Whole-brain irradiation with concomitant daily fixed-dose Temozolomide for brain metastases treatment: A randomised phase II trial
| Autor: | Oscar Arrieta, Tabare Ferrari-Carballo, Alejandro Mohar, Carlos Gamboa-Vignolle |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Male
Oncology medicine.medical_specialty medicine.medical_treatment Phases of clinical research law.invention Randomized controlled trial law Internal medicine Temozolomide Humans Medicine Radiology Nuclear Medicine and imaging Antineoplastic Agents Alkylating Survival rate Aged Proportional Hazards Models Aged 80 and over Chi-Square Distribution Brain Neoplasms business.industry Hazard ratio Dose fractionation Radiotherapy Dosage Hematology Middle Aged Surgery Dacarbazine Survival Rate Treatment Outcome Concomitant Female Dose Fractionation Radiation Cranial Irradiation business Adjuvant medicine.drug |
| Zdroj: | Radiotherapy and Oncology. 102:187-191 |
| ISSN: | 0167-8140 |
| DOI: | 10.1016/j.radonc.2011.12.004 |
| Popis: | Background and purpose This randomised phase II study evaluated the use of Temozolomide (TMZ) concomitant with 30Gray (Gy) of Whole-brain irradiation (WBI) for 2weeks without adjuvant TMZ vs. WBI alone in patients with Brain metastases (BM) from solid tumours. Materials and methods Fifty-five patients were randomised into the following groups: 28 patients received WBI (30Gy in 10 fractions over 2weeks) concomitant with once-daily 200mg TMZ on Mondays, Wednesdays, and Fridays, and 300mg TMZ on Tuesdays and Thursdays (TMZ plus WBI arm). Twenty-seven patients received the same schedule of WBI alone (control arm). Results 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 11.8months (CI, 4.7–8.9months) and 5.6months (4.9–6.2months) 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 8.1months for the control arm, were not significantly different. Conclusion 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). |
| Databáze: | OpenAIRE |
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