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01.06.2008 | Original Article

A phase II study of patients with metastatic or locoregionally recurrent nasopharyngeal carcinoma and evaluation of plasma Epstein–Barr virus DNA as a biomarker of efficacy

verfasst von: Brigette Ma, Edwin P. Hui, Ann King, K. F. To, Frankie Mo, Sing F. Leung, Michael Kam, Y. M. Dennis Lo, Benny Zee, Tony Mok, Anil Ahuja, Anthony T. C. Chan

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 1/2008

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Abstract

Background

The epidermal growth factor receptor (EGFR) is commonly overexpressed in nasopharyngeal carcinoma (NPC) and gefitinib inhibits NPC growth in vitro.

Method

Patients who progressed after prior platinum-based chemotherapy for recurrent NPC were given gefitinib orally at 500 mg/day at a 28-day cycle. Plasma Epstein–Barr virus (pEBV) DNA levels were obtained at specific intervals.

Results

Sixteen patients enrolled and 15 were evaluable for response. The median age was 49 years (range 34–64 years), and most patients were males with metastatic NPC. No objective response was seen and three patients had stable disease (SD) for 2.8 to 8.5 months. Radiological progression of disease coincided with rising levels of pEBV DNA in most patients, while the level of a patient with the longest duration of SD fell to an undetectable level at study completion. The mean time to progression and overall survival was 2.7 (standard error, SE +/− 0.5 months) and 12 months (SE +/− 1.7 months), respectively. No unexpected drug-related toxicities were seen. The study was prematurely terminated because there was insufficient activity to warrant progression to the second stage of accrual.

Conclusion

This study found limited activity of gefitinib in recurrent NPC. Further evaluation of pEBV DNA as a biomarker of response in clinical trials of target-based agents is warranted.

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Titel: A phase II study of patients with metastatic or locoregionally recurrent nasopharyngeal carcinoma and evaluation of plasma Epstein–Barr virus DNA as a biomarker of efficacy
verfasst von: Brigette Ma
Edwin P. Hui
Ann King
K. F. To
Frankie Mo
Sing F. Leung
Michael Kam
Y. M. Dennis Lo
Benny Zee
Tony Mok
Anil Ahuja
Anthony T. C. Chan
Publikationsdatum: 01.06.2008
Verlag: Springer-Verlag
Erschienen in: Cancer Chemotherapy and Pharmacology / Ausgabe 1/2008
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-007-0575-8

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A phase II study of patients with metastatic or locoregionally recurrent nasopharyngeal carcinoma and evaluation of plasma Epstein–Barr virus DNA as a biomarker of efficacy