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Erschienen in: Journal of Neuro-Oncology 2/2017

01.07.2017 | Clinical Study

Report of safety of pulse dosing of lapatinib with temozolomide and radiation therapy for newly-diagnosed glioblastoma in a pilot phase II study

verfasst von: Andrew Yu, Nadia Faiq, Stacey Green, Albert Lai, Richard Green, Jethro Hu, Timothy F. Cloughesy, Ingo Mellinghoff, P. Leia Nghiemphu

Erschienen in: Journal of Neuro-Oncology | Ausgabe 2/2017

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Abstract

Epidermal growth factor receptor (EGFR) mutations are commonly observed in Glioblastoma (GBM) and have long posed as a target for new therapies. Trials involving erlotinib have shown mixed results, likely owing to a mechanism of the mutation that may instead favor other EGFR inhibitors, such as lapatinib. We aimed to determine whether or not pulse high-dose lapatinib was a safe and tolerable regimen in addition to standard therapy. We recruited adult patients with newly-diagnosed GBM who had Karnofsky Performance Status ≥60, normal baseline hematological, hepatic, and renal function tests, and no prior history of radiation or treatment with EGFR inhibitor. Lapatinib was administered at 2500 mg twice daily for two consecutive days per week on a weekly basis throughout concomitant and adjuvant standard therapy. The primary endpoints were tolerability and safety. 12 patients were enrolled in this study over 2 years. Of the non-hematological adverse events, there were 2 grade 3 events, fatigue and post-radiation cystic brain necrosis. The most common adverse events in general were fatigue, rashes, and diarrhea. Of the hematological adverse events, there were 13 grade 3 events, all of which were due to lymphopenia and affected 6 of 12 patients. Pulse high-dose lapatinib in addition to standard therapy for newly-diagnosed GBM is a tolerable and safe regimen, but higher rates of lymphopenia should be noted. However, further investigations will be required to evaluate the efficacy of this combination for the treatments of GBM.
Trial registration ClinicalTrials.gov Identifier: NCT01591577.
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Metadaten
Titel
Report of safety of pulse dosing of lapatinib with temozolomide and radiation therapy for newly-diagnosed glioblastoma in a pilot phase II study
verfasst von
Andrew Yu
Nadia Faiq
Stacey Green
Albert Lai
Richard Green
Jethro Hu
Timothy F. Cloughesy
Ingo Mellinghoff
P. Leia Nghiemphu
Publikationsdatum
01.07.2017
Verlag
Springer US
Erschienen in
Journal of Neuro-Oncology / Ausgabe 2/2017
Print ISSN: 0167-594X
Elektronische ISSN: 1573-7373
DOI
https://doi.org/10.1007/s11060-017-2533-6

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