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Phase II Trial of Amrubicin for Treatment of Refractory or Relapsed Small-Cell Lung Cancer: Thoracic Oncology Research Group Study 0301

Sayaka Onoda, Noriyuki Masuda, Takashi Seto, Kenji Eguchi, Yuichi Takiguchi, Hiroshi Isobe, Hiroaki Okamoto, Takashi Ogura, Akira Yokoyama, Nobuhiko Seki, Yoshiko Asaka-Amano, Masao Harada, Akihiro Tagawa, Hiroshi Kunikane, Masanori Yokoba, Kazutsugu Uematsu, Takayuki Kuriyama, Yumi Kuroiwa, Koshiro Watanabe

From the Department of Respiratory Medicine, Kitasato University School of Medicine, Sagamihara, Kanagawa; Department of Respirology, Tokai University School of Medicine, Isehara; Department of Respirology, Graduate School of Medicine, Chiba University, Chiba; Department of Pulmonary Disease, National Hospital Hokkaido Cancer Center, Sapporo; Department of Respirology, Yokohama Municipal Citizen's Hospital; Department of Respiratory Medicine, Kanagawa Cardiovascular & Respiratory Center, Yokohama; and Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan

Address reprint requests to Noriyuki Masuda, MD, PhD, Department of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1 Kitasato, Sagamihara, Kanagawa 228-0022, Japan; e-mail: masuda{at}med.kitasato-u.ac.jp

PURPOSE: This multicenter, phase II study was conducted to evaluate the activity of amrubicin, a topoisomerase II inhibitor, against refractory or relapsed small-cell lung cancer (SCLC).

PATIENTS AND METHODS: SCLC patients with measurable disease who had been treated previously with at least one platinum-based chemotherapy regimen and had an Eastern Cooperative Oncology Group performance status of 0 to 2 were eligible. Two groups of patients were selected: patients who experienced first-line treatment failure less than 60 days from treatment discontinuation (refractory group), and patients who responded to first-line treatment and experienced disease progression 60 days after treatment discontinuation (sensitive group). Amrubicin was administered as a 5-minute daily intravenous injection at a dose of 40 mg/m² for 3 consecutive days, every 3 weeks.

RESULTS: Between June 2003 and December 2004, 60 patients (16 refractory and 44 sensitive) were enrolled. The median number of treatment cycles was four (range, one to eight). Grade 3 or 4 hematologic toxicities comprised neutropenia (83%), thrombocytopenia (20%), and anemia (33%). Febrile neutropenia was observed in three patients (5%). Nonhematologic toxicities were mild. No treatment-related death was observed. The overall response rates were 50% (95% CI, 25% to 75%) in the refractory group, and 52% (95% CI, 37% to 68%) in the sensitive group. The progression-free survival, overall survival, and 1-year survival in the refractory group and the sensitive group were 2.6 and 4.2 months, 10.3 and 11.6 months, and 40% and 46%, respectively.

CONCLUSION: Amrubicin exhibits significant activity against SCLC, with predictable and manageable toxicities; this agent deserves to be studied more extensively in additional trials.

Presented in part at the 42nd Annual Meeting of the American Society of Clinical Oncology, June 2-6, 2006, Atlanta, GA.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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