Abstract | OBJECTIVES: 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:
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Authors | Jessica A Hellyer, Matthew A Gubens, Kristen M Cunanan, Sukhmani K Padda, Matthew Burns, A John Spittler, Jonathan W Riess, Melanie San Pedro-Salcedo, Kavitha J Ramchandran, Joel W Neal, Heather A Wakelee, Patrick J Loehrer Sr |
Journal | Lung cancer (Amsterdam, Netherlands)
(Lung Cancer)
Vol. 137
Pg. 71-75
(11 2019)
ISSN: 1872-8332 [Electronic] Ireland |
PMID | 31557562
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2019 Elsevier B.V. All rights reserved. |
Chemical References |
- Anthracyclines
- Antineoplastic Agents
- amrubicin
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Topics |
- Anthracyclines
(therapeutic use)
- Antineoplastic Agents
(therapeutic use)
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Non-Randomized Controlled Trials as Topic
- Patient Selection
- Prognosis
- Prospective Studies
- Salvage Therapy
- Survival Rate
- Thymoma
(drug therapy, pathology)
- Thymus Neoplasms
(drug therapy, pathology)
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