SCI

1 March 2023

Durvalumab and PET-directed chemoradiation in locally advanced esophageal adenocarcinoma – A phase Ib/II study

 (IF: Ann Surg., 13.787)

Cowzer D, Wu AJ, Sihag S, Walch HS, Park BJ, Jones DR, Gu P, Maron SB, Sugarman R, Chalasani SB, Shcherba M, Capanu M, Chou JF, Choe JK, Nosov A, Adusumilli PS, Yeh R, Tang LH, Ilson DH, Janjigian YY, Molena D, Ku GY. Durvalumab and pet-directed chemoradiation in locally advanced esophageal adenocarcinoma - a phase ib/ii study. Ann Surg. 2023 Feb 10. 

Correspondence:Geoffrey Ku, MD，300 E. 66th Street, Rm 1035，New York, NY 10065，Tel: 646-888-4588，Email: kug@mskcc.org

Objective 目的 

To determine the safety and efficacy of adding the anti-PD-1 antibody durvalumab to induction FOLFOX and preoperative chemotherapy in locally advanced esophageal adenocarcinoma.

为了确定在局部晚期食管腺癌中加入抗PD-1抗体度伐利尤单抗以诱导FOLFOX和术前化疗的安全性和有效性。

Background 背景 

Neoadjuvant induction FOLFOX followed by PET directed chemoradiation has demonstrated improved survival for esophageal adenocarcinoma. There is clear benefit now for the addition of immune checkpoint inhibitors both in early and advanced stage disease. Given these results we investigated the safety and efficacy of adding durvalumab to induction FOLFOX and preoperative chemoradiotherapy.

新辅助诱导FOLFOX和PET导向的化学辐射已证明，食管腺癌的生存率有所提高。现在在早期和晚期疾病中添加免疫检查点抑制剂有明显的益处。鉴于这些结果，我们研究了在诱导FOLFOX和术前放化疗中加入度伐利尤单抗的安全性和有效性。

Methods 方法 

Patients with locally advanced resectable esophageal/GEJ adenocarcinoma received PET directed chemoradiation with durvalumab prior to esophagectomy. Patients who had R0 resections received adjuvant durvalumab 1,500mg every 4 weeks for 6 treatments. The primary endpoint of the study was pathologic complete response (pCR).

局部晚期可切除食管/GEJ腺癌患者在食管切除术前接受了度伐利尤单抗PET定向化疗。R0切除的患者每4周接受一次辅助度伐利尤单抗1500mg，共6次治疗。研究的主要终点是病理完全缓解（pCR）。

Results 结果 

We enrolled 36 patients, 33 of whom completed all preoperative treatment and underwent surgery. Preoperative treatment was well tolerated, with no delays to surgery nor new safety signals. pCR was identified in 8 (22% [one-sided 90% lower bound: 13.3%]) patients with mPR in 22 (61% [one sided 90% lower bound: 50%]) patients. Twelve and 24-month OS was 92% and 85% respectively.

我们招募了36名患者，其中33人完成了所有术前治疗并接受了手术。术前治疗耐受性良好，没有延期手术，也没有新的安全信号。8例（22% [单侧90%下限：13.3%]）mPR患者中发现pCR，22例（61% [单侧90%上限：50%]）患者中发现mPR。12个月和24个月OS分别为92%和85%。

Conclusions 结论 

The addition of durvalumab to induction FOLFOX and PET directed CRT prior to surgery is safe, with a high rate of pathologic response, as well as encouraging survival data.

在手术前将度伐利尤单抗添加到诱导FOLFOX和PET定向CRT中是安全的，具有较高的病理缓解率，以及令人鼓舞的生存数据。

来源 | 健康界

版权归原作者所有，若有违规、侵权请联系我们