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abstracts
small cell lung cancer and other
thoracic malignancies
1519PD PHASE II STUDY OF AMRUBICIN IN PATIENTS WITH
REFRACTORY OR RESISTANT RELAPSED SMALL-CELL
LUNG CANCER: JAPAN CLINICAL ONCOLOGY GROUP
STUDY (JCOG0901)
H. Daga 1 , H. Murakami 2 , N. Yamamoto 2 , T. Shibata 3 , M. Endo 4 , H. Watanabe 5 ,
Y. Ichinose 6 , N. Yamamoto 7 ,Y.Ohe 8 , T. Tamura 7
1 Department of Clinical Oncology, Osaka City General Hospital, Osaka, JAPAN,
2 Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, JAPAN, 3 Regulatory
Science Section Multi-institutional Clinical Trial Support Center, National Cancer
Center Hospital, Tokyo, JAPAN, 4 Department of Radiology, Shizuoka Cancer
Center, Shizuoka, JAPAN, 5 Department of Radiology, National Cancer Center
Hospital, Tokyo, JAPAN, 6 Department of Thoracic Oncology, National Kyushu
Cancer Center, Fukuoka, JAPAN, 7 Department of Thoracic Oncology, National
Cancer Center Hospital, Tokyo, JAPAN, 8 Thoracic Oncology, National Cancer
Center Hospital East, Kashiwa, JAPAN
Background: Standard therapy for refractory or resistant relapsed small-cell lung
cancer (SCLC) has not yet been established. We conducted an open-label,
multicenter, non-randomized phase II study to confirm the efficacy and safety of
amrubicin, a topoisomerase inhibitor, in the treatment of refractory or resistant
SCLC.
Material and methods: Patients with SCLC that is refractory or relapsed within 90
days of completing previous treatment received amrubicin at a dose of 40 mg/m 2 for
3 consecutive days, every 21 days.The study treatment was repeated until disease
progression or intolerable toxicity. The primary end point was overall response rate
(ORR), and secondary end points were progression-free survival (PFS), overall
survival (OS), and safety. Planned sample size was 80 patients to achieve power of at
least 80% with one-sided alpha of 0.05, and expected and threshold value for
primary endpoint as 20% and 10%. All patients were followed-up until one year after
the last patient enrollment.
Results: Between November 2009 and February 2011, 82 patients were enrolled from
25 institutions. The median number of treatment cycles was four (range, one to 22
cycles).The ORR was 32.9% (p < 0.0001 by the exact binomial test for null hypothesis
that ORR =