Investigator
Chinese Academy Of Medical Sciences Peking Union Medical College
The necessity of adjuvant surgery for patients with high-risk chemorefractory or relapsed gestational choriocarcinoma with complete remission after anti-PD-1 therapy
Anti-programmed cell death protein 1 (PD-1) therapy has demonstrated favorable therapeutic responses in patients with chemorefractory gestational trophoblastic neoplasia. The need for combined surgery to remove resistant foci in patients treated with anti-PD-1 therapy after complete remission (CR), however, has not been investigated. We therefore compared the prognosis of patients with high-risk chemorefractory or relapsed choriocarcinoma who underwent anti-PD-1 therapy with or without surgery. Patients with high-risk chemorefractory or relapsed choriocarcinoma who experienced CR following immunotherapy in conjunction with either surgical or non-surgical interventions were selected at Peking Union Medical College Hospital (PUMCH) between August 2018 and December 2023. Study endpoints included progression-free survival (PFS) and overall survival (OS). The results were analyzed using Mann-Whitney U tests and Kaplan-Meier analysis. Forty-three patients who received andi-PD-1 therapy were enrolled in this study, including 18 patients with surgery and 25 without. Most of the foci in the surgery group were solitary (77.8%). The median maximum diameters of resistant foci before immunotherapy were 2.9 (0.7-7.3) cm and 1.4 (0.8-11.2) cm in the surgery and non-surgery groups, respectively (p=0.184). The 2-year PFS rate was both 91.5% in the non-surgery group and 90.9% in the surgery group. The 2-year and 3-year OS rates were 100.0% in both groups. There was no significant difference in PFS (p=0.849) or OS (p=0.371) between the 2 groups. These results suggest that surgical resection of drug-resistant lesions may not be necessary in patients with high-risk chemorefractory or relapsed choriocarcinoma who achieve CR after anti-PD-1 therapy.
Toripalimab combined with bevacizumab plus chemotherapy as first-line treatment for refractory recurrent or metastatic cervical cancer: a single-arm, open-label, phase II study (JS001-ISS-CO214)
To evaluate the efficacy and safety of adding toripalimab to bevacizumab and platinum-based chemotherapy as first-line treatment for refractory recurrent or metastatic (R/M) cervical cancer (CC). Patients were administered toripalimab (240 mg) + bevacizumab (7.5 mg/kg) combined with platinum-based chemotherapy once every three weeks for six cycles, followed by the maintenance therapy involving toripalimab + bevacizumab once every 3 weeks for 12 months or when disease progression or intolerable toxicity occurred. The primary endpoint was the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1. The secondary endpoints were safety profiles, disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Twenty-four patients were enrolled in this study and in the final analysis. The median follow-up duration was 18.6 (range, 3.3-28.5) months. The ORR was 83.3% (95% confidence interval [CI]=62.6-95.3) and the DCR was 95.8% (95% CI=78.9-99.9); 9 (37.5%) patients achieved complete response, 11 (45.8%) achieved partial response, and 3 (12.5%) had stable disease. The median PFS was 22.6 (95% CI=10.4-34.7) months and the median OS was not reached. The most common grade 3 treatment-related adverse events (AEs) were neutropenia (41.7%) and leukopenia (16.7%). The most common immune-related AEs (irAEs) were thyroid dysfunction (37.5%) and increased adrenocorticotropic hormone (37.5%) and serum cortisol levels (33.3%). No grade ≥3 irAEs were observed. Toripalimab combined with bevacizumab and platinum-based chemotherapy show promising clinical efficacy and favorable safety profile, providing an alternative first-line treatment option for patients with R/M CC. ClinicalTrials.gov Identifier: NCT04973904.
Toripalimab Combined With Chemotherapy and Bevacizumab as First-Line Treatment in Patients With Advanced Cervical Cancer
This is a single-arm, multicenter, phase II study to investigate efficacy and safety of Toripalimab combined with chemotherapy (paclitaxel and cisplatin) and Bevacizumab as first-line treatment in patients with recurrent, refractory and metastatic cervical cancer
