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Journal of Rural Medicine : JRM Oct 2021The utility of topotecan monotherapy for relapsed small-cell lung cancer (SCLC) after failure of amrubicin monotherapy has not been evaluated. We aimed to investigate...
The utility of topotecan monotherapy for relapsed small-cell lung cancer (SCLC) after failure of amrubicin monotherapy has not been evaluated. We aimed to investigate the efficacy and safety of topotecan monotherapy in patients with relapsed SCLC after amrubicin monotherapy. We retrospectively analyzed data from 16 patients with relapsed SCLC who were treated with topotecan monotherapy after amrubicin monotherapy at our hospital. The response rate, progression-free survival, and overall survival were 0%, 32.5 days (95% confidence interval [CI] = 18-51), and 112 days (95% CI = 55-267), respectively. The most common adverse events (grade ≥3) were leukopenia (31.3%) and thrombocytopenia (31.3%), followed by anemia, anorexia, edema, and lung infections. The efficacy of topotecan monotherapy for relapsed SCLC after amrubicin monotherapy is inconclusive. Therefore, further studies are warranted.
PubMed: 34707735
DOI: 10.2185/jrm.2021-014 -
International Journal of Clinical... Oct 2010This study was conducted to evaluate the efficacy of amrubicin as first-line chemotherapy for elderly and poor-risk patients with extensive-disease small-cell lung...
BACKGROUND
This study was conducted to evaluate the efficacy of amrubicin as first-line chemotherapy for elderly and poor-risk patients with extensive-disease small-cell lung cancer (ED-SCLC).
METHODS
Untreated SCLC patients who were >75 years of age or had a performance status of 2 or more were eligible. Amrubicin (35 or 40 mg/m(2) on days 1-3 every 3 weeks) was administered.
RESULTS
Between January 2003 and May 2009, 27 patients were evaluated. The median number of treatment cycles was 4 (1-6). Grade 3 or 4 hematologic toxicities comprised neutropenia (63%), leukopenia (56%), thrombocytopenia (15%), and anemia (19%). Febrile neutropenia was observed in four (15%) patients. No treatment-related deaths occurred. The nonhematologic toxicities were mild. The overall response rate was 70%. Progression-free survival, median survival time, and the 1-year survival rate were 6.6 months, 9.3 months, and 30%, respectively. The 40 mg/m(2) dose was feasible and had a tendency to be more effective than the 35 mg/m(2) dose.
CONCLUSIONS
Amrubicin exhibits activity and acceptable toxicities for elderly and poor-risk patients with ED-SCLC in the first-line treatment setting.
Topics: Age Factors; Aged; Aged, 80 and over; Anthracyclines; Antineoplastic Agents; Disease-Free Survival; Drug Administration Schedule; Female; Humans; Japan; Kaplan-Meier Estimate; Lung Neoplasms; Male; Middle Aged; Retrospective Studies; Risk Assessment; Risk Factors; Small Cell Lung Carcinoma; Survival Rate; Time Factors; Treatment Outcome
PubMed: 20464623
DOI: 10.1007/s10147-010-0085-2 -
Anti-cancer Drugs Sep 2016Although the same treatment strategy as used for small cell lung cancer, including second-line chemotherapy, is generally applied to metastatic neuroendocrine carcinoma... (Clinical Trial)
Clinical Trial
Although the same treatment strategy as used for small cell lung cancer, including second-line chemotherapy, is generally applied to metastatic neuroendocrine carcinoma (NEC) and mixed adenoneuroendocrine carcinoma (MANEC) of the gastrointestinal tract (GIT; GIT-NEC/MANEC), the efficacy of amrubicin (AMR) for GIT-NEC/MANEC is not well known. We retrospectively analyzed platinum-refractory GIT-NEC/MANEC patients who received AMR between February 2004 and July 2012 at the National Cancer Center Hospital. The AMR dose administered was 30-45 mg/m on days 1-3 every 3-4 weeks. The overall response rate according to Response Evaluation Criteria in Solid Tumors guidelines, version 1.0, progression-free survival, overall survival, and adverse events by National Cancer Institute-Common Terminology Criteria for Adverse Events guidelines, version 4.0 were evaluated. Nineteen patients received AMR. The response rate for 16 assessable patients was 18.8% (95% confidence interval, 4.1-45.7), the median progression-free survival was 3.8 months (2.3-5.3), and the median overall survival was 7.7 months (7.1-8.2). Grade 3/4 neutropenia occurred in 52.6% of patients and febrile neutropenia occurred in 10.5%. Other nonhematological toxicities were mild and treatment-related deaths were not observed. AMR may have a modest effect, with tolerable toxicities, on patients with platinum-refractory GIT-NEC/MANEC. Further prospective evaluations are warranted.
Topics: Adult; Aged; Aged, 80 and over; Anthracyclines; Antineoplastic Agents; Carcinoma, Neuroendocrine; Disease-Free Survival; Female; Gastrointestinal Neoplasms; Humans; Male; Middle Aged; Platinum Compounds; Retrospective Studies; Treatment Outcome
PubMed: 27341105
DOI: 10.1097/CAD.0000000000000393 -
Cancer Management and Research 2020Amrubicin (AMR) is an anticancer drug for patients with relapsed small-cell lung cancer (SCLC). However, the efficacy of AMR in elderly patients with relapsed SCLC after...
PURPOSE
Amrubicin (AMR) is an anticancer drug for patients with relapsed small-cell lung cancer (SCLC). However, the efficacy of AMR in elderly patients with relapsed SCLC after chemotherapy by carboplatin plus etoposide (CE) has not been sufficiently evaluated.
PATIENTS AND METHODS
The medical records of patients with relapsed SCLC who received AMR as second-line chemotherapy were retrospectively reviewed, and their treatment outcomes were evaluated.
RESULTS
Forty-one patients with a median age of 76 years were analyzed. The overall response rate was 26.8%. Median progression-free survival (PFS) and overall survival (OS) were 3.5 and 8.1 months, respectively. While the median PFS of 4.7 and 2.8 months in the sensitive relapse and the refractory relapse group differed significantly (=0.043), respectively, the median OS of 10.7 and 6.8 months in the respective relapse groups did not indicate a statistically significant difference (=0.24). The median PFS in a group with a modified Glasgow prognostic score (mGPS) of 0 and a group with a mGPS 1 or 2 were 4.5 and 1.6 months (=0.052), respectively, and the median OS in the respective mGPS groups were 10.7 and 4.4 months (=0.034). Multivariate analysis identified good performance status, limited disease, and mGPS 0 as favorable independent predictors of PFS and OS of AMR monotherapy. Grade 3 or higher neutropenia was observed in 23 patients (56%), and febrile neutropenia was observed in nine patients (22%). Non-hematological toxic effects were relatively mild, and pneumonitis and treatment-related deaths were not observed.
CONCLUSION
AMR is an effective and feasible regimen for elderly patients with relapsed SCLC after CE therapy.
PubMed: 32606979
DOI: 10.2147/CMAR.S255552 -
Thoracic Cancer Dec 2023Amrubicin (AMR) regimens have shown efficacy as second-line treatment in patients with small cell lung cancer (SCLC); however, adverse events such as febrile neutropenia...
BACKGROUND
Amrubicin (AMR) regimens have shown efficacy as second-line treatment in patients with small cell lung cancer (SCLC); however, adverse events such as febrile neutropenia (FN) sometimes preclude their use. Further, the safety and efficacy of AMR with primary prophylactic pegfilgrastim (P-PEG) have not been sufficiently evaluated. In this study, we evaluated the safety and efficacy of AMR with or without P-PEG as second-line chemotherapy for SCLC.
METHODS
We retrospectively reviewed patients with SCLC who received AMR as second-line chemotherapy at Shizuoka Cancer Center, between December 2014 and November 2021. Based on presence/absence of P-PEG in their regimen, patients (n = 60) were divided into P-PEG (n = 21) and non-P-PEG groups, and their clinical outcomes were evaluated.
RESULTS
Median of AMR treatment cycles was five (range: 1-39 cycles) in P-PEG group and four (range: 1-15 cycles) in non-P-PEG group. The incidence of FN (4.8% vs. 30.8%; p = 0.02) and AMR dose reduction because of adverse events (4.8% vs. 25.6%; p = 0.08) were lower in the P-PEG group than in the non-P-PEG group. The objective response rates were 52.4% and 30.8%, and median progression-free and overall survival were 4.7 and 3.0 months, and 9.6 and 6.8 months, in the P-PEG and non-P-PEG groups, respectively.
CONCLUSIONS
AMR with P-PEG as second-line chemotherapy for SCLC reduced the incidence of FN at a maintained AMR dose intensity and was associated with favorable tumor responses and survival outcomes. P-PEG should be considered for patients treated with AMR for SCLC including refractory relapsed SCLC.
Topics: Humans; Small Cell Lung Carcinoma; Lung Neoplasms; Retrospective Studies; Neoplasm Recurrence, Local; Antineoplastic Combined Chemotherapy Protocols
PubMed: 37873674
DOI: 10.1111/1759-7714.15140 -
Zhonghua Jie He He Hu Xi Za Zhi =... Apr 2015To evaluate the response, toxicity and prognostic factors of amrubicin in the therapy of small cell lung cancer (SCLC).
OBJECTIVE
To evaluate the response, toxicity and prognostic factors of amrubicin in the therapy of small cell lung cancer (SCLC).
METHODS
Thirty-one SCLC patients treated with amrubicin in Beijing Cancer Hospital from Dec.2008 to Apr.2013, including 21 males and 10 females, aged from 32 to 75 years, were enrolled in this study. Amrubicin was injected intravenously with 40 mg/m² d1-3, Q21 d or combined with cisplatin 60 mg/m² d1, Q 21 d. The first line chemotherapy regimens included amrubicin plus cisplatin in 11 cases, etopside plus platin in 18 cases and other drugs in 2 cases. The second and more line chemotherapy treatments included amrubicin in 20 cases, topotican in 14 cases and others in 28 cases. SPSS 16.0 statistical analysis software was used to analyze the clinical characteristics and survivals.
RESULTS
The median progression free survival (PFS) of patients receiving amrubicin plus cisplatin and single amrubicin were 7.5 months (95% CI: 6.2 to 8.8 ) and 4.1 months (95% CI:1.2 to 7.0) respectively (P= 0.090). There were 16 refractory patients whose disease progressed within 3 months after first line chemotherapy and 15 sensitive patients who had tumor progression after more than 3 months; the median survival time (MST) were 14.2 months (95% CI 11.1-17.3) and 21.3 months (95% CI 15.7-26.9) respectively (P= 0.018). Patients treated with amrubicin plus cisplatin as first line therapy had a prolonged median PFS compared with etopside plus platin, which were 7.5 months (95% CI:6.2-8.8) vs. 4.6 months (95% CI:1.7-7.5) (P= 0.055). Patients received amrubicin, topotican or other drugs as second or more line therapy had median PFS of 4.1 months (95% CI: 1.2-7.0), 1.4 months (95% CI: 0.8-2.0) and 1.6 months (95% CI:1.2-1.9) respectively (P= 0.013), while the median PFS was 5.6 months (95% CI: 2.0-9.2), 1.4 months (95% CI: 0.6-2.2) and 1.4 months (95% CI: 0.8-2.0) (P= 0.005 and 0.003) in refractory patients.
CONCLUSIONS
Amrubicin as second or more line treatment was shown to be an effective and safe drug for SCLC patients with a significant survival benefit compared with other drugs, especially in refractory patients. It suggested that amrubicin might be one of the preferred therapies for refractory SCLC.
Topics: Adult; Aged; Anthracyclines; Antineoplastic Agents; Beijing; Cisplatin; Disease Progression; Disease-Free Survival; Female; Humans; Lung Neoplasms; Male; Middle Aged; Small Cell Lung Carcinoma; Treatment Outcome
PubMed: 26268231
DOI: No ID Found -
Gan To Kagaku Ryoho. Cancer &... Aug 2020Standard regimens for extrapulmonary neuroendocrine carcinomas(EPNEC)are not established. Treatment used for small cell lung cancer is also used for EPNECs....
Standard regimens for extrapulmonary neuroendocrine carcinomas(EPNEC)are not established. Treatment used for small cell lung cancer is also used for EPNECs. Amrubicin(AMR) monotherapy is used as salvage therapy for small cell lung cancer, but its efficacy in EPNEC is not clear. The aim of this study was to estimate the efficacy of AMR monotherapy in EPNEC. We retrospectively investigated patients with EPNEC who received first-line platinum-based chemotherapy between April 2007 and March 2019. The time to treatment failure(TTF)and the efficacy and toxicity was analyzed in the patients who received AMR monotherapy. Among 43 patients with EPNEC, 14(13 males, one female; median age, 58 years)received AMR monotherapy. Primary site included the pancreas(n=3), stomach(n=3), rectum(n=1), anal canal(n=1), salivary glands(n= 1), urothelial(n=1), bladder(n=1), prostate(n=1), and 2 patients had primary unknown cancer. Pathological type included small cell(n=4), large cell(n=2), and other types(n=8). Prior chemotherapy comprised CDDP plus CPT-11(n =5), CDDP plus ETP(n=2), and CBDCA plus ETP(n=6). The median TTF was 49(20-61)days. One patient had a partial response and the disease control rate was 33%. The common adverse events of >Grade 3 were leukopenia(69%), neutropenia(62%), and febrile neutropenia(23%). AMR monotherapy was clinically effective and safe for EPNEC.
Topics: Anthracyclines; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Neuroendocrine; Female; Humans; Lung Neoplasms; Male; Middle Aged; Platinum; Retrospective Studies; Treatment Outcome
PubMed: 32829355
DOI: No ID Found -
In Vivo (Athens, Greece) 2019Amrubicin is usually administered on days 1-3 every 3 weeks by intravenous infusion. However, it causes severe hematological toxicity, especially febrile neutropenia. It...
BACKGROUND
Amrubicin is usually administered on days 1-3 every 3 weeks by intravenous infusion. However, it causes severe hematological toxicity, especially febrile neutropenia. It was reported that weekly administration confers higher dose intensity, less severe adverse events, and anti-tumor activity that is as effective as that of treatment with a conventional schedule.
PATIENTS AND METHODS
Weekly amrubicin was administered at a dose of 60 mg/m on days 1 and 8 every 3 weeks. The primary endpoint was overall response rate.
RESULTS
A total of 33 patients were enrolled. The overall response rate was 6.1% (95% confidence interval(CI)=0.7-20.2%) and the disease control rate after 2 months was 51.5%. The median progression-free survival was 2.93 months. Febrile neutropenia was observed in only two patients.
CONCLUSION
The primary endpoint was not met in this study. However, weekly amrubicin achieved a high disease control rate and good tolerability.
Topics: Adult; Aged; Aged, 80 and over; Anthracyclines; Carcinoma, Non-Small-Cell Lung; Dose-Response Relationship, Drug; Female; Humans; Male; Middle Aged; Neoplasm Recurrence, Local; Progression-Free Survival
PubMed: 30587617
DOI: 10.21873/invivo.11453 -
Lung Cancer (Amsterdam, Netherlands) Nov 2019There are limited treatment options for patients with thymic malignancies. Here we present data supporting treatment with single agent amrubicin, a third generation...
OBJECTIVES
There are limited treatment options for patients with thymic malignancies. Here we present data supporting treatment with single agent amrubicin, a third generation anthracycline and topoisomerase II inhibitor.
MATERIALS AND METHODS
This was a phase 2 open-label, single arm trial of amrubicin in patients with thymoma (T) or thymic carcinoma (TC), conducted at two academic institutions. Patients were included if they had received at least one prior chemotherapy regimen. The first 18 patients received amrubicin at 40 mg/m2 IV days 1-3 repeated every 3-weeks. Due to the high incidence of febrile neutropenia, dosing was subsequently amended to 35 mg/m2 for the final 15 patients.
RESULTS
A total of 33 patients (14 T/19 TC) were enrolled from 2011 to 2014. Median number of prior therapies was 2. Best response included 6 partial responses, 21 stable disease, and 6 progressive disease (all TC). Objective response rate was 18% (90% exact binomial CI 8.2%-32.8%; T = 4/14 (29%), TC = 2/19 (11%)). Median progression-free survival was 7.7 months (T: 8.3 months; TC: 7.3) and median overall survival was 29.7 months (T: 54.1 months; TC: 18 months). There was a high rate of febrile neutropenia (7 patients) that occurred despite a reduction in amrubicin dose and one related death. Five patients had reduction in LVEF below 50% during the course of treatment resulting in treatment discontinuation in one patient.
CONCLUSION
Amrubicin shows promise as a single agent in heavily pre-treated patients with thymic malignancies. Notable side effects include febrile neutropenia and the use of growth factor support is essential. Further investigation of this agent is warranted.
Topics: Anthracyclines; Antineoplastic Agents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Non-Randomized Controlled Trials as Topic; Patient Selection; Prognosis; Prospective Studies; Salvage Therapy; Survival Rate; Thymoma; Thymus Neoplasms
PubMed: 31557562
DOI: 10.1016/j.lungcan.2019.09.015 -
Cancer Chemotherapy and Pharmacology Nov 2019Amrubicin and cisplatin is one of the active regimens used to treat patients with extensive-disease (ED)-small cell lung cancer (SCLC), whereas combined therapy...
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 dose of cisplatin on day 1. Four cycles of chemotherapy were administered, with each cycle lasting 4 weeks. TRT involving 2 Gy/day, once daily, commenced on day 2 of the first cycle of chemotherapy. The initial dose of amrubicin was 20 mg/m (level 1), and the dose was escalated to 25 mg/m (level 2) and then 30 mg/m (level 3).
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 for amrubicin and 60 mg/m for cisplatin. In addition, neutropenia and leukopenia were DLT, and doses of 25 mg/m for amrubicin and 60 mg/m for cisplatin are recommended for this regimen.
Topics: Aged; Anthracyclines; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Dose-Response Relationship, Drug; Female; Humans; Lung Neoplasms; Male; Maximum Tolerated Dose; Middle Aged; Progression-Free Survival; Small Cell Lung Carcinoma; Survival Rate
PubMed: 31486872
DOI: 10.1007/s00280-019-03940-0