all 40 patients treated with MGDF, 1 h ad deep venous thrombosis and pulmonary embolism, and another had supe rficial thrombophlebitis. Conclusions MGDF has potent stimulatory effe cts on platelet production in patients with chemotherapy-induced throm bocytopenia. (C) 1997, Massachusetts Medical Society.