Title: A phase II study of temozolomide administered 21 out of 28 days for the treatment of patients with recurrent anaplastic (oligo)astrocytoma: An interim analysis of toxicity
Authors: Neyns, B ×
van Mierlo, B
Menten, Johan
Dhondt, L
Joosens, E
Vastesaeger, N
Branle, F #
Issue Date: Jun-2005
Publisher: Amer soc clinical oncology
Host Document: Journal of Clinical Oncology vol:23 issue:16 pages:129S-129S
Conference: 2005 ASCO Annual Meeting edition:42 location:Orlando, Florida date:13 - 17 may
Article number: 1560
Abstract: Background: Temozolomide (TemodalR, TMZ) is an active alkylating agent for the treatment of gliomas. Conventional dosing of TMZ consists of an oral dose of 150-200 mg/m²/day for 5 consecutive days every 28 days. Extended daily dosing of TMZ might be more active because of the depletion of the AGAT repair protein. TMZ administered for 21 consecutive days (at a dose of 100 mg/m²/day) every 28 days, is being tested in a multicenter Belgian phase II study for the treatment of recurrent anaplastic (oligo)astrocytoma. We report the toxicity that was associated with this regimen at the occasion of the first interim monitoring of the adverse events. Methods: For the monitoring of toxicity (CTCAEv3.0), the protocol requested a weekly clinical and hematological evaluation during the first 8 wks and every 2 wks thereafter. An interim analysis was carried out for the toxicity seen during the first 67 administered treatment cycles. Results: 17 patients (pts) were recruited into this study (4 F, 13 M; median age 42 y, range 23-69 y). A median nr of 4 cycles were administered per pt (range 1-12). The most frequent observed adverse event was lymphopenia (LP); 14/17 pts experienced at least 1 episode of LP; Gr3 LP: 12 pts (20 cycles) and gr 4 LP: 4 pts (8 cycles). For the 28 cycles associated with gr3/4 LP, only 5 times treatment was adjusted according to protocol. There was a low incidence of other myelotoxicities (3x gr3/4 thrombocytopenia in 3 pts, 2x gr4 neutropenia, and no gr3/4 anemia). There was no case of febrile neutropenia. One pt had a herpes zoster reactivation (with concomitant gr2 LP). There was only 1 event of gr3 vomiting, 1x gr3 skin rash and 1x gr3 increase in AST/ALT and gammaGT. Updated results on toxicity and an analysis of tumor response will be reported at the meeting (including an 8 additional months of follow-up). Conclusions: Extended dosing of TMZ by a 21/28 days scheme in pts with recurrent anaplastic (oligo)astrocytoma, has a low-toxicity profile but is associated with a high incidence of lymphopenia. This toxicity profile is different from what is seen with the more conventional 5 out of 28 days schedule and investigators should pay attention to this uncommon toxicity
ISSN: 0732-183X
Publication status: published
KU Leuven publication type: IMa
Appears in Collections:Laboratory of Experimental Radiotherapy
× corresponding author
# (joint) last author

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