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Lung Cancer. 2014 Apr;84(1):67-72. doi: 10.1016/j.lungcan.2014.01.012. Epub 2014 Jan 25.

A single-arm confirmatory study of amrubicin therapy in patients with refractory small-cell lung cancer: Japan Clinical Oncology Group Study (JCOG0901).

Author information

1
Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka 411-8777, Japan. Electronic address: ha.murakami@scchr.jp.
2
Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka 411-8777, Japan; Third Department of Internal Medicine, Wakayama Medical University, Wakayama 641-8509, Japan.
3
Japan Clinical Oncology Group Data Center, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo 104-0045, Japan.
4
Department of Clinical Oncology, Osaka City General Hospital, Osaka 534-0021, Japan.
5
Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka 811-1395, Japan.
6
Division of Thoracic Oncology, National Cancer Center Hospital East, Chiba 277-8577, Japan.
7
Division of Thoracic Oncology, National Cancer Center Hospital, Tokyo 104-0045, Japan.
8
Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo 162-8655, Japan.
9
Department of Respiratory Medicine, Osaka City University Hospital, Osaka 545-8586, Japan.
10
Department of Thoracic Oncology, Kinki-Chuo Chest Medical Center, Osaka 591-8555, Japan.
11
Department of Thoracic Oncology, Hyogo Cancer Center, Hyogo 673-8558, Japan.
12
Department of Respiratory Medicine, Okayama University Hospital, Okayama 700-8558, Japan.
13
Department of Thoracic Oncology, Shikoku Cancer Center, Ehime 791-0280, Japan.
14
Division of Diagnostic Radiology, Shizuoka Cancer Center, Shizuoka 411-8777, Japan.
15
Division of Diagnostic Radiology, National Cancer Center Hospital, Tokyo 104-0045, Japan.

Abstract

OBJECTIVES:

We conducted an open-label, multicenter, single-arm study to confirm the efficacy and safety of amrubicin (AMR), a topoisomerase II inhibitor, for treating refractory small-cell lung cancer (SCLC).

PATIENTS AND METHODS:

Patients with chemotherapy-refractory SCLC received 40 mg/m(2) AMR for 3 consecutive days, every 21 days. The primary endpoint was the overall response rate (ORR) and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety.

RESULTS:

Between November 2009 and February 2011, 82 patients were enrolled. Each patient received a median of four treatment cycles (range, 1-22 cycles). ORR was 32.9% [P<0.0001 by the exact binomial test for the null hypothesis that ORR ≤ 10%; 95% confidence interval (CI), 22.9-44.2%]. The median PFS and OS periods were 3.5 months (95% CI, 3.0-4.3 months) and 8.9 months (95% CI, 7.6-11.3 months), respectively. Significant differences in ORR (21.4% v 45.0%; P=0.034), PFS (median, 2.9 v 5.1 months; P=0.0009), and OS (median, 7.9 v 13.1 months; P=0.0128) were observed between patients previously treated with etoposide and others. Neutropenia was the most common grade 3 or 4 adverse events (93.9%), and febrile neutropenia developed in 26.8% patients. No treatment-related death occurred.

CONCLUSIONS:

AMR monotherapy can be considered an effective and safe treatment option for refractory SCLC. Previous chemotherapy with etoposide may influence AMR efficacy.

KEYWORDS:

Amrubicin; Chemotherapy; Etoposide; Phase II; Refractory; Small-cell lung cancer

PMID:
24530204
DOI:
10.1016/j.lungcan.2014.01.012
[Indexed for MEDLINE]
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