934P - Antitumor activity and safety profile of camrelizumab plus docetaxel, cisplatin, and capecitabine for induction therapy in advanced stage hypopharyngeal carcinoma

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.