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一项评估厄洛替尼(特罗凯)治疗的非小细胞肺癌患者中 ¹⁸F-氟代脱氧葡萄糖 PET-CT 的 II 期研究;6 周和 12 周时的客观和症状应答。

A phase II study of ¹⁸F-fluorodeoxyglucose PET-CT in non-small cell lung cancer patients receiving erlotinib (Tarceva); objective and symptomatic responses at 6 and 12 weeks.

机构信息

Royal Marsden Hospital, Downs Road, Sutton, Surrey SM2 5PT, United Kingdom.

出版信息

Eur J Cancer. 2012 Jan;48(1):68-74. doi: 10.1016/j.ejca.2011.10.033. Epub 2011 Nov 24.

Abstract

BACKGROUND

The aim of this study was to assess if (18)F-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)-CT scanning could minimise the time non-responding patients were exposed to erlotinib (Tarceva).

METHODS

Patients were selected for clinical factors that would predict response to erlotinib. A FDG PET-CT and diagnostic contrast-enhanced (traditional) CT scan were carried out at baseline, and then a FDG PET-CT at 6 weeks and a traditional CT at 12 weeks were repeated. The primary end-point was rate of early progression in patients after 6 weeks, of which a minimum 12 out of 35 were required to make the study worthwhile. The responses at 6 (PET-CT) and 12 weeks (traditional CT) were compared and correlated with symptomatic response at both these time points.

RESULTS

Forty seven patients were recruited with 38 and 33 patients assessable by FDG PET-CT at 6 weeks and traditional CT at 12weeks, respectively. There was good correlation between Partial response (PR) at both time points and all 10 patients who had a PR at 12 weeks had a PR at 6 weeks. Of the 13 patients with progressive disease (PD) at 12 weeks, seven had PD at 6 weeks and could have had their treatment stopped early. No evaluable patient with stable disease (SD) (8/38) or PD (9/38) on FDG PET-CT at 6 weeks went on to have a later response. Symptomatic response at 6 or 12 weeks did not correlate well with objective response on scanning at either time point.

CONCLUSIONS

The primary end-point of this study was met as >12 (15/38) patients could have stopped treatment early on the basis of the FDG PET-CT scan result. A FDG PET-CT evaluable response of SD or PD at 6 weeks does predict future lack of response. No correlation was found between response and symptomatic response at either 6 or 12 weeks.

摘要

背景

本研究旨在评估 18 氟-脱氧葡萄糖(FDG)正电子发射断层扫描(PET-CT)扫描是否可以减少时间非应答患者暴露于厄洛替尼(特罗凯)。

方法

患者因可能预测对厄洛替尼反应的临床因素而被选择。在基线时进行 FDG PET-CT 和诊断性对比增强(传统)CT 扫描,然后在 6 周时重复 FDG PET-CT 和在 12 周时重复传统 CT。主要终点是 6 周后患者的早期进展率,需要至少 35 例中的 12 例才能使研究有价值。比较 6 周(PET-CT)和 12 周(传统 CT)时的反应,并与这两个时间点的症状反应相关。

结果

共招募了 47 例患者,其中 38 例和 33 例患者可通过 6 周的 FDG PET-CT 和 12 周的传统 CT 评估。在两个时间点的部分反应(PR)之间有很好的相关性,并且在 12 周时所有 10 例 PR 患者在 6 周时均有 PR。在 12 周时进展性疾病(PD)的 13 例患者中,有 7 例在 6 周时 PD,可能已经可以提前停止治疗。在 6 周时无可评估的稳定疾病(SD)(8/38)或 PD(9/38)的患者随后出现后期反应。在 6 周或 12 周时的症状反应与扫描时的客观反应之间相关性不好。

结论

本研究的主要终点已经达到,因为基于 FDG PET-CT 扫描结果,有 15/38 例以上的患者可以提前停止治疗。在 6 周时的 SD 或 PD 的 FDG PET-CT 评估反应确实预测了未来的缺乏反应。在 6 周或 12 周时,反应与症状反应之间均无相关性。

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