This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Onoda, S. Articles by Watanabe, K. Search for Related Content PubMed PubMed Citation Articles by Onoda, S. Articles by Watanabe, K. Social Bookmarking                            What's this?

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.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				J. R. Eckardt, D. L. Bentsion, O. N. Lipatov, I. S. Polyakov, F. R. MacKintosh, D. A. Karlin, G. S. Baker, and H. B. Breitz Phase II Study of Picoplatin As Second-Line Therapy for Patients With Small-Cell Lung Cancer J. Clin. Oncol., April 20, 2009; 27(12): 2046 - 2051. [Abstract] [Full Text] [PDF]

				G. Chen, M. Huynh, L. Fehrenbacher, H. West, P. N. Lara Jr, L. L. Yavorkovsky, M. Russin, D. Goldstein, D. Gandara, and D. Lau Phase II Trial of Irinotecan and Carboplatin for Extensive or Relapsed Small-Cell Lung Cancer J. Clin. Oncol., March 20, 2009; 27(9): 1401 - 1404. [Abstract] [Full Text] [PDF]

				L. M. Krug and M. C. Pietanza Emerging Therapies in Small Cell Lung Cancer ASCO Educational Book, January 1, 2009; 2009(1): 455 - 460. [Abstract] [Full Text] [PDF]

				A. Inoue, S. Sugawara, K. Yamazaki, M. Maemondo, T. Suzuki, K. Gomi, S. Takanashi, C. Inoue, M. Inage, H. Yokouchi, et al. Randomized Phase II Trial Comparing Amrubicin With Topotecan in Patients With Previously Treated Small-Cell Lung Cancer: North Japan Lung Cancer Study Group Trial 0402 J. Clin. Oncol., November 20, 2008; 26(33): 5401 - 5406. [Abstract] [Full Text] [PDF]

				T. Sher, G. K. Dy, and A. A. Adjei Small Cell Lung Cancer Mayo Clin. Proc., March 1, 2008; 83(3): 355 - 367. [Abstract] [Full Text] [PDF]