Temozolomide Added to Whole Brain Radiotherapy in Patients with Multiple Brain Metastases of Non-small-cell Lung Cancer: a Multicentric Austrian Phase II Study

Overview

Journal Wien Klin Wochenschr

Publisher Springer

Specialty General Medicine

Date 2013 Aug 3

PMID 23907204

Citations 17

Authors

Marco Ronald Hassler

Wolfgang Pfeifer

Thomas Hendrik Knocke-Abulesz

Klaus Geissler

Gabriele Altorjai

Karin Dieckmann

Christine Marosi

Affiliations

Soon will be listed here.

Abstract

Background: This multicentric randomized phase II study investigated the feasibility and toxicity of temozolomide (TMZ) added to whole brain radiotherapy (WBRT) followed by adjuvant TMZ in patients with multiple brain metastases of non-small-cell lung cancer (NSCLC).

Methods: Patients with multiple brain metastases from NSCLC aged ≥ 18 years, classified according to recursive partitioning analysis class I or II and with adequate organ functions were eligible. Treatment consisted of WBRT + TMZ 75 mg/m² for 2 weeks followed at day 28 by TMZ 100 mg/m²/day 2 weeks on/2 weeks off for up to 6 months (radiochemotherapy, RCT) or WBRT alone (radiotherapy, RT).

Results: The study enrolled only 35 patients (22 patients in RCT and 13 in RT) and had to be closed prematurely due to poor accrual. The toxicity was mainly due to TMZ with WHO grade 3 and 4 thrombocytopenia in 3/22 versus 0/13, leucocytopenia in 1/22 versus 0/13 and lymphocytopenia in 7/22 versus 12/13 patients in RCT and RT respectively. Thirteen patients in RCT and six in RT progressed systemically and dropped out before first restaging of the response in brain. Median time to progression (TTP) was 2.4 months (95 % CI: 2-2.6 months) and 2.0 months (95 % CI: 0.5-3.5 months), median overall survival (OAS) was 3 months (95% CI: 1.7-3.1 months) and 6.3.months (95 % CI: 0.2-7.6 months) in RCT and RT, respectively.

Conclusions: Like other studies before on patients with brain metastases, insufficient number of recruited patients does not allow conclusions on efficacy and toxicity as the study closed prematurely.

Citing Articles

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