First-Line Immun-Checkpoint-Inhibitor-Therapy: Real World Data – Relevance of M0 versus M1 situation

Introduction Immune checkpoint inhibitors (ICI) have been shown to be effective in recurrent/metastatic head and neck cancer (rmHNSCC),. Here, the impact of the indication of recurrence and/or metastasis remains unclear. To investigate the relevance of M0/M1 status on the response of rmHNSCC to ICI in first-line therapy, we retrospectively analyzed patients with rmHNC who received checkpoint inhibitors.

Material and methods We retrospectively examined clinical data from 52 patients who received first-line therapy with ICI during 2017-2021. Objective complete response rate and organ-specific response rate were determined for each lesion according to iRECIST criteria as follows: Response (RP) – complete (CR), partial (PR), no (NRP).

Results 52 patients received first-line therapy with an ICI – 12 (23%) due to local recurrence (M0) and 40 (77%) due to distant metastasis with/without local recurrence (M1). 19 (37%) patients showed treatment response (7 CR, 12 PR), 33 (63%) were NR. Considering the M0 versus M1 situation, 4 vs. 3 patients showed CR and 1 vs. 11 showed PR. Comparing M0 vs. MI, there was no significant difference between RP and NRP, although patients with CR showed a disproportionate response in the M0 group (4 of 12 – 33.3%) compared to the M1 group (3 of 40 – 7.5%). No effect on response was found for CPS.

Conclusion More responders tended to be found in the Real World Data group than in the pivotal study and there appears to be a positive trend in CR toward M0 status. Whereas the small numbers of patients in each subgroup requires investigation in larger patient collectives.

Publication History

Article published online:
12 May 2023