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Article ; Online: Predictive significance of circulating tumor DNA against patients with T790M-positive EGFR-mutant NSCLC receiving osimertinib.

2023 Volume 13, Issue 1, Page(s) 20848

Abstract: Circulating tumor DNA (ctDNA) provides molecular information on tumor heterogeneity. The prognostic usefulness of ctDNA after first-line epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are limited. Therefore, the present study ... ...

Abstract	Circulating tumor DNA (ctDNA) provides molecular information on tumor heterogeneity. The prognostic usefulness of ctDNA after first-line epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are limited. Therefore, the present study evaluated ctDNA during osimertinib administration as a second-line or more setting to identify the relationship between EGFR mutation levels and outcomes in patients with advanced non-small cell lung cancer (NSCLC). Forty patients with EGFR T790M-positive NSCLC receiving osimertinib after prior EGFR-TKI treatment were registered. Plasma samples were collected at osimertinib pretreatment, after 1 month of treatment, and at the time of progressive disease (PD). ctDNA analysis was performed by digital polymerase chain reaction. The detection rate of copy numbers of exon 19 deletion, L858R, and T790M in plasma samples was significantly lower 1 month after osimertinib than at pretreatment, and significantly higher at PD than at 1 month, whereas that of C797S was significantly higher at PD than at 1 month. No statistically significant difference was observed in the copy numbers of exon 19 deletion, L858R, T790M, and C797S between complete response or partial response and stable disease or PD. The detection of T790M at PD after osimertinib initiation was a significant independent prognostic factor for predicting shorter prognosis, and the presence of major EGFR mutations at pretreatment and PD was closely linked to worse survival after osimertinib initiation. Molecular testing based on ctDNA is helpful for predicting outcomes of osimertinib treatment in T790M-positive NSCLC after previous EGFR-TKI treatment.
MeSH term(s)	Humans ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/genetics ; Carcinoma, Non-Small-Cell Lung/pathology ; Circulating Tumor DNA/genetics ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; Lung Neoplasms/pathology ; ErbB Receptors ; Antineoplastic Agents/therapeutic use ; Mutation ; Protein Kinase Inhibitors/therapeutic use ; Protein Kinase Inhibitors/pharmacology ; Aniline Compounds/therapeutic use
Chemical Substances	Circulating Tumor DNA ; ErbB Receptors (EC 2.7.10.1) ; osimertinib (3C06JJ0Z2O) ; Antineoplastic Agents ; Protein Kinase Inhibitors ; Aniline Compounds ; EGFR protein, human (EC 2.7.10.1)
Language	English
Publishing date	2023-11-27
Publishing country	England
Document type	Journal Article
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-023-48210-5
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Predictive significance of circulating tumor DNA against patients with T790M-positive EGFR-mutant NSCLC receiving osimertinib

Scientific Reports, Vol 13, Iss 1, Pp 1-

2023 Volume 10

Abstract: Abstract Circulating tumor DNA (ctDNA) provides molecular information on tumor heterogeneity. The prognostic usefulness of ctDNA after first-line epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are limited. Therefore, the ... ...

Abstract	Abstract Circulating tumor DNA (ctDNA) provides molecular information on tumor heterogeneity. The prognostic usefulness of ctDNA after first-line epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are limited. Therefore, the present study evaluated ctDNA during osimertinib administration as a second-line or more setting to identify the relationship between EGFR mutation levels and outcomes in patients with advanced non-small cell lung cancer (NSCLC). Forty patients with EGFR T790M-positive NSCLC receiving osimertinib after prior EGFR-TKI treatment were registered. Plasma samples were collected at osimertinib pretreatment, after 1 month of treatment, and at the time of progressive disease (PD). ctDNA analysis was performed by digital polymerase chain reaction. The detection rate of copy numbers of exon 19 deletion, L858R, and T790M in plasma samples was significantly lower 1 month after osimertinib than at pretreatment, and significantly higher at PD than at 1 month, whereas that of C797S was significantly higher at PD than at 1 month. No statistically significant difference was observed in the copy numbers of exon 19 deletion, L858R, T790M, and C797S between complete response or partial response and stable disease or PD. The detection of T790M at PD after osimertinib initiation was a significant independent prognostic factor for predicting shorter prognosis, and the presence of major EGFR mutations at pretreatment and PD was closely linked to worse survival after osimertinib initiation. Molecular testing based on ctDNA is helpful for predicting outcomes of osimertinib treatment in T790M-positive NSCLC after previous EGFR-TKI treatment.
Keywords	Medicine ; R ; Science ; Q
Subject code	616
Language	English
Publishing date	2023-11-01T00:00:00Z
Publisher	Nature Portfolio
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Remarkable response of nivolumab-refractory lung cancer to salvage chemotherapy.

Ogawara, Daiki / Soda, Hiroshi / Iwasaki, Keisuke / Suyama, Takayuki / Taniguchi, Hirokazu / Fukuda, Yuichi / Mukae, Hiroshi

Thoracic cancer

2017 Volume 9, Issue 1, Page(s) 175–180

Abstract: Promising outcomes of salvage chemotherapy after nivolumab therapy have been reported; however, little is known about the detailed clinical and immunologic features in lung cancer patients in whom nivolumab is unsuccessful. We report two cases of ... ...

Abstract	Promising outcomes of salvage chemotherapy after nivolumab therapy have been reported; however, little is known about the detailed clinical and immunologic features in lung cancer patients in whom nivolumab is unsuccessful. We report two cases of nivolumab-refractory lung cancer, in which chemotherapy resulted in rapid regression of the lung cancer. Upon initial diagnosis, the biopsy specimens showed PD-ligand 1 (PD-L1)-expressing cancer cells, accompanied by tumor-infiltrating lymphocytes with a favorable CD8/CD4 ratio. Immunosuppressive regulatory T cells and cells positive for TIM-3 were also observed. Physicians should take caution in treating lung cancer patients after progression on nivolumab. Further studies with a large cohort are warranted to identify the patients that may benefit from salvage chemotherapy.
MeSH term(s)	Aged ; Antibodies, Monoclonal/pharmacology ; Antibodies, Monoclonal/therapeutic use ; Antineoplastic Agents/pharmacology ; Antineoplastic Agents/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Female ; Humans ; Lung Neoplasms/drug therapy ; Lung Neoplasms/pathology ; Male ; Salvage Therapy/methods
Chemical Substances	Antibodies, Monoclonal ; Antineoplastic Agents ; nivolumab (31YO63LBSN)
Language	English
Publishing date	2017-10-24
Publishing country	Singapore
Document type	Case Reports ; Journal Article
ZDB-ID	2625856-0
ISSN	1759-7714 ; 1759-7706
ISSN (online)	1759-7714
ISSN	1759-7706
DOI	10.1111/1759-7714.12543
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Article ; Online: Pitfalls in diagnosis with the use of circulating tumor-derived epidermal growth factor receptor mutations in lung cancer harboring pretreatment T790M.

Ogawara, Daiki / Soda, Hiroshi / Suyama, Takayuki / Yoshida, Masataka / Harada, Tatsuhiko / Fukuda, Yuichi / Mukae, Hiroshi

Thoracic cancer

2017 Volume 9, Issue 1, Page(s) 171–174

Abstract: The circulating tumor DNA (ctDNA) assay has recently been approved for the selection of EGFR-tyrosine kinase inhibitors as first-line treatment in lung cancer. However, it remains to be determined whether this assay can detect all complex EGFR mutations ... ...

Abstract	The circulating tumor DNA (ctDNA) assay has recently been approved for the selection of EGFR-tyrosine kinase inhibitors as first-line treatment in lung cancer. However, it remains to be determined whether this assay can detect all complex EGFR mutations within a single tumor. We report a case of an elderly woman with stage IV lung adenocarcinoma, in which EGFR mutation assays detected L858R and pretreatment T790M from a tissue biopsy. In contrast, the circulating tumor DNA assay detected L858R, but not pretreatment T790M in the plasma, regardless of the fact that similar amounts of each mutation were present in the biopsy specimen. Treatment with afatinib was not effective, but subsequent treatment with osimertinib remarkably regressed the tumor. Our findings indicate that physicians should accurately evaluate EGFR-tyrosine kinase inhibitor-insensitive mutations using tissue samples in the first-line setting, even when L858R and exon 19 deletions are detected in the plasma.
MeSH term(s)	Aged ; ErbB Receptors/genetics ; Female ; Humans ; Lung Neoplasms/genetics ; Mutation
Chemical Substances	ErbB Receptors (EC 2.7.10.1)
Language	English
Publishing date	2017-10-24
Publishing country	Singapore
Document type	Case Reports ; Journal Article
ZDB-ID	2625856-0
ISSN	1759-7714 ; 1759-7706
ISSN (online)	1759-7714
ISSN	1759-7706
DOI	10.1111/1759-7714.12538
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Article ; Online: Efficacy of S-1 after pemetrexed in patients with non-small cell lung cancer: A retrospective multi-institutional analysis.

Takemoto, Shinnosuke / Akagi, Kazumasa / Ono, Sawana / Tomono, Hiromi / Honda, Noritaka / Suyama, Takayuki / Umeyama, Yasuhiro / Dotsu, Yosuke / Taniguchi, Hirokazu / Ogawara, Daiki / Senju, Hiroaki / Gyotoku, Hiroshi / Sugasaki, Nanae / Yamaguchi, Hiroyuki / Nakatomi, Katsumi / Fukuda, Minoru / Mukae, Hiroshi

Thoracic cancer

2021 Volume 12, Issue 17, Page(s) 2300–2306

Abstract: Background: S-1 and pemetrexed (PEM) are key treatments for non-small cell lung cancer (NSCLC). However, the mechanism of anticancer activity of S-1 and PEM is similar. Cross-resistance between S-1 and PEM is of concern. This exploratory study was ... ...

Abstract	Background: S-1 and pemetrexed (PEM) are key treatments for non-small cell lung cancer (NSCLC). However, the mechanism of anticancer activity of S-1 and PEM is similar. Cross-resistance between S-1 and PEM is of concern. This exploratory study was designed to evaluate the treatment effect of S-1 following PEM-containing treatment. Methods: This retrospective study included patients with advanced (c-stage III or IV, UICC seventh edition) or recurrent NSCLC who received S-1 monotherapy following the failure of previous PEM-containing chemotherapy at six hospitals in Japan. The primary endpoint of the study was the overall response rate (ORR). The secondary endpoint was the disease control rate (DCR), time to treatment failure (TTF), progression-free survival (PFS), and overall survival (OS). Results: A total of 53 NSCLC patients met the criteria for inclusion in the study. Forty-six patients had adenocarcinoma (88.7%) and no patients had squamous cell carcinoma. Thirty-one patients (58.5%) received the standard S-1 regimen and 18 patients (34.0%) received the modified S-1 regimen. ORR was 1.9% (95% confidence interval [CI]: 0.00%-10.1%). Median TTF, PFS, and OS were 65, 84, and 385 days, respectively. Conclusions: Although there were several limitations in this study, the ORR of S-1 after PEM in patients with nonsquamous (non-SQ) NSCLC was low compared to the historical control. One of the options in the future might be to avoid S-1 treatment in PEM-treated patients who need tumor shrinkage.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Antimetabolites, Antineoplastic/therapeutic use ; Antineoplastic Agents/therapeutic use ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Disease-Free Survival ; Drug Combinations ; Female ; Humans ; Lung Neoplasms/drug therapy ; Male ; Middle Aged ; Oxonic Acid/therapeutic use ; Pemetrexed/therapeutic use ; Retrospective Studies ; Tegafur/therapeutic use
Chemical Substances	Antimetabolites, Antineoplastic ; Antineoplastic Agents ; Drug Combinations ; Pemetrexed (04Q9AIZ7NO) ; S 1 (combination) (150863-82-4) ; Tegafur (1548R74NSZ) ; Oxonic Acid (5VT6420TIG)
Language	English
Publishing date	2021-07-13
Publishing country	Singapore
Document type	Journal Article ; Multicenter Study
ZDB-ID	2625856-0
ISSN	1759-7714 ; 1759-7706
ISSN (online)	1759-7714
ISSN	1759-7706
DOI	10.1111/1759-7714.14055
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Article ; Online: Alert Regarding Cisplatin-induced Severe Adverse Events in Cancer Patients with Xeroderma Pigmentosum.

Sumiyoshi, Makoto / Soda, Hiroshi / Sadanaga, Noriaki / Taniguchi, Hirokazu / Ikeda, Takaya / Maruta, Hiroshi / Dotsu, Yosuke / Ogawara, Daiki / Fukuda, Yuichi / Mukae, Hiroshi

Internal medicine (Tokyo, Japan)

2017 Volume 56, Issue 8, Page(s) 979–982

Abstract: Xeroderma pigmentosum (XP) is a genetic disease in which DNA repair mechanisms are impaired. Cisplatin (CDDP) exerts cytotoxic effects by forming mainly intrastrand DNA cross-links, and sensitivity to CDDP depends on the DNA repair system. Several in ... ...

Abstract	Xeroderma pigmentosum (XP) is a genetic disease in which DNA repair mechanisms are impaired. Cisplatin (CDDP) exerts cytotoxic effects by forming mainly intrastrand DNA cross-links, and sensitivity to CDDP depends on the DNA repair system. Several in vitro studies have suggested that treatment with CDDP may cause enhanced adverse events as well as anti-tumor activity in cancer patients with XP. This article is the first to describe two cancer patients with XP showing severe adverse events following CDDP-based chemotherapy. Physicians should pay attention when administering CDDP in cancer patients with XP.
MeSH term(s)	Aged ; Antineoplastic Agents/adverse effects ; Cisplatin/adverse effects ; Fatal Outcome ; Female ; Humans ; Male ; Multiple Organ Failure/chemically induced ; Neoplasms/drug therapy ; Xeroderma Pigmentosum
Chemical Substances	Antineoplastic Agents ; Cisplatin (Q20Q21Q62J)
Language	English
Publishing date	2017-04-15
Publishing country	Japan
Document type	Case Reports ; Journal Article
ZDB-ID	32371-8
ISSN	1349-7235 ; 0021-5120 ; 0918-2918
ISSN (online)	1349-7235
ISSN	0021-5120 ; 0918-2918
DOI	10.2169/internalmedicine.56.7866
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Article ; Online: Efficacy and safety of amrubicin hydrochloride for treatment of relapsed small cell lung cancer.

Ogawara, Daiki / Fukuda, Minoru / Nakamura, Yoichi / Kohno, Shigeru

Cancer management and research

2010 Volume 2, Page(s) 191–195

Abstract: Long-term survival is quite uncommon in refractory small cell lung cancer (SCLC) patients, with less than 25% of patients with limited-stage disease and 1%-2% of patients with extensive-stage disease remaining alive at five years. Recent clinical studies ...

Abstract	Long-term survival is quite uncommon in refractory small cell lung cancer (SCLC) patients, with less than 25% of patients with limited-stage disease and 1%-2% of patients with extensive-stage disease remaining alive at five years. Recent clinical studies have demonstrated the promising efficacy of amrubicin for patients with relapsed SCLC. This review presents the results of clinical studies showing the efficacy and safety of amrubicin for the treatment of relapsed SCLC. Amrubicin is a synthetic anthracycline agent with a similar structure to doxorubicin, in which the hydroxyl group at position 9 in amrubicin is replaced by an amino group to enhance efficacy. It is converted to an active metabolite, amrubicinol, which is 5-54 times more active than amrubicin. Amrubicin and amrubicinol are inhibitors of DNA topoisomerase II, exerting their cytotoxic effects by stabilizing a topoisomerase II-mediated cleavable complex. The toxicity of amrubicin is similar to that of doxorubicin, although amrubicin shows almost no cardiotoxicity. In the relevant trials, amrubicin was administered intravenously at a dose of 35-40 mg/m(2) on days 1-3 every three weeks. The response rate was 34%-52% and median survival times were 8.1-12.0 months. Common hematologic toxicities included neutropenia, leucopenia, anemia, thrombocytopenia, and febrile neutropenia. Nonhematologic adverse events included Grade 3-4 anorexia, asthenia, hyponatremia, and nausea. The results of the studies which demonstrated the efficacy of monotherapy for relapsed SCLC involved mainly Japanese patients. Therefore, it is necessary to conduct more clinical studies in non-Japanese patients to confirm the efficacy of amrubicin.
Language	English
Publishing date	2010-08-11
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2508013-1
ISSN	1179-1322 ; 1179-1322
ISSN (online)	1179-1322
ISSN	1179-1322
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Article ; Online: Phase II trial of a non-platinum triplet for patients with advanced non-small cell lung carcinoma (NSCLC) overexpressing ERCC1 messenger RNA.

Takemoto, Shinnosuke / Nakamura, Yoichi / Gyoutoku, Hiroshi / Senju, Hiroaki / Ogawara, Daiki / Ikeda, Takaya / Yamaguchi, Hiroyuki / Kitazaki, Takeshi / Nakano, Hirofumi / Nakatomi, Katsumi / Tomari, Shinya / Sato, Shuntaro / Nagashima, Seiji / Fukuda, Minoru / Mukae, Hiroshi

Thoracic cancer

2019 Volume 10, Issue 3, Page(s) 452–458

Abstract: Background: We prospectively evaluated the efficacy and toxicity of a non-platinum triplet regimen for patients with advanced non-small cell lung cancer (NSCLC) expected to be platinum-resistant.: Methods: Patients were diagnosed with NSCLC using ... ...

Abstract	Background: We prospectively evaluated the efficacy and toxicity of a non-platinum triplet regimen for patients with advanced non-small cell lung cancer (NSCLC) expected to be platinum-resistant. Methods: Patients were diagnosed with NSCLC using endobronchial ultrasonography with a guide sheath as a core biopsy. RNA was immediately isolated from unfixed biopsy specimens, and quantitative real-time reverse transcription-PCR assays were performed to determine ERCC1 messenger RNA expression. Patients with advanced, untreated NSCLC showing high ERCC1 levels (ΔCt ≧ 6.5) were assigned a non-platinum triplet regimen of irinotecan and paclitaxel plus bevacizumab. The primary end point was the objective response rate (ORR). Results: A total of 141 untreated patients were evaluated and 30 patients were entered into this phase II trial. The ORR was 66.7% (95% confidence interval [CI] 47.2-82.7) and median progression-free survival (PFS) was 215 days. Grade 4 thrombosis occurred in one patient, but other toxicities were mild and controllable. Fifty-six patients were treated with platinum-containing regimens and 24 patients responded (ORR 42.8%, 95% CI 29.7-56.7). Twenty-nine of these patients had high ERCC1 levels, of which 6 patients responded; 27 patients had low ERCC1 levels, 18 patients responded (P = 0.0053 by Fisher's exact test). Conclusion: The triplet combination might be effective for patients with advanced, untreated NSCLC overexpressing ERCC1. ERCC1 messenger RNA levels may be a predictive factor for response to platinum-containing regimens.
MeSH term(s)	Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Bevacizumab/administration & dosage ; Bevacizumab/adverse effects ; Biomarkers, Tumor/genetics ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/genetics ; Carcinoma, Non-Small-Cell Lung/pathology ; DNA-Binding Proteins/genetics ; Disease-Free Survival ; Endonucleases/genetics ; Female ; Humans ; Irinotecan/administration & dosage ; Irinotecan/adverse effects ; Male ; Middle Aged ; Neoplasm Staging ; Paclitaxel/administration & dosage ; Paclitaxel/adverse effects ; RNA, Messenger/genetics ; Treatment Outcome ; Ultrasonography
Chemical Substances	Biomarkers, Tumor ; DNA-Binding Proteins ; RNA, Messenger ; Bevacizumab (2S9ZZM9Q9V) ; Irinotecan (7673326042) ; ERCC1 protein, human (EC 3.1.-) ; Endonucleases (EC 3.1.-) ; Paclitaxel (P88XT4IS4D)
Language	English
Publishing date	2019-01-09
Publishing country	Singapore
Document type	Clinical Trial, Phase II ; Journal Article
ZDB-ID	2625856-0
ISSN	1759-7714 ; 1759-7706
ISSN (online)	1759-7714
ISSN	1759-7706
DOI	10.1111/1759-7714.12958
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Article ; Online: Successful treatment with nivolumab for lung cancer with low expression of PD-L1 and prominent tumor-infiltrating B cells and immunoglobulin G.

Suyama, Takayuki / Fukuda, Yuichi / Soda, Hiroshi / Ogawara, Daiki / Iwasaki, Keisuke / Hara, Takuya / Yoshida, Masataka / Harada, Tatsuhiko / Umemura, Asuka / Yamaguchi, Hiroyuki / Mukae, Hiroshi

Thoracic cancer

2018 Volume 9, Issue 6, Page(s) 750–753

Abstract: Little is known about the anti-tumor activity of humoral immunity in lung cancer patients treated with nivolumab, an immune checkpoint inhibitor. Herein, we report a case of lung cancer with 5% expression of PD-L1, in which a partial response to ... ...

Abstract	Little is known about the anti-tumor activity of humoral immunity in lung cancer patients treated with nivolumab, an immune checkpoint inhibitor. Herein, we report a case of lung cancer with 5% expression of PD-L1, in which a partial response to nivolumab was sustained for > 7 months. Immunohistochemical analysis of the metastatic lymph node biopsy specimen showed prominent accumulation of plasma cells and immunoglobulin G. These findings suggest that pre-existing humoral immunity may be worth considering as a candidate therapeutic biomarker of nivolumab in some lung cancer patients.
MeSH term(s)	Antineoplastic Agents, Immunological/therapeutic use ; B-Lymphocytes/pathology ; B7-H1 Antigen/metabolism ; Bone Neoplasms/diagnostic imaging ; Bone Neoplasms/secondary ; Humans ; Immunoglobulin G/metabolism ; Lung Neoplasms/drug therapy ; Lung Neoplasms/pathology ; Lymphatic Metastasis/pathology ; Lymphocytes, Tumor-Infiltrating/pathology ; Male ; Middle Aged ; Nivolumab/therapeutic use
Chemical Substances	Antineoplastic Agents, Immunological ; B7-H1 Antigen ; CD274 protein, human ; Immunoglobulin G ; Nivolumab (31YO63LBSN)
Language	English
Publishing date	2018-04-18
Publishing country	Singapore
Document type	Case Reports
ZDB-ID	2625856-0
ISSN	1759-7714 ; 1759-7706
ISSN (online)	1759-7714
ISSN	1759-7706
DOI	10.1111/1759-7714.12644
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Article ; Online: Efficacy and safety of amrubicin hydrochloride for treatment of relapsed small cell lung cancer

Daiki Ogawara / Minoru Fukuda / Yoichi Nakamura

Cancer Management and Research, Vol 2010, Iss default, Pp 191-

2010 Volume 195

Abstract: Daiki Ogawara1, Minoru Fukuda2, Yoichi Nakamura3, Shigeru Kohno31Department of Medicine, Sasebo ...

Abstract	Daiki Ogawara1, Minoru Fukuda2, Yoichi Nakamura3, Shigeru Kohno31Department of Medicine, Sasebo Central Hospital, 2Department of Medicine, Nagasaki Municipal Hospital, 3Second Department of Internal Medicine, Nagasaki University School of Medicine, Nagasaki, JapanAbstract: Long-term survival is quite uncommon in refractory small cell lung cancer (SCLC) patients, with less than 25% of patients with limited-stage disease and 1%–2% of patients with extensive-stage disease remaining alive at five years. Recent clinical studies have demonstrated the promising efficacy of amrubicin for patients with relapsed SCLC. This review presents the results of clinical studies showing the efficacy and safety of amrubicin for the treatment of relapsed SCLC. Amrubicin is a synthetic anthracycline agent with a similar structure to doxorubicin, in which the hydroxyl group at position 9 in amrubicin is replaced by an amino group to enhance efficacy. It is converted to an active metabolite, amrubicinol, which is 5–54 times more active than amrubicin. Amrubicin and amrubicinol are inhibitors of DNA topoisomerase II, exerting their cytotoxic effects by stabilizing a topoisomerase II-mediated cleavable complex. The toxicity of amrubicin is similar to that of doxorubicin, although amrubicin shows almost no cardiotoxicity. In the relevant trials, amrubicin was administered intravenously at a dose of 35–40 mg/m2 on days 1–3 every three weeks. The response rate was 34%–52% and median survival times were 8.1–12.0 months. Common hematologic toxicities included neutropenia, leucopenia, anemia, thrombocytopenia, and febrile neutropenia. Nonhematologic adverse events included Grade 3–4 anorexia, asthenia, hyponatremia, and nausea. The results of the studies which demonstrated the efficacy of monotherapy for relapsed SCLC involved mainly Japanese patients. Therefore, it is necessary to conduct more clinical studies in non-Japanese patients to confirm the efficacy of amrubicin.Keywords: amrubicin, amrubicinol, small cell lung cancer, relapse
Keywords	Neoplasms. Tumors. Oncology. Including cancer and carcinogens ; RC254-282 ; Internal medicine ; RC31-1245 ; Medicine ; R ; DOAJ:Oncology ; DOAJ:Medicine (General) ; DOAJ:Health Sciences
Subject code	550 ; 610
Language	English
Publishing date	2010-08-01T00:00:00Z
Publisher	Dove Medical Press
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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