Phase II trial of amrubicin for second-line treatment of advanced non-small cell lung cancer: results of the West Japan Thoracic Oncology Group trial (WJTOG0401).
BACKGROUND
Amrubicin is a synthetic anthracycline drug that is a potent inhibitor of topoisomerase II. We have performed a multicenter phase II trial to evaluate the efficacy and safety of amrubicin for patients with previously treated non-small cell lung cancer (NSCLC).


METHODS
Patients with advanced NSCLC who experienced disease recurrence after one platinum-based chemotherapy regimen were eligible for enrollment in the study. Amrubicin was administered by intravenous injection at a dose of 40 mg/m2 on 3 consecutive days every 3 weeks.


RESULTS
Sixty-one enrolled patients received a total of 192 treatment cycles (median, 2; range, 1-15). Response was as follows: complete response, 0; partial response, seven (11.5%); stable disease, 20 (32.8%); and progressive disease, 34 (55.7%). Median progression-free survival was 1.8 months, whereas median overall survival was 8.5 months, and the 1-year survival rate was 32%. Hematologic toxicities of grade 3 or 4 included neutropenia (82.0%), leukopenia (73.8%), thrombocytopenia (24.6%), and anemia (27.9%). Febrile neutropenia occurred in 18 patients (29.5%). One treatment-related death due to infection was observed. Nonhematologic toxicities were mild.


CONCLUSIONS
Amrubicin is a possible alternative for second-line treatment of advanced NSCLC, although a relevant hematological toxicity is significant, especially with a febrile neutropenia.
Kaneda
Hiroyasu
H
Department of Medical Oncology, Kinki University School of Medicine, Osaka-sayama, Osaka, Japan.
Okamoto
Isamu
I
Hayashi
Hidetoshi
H
Yoshioka
Hiroshige
H
Miyazaki
Masaki
M
Kudoh
Shinzoh
S
Kimura
Tatsuo
T
Sugiura
Takamune
T
Sawa
Toshiyuki
T
Takeda
Koji
K
Iwamoto
Yasuo
Y
Satouchi
Miyako
M
Akita
Kenji
K
Saito
Hiroshi
H
Goto
Isao
I
Shibata
Kazuhiko
K
Fukuoka
Masahiro
M
Nakagawa
Kazuhiko
K
D000230:Adenocarcinoma / Q000188:drug therapy / Q000556:secondary; D000368:Aged; D018943:Anthracyclines / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018287:Carcinoma, Large Cell / Q000188:drug therapy / Q000556:secondary; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000556:secondary; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D011379:Prognosis; D016879:Salvage Therapy; D015996:Survival Rate; D016896:Treatment Outcome
D018943:Anthracyclines; D000970:Antineoplastic Agents; C055866:amrubicin