IMPORTANCE Tumor-treating fields (TTFields) is an antimitotic treatment modality that interferes with glioblastoma cell division and organelle assembly by delivering low-intensity alternating electric fields to the tumor.OBJECTIVE To investigate whether TTFields improves progression-free and overall survival of patients with glioblastoma, a fatal disease that commonly recurs at the initial tumor site or in the central nervous system. MAIN OUTCOMES AND MEASURESProgression-free survival (tested at α = .046). The secondary end point was overall survival (tested hierarchically at α = .048). Analyses were performed for the intent-to-treat population. Adverse events were compared by group. RESULTSOf the 695 randomized patients (median age, 56 years; IQR, 48-63; 473 men [68%]), 637 (92%) completed the trial. Median progression-free survival from randomization was 6.7 months in the TTFields-temozolomide group and 4.0 months in the temozolomide-alone group (HR, 0.63; 95% CI, 0.52-0.76; P < .001). Median overall survival was 20.9 months in the TTFields-temozolomide group vs 16.0 months in the temozolomide-alone group (HR, 0.63; 95% CI, 0.53-0.76; P < .001). Systemic adverse event frequency was 48% in the TTFields-temozolomide group and 44% in the temozolomide-alone group. Mild to moderate skin toxicity underneath the transducer arrays occurred in 52% of patients who received TTFields-temozolomide vs no patients who received temozolomide alone. CONCLUSIONS AND RELEVANCEIn the final analysis of this randomized clinical trial of patients with glioblastoma who had received standard radiochemotherapy, the addition of TTFields to maintenance temozolomide chemotherapy vs maintenance temozolomide alone, resulted in statistically significant improvement in progression-free survival and overall survival. These results are consistent with the previous interim analysis.TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00916409
clinicaltrials.gov Identifier: NCT00916409.
The management of primary CNS lymphoma is one of the most controversial topics in neurooncology because of the complexity of the disease and the very few controlled studies available. In 2013, the European Association of Neuro-Oncology created a multidisciplinary task force to establish evidence-based guidelines for immunocompetent adults with primary CNS lymphoma. In this Review, we present these guidelines, which provide consensus considerations and recommendations for diagnosis, assessment, staging, and treatment of primary CNS lymphoma. Specifically, we address aspects of care related to surgery, systemic and intrathecal chemotherapy, intensive chemotherapy with autologous stemcell transplantation, radiotherapy, intraocular manifestations, and management of elderly patients. The guidelines should aid clinicians in their daily practice and decision making, and serve as a basis for future investigations in neuro-oncology. DOI: https://doi.org/10.1016/S1470-2045(15) Posted at the Zurich Open Repository and Archive, University of Zurich ZORA URL: https://doi.org/10.5167/uzh-114449 Accepted Version Originally published at: Hoang-Xuan, K; Bessell, E; Bromberg, J; Hottinger, A F; Preusser, M; Rudà, R; Schlegel, U; Siegal, T; Soussain, C; Abacioglu, U; Cassoux, N; Deckert, M; Dirven, C M; Ferreri, A J; Graus, F; Henriksson, R; Herrlinger, U; Taphoorn, M; Soffietti, R; Weller, M (2015). Diagnosis and treatment of primary CNS lymphoma in immunocompetent patients: guidelines from the European Association for Neuro-Oncology. Lancet Oncology, 16(7):e322-332. DOI: https://doi.org/10.1016/S1470-2045 (15) The management of primary central nervous system (PCNSL) is one of the most controversial topics in neuro-oncology because of the complexity of the disease and the very limited number of controlled studies available. In 2013, the European Association of Neuro-Oncology (EANO) created a multidisciplinary task force to establish evidence-based guidelines for immunocompetent adult patients with PCNSL. The guideline provides consensus considerations and recommendations for diagnosis, staging and treatment of PCNSL, including surgery, systemic and intrathecal chemotherapy, intensive chemotherapy with autologous stem cell transplantation, radiotherapy, intraocular manifestations, and specific management of elderly patients. The guideline should aid the clinicians in everyday practice and decision making and serve as a basis for future research in the field.Dear Editor, Thank you for your suggestions to improve further our paper. Please, find in attached file our revised manuscript which have take into account all your editorial recommendations. You will find below our point by point replies to your editorial comments. We hope that you will find now the manuscript suitable for publication in Lancet Oncology. Kind regardsKhe Hoang-Xuan, MD,PhDResponses to the Editor comments 1) In response to Reviewer 1, comment 2, please revert and move the intraocular lymphoma section back to the appendix as in the original version. RE...
It is essential that neurologic immune-related adverse events are recognized and treated as soon as possible, as early treatment increases the odds of a complete recovery.
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