Neoadjuvant camrelizumab plus chemotherapy for resectable, locally advanced esophageal squamous cell carcinoma (NIC-ESCC2019): a multicenter, phase 2 study
Mené sur 56 patients atteints d'un carcinome épidermoïde de l'oesophage de stade localement avancé et résécable, cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse pathologique complète, et la toxicité du camrélizumab en combinaison avec une chimiothérapie néoadjuvante
Optimal treatment for resectable esophageal squamous cell carcinoma (ESCC) is controversial, especially in the context of potential benefit of combining PD-1 blockade with neoadjuvant therapy. This phase 2 study aimed to assess neoadjuvant camrelizumab plus chemotherapy in this population. Patients (clinical stage II-IVA) received two cycles of neoadjuvant chemoimmunotherapy (NIC) with camrelizumab (200 mg on day 1) plus nab-paclitaxel (260 mg/m2 in total on day 1 and day 8) and cisplatin (75 mg/m2 in total on days 1 to 3) of each 21-day cycle. Surgery was performed approximately six weeks after completion of NIC. Primary endpoint was complete pathologic response (CPR) rate in primary tumor. Secondary endpoints were objective response rate (ORR) per RECIST v1.1, two-year progression-free survival (PFS) rate after surgery, PFS, overall survival (OS), and safety during NIC and perioperative period. Between Jan 17, 2020 and Dec 8, 2020, 56 patients were enrolled, and 51 received esophagectomy. Data cutoff date was Aug 25, 2021. The CPR rate was 35.3% (95% CI, 21.7%-48.9%). NIC had an ORR of 66.7% (95% CI, 40.0%-70.4%) and treatment-related adverse events (TRAEs) of low severity (grade 1-2, 75.0%; grade 3, 10.7%; grade 4-5, no). No perioperative mortality occurred. Three (5.9%) patients had tumor recurrence and one (2.0%) patient died. The two-year PFS rate, median PFS, and median OS had not been reached yet. Camrelizumab plus neoadjuvant chemotherapy in resectable ESCC demonstrates promising efficacy with acceptable toxicity, providing a feasible and effective option. Study is ongoing for long-term survival analyses.