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Toripalimab plus intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma: an open-label single-arm, phase II trial
- Source :
- Journal for ImmunoTherapy of Cancer, Vol 9, Iss 11 (2021), Journal for Immunotherapy of Cancer
- Publication Year :
- 2021
- Publisher :
- BMJ Publishing Group, 2021.
-
Abstract
- BackgroundToripalimab is a humanized immunoglobulin G4 monoclonal antibody against programmed death 1. We aimed to investigate the efficacy and safety of toripalimab in combination with intensity-modulated radiotherapy (IMRT) for recurrent nasopharyngeal carcinoma (rNPC).MethodsWe conducted a single-arm, phase II trial with patients with rNPC who had biopsy-proven disease and were unsuitable for local surgery. Eligible patients received IMRT in combination with toripalimab administered via intravenous infusion of 240 mg once every 3 weeks for a maximum of seven cycles. The primary endpoint was the objective response rate at 3 months post radiotherapy. The secondary endpoints included safety profiles, progression-free survival (PFS).ResultsBetween May 2019 and January 2020, a total of 25 patients with rNPC were enrolled (18 men (72.0%) and 7 women (28.0%); median (IQR) age, 49.0 (43.5–52.5) years). With a median (IQR) follow-up duration of 14.6 months (13.1–16.2) months, 19 patients (79.2%) achieved an overall response, and disease control was achieved in 23 (95.8%) patients at 3 months post radiotherapy. The 12-month PFS was 91.8% (95% CI 91.7% to 91.9%). The incidences of acute (grade ≥3) blood triglyceride elevation, creatine kinase elevation, skin reaction, and mucositis were 1 (4.0%), 1 (4.0%), 2 (8.0%), and 1 (4.0%), respectively. The incidences of late severe (grade ≥3) nasopharyngeal wall necrosis, nasal bleeding, and trismus were 28.0%, 12.0%, and 4.0%, respectively.ConclusionsToripalimab combined with IMRT was tolerable and showed promising antitumor activity in patients with rNPC.Trial registration numberNCT03854838.
- Subjects :
- Adult
Male
Cancer Research
medicine.medical_specialty
medicine.medical_treatment
Immunology
Antibodies, Monoclonal, Humanized
Trismus
Gastroenterology
head and neck neoplasms
Internal medicine
Mucositis
Clinical endpoint
Humans
Immunology and Allergy
Medicine
radiotherapy
RC254-282
Clinical/Translational Cancer Immunotherapy
Pharmacology
clinical trials
Nasopharyngeal Carcinoma
biology
business.industry
phase II as topic
Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Middle Aged
medicine.disease
Clinical trial
Radiation therapy
Oncology
biology.protein
Molecular Medicine
Female
Creatine kinase
Recurrent Nasopharyngeal Carcinoma
immunotherapy
Radiotherapy, Intensity-Modulated
Intensity modulated radiotherapy
medicine.symptom
business
Subjects
Details
- Language :
- English
- ISSN :
- 20511426
- Volume :
- 9
- Issue :
- 11
- Database :
- OpenAIRE
- Journal :
- Journal for ImmunoTherapy of Cancer
- Accession number :
- edsair.doi.dedup.....848e5f2ea76b4892f9bc4910a90c71ee