Abstract 930P
Background
Immune-checkpoint inhibitors (ICI) are currently the standard of care as a first line treatment for pts with R/M HNSCC. There is limited data on the impact of adding PT to ICI in this population.
Methods
We retrospectively analyzed pts with R/M HNSCC who received first line ICI alone or along with PT, between July 1st 2016 and November 1st 2022. We collected data on original tumor site, P-16 status, combined positive score (CPS), absolute lymphocyte count (lymph) prior to starting ICI, time elapsed between finishing radiation to the original tumor site and starting ICI (RT-ICI), response to therapy, progression free survival (PFS), and overall survival (OS). PFS was defined as the time from ICI initiation and disease progression or death. OS was defined as the time from ICI initiation and death. Descriptive statistics were used to explore study variables.
Results
Of the 207 pts analyzed, 81% were male, median age 61 years (IQR: 56, 68). Tumor site: Oropharynx 85 (41%), oral cavity 54 (26%), others 68 (33%). 138 pts (67%) received ICI alone, 69 (33%) PT+ICI triweekly. 64 pts (31%) had RT-ICI of less than 6 months (mo). 144 pts (70%) had CPS available. CPS values: 0 (43 [30%]), 1-20 (50 [35%]), 21-100 (51 [35%]). Median follow-up: PFS: 4.4 mo (IQR: 2.3, 9.8), OS: 8.5 mo (IQR: 3.7, 17.7). Overall response rate (ORR): PT+ICI (33%), ICI (16%), p=0.002. Median survival time: PFS: 4.5 mo (95% CI: 4, 6.2), OS: 11 mo (95% CI: 8.8, 14.3). Median OS: PT+ICI: 15.4 mo (95% CI: 11.3, –), ICI: 9.1 mo (95% CI: 7.1, 13), p=0.062. On multivariable analysis for OS: PT+ICI had reduced hazard compared to ICI (HR: 0.79, 95% CI: 0.53, 1.17, p=0.2); P-16 positive had reduced hazard compared to p-16 negative (HR: 0.46, 95% CI: 0.31, 0.68, p <0.001); high lymph compared to low lymph (HR: 0.48, CI: 0.32, 0.73, p <0.001); CPS of 1-20 and 21-100 had reduced hazard compared to CPS of 0 (HR: 0.72, 95% CI: 0.44, 1.2; HR: 0.48, 95% CI: 0.29, 0.82; respectively, p=0.024); RT-ICI of more than 6 mo had reduced hazard compared to 0-6 mo (HR: 0.68, 95% CI: 0.47, 0.99; p=0.11).
Conclusions
In pts with R/M HNSCC, the addition of PT to ICI was associated with better ORR. Negative P-16, low lymph, CPS of 0, and relapse within 6 mo of finishing RT, were all associated with worse survival outcomes.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
818TiP - REFRaME-O1/ENGOT-OV79/GOG-3086: A phase II/III open-label study evaluating the efficacy and safety of luveltamab tazevibulin versus investigator’s choice of chemotherapy in women with relapsed platinum-resistant epithelial ovarian cancer expressing folate receptor alpha (FolRα)
Presenter: R. Wendel Naumann
Session: Poster session 12
819TiP - FONTANA: A phase I/IIa study of AZD5335 as monotherapy and in combination with anti-cancer agents in patients with solid tumours
Presenter: Funda Meric-Bernstam
Session: Poster session 12
820TiP - A randomized phase II study of secondary cytoreductive surgery (CRS) in patients with relapsed ovarian cancer who have progressed on PARP inhibitor maintenance (KGOG 3067/SOCCER-P trial)
Presenter: Hyun-woong Cho
Session: Poster session 12
821TiP - Phase I study of ceralasertib (cerala) in combination with AZD5305 in patients (pts) with advanced/metastatic ovarian cancer (OC) previously treated with PARP inhibitors (PARPis)
Presenter: Geoffrey Shapiro
Session: Poster session 12
862P - Clinical utility of circulating tumor HPV16 DNA detection in plasma from oropharyngeal squamous cell carcinoma patients
Presenter: Ana Carolina de Carvalho
Session: Poster session 12
863P - Microbiota and cytokines profile in patients (pts) affected by recurrent metastatic head and neck squamous cell carcinoma (R/M HNSCC) treated with immune checkpoint inhibitors (ICIs) +/- chemotherapy (CT) and prebiotic inulin in the PRINCESS study
Presenter: Danilo Galizia
Session: Poster session 12
864P - Serial cell-free tumor DNA in prognosing survival in patients with head and neck squamous cell carcinoma treated with upfront surgery
Presenter: Grégoire Marret
Session: Poster session 12
865P - Molecular analysis of surgical margins in early oral carcinomas (OSCC)
Presenter: Antoine Moya-Plana
Session: Poster session 12
866P - Prognostic performance of a genome-wide methylome enrichment platform in head and neck cancer
Presenter: Geoffrey Liu
Session: Poster session 12
867P - Predicting HPV-association using regular H&E slides can identify subgroups of patients with favorable prognosis at a highly detailed level
Presenter: Jens Peter Klussmann
Session: Poster session 12