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帕尼单抗在化疗初治的虚弱或老年 RAS 野生型结直肠癌患者中的 II 期研究:OGSG1602 最终结果。

The Phase II Study of Panitumumab in Chemotherapy-Naïve Frail or Elderly Patients with RAS Wild-type Colorectal Cancer: OGSG 1602 Final Results.

机构信息

Cancer Chemotherapy Center, Osaka Medical and Pharmaceutical University, Takatsuki-City, Japan.

Department of Gastroenterological Surgery, National Hospital Organization Osaka National Hospital, Higashiosaka, Japan.

出版信息

Oncologist. 2023 Jul 5;28(7):e565-e574. doi: 10.1093/oncolo/oyac145.

DOI:10.1093/oncolo/oyac145
PMID:35947993
原文链接:
https://pmc.ncbi.nlm.nih.gov/articles/PMC10322121/
Abstract

BACKGROUND

We previously reported the response rate of a phase II OGSG1602 study on panitumumab in chemotherapy-naive frail or elderly patients with RAS wild-type unresectable colorectal cancer (CRC) [Terazawa T, Kato T, Goto M, et al. Oncologist. 2021;26(1):17]. Herein, we report a survival analysis.

METHODS

Patients aged ≥65 years and considered unsuitable for intensive chemotherapy or aged ≥76 years were enrolled. Primary tumors located from the cecum to the transverse colon were considered right-sided tumors (RSTs); those located from the splenic flexure to the rectum were considered left-sided tumors (LSTs).

RESULTS

Among the 36 enrolled patients, 34 were included in the efficacy analysis, with 26 and 8 having LSTs and RSTs, respectively. The median progression-free survival (PFS) and overall survival (OS) were 6.0 [95% CI, 5.4-10.0] and 17.5 months (95% CI, 13.8-24.3), respectively. Although no significant differences existed in PFS between patients with LST and RST {6.6 (95% CI, 5.4-11.5) vs. 4.9 months [95% CI, 1.9-not available (NA), P = .120]}, there were significant differences in OS [19.3 (95% CI, 14.2-NA) vs.12.3 months (95% CI, 9.9-NA), P = .043].

CONCLUSION

Panitumumab showed favorable OS in frail or elderly patients with RAS wild-type CRC and no prior exposure to chemotherapy. Panitumumab may be optimal for patients with LSTs (UMIN Clinical Trials Registry Number UMIN000024528).

摘要

背景

我们之前报道了 OGSG1602 期研究中帕尼单抗在 RAS 野生型不可切除结直肠癌(CRC)初治虚弱或老年患者中的缓解率[Terazawa T, Kato T, Goto M, et al. Oncologist. 2021;26(1):17]。在此,我们报告一项生存分析。

方法

纳入年龄≥65 岁且不适合强化化疗或年龄≥76 岁的患者。起始肿瘤位于盲肠至横结肠之间被认为是右侧肿瘤(RST);起始肿瘤位于脾曲至直肠被认为是左侧肿瘤(LST)。

结果

在纳入的 36 例患者中,34 例纳入疗效分析,其中 26 例为 LST,8 例为 RST。中位无进展生存期(PFS)和总生存期(OS)分别为 6.0 个月(95%CI,5.4-10.0)和 17.5 个月(95%CI,13.8-24.3)。尽管 LST 和 RST 患者的 PFS 无显著差异[6.6 个月(95%CI,5.4-11.5)vs.4.9 个月(95%CI,1.9-不可评估(NA),P=.120],但 OS 存在显著差异[19.3 个月(95%CI,14.2-NA)vs.12.3 个月(95%CI,9.9-NA),P=.043]。

结论

帕尼单抗在未经化疗治疗的 RAS 野生型 CRC 虚弱或老年患者中表现出良好的 OS。帕尼单抗可能是 LST 患者的最佳选择(UMIN 临床研究注册编号 UMIN000024528)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c6ea/10322121/7e3b50045c2d/oyac145_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c6ea/10322121/403ed371bf76/oyac145_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c6ea/10322121/1bc5ae35506c/oyac145_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c6ea/10322121/35a113bd559b/oyac145_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c6ea/10322121/7e3b50045c2d/oyac145_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c6ea/10322121/403ed371bf76/oyac145_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c6ea/10322121/1bc5ae35506c/oyac145_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c6ea/10322121/35a113bd559b/oyac145_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c6ea/10322121/7e3b50045c2d/oyac145_fig4.jpg

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