Zhang T W, Rodrigues G B, Louie A V, Palma D, Dar A R, Dingle B, Kocha W, Sanatani M, Yaremko B, Yu E, Younus J, Vincent M D
Department of Oncology, London Regional Cancer Program, London, ON.
Curr Oncol. 2018 Feb;25(1):22-31. doi: 10.347/co.25.3657. Epub 2018 Feb 28.
We designed a phase i study of concurrent chemoradiotherapy (ccrt) with docetaxel (D) and cisplatin (C), followed by consolidation dc, for unresectable stage iii non-small cell lung cancer (nsclc).
Patients with histologically proven and unresectable stage iii nsclc were eligible. During ccrt, C was given every 3 weeks (75 mg/m) and D given weekly. The starting dose of D was 20 mg/m, escalated in cohorts of 3 to define the maximum tolerated dose (mtd). Radiotherapy was prescribed to a dose of 60 Gy in 30 fractions. This was followed by 2 cycles of consolidation dc, which were dose escalated if ccrt was tolerated.
Twenty-six patients were enrolled, with 1 excluded following evidence of metastatic disease. Nineteen patients completed both phases of treatment. There were 7 grade 3 events during ccrt (5 esophagitis, 2 nausea), and 8 grade 3 events during consolidation (2 neutropenia, 2 leukopenia, 1 esophagitis, 2 nausea, and 1 pneumonitis). Three patients had grade 4 neutropenia. No patients died due to toxicities. The mtd of concurrent weekly D was 20 mg/m. Consolidation D and C were each dose escalated to 75 mg/m in 8 patients. The median overall survival (os) and progression-free survival (pfs) of all patients were 33.6 months and 17.2 months, respectively, with median follow-up of 26.6 months (range 0.43-110.8).
The use of docetaxel 20 mg/m weekly and cisplatin 75 mg/m every 3 weeks concurrent with thoracic radiotherapy, followed by consolidation docetaxel and cisplatin, both given at 75 mg/m every 3 weeks, appears to be safe in this phase i trial.
我们设计了一项针对不可切除的III期非小细胞肺癌（NSCLC）的I期同步放化疗（CCRT）研究，采用多西他赛（D）和顺铂（C）同步放化疗，随后进行巩固性DC化疗。
组织学确诊且不可切除的III期NSCLC患者符合条件。在CCRT期间，C每3周给药一次（75mg/m²），D每周给药一次。D的起始剂量为20mg/m²，以3例为一组逐步增加剂量以确定最大耐受剂量（MTD）。放疗剂量为60Gy，分30次给予。随后进行2个周期的巩固性DC化疗，如果CCRT耐受则增加剂量。
26例患者入组，1例因有转移疾病证据被排除。19例患者完成了两个治疗阶段。CCRT期间有7例3级事件（5例食管炎，2例恶心），巩固治疗期间有8例3级事件（2例中性粒细胞减少，2例白细胞减少，1例食管炎，2例恶心，1例肺炎）。3例患者出现4级中性粒细胞减少。无患者因毒性死亡。同步每周使用D的MTD为20mg/m²。8例患者的巩固性D和C剂量均增加至75mg/m²。所有患者的中位总生存期（OS）和无进展生存期（PFS）分别为33.6个月和17.2个月，中位随访时间为26.6个月（范围0.43 - 110.8）。
在这项I期试验中，每周使用20mg/m²多西他赛和每3周使用75mg/m²顺铂与胸部放疗同步，随后进行每3周75mg/m²的巩固性多西他赛和顺铂化疗，似乎是安全的。
