Toripalimab Plus Concurrent Chemoradiation Produces Activity in Locally Advanced Cervical Cancer

Toripalimab and concurrent chemoradiation (CCRT) elicited encouraging activity with acceptable tolerability in patients with locally advanced cervical cancer, according to data from a Chinese trial (ChiCTR2000032879) presented during the 2022 ASCO Annual Meeting.¹

At a median follow-up of 10 months (range, 2.20-16.73), the 3-month objective response rate (ORR) achieved with this approach was 95.5% among 22 patients. Moreover, the local control (LC) rate was 100%, the progression-free survival (PFS) rate was 90.1%, and the overall survival (OS) rate was 95.5%.

“Longer follow-up results and further phase 2/3 studies are expected,” lead study author Dan Ou, MD, of the Department of Radiation Oncology at Ruijin Hospital, Shanghai Jiaotong University School of Medicine, and colleagues, wrote in a poster on the data.

The trial enrolled 22 patients with locally advanced cervical cancer, irrespective of PD-L1 status.

Study participants received cisplatin at 40 mg/m² once weekly for 5 weeks, external irradiation at 45 Gy to 50 Gy/25 Fx to 28 Fx for 5 fractions a week, followed by brachytherapy at 24 Gy to 30 Gy/3 Fx to 5 Fx, and toripalimab at 240 mg on days 1, 22, and 43.

Safety and feasibility served as the primary end points of the trial. Key secondary end points comprised ORR, PFS rate, LC rate, and OS rate.

The median age of patients was 55 years (range, 42-72); 2 patients had FIGO stage II disease, 15 had stage IIIC disease, and 5 had stage IVA disease. All participants successfully received CCRT.

Regarding safety, 45.5% of patients (n = 10/22) experienced adverse effects (AEs) that were grade 3 or higher. Notably, no patients experienced a grade V AE.

The most common AEs reported in those who received toripalimab and CCRT were leukopenia (grade 1, 4.5%; grade 2, 50%; grade 3, 36.4%), neutropenia (grade 1, 22.7%; grade 2, 27.3%; grade 3, 27.3%), anemia (grade 2, 4.5%), thrombocytopenia (grade 1, 31.8%; grade 2, 13.6%; grade 3, 9.1%), nausea (grade 1, 36.4%; grade 2, 31.8%; grade 3, 9.1%), vomiting (grade 1, 9.1%; grade 2, 9.1%; grade 3, 9.1%), hypothyroidism (grade 2, 9.1%), and hypokalemia (grade 4, 4.5%).

At a data cutoff of January 31, 2022, 1 patient developed several metastases 3 months following treatment. One patient developed lung metastasis at 6 months following treatment.

Reference

Ou D, Xu H. Toripalimab combined with chemoradiotherapy for locally advanced cervical squamous cell carcinoma patients. J Clin Oncol. 2022;40(suppl 16):5538. doi:10.1200/JCO.2022.40.16_suppl.5538