Department of Surgery, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi, Tokyo, 173-8606, Japan.
Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan.
BMC Gastroenterol. 2024 Sep 2;24(1):295. doi: 10.1186/s12876-024-03382-w.
Pembrolizumab plus cisplatin and 5-fluorouracil administered as first-line therapy for advanced esophageal cancer patients has shown a better objective response and survival than conventional chemotherapy with less severe hematological adverse events. The safety and efficacy of this regimen were evaluated in patients with T4b esophageal squamous cell carcinoma (ESCC).
Eight consecutive patients with T4b ESCC received this regimen according to KEYNOTE-590 as induction, and they were evaluated after 1-3 courses. The programmed death-ligand 1 (PD-L1) combined positive score (CPS) was also evaluated before chemotherapy. Efficacy for the primary lesion was evaluated by our original formula for the tumor reduction rate.
The numbers of patients with partial response (PR), stable disease, and progressive disease (PD) were 5, 1, and 2, respectively. The tumor reduction rate ranged from 69 to 87% in PR patients, and all PR patients had relief from T4b. Two patients underwent conversion surgery with R0 resection. PD-L1 CPS was over 90 in 2 PR patients, but under 10 in 2 other PR patients. PD-L1 CPS was under 10 in PD patients. One patient had hyperprogression, resulting in an esophago-pulmonary fistula. Greater than grade 3 adverse events were bleeding gastric ulcer in one patient (12.5%), neutropenia without G-CSF in 3 patients (37.5%), and hypopotassemia in 1 patient (12.5%). No patient had febrile neutropenia.
Marked tumor reduction was confirmed in 62.5% of patients with pembrolizumab plus cisplatin and 5-fluorouracil with less adverse events. This regimen could be administered as induction chemotherapy for patients with T4b ESCC.
帕博利珠单抗联合顺铂和氟尿嘧啶作为一线治疗晚期食管癌患者的方案，与常规化疗相比，具有更好的客观缓解率和生存率，且血液学不良事件更轻微。本研究评估了该方案在 T4b 食管鳞癌（ESCC）患者中的安全性和有效性。
连续 8 例 T4b ESCC 患者按照 KEYNOTE-590 方案接受诱导治疗，1-3 个疗程后进行评估。在化疗前还评估了程序性死亡配体 1（PD-L1）联合阳性评分（CPS）。通过我们提出的肿瘤退缩率公式评估原发病灶的疗效。
部分缓解（PR）、疾病稳定（SD）和疾病进展（PD）患者的数量分别为 5、1 和 2。PR 患者的肿瘤退缩率为 69%至 87%，所有 PR 患者 T4b 缓解。2 例患者接受了 R0 切除的转化手术。2 例 PR 患者的 PD-L1 CPS 超过 90，而另外 2 例 PR 患者的 PD-L1 CPS 低于 10。PD 患者的 PD-L1 CPS 低于 10。1 例患者发生超进展，导致食管-肺瘘。1 例患者（12.5%）发生严重出血性胃溃疡，3 例患者（37.5%）发生中性粒细胞减少而未使用 G-CSF，1 例患者（12.5%）发生低钾血症。无发热性中性粒细胞减少症患者。
帕博利珠单抗联合顺铂和氟尿嘧啶治疗 62.5%的患者肿瘤显著退缩，且不良反应较少。该方案可作为 T4b ESCC 患者的诱导化疗。
