A phase II study of amrubicin, a synthetic 9-aminoanthracycline, in patients with previously treated lung cancer

Kaira, Kyoichi; Sunaga, Noriaki; Tomizawa, Yoshio; Yanagitani, Noriko; Shimizu, Kimihiro; Imai, Hisao; Utsugi, Mitsuyoshi; Iwasaki, Yasuki; Iijima, Hironobu; Tsurumaki, Hiroaki; Yoshii, Akihiro; Fueki, Naoto; Hisada, Takeshi; Ishizuka, Tamotsu; Saito, Ryusei; Mori, Masatomo

doi:10.1016/j.lungcan.2009.09.012

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Volume 69, Issue 1 , Pages 99-104, July 2010

A phase II study of amrubicin, a synthetic 9-aminoanthracycline, in patients with previously treated lung cancer☆

Kyoichi Kaira
- Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Showa-machi, Maebashi, Gunma 371-8511, Japan
- Corresponding author. Tel.: +81 27 220 8136; fax: +81 27 220 8136.
Noriaki Sunaga
- Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Showa-machi, Maebashi, Gunma 371-8511, Japan
Yoshio Tomizawa
- Department of Respiratory Medicine, National Hospital Organization Nishigunma Hospital, 2854 Kanai, Shibukawa, Gunma 377-8511, Japan
Noriko Yanagitani
- Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Showa-machi, Maebashi, Gunma 371-8511, Japan
Kimihiro Shimizu
- Department of Thoracic and Visceral Organ Surgery, Gunma University Graduate School of Medicine, Showa-machi, Maebashi, Gunma 371-8511, Japan
Hisao Imai
- Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Showa-machi, Maebashi, Gunma 371-8511, Japan
Mitsuyoshi Utsugi
- Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Showa-machi, Maebashi, Gunma 371-8511, Japan
Yasuki Iwasaki
- Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Showa-machi, Maebashi, Gunma 371-8511, Japan
Hironobu Iijima
- Department of Respiratory Medicine, National Hospital Organization Nishigunma Hospital, 2854 Kanai, Shibukawa, Gunma 377-8511, Japan
Hiroaki Tsurumaki
- Department of Respiratory Medicine, National Hospital Organization Nishigunma Hospital, 2854 Kanai, Shibukawa, Gunma 377-8511, Japan
Akihiro Yoshii
- Department of Respiratory Medicine, National Hospital Organization Nishigunma Hospital, 2854 Kanai, Shibukawa, Gunma 377-8511, Japan
Naoto Fueki
- Jobu Hospital for Respiratory Disease 586-1 Taguchi-machi, Maebashi, Gunma 371-0048, Japan
Takeshi Hisada
- Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Showa-machi, Maebashi, Gunma 371-8511, Japan
Tamotsu Ishizuka
- Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Showa-machi, Maebashi, Gunma 371-8511, Japan
Ryusei Saito
- Department of Respiratory Medicine, National Hospital Organization Nishigunma Hospital, 2854 Kanai, Shibukawa, Gunma 377-8511, Japan
Masatomo Mori
- Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Showa-machi, Maebashi, Gunma 371-8511, Japan

Received 9 June 2009; received in revised form 22 August 2009; accepted 28 September 2009. published online 26 October 2009.

Abstract

Purpose

This study was designed to confirm the efficacy and safety of amrubicin, a new anthracycline agent, in patients with previously treated non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).

Methods

Eligible patients were required to have recurrent or refractory NSCLC and SCLC after one or two previous chemotherapy regimens. All patients received intravenous amrubicin 35mg/m² on days 1–3 every 3 weeks. Overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) were evaluated.

Results

Sixty-six patients (37 NSCLC and 29 SCLC) were assessable for efficacy and safety evaluation. Grade 3 or 4 neutropenia was observed in 39.4% of all patients (NSCLC, 37.8%; SCLC, 41.4%). Nonhematological toxicities were mild. No treatment-related death was observed. The ORRs were 13.5% (95% CI, 4.5–28.8%) in NSCLC and 44.8% (95% CI, 26.4–64.3%) in SCLC. In SCLC, ORRs were 60.0% in the sensitive relapse and 36.8% in the refractory relapse (p=0.2332). In NSCLC, the PFS, OS, and 1-year survival were 3.3 months, 12.0 months, and 35.3%, respectively. In SCLC, the PFS, OS, and 1-year survival were 4.0 months, 12.0 months, and 46.7%, respectively.

Conclusions

Amrubicin is an active and well-tolerated regimen in patients with previously treated lung cancer. Amrubicin 35mg/m² seems to achieve similar efficacy with less toxicity than amrubicin 40mg/m² in this patient population. These results warrant further evaluation in previously treated lung cancer.

Keywords: Amrubicin, Relapse, Phase II trial, Non-small cell lung cancer, Small cell lung cancer, Previously treated lung cancer