Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma

作者：Roger Stupp, Sophie Taillibert, Andrew A. Kanner, Santosh Kesari, David M. Steinberg, Steven A. Toms, Lynne Patricia Taylor, Frank Scott Lieberman, Antonio Silvani, Karen E. Fink, Gene H. Barnett, Jay‐Jiguang Zhu, John W. Henson, Herbert H. Engelhard, Thomas C. Chen, David Dinh Tran, Jan Šroubek, Nam Tran, Andreas Felix Hottinger, Joseph C. Landolfi, Rajiv D. Desai, Manuela Caroli, Yvonne Kew, Jérôme Honnorat, Ahmed Idbaïh, Eilon David Kirson, Uri Weinberg, Yoram Palti, Monika E. Hegi, Zvi Ram · 发表于：JAMA · 年份：2015 · DOI：10.1001/jama.2015.16669 · 被引用次数：1251 · 研究领域：Glioma Diagnosis and Treatment、Cancer Research and Treatments、Brain Metastases and Treatment

IMPORTANCE: Glioblastoma is the most devastating primary malignancy of the central nervous system in adults. Most patients die within 1 to 2 years of diagnosis. Tumor-treating fields (TTFields) are a locoregionally delivered antimitotic treatment that interferes with cell division and organelle assembly. OBJECTIVE: To evaluate the efficacy and safety of TTFields used in combination with temozolomide maintenance treatment after chemoradiation therapy for patients with glioblastoma. DESIGN, SETTING, AND PARTICIPANTS: After completion of chemoradiotherapy, patients with glioblastoma were randomized (2:1) to receive maintenance treatment with either TTFields plus temozolomide (n = 466) or temozolomide alone (n = 229) (median time from diagnosis to randomization, 3.8 months in both groups). The study enrolled 695 of the planned 700 patients between July 2009 and November 2014 at 83 centers in the United States, Canada, Europe, Israel, and South Korea. The trial was terminated based on the results of this planned interim analysis. INTERVENTIONS: Treatment with TTFields was delivered continuously (>18 hours/day) via 4 transducer arrays placed on the shaved scalp and connected to a portable medical device. Temozolomide (150-200 mg/m2/d) was given for 5 days of each 28-day cycle. MAIN OUTCOMES AND MEASURES: The primary end point was progression-free survival in the intent-to-treat population (significance threshold of .01) with overall survival in the per-protocol population (n = 280)...