Second-line immune checkpoint inhibitor therapy: real world data – relevance of M0 versus M1 status.

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

Material and methods We retrospectively examined clinical data from 20 patients who received second-line therapy with ICI from 2017 to 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), none (NRP).

Results 20 patients received second-line ICI therapy – 3 (15%) due to local recurrence (M0) and 17 (85%) due to distant metastasis with/without local recurrence (M1). 6 (30%) patients showed treatment response (3 CR, 3 PR), 14 (63%) were NRP. Considering the M0 versus M1 situation, 2 (66.6%) vs. 1 (6%) patients showed CR and 1 (33.3%) vs. 2 (12%) showed PR. In the M0 vs. M1 comparison, there was a significant difference between RP and NRP – 100% vs. 18%; in patients with CR – 66.6% (2 of 3) vs. 12% (2 of 17). In the responder group, the CPS was as follows: 1x 60, 1x 15, 3 x 0, 1 x not determined.

Conclusion There was a good response rate to second-line therapy in the Real World Data group and there appears to be a positive trend in the response rate to ICI to M0 status. The small numbers of patients in each subgroup warrant investigation in larger patient collectives.

Publication History

Article published online:
12 May 2023