A single-arm confirmatory study of amrubicin therapy in patients with refractory small-cell lung cancer: Japan Clinical Oncology Group Study (JCOG0901)

Murakami, Haruyasu
Yamamoto, Nobuyuki
Shibata, Taro
Takeda, Koji
Ichinose, Yukito
Ohe, Yuichiro
Yamamoto, Noboru
Takeda, Yuichiro
Kudoh, Shinzoh
Atagi, Shinji
Satouchi, Miyako
Kiura, Katsuyuki
Nogami, Naoyuki
Endo, Masahiro
Watanabe, Hirokazu
Tamura, Tomohide

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Publication date

April 2014

DOI

10.1016/j.lungcan.2014.01.012

Publisher

Elsevier BV

ISSN

0169-5002

Citation count (estimate)

Abstract

AbstractObjectivesWe conducted an open-label, multicenter, single-arm study to confirm the efficacy and safety of amrubicin (AMR), a topoisomerase II inhibitor, for treating refractory small-cell lung cancer (SCLC).Patients and methodsPatients with chemotherapy-refractory SCLC received 40mg/m2 AMR for 3 consecutive days, every 21 days. The primary endpoint was the overall response rate (ORR) and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety.ResultsBetween November 2009 and February 2011, 82 patients were enrolled. Each patient received a median of four treatment cycles (range, 1–22 cycles). ORR was 32.9% [P<0.0001 by the exact binomial test for the null hypothesis that ORR≤10%; 95% confidenc...