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- W4244689898 abstract "This randomised phase II study evaluated the use of Temozolomide (TMZ) concomitant with 30 Gray (Gy) of Whole-brain irradiation (WBI) for 2 weeks without adjuvant TMZ vs. WBI alone in patients with Brain metastases (BM) from solid tumours.Fifty-five patients were randomised into the following groups: 28 patients received WBI (30 Gy in 10 fractions over 2 weeks) concomitant with once-daily 200 mg TMZ on Mondays, Wednesdays, and Fridays, and 300 mg TMZ on Tuesdays and Thursdays (TMZ plus WBI arm). Twenty-seven patients received the same schedule of WBI alone (control arm).The objective response (OR) was 78.6% for the TMZ plus WBI arm, (95% confidence interval [CI], 63.4–93.8%) and 48.1% (29.3–66.9%) for the control arm (p = 0.019). Median Progression-free survival (PFS) of BM was 11.8 months (CI, 4.7–8.9 months) and 5.6 months (4.9–6.2 months) for the TMZ plus WBI and control arms, respectively, (Hazard ratio [HR], 0.24; CI, 0.09–0.65; p = 0.005). Overall survival (OS) of 8.0 Months for the TMZ plus WBI arm and 8.1 months for the control arm, were not significantly different.A daily fixed dose of TMZ during WBI without adjuvant TMZ was well tolerated and significantly improved local control of BM compared with WBI alone. These findings require confirmation in a phase III trial (ClinicalTrials.gov number, NCT01015534)." @default.
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- W4244689898 date "1954-04-01" @default.
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- W4244689898 doi "https://doi.org/10.1016/0016-0032(54)90628-6" @default.
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