Abstract 1522P
Background
Preoperative chemoradiotherapy (CRT) is the current standard treatment for locally advanced oesophageal cancer in the world. In previous single-arm clinical trials, neoadjuvant camrelizumab (anti-PD-1 antibody) plus chemotherapy showed durable antitumor activity with a manageable safety profile in patients with locally advanced oesophageal squamous cell carcinoma (ESCC). In this multicenter, randomized, open-label, phase II REVO trial, we compared immunochemotherapy (ICT) with concurrent CRT as neoadjuvant therapy in patients with resectable thoracic ESCC using a non-inferiority design.
Methods
Patients were randomly assigned to two to four 21-day cycles of intravenous camrelizumab (200 mg, day 1) plus albumin-bound paclitaxel (125 mg/m2, days 1 and 8) and cisplatin (75 mg/m2, day 1), or two 21-day cycles of albumin-bound paclitaxel and cisplatin combined with concurrent radiotherapy (36-40Gy in 20 fractions, 5 days per week), followed by surgery. The primary endpoint was pathological complete response (pCR) rate.
Results
Between September 2021 and March 2023, 85 patients had been enrolled, and the enrolment is still ongoing. As of April 6, 2023, 32 of 41 and 28 of 44 patients underwent surgery in the ICT and CRT groups, respectively. All patients achieved R0 resection. The pCR (ypT0N0) and major pathological response (MPR) rates were 40.6% (13/32) and 62.5% (20/32) in the ICT group and 35.7% (10/28) and 71.4% (20/28) in the CRT group, respectively. The incidence of grade ≥3 treatment-related adverse events (TRAEs) was 22.0% in the ICT group and 31.8% in the CRT group. The most common grade ≥3 TRAE was decreased lymphocyte count (14.6%) in the ICT group, and decreased lymphocyte count (18.2%) and decreased platelet count (6.8%) in the CRT group. One patient in the CRT group died due to pneumonia after surgery.
Conclusions
The current results suggest that neoadjuvant camrelizumab plus chemotherapy is non-inferior to concurrent CRT for patients with locally advanced ESCC, with better safety. The final results and long-term survival will be reported in the future.
Clinical trial identification
NCT05007145.
Editorial acknowledgement
Legal entity responsible for the study
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Funding
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1468P - Patients’ perspective on tolerability of dostarlimab in NSCLC: Patient-reported outcomes from the phase II PERLA trial
Presenter: Martin Reck
Session: Poster session 21
1469P - The role of the CXCL12/CXCR4 pathway in the immunotherapy of non-small cell lung cancer
Presenter: Jacobo Rogado
Session: Poster session 21
1470P - Statin use and overall mortality in patients with advanced non-small cell lung cancer receiving anti-PD(L)1 immunotherapy: A SEER Medicare database analysis
Presenter: Joshua Reuss
Session: Poster session 21
1471P - Immunotherapy prolongs long-term real-world survival compared to chemotherapy for metastatic non-small cell lung cancer: A propensity score-matched analysis
Presenter: Kun Kim
Session: Poster session 21
1472P - Radiotherapy affects immunotherapy efficacy based on tumor mutation status in patients with metastatic NSCLC
Presenter: Shenduo Li
Session: Poster session 21
1473P - Efficacy of anti-PD1/PDL1 antibody monotherapy in patients with advanced non-small cell lung cancer with increased hepcidin expression
Presenter: Masaki Yamamoto
Session: Poster session 21
1474P - Outcome of nivolumab and ipilimumab-based therapy for advanced non-small cell lung cancer with low or negative PD-L1 expression
Presenter: Takafumi Fukui
Session: Poster session 21
1475P - Torque teno virus DNA load as biomarker for tumor response to mono immune checkpoint inhibition in non-small cell lung cancer
Presenter: Benthe Muntinghe
Session: Poster session 21
1476P - Outcomes to first-line pembrolizumab in patients with advanced NSCLC and high PD-L1 expression: A Spanish multicentric study
Presenter: Aida Piedra
Session: Poster session 21
1477P - STK11 mutations predict poor prognosis for advanced NSCLC treated with first-line immunotherapy or chemo-immunotherapy according to KRAS, TP53, KEAP1, and SMARCA4 status
Presenter: Andrea De Giglio
Session: Poster session 21