Wei Zhigang, Ye Xin, Yang Xia, Huang Guanghui, Li Wenhong, Wang Jiao, Han Xiaoying
Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jingwuweiqi Road, Jinan, 250021, Shandong Province, China,
Med Oncol. 2015 Feb;32(2):464. doi: 10.1007/s12032-014-0464-z. Epub 2015 Jan 9.
The aim of the study was to determine survival benefit of the microwave ablation (MWA)/chemotherapy combination compared with chemotherapy alone. Patients with untreated, stage IIIB or IV NSCLC and at least one additional measurable site other than the ablative site were enrolled. They were divided into MWA/chemotherapy group and chemotherapy group. The primary endpoint was progression-free survival (PFS); secondary endpoints included response, time to local progression (TTLP), overall survival (OS), and adverse events (AEs). Forty-six and twenty-eight patients were enrolled in the MWA/chemotherapy group and chemotherapy group, respectively. Complete ablation was observed in 84.8 % patients in the MWA/chemotherapy group. Median TTLP was 27.0 months. Objective response rate and disease control rate in MWA/chemotherapy group were 21.7 and 76.1 %, and in the chemotherapy group were 32.1 % (p = 0.320) and 75.0 % (p = 0.916), respectively. MWA/chemotherapy combination prolonged PFS [MWA/chemotherapy group 10.9 (95 % CI 5.1-16.7) ms vs. chemotherapy group 4.8 (95 % CI 3.9-5.8) ms, p = 0.001] and tended to improve OS [MWA/chemotherapy group 23.9 (95 % CI 15.2-32.6) ms vs. chemotherapy group 17.3 (95 % CI 15.2-19.3) ms, p = 0.140]. Multivariate analyses showed that MWA was an independent prognostic factor of PFS and primary tumor size was an independent prognostic factor of OS. AEs of MWA were observed in 67.4 % patients. Chemotherapy-associated AEs were observed in 39.1 and 53.6 % of patients in the MWA/chemotherapy and chemotherapy group, respectively. MWA/chemotherapy combination improved PFS of advanced NSCLC compared to chemotherapy alone, and the combination did not increase the adverse events of chemotherapy.
本研究的目的是确定微波消融(MWA)/化疗联合治疗与单纯化疗相比的生存获益。纳入未经治疗的IIIB期或IV期非小细胞肺癌(NSCLC)患者,且除消融部位外至少有一个其他可测量部位。将他们分为MWA/化疗组和化疗组。主要终点是无进展生存期(PFS);次要终点包括缓解率、局部进展时间(TTLP)、总生存期(OS)和不良事件(AE)。MWA/化疗组和化疗组分别纳入了46例和28例患者。MWA/化疗组84.8%的患者观察到完全消融。中位TTLP为27.0个月。MWA/化疗组的客观缓解率和疾病控制率分别为21.7%和76.1%,化疗组分别为32.1%(p = 0.320)和75.0%(p = 0.916)。MWA/化疗联合治疗延长了PFS[MWA/化疗组10.9(95%CI 5.1 - 16.7)个月 vs. 化疗组4.8(95%CI 3.9 - 5.8)个月,p = 0.001],并倾向于改善OS[MWA/化疗组23.9(95%CI 15.2 - 32.6)个月 vs. 化疗组17.3(95%CI 15.2 - 19.3)个月,p = 0.140]。多因素分析显示,MWA是PFS的独立预后因素,原发肿瘤大小是OS的独立预后因素。67.4%的患者观察到MWA相关的AE。MWA/化疗组和化疗组分别有39.1%和53.6%的患者观察到化疗相关的AE。与单纯化疗相比,MWA/化疗联合治疗改善了晚期NSCLC的PFS,且该联合治疗未增加化疗的不良事件。