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Concurrent chemoradiation therapy with Docetaxel/Cisplatin followed by Docetaxel consolidation therapy in inoperable stage IIIA/B non-small-cell lung cancer: results of a phase I study

Introduction - Docetaxel consolidation therapy (DCT) after concurrent cisplatin/docetaxel chemoradiation therapy (CRT) produces high tumor control in non-small-cell lung cancer (NSCLC); toxicity is, however, considerable. We aimed to determine the maximally tolerated dose (MTD) for DCT. - Patients a...

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Hauptverfasser: Huber, Rudolf M. (VerfasserIn) , Borgmeier, Astrid (VerfasserIn) , Flentje, Michael (VerfasserIn) , Willner, Jochen (VerfasserIn) , Schmidt, Michael (VerfasserIn) , Manegold, Christian (VerfasserIn) , Bramlage, Peter (VerfasserIn) , Debus, Jürgen (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: [January 2010]
In: Clinical lung cancer
Year: 2010, Jahrgang: 11, Heft: 1, Pages: 45-50
ISSN:1938-0690
DOI:10.3816/CLC.2010.n.007
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.3816/CLC.2010.n.007
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S1525730411700377
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Verfasserangaben:Rudolf M. Huber, Astrid Borgmeier, Michael Flentje, Jochen Willner, Michael Schmidt, Christian Manegold, Peter Bramlage, Jürgen Debus
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Zusammenfassung:Introduction - Docetaxel consolidation therapy (DCT) after concurrent cisplatin/docetaxel chemoradiation therapy (CRT) produces high tumor control in non-small-cell lung cancer (NSCLC); toxicity is, however, considerable. We aimed to determine the maximally tolerated dose (MTD) for DCT. - Patients and Methods - Patients with inoperable stage IIIB NSCLC received docetaxel 20 mg/m2 and cisplatin 25 mg/m2 on days 1, 8, 15, 22, 29, and 36, with concurrent radiation therapy 5 days per week for a total dose of 66 Gy. Patients achieving stable disease, partial response, or complete response were given DCT on days 71, 92, and 113. DCT was started with 75 mg/m2 and titrated depending on tolerability. The MTD of docetaxel was defined as the dose preceding that at which 3 or more patients experienced dose-limiting toxicity (DLT). - Results - Of 23 patients enrolled (median age, 58.8 years ± 7.3 years), 19 received complete CRT (4 withdrew because of toxicity). Of the patients receiving complete CRT, 1 patient died and 1 became operable, leaving 17 patients eligible for DCT starting at 75 mg/m2. After the third patient with DLT, dose was reduced to 60 mg/m2. Median survival was 27.6 months ± 23.1 months. Median TTP was 12.4 months ± 10.7 months. - Conclusion - The MTD of DCT after concurrent cisplatin/docetaxel CRT was determined to be 60 mg/m2, but toxicity was considerable. The benefit-risk ratio of DCT has, however, been questioned by a placebo-controlled phase III trial. Further phase III trials need to consider further stratification factors (pretreatment forced expiratory volume [FEV]1, hemoglobin, performance, and stage) to define a role for DCT in patients with NSCLC.
Beschreibung:Gesehen am 23.05.2023
Beschreibung:Online Resource
ISSN:1938-0690
DOI:10.3816/CLC.2010.n.007

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