Abstract 934P
Background
Locally advanced hypopharyngeal carcinoma (LAHC), an aggressive type of head and neck cancer (HNC), generally exhibits poor prognosis. Currently, The programmed death 1 inhibitors, implicated in antitumor activity, emerge as meaningful option in patients with recurrent or metastatic HNC, but the role of camrelizumab remains uncertain. Aim to determine effects and safety of induction therapy of camrelizumab plus TPF (docetaxel, cisplatin, and capecitabine) in LAHC.
Methods
In this single-arm, phase 2, prospective, and single-center trial, patients with T3-4aN0-3M0 LAHC received induction therapy for three cycles: camrelizumab 200 mg on day 1, docetaxel 75 mg/m2 on day 1, cisplatin 25 mg/m2 on day 1-3, capecitabine 800 mg/m2 bid on day 1-14, every three weeks. Patients were assigned to radiotherapy and immunotherapy if they had a complete response or partial response (PR) or assigned to surgery and adjuvant (chemo)radiotherapy if they had stable disease (SD) or progressive disease that was defined by using a tumor volume evaluation system. Camrelizumab was maintained postradiotherapy and immunotherapy for a total of 18 doses. This trial was registered with ClinicalTrials.gov, No. NCT04156698 and is ongoing.
Results
Fifty-one patients were enrolled from May 21, 2020, to April 15, 2023, and the mean duration of follow-up was 16.5 ± 8.7 months. After induction therapy, 42 (82.4%) patients showed PR, and 9 (17.6%) showed SD. Treatment-related adverse events were recorded, leading to treatment suspension in 9 (17.6%) patients but no death. The most common adverse event was alopecia (100%), followed by RCCEP (90.2%), nausea/vomiting (84.3%), and fatigue (58.8%) in the induction therapy period. Twenty-six (51.0%) patients experienced grade 3 or 4 induction therapy-related adverse events. The two-year overall survival, progression-free survival, and laryngeal function preservation rates were 85.5%,72.8%, and 65.4%, respectively.
Conclusions
Camrelizumab plus TPF was well tolerated and demonstrated effective antitumor activity in LAHC, indicating future therapy options of camrelizumab as antitumor MAb for advanced HNC.
Clinical trial identification
NCT04156698.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
This study was supported by the National Natural Science Foundation of China (81502343 and 81972529), Clinical Research Plan of SHDC (SHDC2020CR6011), the Science and Technology Commission of Shanghai Municipality (21Y11900100 and 19411961300).
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
878P - INHBA is overexpressed in HPV-negative oropharyngeal squamous cell carcinoma and contributes to an aggressive phenotype
Presenter: Simon Laban
Session: Poster session 12
880P - ctHPV16-DNA in Liquid Biopsy: A promising biomarker to monitor disease status in patients with HPV-positive oropharyngeal squamous cell carcinoma
Presenter: Nora Würdemann
Session: Poster session 12
881P - SOTO study: Prospective study to correlate the treatment sensitivity of patient-derived organoids (PDOs) with treatment outcomes in head and neck cancer patients
Presenter: Ifigenia Vasiliadou
Session: Poster session 12
882P - Claudin-1 (CLDN1) expression in head and neck squamous cell carcinoma (HNSCC) patients
Presenter: Stefano Cavalieri
Session: Poster session 12
884P - Prognostic value and immune characteristics of LGALS1 in head and neck squamous cell carcinoma
Presenter: Yanfei Min
Session: Poster session 12
885P - Clinical significance of folate receptor-positive circulating tumor cells detected by ligand-targeted polymerase chain reaction in nasopharyngeal carcinoma
Presenter: Dingyi Wang
Session: Poster session 12
887P - Antitumor activity of the radioenhancer NBTXR3 on injected lesions to estimate overall survival: Exploratory analyses from a phase I in cisplatin-ineligible locally advanced HNSCC patients
Presenter: Christophe Le Tourneau
Session: Poster session 12
888P - Phase I study of olaparib combined with loco-regional radiotherapy in patients with head and neck squamous cell carcinoma
Presenter: Marcel Verheij
Session: Poster session 12