413MO - Impacts of time-of-day of nivolumab infusion on treatment efficacy for patients with head and neck squamous cell carcinoma

Background

Nivolumab, an immune checkpoint inhibitor (ICI), is the standard treatment for platinum-resistant head and neck squamous cell carcinoma (HNSCC). Recent studies in other cancer types demonstrate that earlier time-of-day infusion of ICIs prolongs progression-free-survival (PFS) and overall survival (OS). We aimed to investigate how the time-of-day patterns of nivolumab infusion affect the efficacy of HNSCC treatment.

Methods

We conducted a retrospective analysis of 123 HNSCC patients who received more than 2 courses of nivolumab monotherapy between April 2017 and November 2023 at Aichi Cancer Center Hospital and examined the impact of nivolumab infusion timing on efficacy. PFS and OS were evaluated using univariate and multivariable COX proportional hazards regression.

Results

We divided the 123 patients into two groups: the early group, comprising patients who received more than 20% of all nivolumab infusions before 12:00, and the late group, comprising patients who received less than 20%. Sixty-two patients were classified in the early group and 61 patients were in the late group. There were no significant differences in patient characteristics between the two groups. With the median observation period was 12 months (0-78), the early group showed longer PFS and OS compared to the late group (1-year PFS 25% vs. 13% p=0.049; 1-year OS 65% vs 48%, p=0.047). Multivariate analysis, including major factors such as age, ECOG PS, metastatic organs, and infusion time group, indicated that the early group would prolong PFS (HR0.58 95%CI 0.34-0.98 p=0.047) and OS (HR0.56 95%CI 0.31-1.00 p=0.048).

Conclusions

Early infusion of nivolumab for HNSCC may be associated with improved treatment efficacy. Our results align with mechanisms of chrono-immunology and are in line with similar studies conducted previously in melanoma, lung and gastrointestinal cancer. Further prospective randomized trials are warranted.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Aichi Cancer Center Hospital.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.