Department of Medical Oncology, Complexo Hospitalario Universitario de Vigo, Clara Campoamor 341, 36312, Vigo, Spain.
Department of Medical Oncology, Complexo Hospitalario Universitario de Ourense, Ourense, Spain.
Clin Transl Oncol. 2018 Nov;20(11):1467-1473. doi: 10.1007/s12094-018-1880-x. Epub 2018 Apr 25.
The aim of this phase II study was to evaluate the activity and safety of the combination of cisplatin and vinorelbine with thoracic radiotherapy in unresectable locally advanced stage III non-small cell lung cancer (NSCLC). The primary endpoint was the objective response rate (ORR). Secondary objectives included toxicity profile, progression-free survival (PFS), and overall survival (OS).
A total of 48 NSCLC patients were enrolled (median age 60 years, 52% stage IIIA and 48% stage IIIB, 52% adenocarcinoma). Patients received three cycles of chemotherapy every 21 days [intravenous cisplatin 80 mg/m and intravenous vinorelbine 25 mg/m on day 1 and oral vinorelbine on day 8 (60 mg/m)] concurrent with radiotherapy (66 Gy, administered at 1.8 Gy per day, five consecutive days per week).
ORR was 79.2% (72.9% showing partial response and 6.3% showing complete response). With a median follow-up of 20.7 months, median PFS was 12 months and median OS was 36 months. Grade 3/4 toxicities were: neutropenia (14.5%), anaemia (6.2%), vomiting (2%), and oesophagitis (4.2%). No toxic deaths were reported.
This combined regimen shows efficacy and a manageable safety profile. PFS and OS outcomes are encouraging and warrant further research.
本 II 期研究旨在评估顺铂和长春瑞滨联合胸部放疗治疗不可切除局部晚期 III 期非小细胞肺癌（NSCLC）的疗效和安全性。主要终点为客观缓解率（ORR）。次要目标包括毒性谱、无进展生存期（PFS）和总生存期（OS）。
共纳入 48 例 NSCLC 患者（中位年龄 60 岁，52%为 IIIA 期，48%为 IIIB 期，52%为腺癌）。患者接受每 21 天 3 个周期的化疗[静脉注射顺铂 80mg/m 和长春瑞滨 25mg/m，第 1 天和第 8 天（60mg/m）口服长春瑞滨]，同时进行放疗（66Gy，每天 1.8Gy，每周连续 5 天）。
ORR 为 79.2%（72.9%显示部分缓解，6.3%显示完全缓解）。中位随访 20.7 个月，中位 PFS 为 12 个月，中位 OS 为 36 个月。3/4 级毒性为：中性粒细胞减少（14.5%）、贫血（6.2%）、呕吐（2%）和食管炎（4.2%）。无治疗相关死亡报告。
该联合方案显示出疗效和可管理的安全性。PFS 和 OS 结果令人鼓舞，值得进一步研究。
