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

Abstract Objectives We 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 methods Patients with chemotherapy-refractory SCLC received 40 mg/m2...

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Published in:Lung cancer (Amsterdam, Netherlands) Netherlands), 2014-04, Vol.84 (1), p.67-72
Main Authors: 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
Format: Article
Language:English
Subjects:
Adult
Aged
Amrubicin
Anthracyclines - administration & dosage
Anthracyclines - adverse effects
Anthracyclines - therapeutic use
Antineoplastic Agents - administration & dosage
Antineoplastic Agents - adverse effects
Antineoplastic Agents - therapeutic use
Biological and medical sciences
Chemotherapy
Etoposide
Female
Hematology, Oncology and Palliative Medicine
Humans
Lung Neoplasms - drug therapy
Lung Neoplasms - mortality
Male
Medical sciences
Middle Aged
Multiple tumors. Solid tumors. Tumors in childhood (general aspects)
Phase II
Pneumology
Pulmonary/Respiratory
Refractory
Retreatment
Small Cell Lung Carcinoma - drug therapy
Small Cell Lung Carcinoma - mortality
Small-cell lung cancer
Treatment Outcome
Tumors
Tumors of the respiratory system and mediastinum
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Summary:Abstract Objectives We 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 methods Patients with chemotherapy-refractory SCLC received 40 mg/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. Results Between 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% confidence interval (CI), 22.9–44.2%]. The median PFS and OS periods were 3.5 months (95% CI, 3.0–4.3 months) and 8.9 months (95% CI, 7.6–11.3 months), respectively. Significant differences in ORR (21.4% v 45.0%; P = 0.034), PFS (median, 2.9 v 5.1 months; P = 0.0009), and OS (median, 7.9 v 13.1 months; P = 0.0128) were observed between patients previously treated with etoposide and others. Neutropenia was the most common grade 3 or 4 adverse events (93.9%), and febrile neutropenia developed in 26.8% patients. No treatment-related death occurred. Conclusions AMR monotherapy can be considered an effective and safe treatment option for refractory SCLC. Previous chemotherapy with etoposide may influence AMR efficacy.
ISSN:0169-5002
1872-8332
DOI:10.1016/j.lungcan.2014.01.012