TY - JOUR
T1 - Clinical study with bleomycin
T2 - Tolerance to twice weekly dosage
AU - Ohnuma, Takao
AU - Selawry, Oleg S.
AU - Holland, James F.
AU - DeVita, Vincent T.
AU - Shedd, Donald P.
AU - Hansen, Heine H.
AU - Muggia, Franco M.
PY - 1972/10
Y1 - 1972/10
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=0015412442&partnerID=8YFLogxK
U2 - 10.1002/1097-0142(197210)30:4<914::AID-CNCR2820300409>3.0.CO;2-8
DO - 10.1002/1097-0142(197210)30:4<914::AID-CNCR2820300409>3.0.CO;2-8
M3 - Article
C2 - 4116909
AN - SCOPUS:0015412442
SN - 0008-543X
VL - 30
SP - 914
EP - 922
JO - Cancer
JF - Cancer
IS - 4
ER -