Phase II study of amrubicin combined with carboplatin for refractory relapsed small-cell lung cancer: North Japan Lung Cancer Group Trial 0802

Yosuke Kawashima; Akira Inoue; Shunichi Sugawara; Satoshi Oizumi; Makoto Maemondo; Koichi Okudera; Toshiro Suzuki; Kazuhiro Usui; Masao Harada; Naoto Morikawa; Yukihiro Hasegawa; Ryota Saito; Osamu Ishimoto; Tomohiro Sakakibara; Hajime Asahina; Toshihiro Nukiwa

doi:10.1016/j.resinv.2013.12.005

Phase II study of amrubicin combined with carboplatin for refractory relapsed small-cell lung cancer: North Japan Lung Cancer Group Trial 0802

Respir Investig. 2014 May;52(3):190-4. doi: 10.1016/j.resinv.2013.12.005. Epub 2014 Jan 28.

Authors

Yosuke Kawashima¹, Akira Inoue², Shunichi Sugawara³, Satoshi Oizumi⁴, Makoto Maemondo⁵, Koichi Okudera⁶, Toshiro Suzuki⁷, Kazuhiro Usui⁸, Masao Harada⁹, Naoto Morikawa¹⁰, Yukihiro Hasegawa¹¹, Ryota Saito¹², Osamu Ishimoto¹³, Tomohiro Sakakibara¹⁴, Hajime Asahina¹⁵, Toshihiro Nukiwa¹⁶

Affiliations

¹ Department of Pulmonary Medicine, Sendai Kousei Hospital, 4-15 Hirose-machi, Aoba-ku, Sendai 980-0873, Japan. Electronic address: [email protected].
² Department of Respiratory Medicine, Tohoku University Hospital, 1-1 Seiryou-machi, Aoba-ku, Sendai 980-8574, Japan. Electronic address: [email protected].
³ Department of Pulmonary Medicine, Sendai Kousei Hospital, 4-15 Hirose-machi, Aoba-ku, Sendai 980-0873, Japan. Electronic address: [email protected].
⁴ First Department of Medicine, Hokkaido University School of Medicine, Kita 15-jo Nishi 7-chome, Kita-ku, Sapporo 060-8638, Japan. Electronic address: [email protected].
⁵ Department of Respiratory Medicine, Miyagi Cancer Center, 47-1 Nodayama, Medeshima-shiote, Natori 981-1293, Japan. Electronic address: [email protected].
⁶ Department of Respiratory Medicine, Hirosaki Central Hospital, 3-1 Yoshino-machi, Hirosaki 036-8188, Japan. Electronic address: [email protected].
⁷ Department of Respiratory Medicine, Isawa Hospital, 61 Ryugababa, Mizusawa-ku, Oshu 023-0864, Japan. Electronic address: [email protected].
⁸ Division of Respirology, NTT Medical Center Tokyo, 5-9-22 Higashi Gotanda, Shinagawa-ku, Tokyo 141-8625, Japan. Electronic address: [email protected].
⁹ Department of Respiratory Medicine, Hokkaido Cancer Center, 2-3-54 Kikusui 4-jo, Shiroishi-ku, Sapporo 003-0804, Japan. Electronic address: [email protected].
¹⁰ Division of Pulmonary Medicine, Allergy, and Rheumatology, Department of Internal Medicine, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka 020-8505, Japan. Electronic address: [email protected].
¹¹ Department of Respiratory Medicine, Aomori Prefectural Central Hospital, 2-1-1 Higashitukurimichi, Aomori 030-8553, Japan. Electronic address: [email protected].
¹² Department of Respiratory Medicine, Tohoku University Hospital, 1-1 Seiryou-machi, Aoba-ku, Sendai 980-8574, Japan. Electronic address: [email protected].
¹³ Department of Pulmonary Medicine, Sendai Kousei Hospital, 4-15 Hirose-machi, Aoba-ku, Sendai 980-0873, Japan. Electronic address: [email protected].
¹⁴ Department of Respiratory Medicine, Tohoku University Hospital, 1-1 Seiryou-machi, Aoba-ku, Sendai 980-8574, Japan. Electronic address: [email protected].
¹⁵ First Department of Medicine, Hokkaido University School of Medicine, Kita 15-jo Nishi 7-chome, Kita-ku, Sapporo 060-8638, Japan. Electronic address: [email protected].
¹⁶ South Miyagi Medical Center, 38-1 Nishi, Ogawara, Shibata 989-1253, Japan. Electronic address: [email protected].

PMID: 24853020
DOI: 10.1016/j.resinv.2013.12.005

Abstract

Background: Amrubicin (AMR), a new anthracycline agent, has shown promising results for advanced small-cell lung cancer (SCLC), although the efficacy of AMR alone against refractory relapsed SCLC is insufficient. This study was conducted to evaluate the safety and efficacy of the combination of AMR and carboplatin (CBDCA) in patients with refractory relapsed SCLC.

Methods: Patients with advanced SCLC who relapsed within 90 days after the completion of first-line chemotherapy received AMR (30mg/m(2), days 1-3) and CBDCA (area under the curve 4.0mgmL(-1)min(-1), day 1) every 3 weeks. The primary endpoint of this study was the overall response rate (ORR), and the secondary endpoints were progression-free survival (PFS), overall survival, and the toxicity profile. Assuming that an ORR of 45% in eligible patients would indicate potential usefulness and an ORR of 20% would be the lower limit of interest, with α=0.10 and β=0.10, at least 24 patients were required.

Results: Among 29 eligible patients, the ORR was 34% (90% confidence interval, 20-48). The median PFS was 3.5 months, whereas the median survival time was 7.3 months. The most common grade 3-4 toxicity was neutropenia (79%), although only one patient (3%) suffered from febrile neutropenia. Non-hematological toxicities were of moderate severity and no treatment-related death was observed.

Conclusions: This is the first prospective study of AMR combined with CBDCA for refractory relapsed SCLC, which was effective and well tolerated. However, further investigation of this regimen is warranted.

Keywords: Amrubicin; Phase II trial; Refractory relapse; Small-cell lung cancer.

Publication types

Clinical Trial, Phase II
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aged, 80 and over
Anthracyclines / administration & dosage
Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
Carboplatin / administration & dosage
Female
Humans
Lung Neoplasms / drug therapy*
Male
Middle Aged
Neoplasm Recurrence, Local*
Prospective Studies
Small Cell Lung Carcinoma / drug therapy*
Treatment Outcome

Substances

Anthracyclines
amrubicin
Carboplatin