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).

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.

• Authors: 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, West Japan Thoracic Oncology Group
• Journal: Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer (J Thorac Oncol) Vol. 5 Issue 1 Pg. 105-9 (Jan 2010) ISSN: 1556-1380 [Electronic] United States
• PMID: 19884859 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Anthracyclines
• Antineoplastic Agents
• amrubicin

Topics

• Adenocarcinoma (drug therapy, secondary)
• Aged
• Anthracyclines (therapeutic use)
• Antineoplastic Agents (therapeutic use)
• Carcinoma, Large Cell (drug therapy, secondary)
• Carcinoma, Non-Small-Cell Lung (drug therapy, secondary)
• Carcinoma, Squamous Cell (drug therapy, secondary)
• Female
• Follow-Up Studies
• Humans
• Japan
• Lung Neoplasms (drug therapy, pathology)
• Male
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy, pathology)
• Neoplasm Staging
• Prognosis
• Salvage Therapy
• Survival Rate
• Treatment Outcome