≤3 cycles) and thoracic RT dose (>60 Gy vs. ≤64 days), number of chemotherapy cycles (>3 cycles vs. stage IIIa) and prior treatment (total concurrent chemo-RT time (>64 days vs. In addition to the predefined subgroup analyses previously published, post hoc subgroup analyses were performed for subgroups based on age (>61 years vs. Brain imaging was performed only after patients reported symptoms suggestive of BM or at the discretion of the treating physician. Both physician and patient reported measures were included in these assessments. Follow-up assessments took place 4 weeks, 3, 6, 12, 24 and 36 months after completion of treatment, or earlier when symptoms of BM occurred. The primary endpoint of the study was the proportion of patients developing symptomatic BM within 24 months from randomization, defined as a combination of key symptoms suggesting BM (e.g., signs of increased intracranial pressure, headache, cognitive or affective disturbances) and MRI or CT proving evidence of BM. 2) and prior surgery and were subsequently randomized between PCI and observation. In short, after treatment with curative intent (mostly concurrent chemo-RT) patients with stage-III NSCLC were stratified according to histology, WHO performance score (0-1 vs.
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The Dutch NVALT-11/DLCRG-02 randomized phase-III trial has been reported previously. stage IIIa) and prior treatment (total concurrent chemo-radiotherapy (RT) time (>64 days vs. Specifically, we performed additional exploratory subgroup analyses to examine the risk of developing symptomatic BM and PCI interaction effects for age (>61 years vs. Therefore, to obtain maximum information from the NVALT-11/DLCRG-02 trial on top of the stratification factors, we aimed to identify subsets of patients that may be more likely to benefit from PCI. Furthermore, evidence from the literature showed that the type of (multi)modality therapy may also influence the risk of developing BM. Literature suggests that the BM risk increases when disease stage advances and that patients with non-squamous histology have a higher risk of developing BM than patients with squamous histology. Additional analyses to assess the impact of PCI on symptomatic BM in predefined subgroups did not show statistically significant differences between both arms. The NVALT-11/DLCRG-02 trial showed that two years after PCI, the proportion of patients with symptomatic BM was significantly lower in the PCI arm, compared to the observation arm (7.0% vs. The effectiveness of prophylactic cranial irradiation (PCI) to reduce BM has been investigated in several randomized controlled trials (RCTs). Patients with stage-III NSCLC have a BM incidence of approximately 30%. NSCLC patients frequently develop (symptomatic) brain metastases (BM), and the more advanced the disease is, the more frequent BM occur. One-third of all patients who develop nonsmall cell lung cancer (NSCLC) are diagnosed with locally advanced (stage III) disease.
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