BackgroundThe ATLAS trial compared axitinib versus placebo in patients with locoregional renal cell carcinoma (RCC) at risk of recurrence after nephrectomy.Patients and methodsIn a phase III, randomized, double-blind trial, patients had >50% clear-cell RCC, had undergone nephrectomy, and had no evidence of macroscopic residual or metastatic disease [independent review committee (IRC) confirmed]. The intent-to-treat population included all randomized patients [≥pT2 and/or N+, any Fuhrman grade (FG), Eastern Cooperative Oncology Group status 0/1]. Patients (stratified by risk group/country) received (1 : 1) oral twice-daily axitinib 5 mg or placebo for ≤3 years, with a 1-year minimum unless recurrence, occurrence of second primary malignancy, significant toxicity, or consent withdrawal. The primary end point was disease-free survival (DFS) per IRC. A prespecified DFS analysis in the highest-risk subpopulation (pT3, FG ≥ 3 or pT4 and/or N+, any T, any FG) was conducted.ResultsA total of 724 patients (363 versus 361, axitinib versus placebo) were randomized from 8 May 2012, to 1 July 2016. The trial was stopped due to futility at a preplanned interim analysis at 203 DFS events. There was no significant difference in DFS per IRC [hazard ratio (HR) = 0.870; 95% confidence interval (CI) : 0.660–1.147; P = 0.3211). In the highest-risk subpopulation, a 36% and 27% reduction in risk of a DFS event (HR; 95% CI) was observed per investigator (0.641; 0.468–0.879; P = 0.0051), and by IRC (0.735; 0.525–1.028; P = 0.0704), respectively. Overall survival data were not mature. Similar adverse events (AEs; 99% versus 92%) and serious AEs (19% versus 14%), but more grade 3/4 AEs (61% versus 30%) were reported for axitinib versus placebo.ConclusionsATLAS did not meet its primary end point; however, improvement in DFS per investigator was seen in the highest-risk subpopulation. No new safety signals were reported.Trial registration numberNCT01599754

Purpose The treatment of symptomatic Schwannoma is surgical excision. However, in the case of major peripheral nerves with motor function, there are concerns including neurological complications following surgery. This study was designed to evaluate the surgical outcome of Schwannomas originating from major peripheral nerves of the lower limb. Additionally, we sought to find out the predictable factors for permanent neurological deficits. Methods Between 2004 and 2008, 30 consecutive Schwannomas underwent simple excision or enucleation. Surgical outcomes after excision were evaluated with an emphasis on neurological deficits and recurrence. Neurological complications were classified as major or minor neurological deficits and evaluated immediately after surgery and at final follow-up. Risk factors for development of neurological deficits were identified. Results Twenty-three patients (23/30, 76.7 %) developed neurological deficits immediately after surgery. After a mean of 58.8 months (32-79 months), 19 patients (19/30, 63.3 %) showed no residual neurological deficits. Among the remaining 11 (11/30, 36.7 %), nine patients had tolerable symptoms and two patients had major neurological deficits including significant motor weakness and sensory impairments. Larger tumours tended to be at greater risk of neurological deficit after surgery. One recurrence of the tumour was seen two years after surgery. There were no cases of reoperation or malignant transformation Conclusions In the majority of cases, Schwannomas in the lower limb can be excised with acceptable risk for neurological deficits. However, meticulous dissection is required in large-sized Schwannomas because these tumours seem to have a higher frequency of fascicular injury during dissection.

The purpose of this study was to assess the diagnostic value of imaging-guided core needle biopsy for the diagnosis of musculoskeletal lesions. Between 2004 and 2007, 309 biopsies (ultrasound 151, computed tomography 89, and fluoroscopy 69) were included. There were 142 soft tissue and 167 bony lesions. Diagnostic yields and accuracies were assessed using the chi-square test or Fisher's exact test with Bonferroni's correction when necessary. Overall diagnostic yield was 90.6% for all 309 lesions (bone 91.6% vs. soft tissue 89.3%, p = 0.5125). The diagnostic accuracy of the 185 core needle biopsies, which were confirmed by definitive surgical biopsies, was 84.3% (bone 88.9% vs. soft tissue 79.1%, p = 0.0669). The yields of homogenous bone tumours (96.8%) were not significantly higher than those of bone tumours with a heterogenic architecture (86.4%, p = 0.0794). The difference between accuracies for homogenous bone tumours (89.1%) and heterogenous bone tumours (85.0%) was not significant (p = 0.6930). However, for soft tissue tumours, homogenous tumours had a significantly higher diagnostic yield than heterogenous tumours (97.5% vs. 81.4%, p = 0.0036). Diagnostic accuracy for homogenous tumours was also significantly higher than that for heterogenous soft tissue tumours (94.4% vs. 60.6%, p < 0.0001). The image-guided percutaneous needle biopsy of musculoskeletal lesions is a safe and effective procedure if it is performed selectively in soft tissue tumours with homogenous architectures.

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