Medical Oncology, Kantonsspital Winterthur, Switzerland.
Medical Oncology, University Hospital Basel, Switzerland.
Lung Cancer. 2013 Sep;81(3):445-450. doi: 10.1016/j.lungcan.2013.06.025. Epub 2013 Jul 23.
Low intensity, intermediate frequency, alternating electric fields (Tumor Treating Fields; TTFields) exhibit anti-mitotic activity in cancer cells. Promising preclinical data have led to a single arm phase I/II trial in NSCLC patients.
Forty-two inoperable stage IIIB (with pleural effusion) and IV NSCLC patients who had had tumor progression received pemetrexed 500 mg/m(2) iv q3w together with daily TTFields therapy until disease progression. The primary endpoint was time to "in-field" progression.
Median age for all patients was 63 years, 76% had stage IV disease, 78% had adenocarcinoma and 17% had performance status of 2. The median time to in-field progression was 28 weeks and the median time to systemic progression was 22 weeks. Six patients (14.6%) had a partial remission (PR) and 20 had stable disease (SD) (48.8%). Median overall survival was 13.8 months and 1 year survival rate was 57%. There were no TTFields-related serious adverse events.
The combination of TTFields and pemetrexed as a second line therapy for NSCLC is safe and potentially more effective than pemetrexed alone. TTFields improved disease control within the treatment field and a phase III study is planned to further investigate its role as a novel treatment in NSCLC.
低强度、中频、交变电场（肿瘤治疗电场；TTFields）在癌细胞中表现出抗有丝分裂活性。有前途的临床前数据导致了 IIIB 期（伴胸腔积液）和 IV 期非小细胞肺癌患者的单臂 I/II 期试验。
42 例无法手术的 IIIB 期（伴胸腔积液）和 IV 期非小细胞肺癌患者在肿瘤进展后接受培美曲塞 500mg/m2 iv q3w 联合每日 TTFields 治疗，直至疾病进展。主要终点是“场内”进展时间。
所有患者的中位年龄为 63 岁，76%为 IV 期疾病，78%为腺癌，17%为体力状态 2 分。场内进展的中位时间为 28 周，系统进展的中位时间为 22 周。6 例（14.6%）患者有部分缓解（PR），20 例患者有稳定疾病（SD）（48.8%）。中位总生存期为 13.8 个月，1 年生存率为 57%。没有与 TTFields 相关的严重不良事件。
TTFields 联合培美曲塞作为二线治疗 NSCLC 的方案安全且可能比培美曲塞单药更有效。TTFields 改善了治疗场内的疾病控制，计划开展 III 期研究进一步探讨其在 NSCLC 中的新型治疗作用。
