Document Detail

Phase II study of plitidepsin in pretreated patients with locally advanced or metastatic non-small cell lung cancer.
MedLine Citation:
PMID:  18054408     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To evaluate the progression-free rate (PFR) at 3 months (13+/-1 weeks), antitumor response, time-to-event efficacy endpoints, and toxicity profile of plitidepsin administered as a 3-h continuous i.v. infusion at a dose of 5mg/m(2), every 2 weeks, to patients with chemotherapy pretreated advanced non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: This was a multicenter, non-randomized, exploratory, phase II study. Treatment lasted until disease progression, unacceptable toxicity, patient refusal or treatment delay for >2 weeks. PFR (primary efficacy endpoint) and objective response rate (secondary efficacy endpoint) were evaluated according to RECIST, while the toxic profile of plitidepsin was assessed using the NCI-CTC, version 2.0. RESULTS: A total of 21 patients with a median age of 61 years and with locally advanced or metastatic non-resectable NSCLC, who had previously received only one line of chemotherapy in an advanced setting, received a total of 54 cycles of treatment (median of two cycles per patient; range: 1-8). Antitumor activity was seen in 3 (1 PR, 2 SD) out of 17 evaluable patients according to RECIST. One patient was responder for the primary (PFR at 13+/-1 weeks) and secondary efficacy endpoint (stable disease according to RECIST). Other two patients were non-responders for the primary efficacy endpoint, but had stable disease (not confirmed at weeks 13+/-1 due to previous withdrawal due to adverse events). With a median follow-up of 12.3 months, the median time to progression (TTP) and the median overall survival (OS) were 1.2 months and 4.3 months, respectively. The incidence of plitidepsin-related toxicities was low and most of them were mild-to-moderate in severity. The most common side effects were anemia, and asymptomatic and non-cumulative increases of gamma-glutamyltransferase (GGT) and liver transaminase levels. CONCLUSION: This study shows that plitidepsin 3-h continuous i.v. infusion (5mg/m(2)) every 2 weeks, was feasible and well tolerated in patients with pretreated NSCLC. The lack of evidence of antitumor activity precludes further studies with this plitidepsin schedule in this tumor setting.
Christian Peschel; Joerg T Hartmann; Alexander Schmittel; Carsten Bokemeyer; Folker Schneller; Ulrich Keilholz; Dieter Buchheidt; Susana Millan; Miguel Angel Izquierdo; Ralf-Dieter Hofheinz
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study     Date:  2007-12-03
Journal Detail:
Title:  Lung cancer (Amsterdam, Netherlands)     Volume:  60     ISSN:  0169-5002     ISO Abbreviation:  Lung Cancer     Publication Date:  2008 Jun 
Date Detail:
Created Date:  2008-06-02     Completed Date:  2008-10-30     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8800805     Medline TA:  Lung Cancer     Country:  Ireland    
Other Details:
Languages:  eng     Pagination:  374-80     Citation Subset:  IM    
Technische Universität, III. Medizinische Klinik, München, Germany.
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MeSH Terms
Anemia / chemically induced
Antineoplastic Combined Chemotherapy Protocols / administration & dosage*,  adverse effects,  blood
Carcinoma, Non-Small-Cell Lung / blood,  drug therapy*,  pathology*
Depsipeptides / administration & dosage*,  adverse effects
Disease Progression
Disease-Free Survival
Infusions, Intravenous
Lung Neoplasms / drug therapy*,  pathology*
Middle Aged
Neoplasm Metastasis
Neoplasm Staging
Transaminases / blood
gamma-Glutamyltransferase / blood
Reg. No./Substance:
0/Depsipeptides; 0/aplidine; EC; EC 2.6.1.-/Transaminases

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