title: Randomized clinical trial of mitomycin-C with or without pretreatment with WR-2721 in patients with advanced colorectal cancer.
abstract: The use of mitomycin for metastatic colorectal cancer has been limited by mitomycin's myelosuppressive potential. The objective of this randomized study was to determine whether WR-2721 would decrease the hematologic toxicity of mitomycin in patients with colorectal cancer resistant to fluorouracil-based therapy. Ninety-seven patients with refractory colorectal cancer were randomized to receive either mitomycin 20 mg/m2 only or the same dose of mitomycin after pretreatment with WR-2721, 910 mg/m2. The principal toxicity in both groups was thrombocytopenia. The platelet nadirs were lower in patients receiving single-agent mitomycin (P = 0.026). Surprisingly, no clinical complete or partial responses were noted in either group, and survival was not different between the two groups. Thus, while WR-2721 decreased the thrombocytopenia associated with mitomycin therapy, mitomycin was ineffective in the treatment of refractory colorectal carcinoma.
authors.affiliation: Harper Hospital, Wayne State University School of Medicine, Detroit, Mich.
authors.forename: E A
authors.initials: EA
authors.lastname: Poplin
authors.forename: P
authors.initials: P
authors.lastname: LoRusso
authors.forename: J J
authors.initials: JJ
authors.lastname: Lokich
authors.forename: J J
authors.initials: JJ
authors.lastname: Gullo
authors.forename: P D
authors.initials: PD
authors.lastname: Leming
authors.forename: J J
authors.initials: JJ
authors.lastname: Schulz
authors.forename: S R
authors.initials: SR
authors.lastname: Veach
authors.forename: W
authors.initials: W
authors.lastname: McCulloch
authors.forename: L
authors.initials: L
authors.lastname: Baker
authors.forename: P
authors.initials: P
authors.lastname: Schein
mesh_terms: D000328:Adult; D000368:Aged; D004999:Amifostine / Q000627:therapeutic use*; D001855:Bone Marrow Diseases / Q000139:chemically induced / Q000517:prevention & control*; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D016685:Mitomycin; D004999:Amifostine