Researchers from Japan have reported Amrubicin®, a new synthetic anthracycline, combined with Paraplatin® (carboplatin) resulted in an 89% overall response rate (ORR) in elderly patients with small cell lung cancer (SCLC). The details of this report appeared in an early online publication in the Annals of Oncology on October 13, 2009.[1]
Small cell lung cancer is very sensitive to a variety of chemotherapy agents, including anthracyclines such as Adriamycin® (doxorubicin). However, anthracyclines are associated with early and late cardiac damage, limiting their use. Amrubicin is a totally synthetic anthracycline developed by the Japanese, which is currently in Phase I/II testing with a focus on patients with SCLC. In March of 2008, Amrubicin received orphan drug status for the treatment of SCLC.
At the 13th World Conference on Lung Cancer in August of 2009, three studies of Amrubicin for treatment of SCLC were presented.[2]
The first study compared Amrubicin to topotecan in patients with platinum-sensitive SCLC. The ORR was 44% in patients treated with Amrubicin compared with 11.5% for patients treated with topotecan. The CR was 12% for the Amrubicin arm compared with 4% for the topotecan arm. For patients aged 65 years or older, the ORR for patients receiving Amrubicin was 46% compared with 7% for patients receiving topotecan. The second study was a single-arm trial of Amrubicin in 75 platinum-resistant patients with SCLC. The ORR was 21%, with one patient achieving a CR. The median duration of response was 4.3 months. The third study evaluated cardiac function in patients treated with Amrubicin.
The current study included 36 patients, ages 70-83, with SCLC who had not received prior chemotherapy. All were treated with Amrubicin and Paraplatin. The ORR was 89% with one CR. Median progression-free survival was 5.8 months, and median survival was 18.6 months. These authors concluded: “Amrubicin combined with carboplatin is quite effective for SCLC with acceptable toxic effects even in the elderly population.”
Comments: It appears that there is continued progress in the evaluation of Amrubicin, which should ultimately lead to approval by the U.S. Food and Drug Administration.
Reference: [1] Inoue A, Ishimoto O, Fukumoto S, et al. A phase II study of amrubicin combined with carboplatin for elderly patients with small-cell lung cancer: North Japan Lung Cancer Study Group Trial 0405. Annals of Oncology [early online publication]. October 13, 2009.
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