A phase II study of amrubicin combined with carboplatin for elderly patients with small-cell lung cancer: North Japan Lung Cancer Study Group Trial 0405.
BACKGROUND
Amrubicin, a new anthracycline agent, has shown high activity for small-cell lung cancer (SCLC) in previous studies. However, a combination regimen with amrubicin and platinum has been investigated little. On the basis of previous phase I study, we conducted this study to evaluate the efficacy and the safety of amrubicin and carboplatin for elderly patients with SCLC.


METHODS
Chemotherapy-naive elderly patients with SCLC received amrubicin (35 mg/m(2), days 1-3) and carboplatin [area under the curve (AUC) 4.0, day1] every 3 weeks. The primary end point was overall response rate (ORR), and secondary end points were progression-free survival (PFS), overall survival and toxicity profile.


RESULTS
From January 2005 to November 2007, 36 patients were enrolled [median age 76 (range 70-83); ECOG performance status of zero and one in 17 and 19 patients, respectively]. One complete response and 31 partial responses were observed (ORR 89%). Median PFS was 5.8 months and median survival time was 18.6 months. Grade 3-4 neutropenia was observed in 97% of the patients and six patients (17%) suffered from grade 3-4 febrile neutropenia. Other toxic effects were moderate and treatment-related death was not observed.


CONCLUSIONS
Amrubicin combined with carboplatin is quite effective for SCLC with acceptable toxic effects even for the elderly population. Further evaluation of this regimen is warranted.
Inoue
A
A
Department of Respiratory Medicine, Tohoku University Hospital, Sendai. Electronic address: akinoue@idac.tohoku.ac.jp.
Ishimoto
O
O
Department of Respiratory Medicine, Sendai Kosei Hospital, Sendai.
Fukumoto
S
S
Department of Respiratory Medicine, Hokkaido Cancer Center, Sapporo.
Usui
K
K
Department of Respiratory Medicine, Kanto Medical Center NTT-EC, Tokyo.
Suzuki
T
T
Department of Respiratory Medicine, Isawa Hospital, Ohshu.
Yokouchi
H
H
Department of Respiratory Medicine, Iwamizawa Rosai Hospital, Iwamizawa.
Maemondo
M
M
Department of Respiratory Medicine, Miyagi Cancer Center, Natori.
Kanbe
M
M
Department of Internal Medicine, Senseki Hospital, Higashi-Matsushima.
Ogura
S
S
Department of Respiratory Medicine, Sapporo City Hospital, Sapporo.
Harada
T
T
Department of Respiratory Medicine, Hokkaido Social Insurance Hospital, Sapporo.
Oizumi
S
S
First Department of Medicine, Hokkaido University School of Medicine, Sapporo, Japan.
Harada
M
M
Department of Respiratory Medicine, Hokkaido Cancer Center, Sapporo.
Sugawara
S
S
Department of Respiratory Medicine, Sendai Kosei Hospital, Sendai.
Fukuhara
T
T
Department of Respiratory Medicine, Tohoku University Hospital, Sendai.
Nukiwa
T
T
Department of Respiratory Medicine, Tohoku University Hospital, Sendai.
D000368:Aged; D000369:Aged, 80 and over; D018943:Anthracyclines / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000401:mortality; D012955:Societies, Medical; D016019:Survival Analysis; D016896:Treatment Outcome
D018943:Anthracyclines; C055866:amrubicin; D016190:Carboplatin