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Originalarbeiten – Original Paper

Final Evaluation of a Phase II Study on the Effect of Edelfosine (an Ether Lipid) in Advanced Non-Small-Cell Bronchogenic Carcinoma

Drings P.a · Günther I.a · Gatzemeier U.b · Ulbrich F.c · Khanavkar B.d · Schreml W.e · Lorenz J.f · Brugger W.g · Schick H.D.h · Pawel J.v.i · Nordström R.k

Author affiliations

aAbteilung Innere Medizin/Onkologie, Thoraxklinik der LVA Baden, Heidelberg-Rohrbach bOnkologische Abteilung, Klinik für Thoraxcrkrankungen, Großhansdorf cPneumologische Klinik an der Lieth, Lenglern dPneumologische Abteilung, Augusta-Krankenanstalten, Bochum eMedizinische Abteilung, Krankcnhaus Günzburg fPneumologische Abteilung. Medizinische Universitätsklinik Mainz gMedizinische Universitätsklinik Freiburg hAbteilung Hämatologie und Onkologie, Klinikum Rechts der Isar der Technischen Universität, München iAbteilung Onkologie, Zentralkrankenhaus Gauting kmcdmark pharma GmbH, Grünwald

Related Articles for ""

Onkologie 1992;15:375–382

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Article / Publication Details

First-Page Preview
Abstract of Originalarbeiten – Original Paper

Published online: April 29, 2009
Issue release date: 1992

Number of Print Pages: 8
Number of Figures: 0
Number of Tables: 0

ISSN: 2296-5270 (Print)
eISSN: 2296-5262 (Online)

For additional information: http://www.karger.com/ORT

Abstract

Background: Ether lipids could provide new prospects in cancer therapy after successful preclinical investigations. Edelfosine has been the most thoroughly investigated substance in the ether lipid group. So far, no standard therapy has been set up for advanced non-small-cell bronchogenic carcinoma. Therefore, in a phase II study 116 patients with advanced inoperable non-small-cell bronchogenic carcinoma were treated with the alkyl-lysophospholipid edelfosine (EF). Material and Methods: The phenotype modifier EF was initially applied in a daily oral dosage of 300 mg (dissolved in milk) over a period of 4 weeks, then increased to a daily dosage of 900 mg if tolerated well, and continued with the highest tolerable dosage. Therapy was continued until either tumor progression or negative side effects were documented. 35 patients could not be treated for the intended therapy period of at least 8 weeks due to early tumor progression (18 patients), unacceptable gastrointestinal side effects (14 patients), lack of compliance (1 patient), refusal of therapy (1 patient) and change of therapy (1 patient). Results: 81 patients could be evaluated for remission status; of these, 2 showed partial remission, 68 showed ‘no change’, and 11 had unaltered progression of the tumor. Median survival time for these 81 patients was 244 days, for all 116 patients it was 199 days. Retrospectively, in these 81 patients the spontaneous tumor development during the 2 months before EF therapy could be analyzed. Tumor progression during this period could be documented in 1 patient with partial remission, in 46 patients with diagnosis ‘no change’, and in 11 patients with unaltered tumor progression. The survival times of these three groups of patients did not differ significantly. All 116 patients were evaluable for toxicity. Manifestations of gastrointestinal problems were anorexia, nausea, vomiting, diarrhea, obstipation (mostly WHO grades I+Π), but treatment was not required. Toxic effects on organs or late toxicity could not be documented.Conclusions: The high proportion of patients with stationary tumor status was remarkable. Objective tumor remission was extremely rare. On the other hand, the rate of progression was low. This might be explained by the fact that EF is rather a phenotype modifier than a typical cytostatic drug.

© 1992 S. Karger AG, Basel


Article / Publication Details

First-Page Preview
Abstract of Originalarbeiten – Original Paper

Published online: April 29, 2009
Issue release date: 1992

Number of Print Pages: 8
Number of Figures: 0
Number of Tables: 0

ISSN: 2296-5270 (Print)
eISSN: 2296-5262 (Online)

For additional information: http://www.karger.com/ORT


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Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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