928P - Prognostic value of body composition and nutritional assessment in recurrent/metastatic squamous cell carcinoma of head and neck (R/M SCCHN) treated with immunotherapy (IO)

Background

Low skeletal muscle index (SMI) and malnutrition (MN) have been associated with poor outcomes in R/M SCCHN patients (pts) treated with IO. The “Immuno-Nutri” study (NCT04721184) evaluates the impact of SMI and MN on outcomes in R/M SCCHN pts treated with IO.

Methods

Single-institutional, prospective observational study recruiting IO-naïve R/M SCCHN pts treated with IO alone or in combination. Planned accrual = 120 pts. A CT scan at L3 vertebra level is performed to assess SMI. MN was evaluated by Patient-Generated Subjective Global Assessment (PG-GSA). Clinical, nutritional and body composition data were collected. Overall response rate (ORR) was evaluated with RECISTv.1.1. Median overall survival (mOS) and progression-free-survival (mPFS) were estimated by Kaplan-Meier; multivariant analysis (MVA) and logistic regression were performed to identify predictors of PFS/OS and ORR, respectively.

Results

61 pts were recruited between 01/2021-04/2023 and 49 had response evaluation at data cut-off (see table). With a median follow up of 9 months (m), mPFS was 2.5m (CI95% 2.1-4.4) and mOS 11.7m (CI95% 8-NR); SMI and MN had no effect on PFS nor OS, only locoregional+metastatic recurrence negatively impacted on OS (HR 3.5 CI95% 1.1-19 p=0.04). In pts treated with IO alone, type of recurrence impacted in both PFS (HR 3.8 CI95% 1.2-13 p=0.03) and OS (HR 4.5 CI95% 1.1-19 p=0.04); a trend for MN in PFS was noted [HR 3 CI95% 0.9-10 p=0.06]. ORR trended to be enhanced in high SMI pts (HR 0.9 CI95% 0.8-1 p=0.06).

Table: 928P

Cohort characteristics

*Continuous variables: mean (standard deviation)

Conclusions

Preliminary results showed a high SMI could predict IO response but did not impact on PFS/OS. Accrual continues and further analysis are on-going.

Clinical trial identification

NCT04721184.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Department of Health, Government of Catalonia (Spain).

Disclosure

Z. Vidales Sepulveda: Non-Financial Interests, Personal, Other, Travel and accommodation: MSD; Financial Interests, Personal, Research Grant: IPSEN; Financial Interests, Personal, Other, Travel and accommodation: Pierre Fabre, Merck. S. Llop Serna: Financial Interests, Personal, Other, Travel and accommodation: BMS, MSD, Merck. J. Brenes Castro: Financial Interests, Personal, Advisory Board, Travel and accommodation: Takeda, Sanofi, MSD, Merck. M. Plana Serrahima: Financial Interests, Advisory Board: BMS; Financial Interests, Invited Speaker: MSD; Financial Interests, Institutional, Other: Nanobiotix. C.M. Juarez Lozano: Financial Interests, Personal, Other, Travel and accommodation: Merck. M. Oliva: Financial Interests, Personal, Other, Travel and accommodation: Merck, MSD. L. Arribas: Financial Interests, Personal, Other: Nestle. All other authors have declared no conflicts of interest.