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- W2591431498 abstract "7586 Background: Amrubicin (AMR), a totally synthetic 9-aminoanthracycline and potent topoisomerase II inhibitor, is approved in Japan for the treatment of lung cancer. We investigate the recommended doses (RD) of AMR in combination with CDDP in a phase I trial, and assess the efficacy and safety in a phase II trial in Japanese patients with advanced NSCLC. Methods: In the phase I trial, patients with advanced NSCLC, with no history of previous chemotherapy, an ECOG performance status (PS) 0–1 and adequate organ functions were eligible. Patients were to receive AMR 35 mg/m2 for 3 successive days IV and CDDP 60 mg/m2 on day 1 (level 1) and AMR 35 mg/m2 for 3 successive days IV and CDDP 80 mg/m2 on day 1 (level 2) every 3 weeks. In the phase II trial, the primary endpoint was objective tumor response rate (ORR, by RECIST). Secondary endpoints included time to progression (TTP) and overall survival (OS). Results: In the phase I trial, six patients were enrolled in each of the level 1 and level 2. treatments. The RD was AMR 35 mg/m2 × 3 days and CDDP 80 mg/m2 (level 2) every 3 weeks. In the phase II trial, the ORR was 23.4% (11/47, CR in 0%, PR in 23.4%). The median TTP was 6.2 months, and the 1-year survival rate was 73.5%. In the safety population (n = 47), the most common grade 3 or 4 adverse events were neutropenia (93.6%) and febrile neutropenia (29.8%). Conclusions: AMR delivers a significant improvement on ORR of 23.4 %, and promising activity on TTP, and on the 1-year survival rate. Furthermore, it has an acceptable safety profile in advanced NSCLC patients at the dose of AMR 35 mg/m2x3 days IV and CDDP 80 mg/m2 on day 1 every 3 weeks. No significant financial relationships to disclose." @default.
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- W2591431498 date "2010-05-20" @default.
- W2591431498 modified "2023-09-24" @default.
- W2591431498 title "Results of a phase I/II trial of amrubicin (AMR) in combination with cisplatin (CDDP) as a first-line treatment in patients with advanced non-small cell lung cancer (NSCLC)." @default.
- W2591431498 doi "https://doi.org/10.1200/jco.2010.28.15_suppl.7586" @default.
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