ECOG 2 局部晚期非小细胞肺癌患者同步放化疗的疗效和安全性：一项随机 III 期试验的亚组分析。
Efficacy and safety of concurrent chemoradiotherapy in ECOG 2 patients with locally advanced non-small-cell lung cancer: a subgroup analysis of a randomized phase III trial.
机构信息
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17 Panjiayuannanli, Chaoyang District, Beijing, 100021, China.
Department of Radiation Oncology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
出版信息
BMC Cancer. 2020 Apr 6;20(1):278. doi: 10.1186/s12885-020-06780-x.
BACKGROUND
There is no consensus on the therapeutic approach to ECOG 2 patients with locally advanced non-small-cell lung cancer (LA-NSCLC), despite the sizable percentage of these patients in clinical practice. This study focused on the efficacy, toxicity and the optimal chemotherapy regimen of CCRT in ECOG 2 patients in a phase III trial.
METHODS
Patients capable of all self-care with bed rest for less than 50% of daytime were classified as ECOG 2 subgroup. A subgroup analysis was performed for ECOG 2 patients recruited in the phase III trial receiving concurrent EP (etoposide + cisplatin)/PC (paclitaxel + carboplatin) chemotherapy with intensity-modulated radiation therapy (IMRT) or three-dimensional conformal external beam radiation therapy (3D-CRT).
RESULTS
A total of 71 ECOG 2 patients were enrolled into the study. Forty-six (64.8%) patients were treated with IMRT technique. The median overall survival (OS) and progression free survival (PFS) for ECOG 2 patients were 16.4 months and 9 months, respectively. No difference was observed in treatment compliance and toxicities between ECOG 2 patients and ECOG 0-1 patients. Within the ECOG 2 group (31 in the EP arm and 40 in the PC arm), median OS and 3-year OS were 15.7 months and 37.5% for the EP arm, and 16.8 months and 7.5% for the PC arm, respectively (p = 0.243). The incidence of grade ≥ 3 radiation pneumonitis was higher in the PC arm (17.5% vs. 0.0%, p = 0.014) with 5 radiation pneumonitis related deaths, while the incidence of grade 3 esophagitis was numerically higher in the EP arm (25.8% vs. 10.0%, p = 0.078).
CONCLUSIONS
CCRT provided ECOG 2 patients promising outcome with acceptable toxicities. EP might be superior to PC in terms of safety profile in the setting of CCRT for ECOG 2 patients. Prospective randomized studies based on IMRT technique are warranted to validate our findings.
TRIAL REGISTRATION
ClinicalTrials.gov registration number: NCT01494558. (Registered 19 December 2011).
背景
尽管临床上有相当大比例的 ECOG 2 患者，但对于局部晚期非小细胞肺癌（LA-NSCLC）的 ECOG 2 患者，其治疗方法尚无共识。本研究在一项 III 期试验中聚焦于 CCRT 对 ECOG 2 患者的疗效、毒性和最佳化疗方案。
方法
能够自理，白天卧床休息少于 50%的患者被归类为 ECOG 2 亚组。对 III 期试验中接受同期 EP（依托泊苷+顺铂）/PC（紫杉醇+卡铂）化疗联合调强放疗（IMRT）或三维适形外照射放疗（3D-CRT）的 ECOG 2 患者进行亚组分析。
结果
共有 71 例 ECOG 2 患者入组本研究。46（64.8%）例患者接受 IMRT 技术治疗。ECOG 2 患者的中位总生存期（OS）和无进展生存期（PFS）分别为 16.4 个月和 9 个月。ECOG 2 患者与 ECOG 0-1 患者的治疗依从性和毒性无差异。在 ECOG 2 组（EP 组 31 例，PC 组 40 例）中，EP 组中位 OS 和 3 年 OS 分别为 15.7 个月和 37.5%，PC 组分别为 16.8 个月和 7.5%（p=0.243）。PC 组的 3 级及以上放射性肺炎发生率较高（17.5%比 0.0%，p=0.014），有 5 例与放射性肺炎相关的死亡病例，而 EP 组的 3 级食管炎发生率较高（25.8%比 10.0%，p=0.078）。
结论
CCRT 为 ECOG 2 患者提供了有希望的结果，且毒性可耐受。在 ECOG 2 患者的 CCRT 中，EP 组在安全性方面可能优于 PC 组。需要前瞻性随机研究来验证我们的发现。
试验注册
ClinicalTrials.gov 注册号：NCT01494558。（2011 年 12 月 19 日注册）
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