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Clinical Trial
. 2019 Jan-Feb;33(1):163-166.
doi: 10.21873/invivo.11453.

Phase II Study of Weekly Amrubicin for Refractory or Relapsed Non-small Cell Lung Cancer

Chiyoe Kitagawa  1   2 , Masahiro Iwasaku  3 , Yoshihito Kogure  4 , Masahiko Ando  5 , Hiroshige Yoshioka  3   6 , Akihiro Nishiyama  3 , Naoki Watanabe  3 , Kei Kunimasa  3 , Kazuya Tsubouchi  3 , Saori Oka  2 , Hideo Saka  4   2
Affiliations
Clinical Trial

Phase II Study of Weekly Amrubicin for Refractory or Relapsed Non-small Cell Lung Cancer

Chiyoe Kitagawa et al. In Vivo. 2019 Jan-Feb.

Abstract

Background: Amrubicin is usually administered on days 1-3 every 3 weeks by intravenous infusion. However, it causes severe hematological toxicity, especially febrile neutropenia. It was reported that weekly administration confers higher dose intensity, less severe adverse events, and anti-tumor activity that is as effective as that of treatment with a conventional schedule.

Patients and methods: Weekly amrubicin was administered at a dose of 60 mg/m2 on days 1 and 8 every 3 weeks. The primary endpoint was overall response rate.

Results: A total of 33 patients were enrolled. The overall response rate was 6.1% (95% confidence interval(CI)=0.7-20.2%) and the disease control rate after 2 months was 51.5%. The median progression-free survival was 2.93 months. Febrile neutropenia was observed in only two patients.

Conclusion: The primary endpoint was not met in this study. However, weekly amrubicin achieved a high disease control rate and good tolerability.

Keywords: Amrubicin; non-small cell lung cancer; phase II; refractory; relapsed.

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Figures

Figure 1
Figure 1. Survival of patients on weekly amrubicin. A: Progression-free survival; B: overall survival.
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