MX2; 3'-deamino-3'-morpholino-13-deoxy-10-hydroxycarminomycin (KRN8602) in refractory metastatic breast cancer: results of a preliminary phase II trial.
We performed a preliminary phase II clinical trial of MX2; 3'-deamino-3'-morpholino-13-deoxy-10-hydroxycarminomycin (KRN8602) in patients with metastatic breast cancer who had failed to respond to previous chemotherapeutic regimens after clinical evidence of systemic disease. Twelve patients at a single institute received KRN8602 at a dose of 35 mg/m2 intravenously once every three weeks. All the patients were followed-up until their disease progressed. There was one complete response lasting 17 weeks and one partial response lasting eight weeks. Among the 12 patients, World Health Organization (WHO) grades 3 and 4 neutropenia were observed in five and two patients, respectively. Grade 3 anemia was observed in three patients but severe thrombocytopenia was not observed. Grade 3 nausea/vomiting was observed in eight patients. Alopecia was not observed. The results of this preliminary phase II trial suggest a need for further testing of the anti-tumor activity of KRN8602 in patients with metastatic breast cancer.
Watanabe
T
T
Department of Medical Oncology, National Cancer Center Hospital, Tokyo.
Narabayashi
M
M
Haga
S
S
Yamada
Y
Y
Kawamura
E
E
Enomoto
K
K
Kusama
M
M
Kimura
K
K
Adachi
I
I
Abe
O
O
D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D002360:Carubicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008875:Middle Aged
D000903:Antibiotics, Antineoplastic; C053537:morpholinoanthracycline MX2; D002360:Carubicin