Background
The goal was to determine whether the addition of temozolomide (TMZ) to the standard treatment of high-dose methotrexate (HD-MTX) and whole-brain radiotherapy (WBRT) for primary central nervous system lymphoma (PCNSL) improves survival.
Methods
An open-label, randomized, phase III trial was conducted in Japan, enrolling immunocompetent patients aged 20-70 years with histologically confirmed, newly diagnosed PCNSL. After administration of HD-MTX, patients were randomly assigned to receive WBRT (30 Gy) ± 10 Gy boost (arm A) or WBRT ± boost with concomitant and maintenance TMZ for two years (arm B). The primary endpoint was overall survival (OS).
Results
Between September 29, 2014 and October 15, 2018, 134 patients were enrolled, of whom 122 were randomly assigned and analyzed. At the planned interim analysis, two-year OS was 86.8% (95% confidence interval [CI]: 72.5-94.0%) in arm A and 71.4% (56.0-82.2%) in arm B. The hazard ratio was 2.18 (95% CI: 0.95 to 4.98), with the predicted probability of showing the superiority of arm B at the final analysis estimated to be 1.3%. The study was terminated early due to futility. O 6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status was measured in 115 tumors, and it was neither prognostic nor predictive of TMZ response.
Conclusions
This study failed to demonstrate the benefit of concomitant and maintenance TMZ in newly diagnosed PCNSL.
Purpose After stent-assisted treatment for intracranial diseases, three-dimensional time-of-flight magnetic resonance angiography is a noninvasive follow-up method, but susceptibility artifacts prevent accurate evaluations of stented arteries. Sampling perfection with application-optimized contrast using different flip angle evolution (SPACE) sequence often used for vessel wall imaging is less susceptible to susceptibility artifacts, since it is a spin-echo sequence. Hence, we evaluated the feasibility of black-blood magnetic resonance angiography generated from vessel wall imaging data obtained using the SPACE sequence in the depiction of stented arteries by comparing with three-dimensional time-of-flight magnetic resonance angiography and digital subtraction angiography. Methods Our study group comprised 11 consecutive patients. For both three-dimensional time-of-flight magnetic resonance angiography and black-blood magnetic resonance angiography, the contrast ratio obtained from the stented artery and the normal artery proximal to the stent were calculated. And the depiction of stented arteries was visually evaluated. Additionally, the relative diameter index obtained from the stented artery and the normal artery proximal to the stent were calculated for three-dimensional time-of-flight magnetic resonance angiography, black-blood magnetic resonance angiography and digital subtraction angiography. Results The contrast ratio of the stented artery was significantly lower than that of the normal artery on three-dimensional time-of-flight magnetic resonance angiography, but no significant difference was seen using black-blood magnetic resonance angiography. Regarding both the diameter index and the visual assessment score, black-blood magnetic resonance angiography was significantly better than three-dimensional time-of-flight magnetic resonance angiography. On black-blood magnetic resonance angiography, the diameter index was equal to that of digital subtraction angiography, and the flow signal was homogeneous and continuous in most the cases.
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