Department of Radiation Oncology, Shanghai Jiao Tong University, Shanghai, China.
Department of Thoracic Surgery, Shanghai Jiao Tong University, Shanghai, China.
J Immunother Cancer. 2022 Mar;10(3). doi: 10.1136/jitc-2021-004291.
Camrelizumab and chemotherapy demonstrated durable antitumor activity with a manageable safety profile as first-line treatment in patients with advanced esophageal squamous cell carcinoma (ESCC). This study aimed to evaluate the safety and efficacy of camrelizumab plus neoadjuvant chemotherapy, using pathologically complete response (pCR) as primary endpoint, in the treatment for locally advanced ESCC.
Patients with locally advanced but resectable thoracic ESCC, staged as T1b-4a, N2-3 (≥3 stations), and M0 or M1 lymph node metastasis (confined to the supraclavicular lymph nodes) were enrolled. Eligible patients received intravenous camrelizumab (200 mg, day 1) plus nab-paclitaxel (100 mg/m, day 1, 8, 15) and carboplatin (area under curve of 5 mg/mL/min, day 1) of each 21-days cycle, for two cycles before surgery. The primary endpoint is pCR rate in the per-protocol population. Safety was assessed in the modified intention-to-treat population that was treated with at least one dose of camrelizumab.
From November 20, 2019 to December 22, 2020, 60 patients were enrolled. 55 (91.7%) patients completed the full two-cycle treatment successfully. 51 patients underwent surgery and R0 resection was achieved in 50 (98.0%) patients. pCR (ypT0N0) was identified in 20 (39.2%) patients and 5 (9.8%) patients had complete response of the primary tumor but residual disease in lymph nodes alone (ypT0N+). 58 patients (96.7%) had any-grade treatment-related adverse events (TRAEs), with the most common being leukocytopenia (86.7%). 34 patients (56.7%) had adverse events of grade 3 or worse, and one patient (1.7%) occurred a grade 5 adverse event. There was no in-hospital and postoperative 30-day as well as 90-day mortality.
The robust antitumor activity of camrelizumab and chemotherapy was confirmed and demonstrated without unexpected safety signals. Our findings established camrelizumab and chemotherapy as a promising neoadjuvant treatment for locally advanced ESCC.
ChiCTR1900026240.
卡瑞利珠单抗联合化疗作为晚期食管鳞癌（ESCC）的一线治疗，具有持久的抗肿瘤活性和可控的安全性。本研究旨在评估卡瑞利珠单抗联合新辅助化疗在治疗局部晚期 ESCC 患者中的安全性和有效性，以病理完全缓解（pCR）为主要终点。
纳入局部晚期可切除的胸段 ESCC 患者，分期为 T1b-4a、N2-3（≥3 个部位）和 M0 或 M1 淋巴结转移（局限于锁骨上淋巴结）。符合条件的患者接受静脉注射卡瑞利珠单抗（200mg，第 1 天）联合 nab-紫杉醇（100mg/m2，第 1、8、15 天）和卡铂（AUC 为 5mg/mL/min，第 1 天），每 21 天为一个周期，共两个周期，然后进行手术。主要终点为方案人群中的 pCR 率。安全性评估在接受至少一剂卡瑞利珠单抗治疗的改良意向治疗人群中进行。
2019 年 11 月 20 日至 2020 年 12 月 22 日，共纳入 60 例患者。55 例（91.7%）患者成功完成了全两周期治疗。51 例患者接受了手术，50 例（98.0%）患者达到了 R0 切除。20 例（39.2%）患者达到了病理完全缓解（ypT0N0），5 例（9.8%）患者肿瘤完全缓解但淋巴结残留疾病（ypT0N+）。58 例（96.7%）患者出现任何级别的治疗相关不良事件（TRAEs），最常见的是白细胞减少（86.7%）。34 例（56.7%）患者发生 3 级或更高级别的不良事件，1 例（1.7%）患者发生 5 级不良事件。无院内及术后 30 天和 90 天死亡率。
卡瑞利珠单抗联合化疗具有较强的抗肿瘤活性，且未出现新的安全性信号。本研究结果证实了卡瑞利珠单抗联合化疗作为局部晚期 ESCC 有前景的新辅助治疗方案。
ChiCTR1900026240。
