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

Minaxi Jhawer, Sridhar Mani, Myrto Lefkopoulou, Richard G. Hahn, Jules Harris, Paul J. Catalano, Daniel Haller

Research output: Contribution to journalArticle

28 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)447-454
Number of pages8
JournalInvestigational New Drugs
Volume24
Issue number5
DOIs
StatePublished - Sep 2006

Fingerprint

Lomustine
Anal Canal
Mitomycin
Doxorubicin
Cisplatin
Anus Neoplasms
Bleomycin
Neoplasms
Muscle Cramp
Colony-Stimulating Factors
Leukopenia
Rare Diseases
Vomiting
Disease Progression
Cardiac Arrhythmias
Leg
Radiotherapy
Therapeutics
indium-bleomycin
Survival

Keywords

  • Adriamycin
  • Anal cancer
  • Bleomycin
  • CCNU
  • Cisplatin
  • Mitomycin-C
  • Phase II

ASJC Scopus subject areas

  • Molecular Medicine
  • Pharmacology

Cite this

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. / Jhawer, Minaxi; Mani, Sridhar; Lefkopoulou, Myrto; Hahn, Richard G.; Harris, Jules; Catalano, Paul J.; Haller, Daniel.

In: Investigational New Drugs, Vol. 24, No. 5, 09.2006, p. 447-454.

Research output: Contribution to journalArticle

Jhawer, Minaxi ; Mani, Sridhar ; Lefkopoulou, Myrto ; Hahn, Richard G. ; Harris, Jules ; Catalano, Paul J. ; Haller, Daniel. / 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. In: Investigational New Drugs. 2006 ; Vol. 24, No. 5. pp. 447-454.
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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.",
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