RANDOMIZED CLINICAL-TRIAL OF MITOMYCIN-C WITH OR WITHOUT PRETREATMENTWITH WR-2721 IN PATIENTS WITH ADVANCED COLORECTAL-CANCER

The use of mitomycin for metastatic colorectal cancer has been limited by mitomycin's myelosuppressive potential. The objective of this rand omized study was to determine whether WR-2721 would decrease the hemat ologic toxicity of mitomycin in patients with colorectal cancer resist ant to fluorouracil-based therapy. Ninety-seven patients with refracto ry colorectal cancer were randomized to receive either mitomycin 20 mg /m(2) only or the same dose of mitomycin after pretreatment with WR-27 21, 910 mg/m(2). The principal toxicity in both groups was thrombocyto penia. The platelet nadirs were lower in patients receiving single-age nt mitomycin (P = 0.026). Surprisingly, no clinical complete or partia l responses were noted in either group, and survival was not different between the two groups. Thus, while WR-2721 decreased the thrombocyto penia associated with mitomycin therapy, mitomycin was ineffective in the treatment of refractory colorectal carcinoma.