| Phase II study of weekly plitidepsin as second-line therapy for small cell lung cancer. | |
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MedLine Citation:
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PMID: 18692272 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To evaluate the antitumor activity and safety profile of plitidepsin administered as a 1h weekly intravenous (i.v.) infusion of 3.2mg/m(2) to patients with small cell lung cancer (SCLC) who relapsed or progressed after one line of chemotherapy. PATIENTS AND METHODS: This was a multicenter, open-label, single-arm, exploratory, phase II clinical trial. Treatment lasted until disease progression, unacceptable toxicity, patient refusal or treatment delay for >2 weeks. Objective response rate (primary efficacy endpoint) was evaluated according to response evaluation criteria in solid tumors (RECIST). The rate of stable disease (SD) lasting for at least 6 months and time-to-event variables were secondary endpoints of efficacy. Toxicity was assessed using National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. RESULTS: Twenty pretreated SCLC patients (median age, 60 years) with extensive (n = 13) or limited-stage disease (n = 7) received a total of 24 treatment cycles (median, one cycle per patient; range, 1-2). Objective tumor responses were not observed and only one of the 17 evaluable patients had SD. With a median follow-up of 11.8 months, the progression-free survival and the median overall survival were 1.3 months and 4.8 months, respectively. The most troubling or common toxicities were fatigue, muscle weakness, lymphopenia, anemia (no patients showed neutropenia), and asymptomatic, non-cumulative increase of transaminases levels and alkaline phosphatase. CONCLUSION: This clinical trial shows that a cycle of 1h weekly i.v. infusion of plitidepsin (3.2mg/m(2)) was generally well tolerated other than fatigue and muscle weakness in patients with pretreated SCLC. One patient died due to multi-organ failure. The absence of antitumor activity found here precludes further studies of this plitidepsin schedule as second-line single-agent treatment of SCLC. |
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Authors:
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Tim Eisen; Nick Thatcher; Serge Leyvraz; Wilson H Miller; Felix Couture; Paul Lorigan; François Lüthi; David Small; Adnan Tanovic; Mary O'Brien |
Publication Detail:
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Type: Clinical Trial, Phase II; Journal Article; Multicenter Study Date: 2008-08-09 |
Journal Detail:
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Title: Lung cancer (Amsterdam, Netherlands) Volume: 64 ISSN: 0169-5002 ISO Abbreviation: Lung Cancer Publication Date: 2009 Apr |
Date Detail:
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Created Date: 2009-03-10 Completed Date: 2009-05-07 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8800805 Medline TA: Lung Cancer Country: Ireland |
Other Details:
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Languages: eng Pagination: 60-5 Citation Subset: IM |
Affiliation:
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Department of Oncology, Addenbrooke's Hospital, Cambridge CB2 0QQ, United Kingdom. tim.eisen@medschl.cam.ac.uk |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adrenal Gland Neoplasms
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drug therapy,
secondary Adult Aged Antineoplastic Agents / administration & dosage* Bone Neoplasms / drug therapy, secondary Depsipeptides / administration & dosage* Female Humans Infusions, Intravenous Liver Neoplasms / drug therapy, secondary Lung Neoplasms / drug therapy*, pathology Lymphatic Metastasis Male Maximum Tolerated Dose Middle Aged Neoplasm Staging Prognosis Salvage Therapy Skin Neoplasms / drug therapy, secondary Small Cell Lung Carcinoma / drug therapy*, secondary Survival Rate Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Antineoplastic Agents; 0/Depsipeptides; 0/aplidine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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