Clinical study with bleomycin: Tolerance to twice weekly dosage

Takao Ohnuma, Oleg S. Selawry, James F. Holland, Vincent T. DeVita, Donald P. Shedd, Heine H. Hansen, Franco M. Muggia

Research output: Contribution to journalArticlepeer-review

26 Scopus citations

Abstract

Fifty‐nine patients with inoperable malignant neoplasms were treated with bleomycin at dose levels ranging rom 1.25 mg/m2 to 35 mg/m2 of estimated body surface area twice weekly in an attempt to define host tolerance to this new antineoplastic agent. The drug was given for a total of 12 doses, if tolerated, and longer in the presence of objective tumor response. At 4 mg/m2, chills and fever, vomiting, and moderate cutaneous toxicity appeared. At 15 mg/m2, 3 of 11 patients developed dose‐limiting skin toxicity. Two additional patients developed pulmonary infiltrates after prolonged courses of treatment to a total of 546 and 582 mg, respectively. At 26 mg/m2 and higher, prohibitive pulmonary and hematologic toxicity developed during the initial course of study requiring premature termination of scheduled courses. At 35 mg/m2, transient hypertension, confusion, abdominal distention, and urinary burning also developed. Four of 19 patients with squamous cell carcinoma of the head and neck, one patient with squamous cell carcinoma of the skin, 3 of 6 patients with lymphosarcoma, and 1 of 4 patients with testicular carcinoma responded with more than 50% tumor regression. One patient with lymphosarcoma was induced into complete remission. Minimal therapeutic dose levels for lymphosarcoma and for squamous cell carcinoma were 4 mg/m2 and 6 mg/m2, respectively. This study indicates that optimal dose levels range between 4 and 15 mg/m2 twice weekly. The present study establishes patient tolerance to twice weekly doses of bleomycin and confirms therapeutic benefit for squamous cell carcinoma and lymphosarcoma over a remarkably wide range of doses.

Original languageEnglish
Pages (from-to)914-922
Number of pages9
JournalCancer
Volume30
Issue number4
DOIs
StatePublished - Oct 1972
Externally publishedYes

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