Open AccessA Phase II Study of Amrubicin as a Third‐Line or Fourth‐Line Chemotherapy for Patients With Non‐Small Cell Lung Cancer: Hokkaido Lung Cancer Clinical Study Group Trial (HOT) 0901
Author(s) -
Harada Toshiyuki,
Oizumi Satoshi,
Ito Kenichiro,
Takamura Kei,
Kikuchi Eiki,
Kuda Tomoya,
Sugawara Shunichi,
Suzuki Aya,
Maemondo Makoto,
Fujita Yuka,
Kinoshita Ichiro,
Inoue Akira,
Hommura Fumihiro,
Katsuura Yutaka,
DosakaAkita Hirotoshi,
Isobe Hiroshi,
Nishimura Masaharu
Publication year - 2013
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2012-0308
Subject(s) - medicine , neutropenia , lung cancer , febrile neutropenia , clinical endpoint , progressive disease , anthracycline , phases of clinical research , oncology , chemotherapy , confidence interval , surgery , gastroenterology , clinical trial , cancer , breast cancer
Amrubicin, a third‐generation synthetic anthracycline agent, has favorable clinical activity and acceptable toxicity for the treatment of patients with non‐small cell lung cancer (NSCLC) and small cell lung cancer. We conducted this study to evaluate the efficacy and safety of amrubicin for advanced NSCLC patients as a third‐ or fourth‐line therapy. Eligible patients had recurrent or refractory advanced NSCLC after second‐ or third‐line therapy. Patients received amrubicin, 35 mg/m 2 i.v. on days 1–3 every 3 weeks. The primary endpoint was the disease control rate (DCR). Secondary endpoints were the overall survival (OS) time, progression‐free survival (PFS) time, response rate, and toxicity profile. Of the 41 patients enrolled, 26 received amrubicin as a third‐line and 15 received it as a fourth‐line therapy. The median number of treatment cycles was two (range, 1–9). Objective responses were complete response ( n = 0), partial response ( n = 4), stable disease ( n = 21), progressive disease ( n = 15), and not evaluable ( n = 1), resulting in a DCR of 61.0% (95% confidence interval, 46.0%–75.9%). The overall response rate was 9.8% (95% confidence interval, 0.6%–18.8%). The median PFS interval was 3.0 months, median OS time was 12.6 months, and 1‐year survival rate was 53.7%. Grade 3 or 4 hematological toxicities were neutropenia (68%), anemia (12%), thrombocytopenia (12%), and febrile neutropenia (17%). Nonhematological toxicities were mild and reversible. No treatment‐related deaths were observed. Amrubicin showed significant clinical activity with manageable toxicities as a third‐ or fourth‐line therapy for patients with advanced NSCLC. This study provides relevant data for routine practice and future prospective trials evaluating third‐ or fourth‐line treatment strategies for patients with advanced NSCLC.