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Article ; Online: Three distinct mechanisms underlying human γδ T cell-mediated cytotoxicity against malignant pleural mesothelioma.

Umeyama, Yasuhiro / Taniguchi, Hirokazu / Gyotoku, Hiroshi / Senju, Hiroaki / Tomono, Hiromi / Takemoto, Shinnosuke / Yamaguchi, Hiroyuki / Tagod, Mohammed S O / Iwasaki, Masashi / Tanaka, Yoshimasa / Mukae, Hiroshi

Frontiers in immunology

2023 Volume 14, Page(s) 1058838

Abstract: Introduction: Malignant pleural mesothelioma (MPM) is a rare and highly aggressive thoracic tumor with poor prognosis and limited therapeutic options. Although immune checkpoint inhibitors exhibit a promising effect in some patients with unresectable ... ...

Abstract	Introduction: Malignant pleural mesothelioma (MPM) is a rare and highly aggressive thoracic tumor with poor prognosis and limited therapeutic options. Although immune checkpoint inhibitors exhibit a promising effect in some patients with unresectable MPM in clinical trials, the majority of MPM patients show only modest response rates to the currently available treatments. It is thus imperative to develop novel and innovative therapeutic modalities for MPM, including immune effector cell-based therapies. Methods: γδ T cells were expanded using tetrakis-pivaloyloxymethyl 2-(thiazole-2-ylamino) ethylidene-1,1-bisphosphonate (PTA) and interleukin-2, and the therapeutic potential of γδ T cells was examined through analyzing cell surface markers and cellular cytotoxicity against MPM in vitro using a europium chelate-based time-resolved fluorescence assay system and a luciferase-based luminescence assay system. Results and discussion: We successfully expanded γδ T cells from peripheral blood mononuclear cells of healthy donors and MPM patients. γδ T cells expressed natural killer receptors such as NKG2D and DNAM-1 and exhibited a moderate level of cytotoxicity to MPM cells in the absence of antigens. The inclusion of PTA, (
MeSH term(s)	Humans ; Mesothelioma, Malignant ; Leukocytes, Mononuclear ; Antineoplastic Agents/pharmacology ; Cytotoxicity, Immunologic ; Interferon-gamma/pharmacology
Chemical Substances	Antineoplastic Agents ; Interferon-gamma (82115-62-6)
Language	English
Publishing date	2023-03-17
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2023.1058838
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Article ; Online: Predictive significance of circulating tumor DNA against patients with T790M-positive EGFR-mutant NSCLC receiving osimertinib.

Scientific reports

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
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Article ; Online: Phase II study of IRInotecan treatment after COmbined chemo-immunotherapy for extensive-stage small cell lung cancer: Protocol of IRICO study.

Thoracic cancer

2023 Volume 14, Issue 28, Page(s) 2890–2894

Abstract: Introduction: Combined treatment using anti-programmed death-ligand 1 antibody (anti-PD-L1) and platinum-etoposide is the current standard first-line treatment for patients with extensive-stage (ES) small cell lung cancer (SCLC). However, the best ... ...

Abstract	Introduction: Combined treatment using anti-programmed death-ligand 1 antibody (anti-PD-L1) and platinum-etoposide is the current standard first-line treatment for patients with extensive-stage (ES) small cell lung cancer (SCLC). However, the best treatment for relapsed ES-SCLC after the first-line treatment remains unclear. There are some approved chemotherapeutic agents that can be used against ES-SCLC, and treatment with irinotecan is well established as both a monotherapy and a combined therapy, in combination with platinum. Therefore, we conduct a phase II study with irinotecan in the second- or later-line setting for patients with ES-SCLC who have been previously treated with combined treatment. Methods: Our study will enroll total 30 patients who are diagnosed with ES-SCLC and have experienced disease progression after the combined treatment. Patients will receive irinotecan on days 1, 8, and 15, which will be repeated every 4 weeks. Doses of irinotecan (100/80/60 mg/m Discussion: Since the present first-line treatment has been changed to the combined treatment, the second- or later-line treatment should be re-evaluated for patients with relapsed SCLC. Irinotecan is a major chemotherapeutic agent used for SCLC. This study demonstrates and re-evaluates the clinical benefits of irinotecan after combined treatment with anti-PD-L1 and platinum-etoposide for patients with ES-SCLC. Registration details: This study was registered in the Japan Registry of Clinical Trials (no. jRCT s071210090) on November 4, 2021.
MeSH term(s)	Humans ; Small Cell Lung Carcinoma ; Irinotecan/pharmacology ; Irinotecan/therapeutic use ; Etoposide ; Lung Neoplasms ; Platinum/therapeutic use ; Cisplatin/therapeutic use ; Camptothecin/therapeutic use ; Camptothecin/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Neoplasm Recurrence, Local/drug therapy ; Neoplasm Recurrence, Local/etiology ; Immunotherapy ; Disease Progression ; Clinical Trials, Phase II as Topic
Chemical Substances	Irinotecan (7673326042) ; Etoposide (6PLQ3CP4P3) ; Platinum (49DFR088MY) ; Cisplatin (Q20Q21Q62J) ; Camptothecin (XT3Z54Z28A)
Language	English
Publishing date	2023-09-07
Publishing country	Singapore
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	2625856-0
ISSN	1759-7714 ; 1759-7706
ISSN (online)	1759-7714
ISSN	1759-7706
DOI	10.1111/1759-7714.15097
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Article ; Online: Intrathoracic amyloid tumors that presented as yellowish multinodular endobronchial protrusions with irregular vascularity and easy bleeding.

Tomono, Hiromi / Soda, Hiroshi / Fukuda, Yuichi / Tanaka, Yasuhiro / Ono, Sawana / Shimada, Midori / Iwasaki, Keisuke / Hisanaga, Masashi / Yamaguchi, Hiroyuki / Mukae, Hiroshi

Thoracic cancer

2019 Volume 10, Issue 10, Page(s) 2026–2030

Abstract: Immunoglobulin light-chain (AL) amyloidosis is a monoclonal plasma cell neoplasm that has a tendency to bleed easily. However, the potential risks of transbronchial biopsy in such cases have not been fully proven. Here, we report a case of parotid and ... ...

Abstract	Immunoglobulin light-chain (AL) amyloidosis is a monoclonal plasma cell neoplasm that has a tendency to bleed easily. However, the potential risks of transbronchial biopsy in such cases have not been fully proven. Here, we report a case of parotid and intrathoracic AL amyloid tumors that presented as endobronchial protrusions that bled easily. Bronchoscopy under conventional white light and narrow band imaging revealed yellowish multinodular protrusions, in which irregular tortuous or dotted vessels were observed. Unexpectedly, biopsy of the lesion resulted in persistent bleeding. The biopsy specimen showed a large amount of amyloid deposition and calcification directly under the bronchial epithelium, as well as amyloid deposits in the blood vessel walls. In patients suspected to have amyloidosis, the presence of yellowish multinodular endobronchial protrusions, particularly with irregular vascularity, should prompt careful attention to avoid fatal postprocedural bleeding.
MeSH term(s)	Biopsy ; Bronchial Diseases/diagnosis ; Bronchoscopes ; Diagnosis, Differential ; Hemorrhage/diagnosis ; Humans ; Immunoglobulin Light-chain Amyloidosis/diagnosis ; Immunohistochemistry ; Male ; Middle Aged ; Neovascularization, Pathologic/diagnosis ; Tomography, X-Ray Computed
Language	English
Publishing date	2019-08-04
Publishing country	Singapore
Document type	Case Reports
ZDB-ID	2625856-0
ISSN	1759-7714 ; 1759-7706
ISSN (online)	1759-7714
ISSN	1759-7706
DOI	10.1111/1759-7714.13159
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Article ; Online: Amrubicin in previously treated patients with malignant pleural mesothelioma: A phase II study.

Ikeda, Takaya / Takemoto, Shinnosuke / Senju, Hiroaki / Gyotoku, Hiroshi / Taniguchi, Hirokazu / Shimada, Midori / Dotsu, Yosuke / Umeyama, Yasuhiro / Tomono, Hiromi / Kitazaki, Takeshi / Fukuda, Masaaki / Soda, Hiroshi / Yamaguchi, Hiroyuki / Fukuda, Minoru / Mukae, Hiroshi

Thoracic cancer

2020 Volume 11, Issue 7, Page(s) 1972–1978

Abstract: Background: The aim of this study was to assess the efficacy and safety of amrubicin for previously treated malignant pleural mesothelioma.: Methods: The eligibility criteria were: previously treated unresectable malignant pleural mesothelioma; ... ...

Abstract	Background: The aim of this study was to assess the efficacy and safety of amrubicin for previously treated malignant pleural mesothelioma. Methods: The eligibility criteria were: previously treated unresectable malignant pleural mesothelioma; performance status 0-1; age ≤ 75; adequate hematological, hepatic, and renal function. The patients were injected with 35 mg/m Results: The study was terminated due to delay in enrollment and 10 patients were subsequently enrolled (nine males and one female; median age 67 [range 49-73]), of which four had epithelioid tumors, three had sarcomatoid tumors and three had biphasic tumors, respectively. According to the International Mesothelioma Interest Group (IMIG), one, four, and four patients had stage II, III, and IV, respectively, and one had postoperative recurrence. There was one (10%) partial response, four (40%) had stable disease, and five (50%) patients exhibited disease progression. The overall response and disease control rates were 10% (95% CI: 0.3-44.5%) and 60% (95% CI: 26.2-87.8%), respectively. The median progression-free survival time was 1.6 months. The median overall survival time was 6.6 months, and the one-, two-, and three-year survival rates were 23%, 23%, and 0%, respectively. The observed grade 3 or 4 toxicities included neutropenia in six (60%) patients; leukopenia in five (50%) patients; and febrile neutropenia, thrombocytopenia, anemia, and pneumonia in one (10%) patient each. Conclusions: There was not enough data to evaluate the efficacy because the study was terminated early. However, amrubicin showed limited activity and acceptable toxicities when used in previously treated malignant pleural mesothelioma patients.
MeSH term(s)	Aged ; Anthracyclines/therapeutic use ; Antineoplastic Agents/therapeutic use ; Female ; Follow-Up Studies ; Humans ; Male ; Mesothelioma, Malignant/drug therapy ; Mesothelioma, Malignant/pathology ; Middle Aged ; Neoplasm Recurrence, Local/drug therapy ; Neoplasm Recurrence, Local/pathology ; Pleural Neoplasms/drug therapy ; Pleural Neoplasms/pathology ; Prognosis ; Salvage Therapy ; Survival Rate
Chemical Substances	Anthracyclines ; Antineoplastic Agents ; amrubicin (93N13LB4Z2)
Language	English
Publishing date	2020-05-28
Publishing country	Singapore
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study
ZDB-ID	2625856-0
ISSN	1759-7714 ; 1759-7706
ISSN (online)	1759-7714
ISSN	1759-7706
DOI	10.1111/1759-7714.13490
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Article ; Online: Vildagliptin-induced ground-glass nodules mimicking lung metastases in a cancer patient receiving Lactobacillus probiotic supplementation.

Tanaka, Yasuhiro / Soda, Hiroshi / Fukuda, Yuichi / Nio, Kenta / Ono, Sawana / Tomono, Hiromi / Shimada, Midori / Yoshida, Masataka / Harada, Tatsuhiko / Umemura, Asuka / Iwasaki, Keisuke / Yamaguchi, Hiroyuki / Mukae, Hiroshi

Thoracic cancer

2020 Volume 11, Issue 2, Page(s) 470–474

Abstract: The association between gut microbiota and the lung immune system has been attracting increasing interest. Here, we report a case of pancreatic cancer in which the dipeptidyl peptidase-4 inhibitor vildagliptin induced unusual manifestations of ... ...

Abstract	The association between gut microbiota and the lung immune system has been attracting increasing interest. Here, we report a case of pancreatic cancer in which the dipeptidyl peptidase-4 inhibitor vildagliptin induced unusual manifestations of interstitial pneumonia, possibly under the influence of Lactobacillus paraplantarum probiotic supplementation. Chest computed tomography and positron emission tomography showed multiple ground-glass nodules (GGNs) mimicking metastatic lung cancer. Transbronchial biopsy specimens showed mild fibrosis and infiltration of lymphocytes consisting of more CD4
MeSH term(s)	Aged ; Diagnosis, Differential ; Dipeptidyl-Peptidase IV Inhibitors/adverse effects ; Female ; Humans ; Lactobacillus/chemistry ; Lung Neoplasms/diagnosis ; Lung Neoplasms/etiology ; Lung Neoplasms/secondary ; Pancreatic Neoplasms/drug therapy ; Pancreatic Neoplasms/pathology ; Probiotics/adverse effects ; Prognosis ; Solitary Pulmonary Nodule/diagnosis ; Solitary Pulmonary Nodule/etiology ; Vildagliptin/adverse effects
Chemical Substances	Dipeptidyl-Peptidase IV Inhibitors ; Vildagliptin (I6B4B2U96P)
Language	English
Publishing date	2020-01-06
Publishing country	Singapore
Document type	Case Reports
ZDB-ID	2625856-0
ISSN	1759-7714 ; 1759-7706
ISSN (online)	1759-7714
ISSN	1759-7706
DOI	10.1111/1759-7714.13292
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Article: Real-World Incidence of Febrile Neutropenia among Patients Treated with Single-Agent Amrubicin: Necessity of the Primary Prophylactic Administration of Granulocyte Colony-Stimulating Factor.

Journal of clinical medicine

2021 Volume 10, Issue 18

Abstract: Background: Single-agent amrubicin chemotherapy is a key regimen, especially for small cell lung cancer (SCLC); however, it can cause severe myelosuppression.: Purpose: The purpose of this study was to determine the real-world incidence of febrile ... ...

Abstract	Background: Single-agent amrubicin chemotherapy is a key regimen, especially for small cell lung cancer (SCLC); however, it can cause severe myelosuppression. Purpose: The purpose of this study was to determine the real-world incidence of febrile neutropenia (FN) among patients treated with single-agent amrubicin chemotherapy for thoracic malignancies. Patients and methods: The medical records of consecutive patients with thoracic malignancies, including SCLC and non-small cell lung cancer (NSCLC), who were treated with single-agent amrubicin chemotherapy in cycle 1 between January 2010 and March 2020, were retrospectively analyzed. Results: One hundred and fifty-six patients from four institutions were enrolled. Their characteristics were as follows: median age (range): 68 (32-86); male/female: 126/30; performance status (0/1/2): 9/108/39; SCLC/NSCLC/others: 111/30/15; and prior treatment (0/1/2/3-): 1/96/31/28. One hundred and thirty-four (86%) and 97 (62%) patients experienced grade 3/4 and grade 4 neutropenia, respectively. One hundred and twelve patients (72%) required therapeutic G-CSF treatment, and 47 (30%) developed FN. Prophylactic PEG-G-CSF was not used in cycle 1 in any case. The median overall survival of the patients with FN was significantly shorter than that of the patients without FN (7.2 vs. 10.0 months, Conclusions: The real-world incidence rate of FN among patients with thoracic malignancies that were treated with single-agent amrubicin chemotherapy was 30%. It is suggested that prophylactic G-CSF should be administered during the practical use of single-agent amrubicin chemotherapy for patients who have already received chemotherapy.
Language	English
Publishing date	2021-09-17
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662592-1
ISSN	2077-0383
ISSN	2077-0383
DOI	10.3390/jcm10184221
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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: Phase I study of amrubicin plus cisplatin and concurrent accelerated hyperfractionated thoracic radiotherapy for limited-disease small cell lung cancer: protocol of ACIST study.

Akagi, Kazumasa / Taniguchi, Hirokazu / Fukuda, Minoru / Yamazaki, Takuya / Ono, Sawana / Tomono, Hiromi / Suyama, Takayuki / Shimada, Midori / Gyotoku, Hiroshi / Takemoto, Shinnosuke / Yamaguchi, Hiroyuki / Dotsu, Yosuke / Senju, Hiroaki / Soda, Hiroshi / Mizowaki, Takashi / Monzen, Yoshio / Ikeda, Takaya / Nagashima, Seiji / Tasaki, Yutaro /

Nakamura, Daisuke / Komiya, Kazutoshi / Nakatomi, Katsumi / Sasaki, Eisuke / Hirakawa, Koichi / Mukae, Hiroshi

Thoracic cancer

2022 Volume 13, Issue 16, Page(s) 2404–2409

Abstract: Background: Etoposide plus cisplatin (EP) combined with concurrent accelerated hyperfractionated thoracic radiotherapy (AHTRT) is the standard treatment strategy for unresectable limited-disease (LD) small cell lung cancer (SCLC), which has remained ... ...

Abstract	Background: Etoposide plus cisplatin (EP) combined with concurrent accelerated hyperfractionated thoracic radiotherapy (AHTRT) is the standard treatment strategy for unresectable limited-disease (LD) small cell lung cancer (SCLC), which has remained unchanged for over two decades. Based on a previous study that confirmed the non-inferiority of amrubicin (AMR) plus cisplatin (AP) when compared with EP for extensive-disease (ED) SCLC, we have previously conducted a phase I study assessing AP with concurrent TRT (2 Gy/time, once daily, 50 Gy in total) for LD-SCLC therapy. Our findings revealed that AP with concurrent TRT could prolong overall survival to 39.5 months with manageable toxicities. Therefore, we plan to conduct a phase I study to investigate and determine the effect of AP combined with AHTRT, recommended dose (RD), maximum tolerated dose (MTD), and dose-limiting toxicity (DLT) of AP in patients with LD-SCLC. Methods: Treatment-naive patients with LD-SCLC, age between 20 and 75 years, who had a performance status of 0 or 1 and adequate organ functions will be enrolled. For chemotherapy, cisplatin 60 mg/m Discussion: Based on our previous study, the initial dose of AMR 25 mg/m
MeSH term(s)	Adult ; Aged ; Anthracyclines ; Chemoradiotherapy/adverse effects ; Cisplatin/therapeutic use ; Clinical Trials, Phase I as Topic ; Etoposide ; Humans ; Lung Neoplasms/therapy ; Middle Aged ; Small Cell Lung Carcinoma/therapy ; Young Adult
Chemical Substances	Anthracyclines ; Etoposide (6PLQ3CP4P3) ; amrubicin (93N13LB4Z2) ; Cisplatin (Q20Q21Q62J)
Language	English
Publishing date	2022-07-08
Publishing country	Singapore
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	2625856-0
ISSN	1759-7714 ; 1759-7706
ISSN (online)	1759-7714
ISSN	1759-7706
DOI	10.1111/1759-7714.14555
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Article ; Online: Dose escalation study of amrubicin and cisplatin with concurrent thoracic radiotherapy for limited-disease small cell lung cancer.

Shimada, Midori / Yamaguchi, Hiroyuki / Fukuda, Minoru / Tomono, Hiromi / Honda, Noritaka / Dotsu, Yosuke / Taniguchi, Hirokazu / Gyotoku, Hiroshi / Senju, Hiroaki / Takemoto, Shinnosuke / Ikeda, Takaya / Nakatomi, Katsumi / Nakamura, Yoichi / Nagashima, Seiji / Yamazaki, Takuya / Mukae, Hiroshi

Cancer chemotherapy and pharmacology

2019 Volume 84, Issue 5, Page(s) 1059–1064

Abstract: Background: Amrubicin and cisplatin is one of the active regimens used to treat patients with extensive-disease (ED)-small cell lung cancer (SCLC), whereas combined therapy involving chemotherapy and concurrent thoracic radiotherapy is the standard ... ...

Abstract	Background: Amrubicin and cisplatin is one of the active regimens used to treat patients with extensive-disease (ED)-small cell lung cancer (SCLC), whereas combined therapy involving chemotherapy and concurrent thoracic radiotherapy is the standard treatment for limited-disease (LD)-SCLC. Purpose: This study aimed to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of amrubicin and cisplatin with concurrent thoracic radiotherapy (TRT) for LD-SCLC. Patients and methods: Patients that fulfilled the following eligibility criteria were enrolled: being aged ≤ 75 years and chemotherapy-naïve and having a performance status (PS) of 0-1, LD-SCLC, and adequate organ function. The patients received escalating doses of amrubicin on days 1, 2, and 3, and a fixed 60-mg/m Results: Eight patients from three institutions were enrolled at three dose levels. The patients' characteristics were as follows: male/female: 3/5; median age (range): 68.5 (60-73); PS 0/1: 4/4; stage IIIA/IIIB disease: 3/5. Both level 3 patients experienced DLT (grade 4 neutropenia and/or leukopenia lasting > 4 days). Level 3 was defined as the MTD, and level 2 was recommended as the dose for this regimen. Seven patients exhibited partial responses, and 1 displayed progressive disease (response rate: 88%). The median progression-free survival and overall survival periods were 11.1 and 39.5 months, respectively. No treatment-related deaths occurred. Conclusions: When this regimen was combined with TRT for LD-SCLC, the MTD was 30 mg/m
MeSH term(s)	Aged ; Anthracyclines/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Cisplatin/administration & dosage ; Dose-Response Relationship, Drug ; Female ; Humans ; Lung Neoplasms/drug therapy ; Lung Neoplasms/radiotherapy ; Male ; Maximum Tolerated Dose ; Middle Aged ; Progression-Free Survival ; Small Cell Lung Carcinoma/drug therapy ; Small Cell Lung Carcinoma/radiotherapy ; Survival Rate
Chemical Substances	Anthracyclines ; amrubicin (93N13LB4Z2) ; Cisplatin (Q20Q21Q62J)
Language	English
Publishing date	2019-09-05
Publishing country	Germany
Document type	Clinical Trial, Phase I ; Journal Article
ZDB-ID	6820-2
ISSN	1432-0843 ; 0344-5704 ; 0943-9404
ISSN (online)	1432-0843
ISSN	0344-5704 ; 0943-9404
DOI	10.1007/s00280-019-03940-0
Database	MEDical Literature Analysis and Retrieval System OnLINE

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