Phase II study of amrubicin, 9-amino-anthracycline, in patients with advanced non-small-cell lung cancer: a West Japan Thoracic Oncology Group (WJTOG) study.
OBJECTIVE
We conducted a multicenter phase II study of amrubicin, a novel 9-aminoanthracycline, to evaluate its efficacy and safety in patients with non-small-cell lung cancer (NSCLC).


METHODS
Entry requirements included cytologically or histologically proven measurable NSCLC, stage III or IV, no prior therapy, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, and adequate organ function. Amrubicin was given by daily intravenous injection at 45 mg/m2/day for three consecutive days, repeated at 3 week intervals. Each patient received at least three treatment cycles.


RESULTS
Sixty-two patients were enrolled in this study. Of the 62 registered patients, 60 were eligible and assessable for efficacy, and 59 for toxicity. Overall response rate was 18.3% (95% confidence interval [CI], 9.5 to 30.4%) and median survival time was 8.2 months (95% CI, 6.7 to 10.4 months). Major toxicity was myelosuppression, with incidences of grade 3 or 4 toxicity of 78.0% for neutropenia, 54.2% for leukopenia, 30.5% for anemia, and 28.8% for thrombocytopenia. Non-hematological toxicities with a greater than 50% incidence were anorexia (69.5%), nausea/vomiting (55.9%), and alopecia (75.9%), but were relatively mild, with grade 3 toxicities observed in only one patient each (1.7%).


CONCLUSIONS
Amrubicin was an active, well-tolerated agent in the treatment of NSCLC.
Takeda
Koji
K
Department of Clinical Oncology, Osaka City General Hospital, 2-13-22, Miyakojimahondohri, Osaka 5340021, Japan. kkk-take@ga2.so-net.ne.jp
Takifuji
Nobuhide
N
Negoro
Shunichi
S
Furuse
Kiyoyuki
K
Nakamura
Shinichiro
S
Takada
Yoshiki
Y
Hoso
Takanobu
T
Hayasaka
Shinichi
S
Nakano
Takashi
T
Araki
Jun
J
Senba
Hiroshi
H
Iwami
Fumiyuki
F
Yamaji
Yasufumi
Y
Fukuoka
Masahiro
M
Ikegami
Harumichi
H
D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D018943:Anthracyclines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007564:Japan; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis
D018943:Anthracyclines; D000970:Antineoplastic Agents; C055866:amrubicin