Amrubicin therapy improves patients with refractory small-cell lung cancer: A single-arm confirmatory Chinese clinical study

Authors

  • Mengli Zheng Department of General Thoracic Surgery, The 309th Hospital of Chinese PLA, Beijing 100-091
  • Naikang Zhou Department of General Thoracic Surgery, The 309th Hospital of Chinese PLA, Beijing 100-091 http://orcid.org/0000-0003-1505-5699
  • Lianjun Ma Department of General Thoracic Surgery, The 309th Hospital of Chinese PLA, Beijing 100-091
  • Wenbo Jin Department of General Thoracic Surgery, The 309th Hospital of Chinese PLA, Beijing 100-091

DOI:

https://doi.org/10.3329/bjp.v11i3.23953

Keywords:

Amrubicin, Chinese, Clinical trial, Small-cell lung cancer

Abstract

Our objective was to evaluate an open-label, multicenter, single-arm study to appraise whether amrubicin therapy improves patients with refractory small-cell lung cancer in Chinese clinical study. Patients (n=95) with refractory small-cell lung cancer received 3 consecutive days amrubicin therapy for 21 days. Overall response rate of response to amrubicin was 39%. Anemia, febrile neutropenia, thrombocytopenia, hyperglycemia, hyponatremia, infection, elevated serum transaminases levels were appeared, but the incidences of adverse events were very few. Our results suggest amrubicin therapy can improve patients with refractory small-cell lung cancer and may be an effective and safe treatment option.

 

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References

Asai N, Ohkuni Y, Matsunuma R, Nakashima K, Iwasaki T, Kaneko N. Efficacy and safety of amurubicin for the elderly patients with refractory relapsed small cell lung cancer as third-line chemotherapy. J Cancer Res Ther. 2012; 8: 266-71.

Bosch X. Small-cell lung cancer responds to amrubicin. Lancet Oncol. 2007; 8: 13.

Cheng CY, Su CC. Tanshinone IIA may inhibit the growth of small cell lung cancer H146 cells by up-regulating the Bax/Bcl-2 ratio and decreasing mitochondrial membrane potential. Mol Med Rep. 2010; 3: 645-50.

Chotenimitkhun R, D'Agostino R Jr., Lawrence JA, Hamilton CA, Jordan JH, Vasu S, Lash TL, Yeboah J, Herrington DM, Hundley WG. Chronic statin administration may attenuate early anthracycline-associated declines in left ventricular ejection function. Can J Cardiol. 2015; 31: 302-07.

Ding C, Li R, Peng J, Li S, Guo Z. A polymorphism at the miR-502 binding site in the 3' untranslated region of the SET8 gene is associated with the outcome of small-cell lung cancer. Exp Ther Med. 2012; 3: 689-92.

Ding Q, Zhan J. Amrubicin: Potential in combination with cisplatin or carboplatin to treat small-cell lung cancer. Drug Des Devel Ther. 2013; 7: 681-89.

Ettinger DS, Jotte R, Lorigan P, Gupta V, Garbo L, Alemany C, Conkling P, Spigel DR, Dudek AZ, Shah C, Salgia R, McNally R, Renschler MF, Oliver JW. Phase II study of amrubicin as second-line therapy in patients with platinum-refractory small-cell lung cancer. J Clin Oncol. 2010; 28: 2598-603.

Gervais R, Le Caer H, Monnet I, Falchero L, Baize N, Olivero G, Thomas P, Berard H, Auliac JB, Chouaid C. Second-line oral chemotherapy (lomustine, cyclophosphamide, etoposide) versus intravenous therapy (cyclophosphamide, doxorubicin, and vincristine) in patients with relapsed small cell lung cancer: A randomized phase II study of GFPC 0501. Clin Lung Cancer. 2015; 16: 100-05.

Hanada M, Noguchi T, Yamaoka T. Amrubicin, a novel 9-aminoanthracycline, enhances the antitumor activity of chemotherapeutic agents against human cancer cells in vitro and in vivo. Cancer Sci. 2007; 98: 447-54.

Hira A, Watanabe H, Maeda Y, Yokoo K, Sanematsu E, Fujii J, Sasaki J, Hamada A, Saito H. Role of P-glycoprotein in accumulation and cytotoxicity of amrubicin and amrubicinol in MDR1 gene-transfected LLC-PK1 cells and human A549 lung adenocarcinoma cells. Biochem Pharmacol. 2008; 75: 973-80.

Igawa S, Sasaki J, Ishihara M, Otani S, Maki S, Hiyoshi Y, Kasajima M, Katono K, Takakura A, Masuda N. Evaluation of amrubicin as a third or later line of chemotherapy for advanced non-small cell lung cancer. Chemotherapy 2013; 59: 99-105.

Ikeda T, Fukuda M, Nakamura Y, Kinoshita A, Senju H, Nakano H, Kitazaki T, Ogawara D, Taniguchi H, Motoshima K, Yamaguchi H, Nakatomi K, Shimada M, Nagashima S, Tsukamoto K, Kohno S. A phase II study of amrubicin and carboplatin for previously untreated patients with extensive-disease small cell lung cancer. Cancer Chemother Pharmacol. 2014; 74: 497-502.

Kobayashi M, Matsui K, Iwamoto Y, Ebi N, Oizumi S, Takeda K, Sawa T, Shibata K, Saka H, Imamura F, Seki N, Saito H, Goto I, Nakagawa K. Phase II study of sequential triplet chemotherapy, irinotecan and cisplatin followed by amrubicin, in patients with extensive-stage small cell lung cancer: West Japan Thoracic Oncology Group Study 0301. J Thorac Oncol. 2010; 5: 1075-80.

Matsunaga Y, Hamada A, Okamoto I, Sasaki J, Moriyama E, Kishi H, Matsumoto M, Hira A, Watanabe H, Saito H. Pharmacokinetics of amrubicin and its active metabolite amrubicinol in lung cancer patients. Ther Drug Monit. 2006; 28: 76-82.

Ohe Y, Negoro S, Matsui K, Nakagawa K, Sugiura T, Takada Y, Nishiwaki Y, Yokota S, Kawahara M, Saijo N, Fukuoka M, Ariyoshi Y. Phase I-II study of amrubicin and cisplatin in previously untreated patients with extensive-stage small-cell lung cancer. Ann Oncol. 2005; 16: 430-36.

Onoda S, Masuda N, Seto T, Eguchi K, Takiguchi Y, Isobe H, Okamoto H, Ogura T, Yokoyama A, Seki N, Asaka-Amano Y, Harada M, Tagawa A, Kunikane H, Yokoba M, Uematsu K, Kuriyama T, Kuroiwa Y, Watanabe K. Phase II trial of amrubicin for treatment of refractory or relapsed small-cell lung cancer: Thoracic Oncology Research Group Study 0301. J Clin Oncol. 2006; 24: 5448-53.

Sekine I, Okamoto H, Horai T, Nakagawa K, Ohmatsu H, Yokoyama A, Katakami N, Shibuya M, Saijo N, Fukuoka M. A randomized phase III study of single-agent amrubicin vs. carboplatin/etoposide in elderly patients with extensive-disease small-cell lung cancer. Clin Lung Cancer. 2014; 15: 96-102.

Shah CM. Amrubicin: A synthetic anthracyclin analogue in the treatment of extensive stage small cell lung cancer. Recent Pat Anticancer Drug Discov. 2009; 4: 241-45.

Wang L, Tan TC, Halpern EF, Neilan TG, Francis SA, Picard MH, Fei H, Hochberg EP, Abramson JS, Weyman AE, Kuter I, Scherrer-Crosbie M. Major cardiac events and the value of echocardiographic evaluation in patients receiving anthracycline-based chemotherapy. Am J Cardiol. 2015; 116: 442-46.

Yamaoka T, Hanada M, Ichii S, Morisada S, Noguchi T, Yanagi Y. Uptake and intracellular distribution of amrubicin, a novel 9-amino-anthracycline, and its active metabolite amrubicinol in P388 murine leukemia cells. Jpn J Cancer Res. 1999; 90: 685-90.

Zhang F, Wang Y, Xu M, Dong H, Liu N, Zhou J, Pang H, Ma N, Zhang N, Pei Y, Zhang H, Liu L. MGr1-Ag promotes invasion and bone metastasis of small-cell lung cancer in vitro and in vivo. Oncol Rep. 2013; 29: 2283-90.

Additional Files

Published

2016-06-01

How to Cite

Zheng, M., N. Zhou, L. Ma, and W. Jin. “Amrubicin Therapy Improves Patients With Refractory Small-Cell Lung Cancer: A Single-Arm Confirmatory Chinese Clinical Study”. Bangladesh Journal of Pharmacology, vol. 11, no. 3, June 2016, pp. 564-9, doi:10.3329/bjp.v11i3.23953.

Issue

Section

Clinical Trial