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根据 RECIST 标准,初始部分缓解和疾病稳定表明晚期非小细胞肺癌化疗患者的生存情况相似。

Initial partial response and stable disease according to RECIST indicate similar survival for chemotherapeutical patients with advanced non-small cell lung cancer.

机构信息

Department of Medical Oncology, The First Hospital, China Medical University, NO,155, North Nanjing Street, Heping District, Shenyang City, China.

出版信息

BMC Cancer. 2010 Dec 14;10:681. doi: 10.1186/1471-2407-10-681.

Abstract

BACKGROUND

Stable disease (SD) has ambiguous clinical significance for patients according to the dominant Response Evaluation Criteria in Solid Tumours (RECIST). The primary aims of the study were: (1) to clarify the clinical significance of SD by comparing the progression-free survival (PFS) of response and SD patients with advanced non-small cell lung cancer (NSCLC) after the first two courses of the standard first-line platinum-based chemotherapy; (2) to explore the relationship between the percentage change in tumour size and PFS among initial SD patients, in order to provide some guidance for clinicians in deciding continuation/termination of the current treatment at a relative early time.

METHODS

A total of 179 advanced NSCLC patients whose baseline CT image was available for review were included in the study. Another CT image was taken in the initial assessment after chemotherapy. A comparison of PFS between initial partial response (PR) and SD was used to determine whether significant differences exist. The relationship between the early percentage of change in tumour size of initial SD patients and their PFS was investigated. In addition, overall survival (OS), the secondary endpoint in this study, was investigated as well.

RESULTS

Patients with initial PR are not significantly distinguished from those with initial SD when their PFS is concerned (median PFS 249 days [95% confidence interval, 187-310 days] versus 220 days [95% confidence interval, 191-248 days], p > 0.05). Their median OS was 364 days (95% confidence interval, 275-452 days) for the initial PR patients versus 350 days (95% confidence interval, 293-406 days) for the initial SD patients, which suggests no significant difference as well p > 0.05). In addition, all the initial SD patients enjoyed similar PFS and OS.

CONCLUSIONS

Initial PR and SD enjoy similar PFS and OS for patients with advanced NSCLC. Within the initial SD subgroup, different percentages of tumour shrinkage or increase undergo similar PFS and OS. RECIST remains a reliable norm in assessing the effectiveness of chemotherapy for patients with advanced NSCLC before functional assessment has been integrated into the criteria.

摘要

背景

根据实体瘤反应评估标准(RECIST),稳定疾病(SD)对患者的临床意义并不明确。本研究的主要目的是:(1)通过比较初治晚期非小细胞肺癌(NSCLC)患者标准一线铂类化疗前两个疗程后有反应和 SD 的患者的无进展生存期(PFS),来阐明 SD 的临床意义;(2)探索初始 SD 患者肿瘤大小变化百分比与 PFS 之间的关系,为临床医生在相对较早的时间决定是否继续/终止当前治疗提供一些指导。

方法

共纳入 179 例基线 CT 图像可评估的晚期 NSCLC 患者。化疗后进行初始评估时,再进行一次 CT 检查。比较初始部分缓解(PR)和 SD 的 PFS,以确定是否存在显著差异。还研究了初始 SD 患者早期肿瘤大小变化百分比与 PFS 的关系。此外,还研究了本研究的次要终点总生存期(OS)。

结果

当涉及到 PFS 时,初始 PR 患者与初始 SD 患者没有显著区别(中位 PFS 249 天[95%置信区间,187-310 天]与 220 天[95%置信区间,191-248 天],p>0.05)。初始 PR 患者的中位 OS 为 364 天(95%置信区间,275-452 天),初始 SD 患者的中位 OS 为 350 天(95%置信区间,293-406 天),差异无统计学意义(p>0.05)。此外,所有初始 SD 患者的 PFS 和 OS 相似。

结论

对于晚期 NSCLC 患者,初始 PR 和 SD 具有相似的 PFS 和 OS。在初始 SD 亚组中,肿瘤缩小或增大的不同百分比经历相似的 PFS 和 OS。在功能评估纳入标准之前,RECIST 仍然是评估晚期 NSCLC 患者化疗疗效的可靠标准。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70d8/3018460/4ad65d9bb105/1471-2407-10-681-1.jpg

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