Phase II trial of amrubicin for second-line treatment of advanced non-small cell lung cancer: Results of the west japan thoracic oncology group trial (WJTOG0401)

Hiroyasu Kaneda, Isamu Okamoto, Hidetoshi Hayashi, Hiroshige Yoshioka, Masaki Miyazaki, Shinzoh Kudoh, Tatsuo Kimura, Takamune Sugiura, Toshiyuki Sawa, Koji Takeda, Yasuo Iwamoto, Miyako Satouchi, Kenji Akita, Hiroshi Saito, Isao Goto, Kazuhiko Shibata, Masahiro Fukuoka, Kazuhiko Nakagawa

Research output: Contribution to journalArticlepeer-review

15 Citations (Scopus)

Abstract

BACKGROUND: Amrubicin is a synthetic anthracycline drug that is a potent inhibitor of topoisomerase II. We have performed a multicenter phase II trial to evaluate the efficacy and safety of amrubicin for patients with previously treated non-small cell lung cancer (NSCLC). METHODS: Patients with advanced NSCLC who experienced disease recurrence after one platinum-based chemotherapy regimen were eligible for enrollment in the study. Amrubicin was administered by intravenous injection at a dose of 40 mg/m2 on 3 consecutive days every 3 weeks. RESULTS: Sixty-one enrolled patients received a total of 192 treatment cycles (median, 2; range, 1-15). Response was as follows: complete response, 0; partial response, seven (11.5%); stable disease, 20 (32.8%); and progressive disease, 34 (55.7%). Median progression-free survival was 1.8 months, whereas median overall survival was 8.5 months, and the 1-year survival rate was 32%. Hematologic toxicities of grade 3 or 4 included neutropenia (82.0%), leukopenia (73.8%), thrombocytopenia (24.6%), and anemia (27.9%). Febrile neutropenia occurred in 18 patients (29.5%). One treatment-related death due to infection was observed. Nonhematologic toxicities were mild. CONCLUSIONS: Amrubicin is a possible alternative for second-line treatment of advanced NSCLC, although a relevant hematological toxicity is significant, especially with a febrile neutropenia.

Original languageEnglish
Pages (from-to)105-109
Number of pages5
JournalJournal of Thoracic Oncology
Volume5
Issue number1
DOIs
Publication statusPublished - Jan 2010
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine

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