title: Phase II study of mitomycin-C, adriamycin, cisplatin (MAP) and Bleomycin-CCNU in patients with advanced cancer of the anal canal: An eastern cooperative oncology group study E7282.
abstract: Metastatic anal cancer is a rare disease in the Western hemisphere and current treatment modalities are not effective. In this study, patients with advanced epithelial cancer of the anal canal received MAP followed by Bleomycin and CCNU upon progression of disease. Twelve out of twenty eligible patients had a partial response 60%, (95% CI {36% -81%}). No complete responses were observed. The median survival was 15 months (95% CI {6-20} months). The median time to progression or death was 8 months (95% CI {4-9 months}). Toxicities were moderate and tolerable with routine supportive care; there were 2 cases of grade 3 vomiting, 2 cases of respiratory distress (one grade 1 and one grade 3), one case each of grade 3 leg cramps and cardiac arrhythmia. Of particular note were 7 cases of grade 3 hematologic toxicity. Two patients had grade 4 leukopenia and thrombocytopenia, respectively, that resolved without sequelae. The combination therapy of MAP followed by Bleomycin and CCNU for patients with advanced anal cancer, not amenable to radiotherapy or surgery, results in a moderate objective response but with moderate toxicities. This regimen and sequence is worthy of further study especially in combination with colony stimulating factors, however, its tolerability may be most applicable for patients who have had minimal prior therapy.
authors.affiliation: Department of Oncology, Montefiore Medical Center, Weiler Hospital, Room 2S-49, 1825 Eastchester Road, Bronx, NY 10461, USA.
authors.forename: Minaxi
authors.initials: M
authors.lastname: Jhawer
authors.forename: Sridhar
authors.initials: S
authors.lastname: Mani
authors.forename: Myrto
authors.initials: M
authors.lastname: Lefkopoulou
authors.forename: Richard G
authors.initials: RG
authors.lastname: Hahn
authors.forename: Jules
authors.initials: J
authors.lastname: Harris
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Catalano
authors.forename: Daniel
authors.initials: D
authors.lastname: Haller
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001005:Anus Neoplasms / Q000188:drug therapy*; D001761:Bleomycin / Q000008:administration & dosage / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008130:Lomustine / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000970:Antineoplastic Agents; D001761:Bleomycin; D016685:Mitomycin; D008130:Lomustine; D004317:Doxorubicin; D002945:Cisplatin