Multicenter phase II study of amrubicin, 9-amino-anthracycline, in patients with advanced non-small-cell lung cancer (Study 1): West Japan Thoracic Oncology Group (WJTOG) trial

Sawa, Toshiyuki; Yana, Takashi; Takada, Minoru; Sugiura, Takahiko; Kudoh, Shinzoh; Kamei, Tadashi; Isobe, Takeshi; Yamamoto, Hidehiko; Yokota, Soichiro; Katakami, Nobuyuki; Tohda, Yuji; Kawakami, Akira; Nakanishi, Yoichi; Ariyoshi, Y

doi:10.1007/s10637-006-5937-2

Cited by 32 publications

(34 citation statements)

References 18 publications

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“…Therefore, we decided to investigate the predictive factors associated with grade 3–4 (<1,000 and ≥500/mm 3 ) rather than grade 4 (<500/mm 3 ) neutropenia in the present study. In this study, the incidence of grade 3–4 neutropenia was 62% (38/61), which was a little lower than that in previous phase II studies (median 78%; range 39–97%) [4,5,6,7,8,9,10,11,12,13,14]. Multivariate logistic analysis revealed that higher doses of AMR, female gender, and lower baseline hematocrit values were significant predictors of grade 3–4 neutropenia in patients with lung cancer treated with AMR monotherapy.…”

Section: Discussioncontrasting

confidence: 67%

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Risk Factors for Predicting Severe Neutropenia Induced by Amrubicin in Patients with Advanced Lung Cancer

et al. 2012

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Background: Neutropenia is one of the most frequent and dose-limiting toxicities in amrubicin (AMR) therapy. However, the predictive factors for the development of severe neutropenia in AMR therapy remain unknown. Methods: The subjects were 61 advanced lung cancer patients treated with AMR monotherapy. All data were retrospectively collected from the electronic medical record system. A stepwise logistic regression analysis was performed to identify risk factors for grade 3–4 neutropenia. Results: Of a total 61 patients, 50 were male and 11 were female. The median dose of AMR was 35.0 mg/m². The incidence of grade 3–4 neutropenia during the first course was 62%. In multivariate analysis, female gender (OR = 6.68; 95% CI 1.01–134.15; p = 0.049), higher AMR doses (40 mg/m² or more) (OR = 5.98; 95% CI 1.77–23.74; p = 0.003), and lower hematocrit values (OR = 2.04 per 5% decrease; 95% CI 1.04–4.38; p = 0.036) were significantly associated with severe neutropenia induced by AMR. Conclusion: The present results suggest that female gender, higher doses of AMR, and lower baseline hematocrit values are predictive factors associated with severe neutropenia induced by AMR in patients with advanced lung cancer. Patients who have these predictive factors should be monitored carefully and considered for early granulocyte colony-stimulating factor support.

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Section: Discussioncontrasting

confidence: 67%

“…In phase II trials of second- or third-line AMR monotherapy for the treatment of SCLC, the response rates and the overall survival were 21–53% and 6–12 months, respectively [4,5,6,7,8,9,10,11]. In the treatment of NSCLC, the response rates of AMR monotherapy were 12–28% [11,12,13,14]. …”

Section: Introductionmentioning

confidence: 99%

Risk Factors for Predicting Severe Neutropenia Induced by Amrubicin in Patients with Advanced Lung Cancer

et al. 2012

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“…Amrubicin chemotherapy was discontinued in all ILD cases; 1 case improved spontaneously, while it was improved after corticosteroid treatment in the other 2 cases. Although ILDrelated deaths have been reported in some of the amrubicin clinical trials (2,5,11,13), the outcome of amrubicin-associated ILD was good in each of our cases. In our study, the ILD group tended to show a poor PS, a higher smoking index and contained a higher proportion of patients with pulmonary emphysema and preexisting pulmonary fibrosis in comparison to the non-ILD group.…”

Section: Discussionmentioning

confidence: 49%

“…The patients of these three cases had asymptomatic interstitial pneumonitis prior to chemotherapy. As a result, the protocol was revised during the trial to exclude the patients who had confirmed or suspected interstitial pneumonitis at baseline (2). In Japan, the package insert of amrubicin warns physicians that it should not be used for patients with symptomatic and chest X-ray-evident interstitial pneumonitis.…”

Section: Introductionmentioning

confidence: 99%

Interstitial lung disease associated with amrubicin chemotherapy in patients with lung cancer: a single institutional study

Miura

Saito

Atsumi

et al. 2016

Jpn. J. Clin. Oncol.

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Objective: Amrubicin, which is used as a chemotherapeutic agent for lung cancer, can induce interstitial lung disease. There is insufficient evidence on the incidence of amrubicin-associated interstitial lung disease under practical use settings. We therefore investigated the occurrence of interstitial lung disease in the patients with lung cancer who received amrubicin in our institution. Methods: We reviewed the data of all patients with lung cancer who

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“…Two phase II studies of amrubicin in patients with previously untreated advanced NSCLC demonstrated in succession an overall response rate of 27.9 and 18.3%, respectively, and a median survival time (MST) of 9.8 months and 8.2 months, respectively [14,15]. This showed that amrubicin is equivalent to newer agents such as taxanes, gemcitabine, vinorelbine and pemetrexed in terms of single-agent activity against NSCLC.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Amrubicin as a Third or Later Line of Chemotherapy for Advanced Non-Small Cell Lung Cancer

Igawa¹,

Sasaki²,

Ishihara³

et al. 2013

Chemotherapy

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Background: Currently, there are no standard cytotoxic treatments for non-small-cell lung cancer (NSCLC) patients beyond third-line therapy. The purpose of this study was to evaluate the efficacy of amrubicin monotherapy as a salvage treatment in heavily pretreated NSCLC patients. Methods: The records of NSCLC patients who received amrubicin monotherapy as a third or later line of chemotherapy at a Kitasato University Hospital between January 2009 and December 2012 were retrospectively reviewed. Amrubicin was administered to patients by intravenous injection at a dose of 35 or 40 mg/m² daily on 3 consecutive days, and cycles were repeated at 3-week intervals. Results: There were 36 patients who met the inclusion criteria. Their median number of prior chemotherapy treatments was 4 (range 2-7), and the median number of chemotherapy cycles per patient was 4 (range 1-9). Grade 3 or 4 hematologic toxicities included neutropenia (61.1%), leukopenia (58.3%), thrombocytopenia (22.2%) and anemia (11.1%). Febrile neutropenia occurred in 8 patients (22.2%). Nonhematologic toxicities were mild. The overall response rate, median progression-free survival time and median survival time were 8.3%, 1.7 months, and 6.3 months, respectively. Progression-free survival time was the same, i.e. 1.7 months in both groups i.e. the 35- and the 40-mg/m²-dose groups. Conclusion: Amrubicin exhibits modest activity and acceptable toxicity when used as a third or later line of chemotherapy for advanced NSCLC.

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Multicenter phase II study of amrubicin, 9-amino-anthracycline, in patients with advanced non-small-cell lung cancer (Study 1): West Japan Thoracic Oncology Group (WJTOG) trial

Abstract: Amrubicin was an active, well-tolerated agent in the treatment of NSCLC.

Cited by 32 publications

References 18 publications

Risk Factors for Predicting Severe Neutropenia Induced by Amrubicin in Patients with Advanced Lung Cancer

Risk Factors for Predicting Severe Neutropenia Induced by Amrubicin in Patients with Advanced Lung Cancer

Interstitial lung disease associated with amrubicin chemotherapy in patients with lung cancer: a single institutional study

Evaluation of Amrubicin as a Third or Later Line of Chemotherapy for Advanced Non-Small Cell Lung Cancer

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