Esorubicin (4'-deoxydoxorubicin, NSC 267469) in advanced breast cancer. A phase II study of the CALGB.
Forty-six eligible women with advanced metastatic breast cancer were entered on a Phase II trial utilizing esorubicin (4'-deoxydoxorubicin) given in a dosage of 30 mg/m2 intravenously every 3 weeks. No patient had received anthracyclines or cytotoxic therapy for metastatic disease. Twenty-three (50% of patients) had prior adjuvant chemotherapy, 21 (46%) had prior hormonal therapy, and 32 (70%) were postmenopausal. Dominant site of disease was visceral in 26 (57%), bone in 14 (30%), and soft tissue in 6 (13%). There were 3 complete and 13 partial responders observed, for a 35% response rate; 95% confidence interval for response was 21-49%. Median response duration was 4.0 months (range 2-21 months), and one partial responder remains on study at 6.3 months. Thirty-nine of 46 patients have died; median survival was 10.1 months. Toxicity was primarily hematologic, with 2 drug-related septic deaths. In addition, 2 patients developed severe congestive heart failure secondary to esorubicin cardiotoxicity (at 687 and 770 mg/m2, respectively), which resulted in one patient death. Nausea and vomiting were severe in 16% of patients, but total alopecia was only noted in 4 (9%). Esorubicin is an active agent in metastatic breast cancer; its role in treatment remains undefined.
Muss
H B
HB
Cancer Center of Wake Forest University, Bowman Gray School of Medicine, Winston-Salem, NC 27103.
Van Echo
D
D
Korzun
A H
AH
Henderson
I C
IC
Campbell
T
T
Vogelzang
N J
NJ
Rice
M A
MA
Wood
W
W
D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D004317:Doxorubicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004341:Drug Evaluation; D005260:Female; D006321:Heart / Q000187:drug effects; D006333:Heart Failure / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D012074:Remission Induction
D000903:Antibiotics, Antineoplastic; D004317:Doxorubicin; C030851:esorubicin