RESUMO
BACKGROUND AND PURPOSE: 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. MATERIALS AND METHODS: 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). 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 11.8 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. 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).
Assuntos
Antineoplásicos Alquilantes/uso terapêutico , Neoplasias Encefálicas/tratamento farmacológico , Neoplasias Encefálicas/radioterapia , Neoplasias Encefálicas/secundário , Irradiação Craniana/métodos , Dacarbazina/análogos & derivados , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos Alquilantes/administração & dosagem , Distribuição de Qui-Quadrado , Dacarbazina/administração & dosagem , Dacarbazina/uso terapêutico , Fracionamento da Dose de Radiação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Dosagem Radioterapêutica , Taxa de Sobrevida , Temozolomida , Resultado do TratamentoRESUMO
BACKGROUND: The presence and detection of multifocal and multicentric disease significantly increases the risk of recurrence and changes the best therapeutic approach in patients with breast cancer. Mammography has low sensitivity to detect multiple malignant foci in patients with dense breast parenchyma. We prospectively evaluated Magnetic Resonance Imaging (MRI) as part of preoperative assessment. MATERIAL AND METHODS: Women with clinical and radiological suspicion of breast cancer and dense breast parenchyma (> 75% dense tissue) were included. All patients underwent mammography, ultrasonogram and MRI prior to surgery. Surgical specimens were used for the detection of multifocal and multicentric disease. Patients who required neoadjuvant chemotherapy or radiotherapy were excluded. RESULTS: Nineteen patients were evaluated. Histological diagnosis was confirmed in 14 patients, multifocal and multicentric disease was found in five and two patients, respectively. Sensitivity and accuracy to detect multiple malignant foci were 42 and 64%, respectively, for mammography plus ultrasound and 100 and 92% for MRI (p<0.05). CONCLUSIONS: MRI is more sensible and has a better accuracy than mammography plus ultrasound to detect both multicentric and multifocal breast cancer in women with dense breast parenchyma. MRI can improve preoperative assessment of breast cancer in this group of patients.