Abstract 5262
Background
ICI is a standard of care in R/M HNSCC pts progressing to platinum compounds. However, few pts respond to ICI and irAEs could limit their use.There are contradictory reports regarding the association of irAEs and outcomes to ICI. The aim of this study is to further evaluate the potential impact of irAEs on outcomes for HNSCC.
Methods
We performed a retrospective observational study based on all R/M HNSCC pts treated by ICI in our center during 2014-19. To limit the bias due to the association between ICI administration duration, obtention of objective response (OR) and occurrence of irAE, a Landmark analysis method with 90 days (d) cut-off was used.
Results
We included 103 R/M HNSCC pts (80% male, 73% smokers). Primary tumor locations were: oropharynx (42%), oral cavity (23%), hypopharynx (18%) and larynx (17%). ICI were administered as monotherapy (43%) or combination (57%; CTLA-4 inhibitor, ICOS agonist). There were 14 responders (R) with median time to obtain OR of 102 d (8 after 90 d). Median ICI duration was 376 d in R pts and 84 d in others. irAEs were observed in 38 pts (37%), with low frequency of grade (G) 3-4 (6%). Occurrence of irAEs within the first 90 d (named early AEs) was observed in 25 pts (24%). 51 pts (50%) remained on ICI beyond 90 d, including all the 14 R: 30 pts (59%) had irAEs and 17 (33%) had early irAEs. In total cohort, OR was more frequent in pts with any irAE (32%) than in others (3%). Results were similar with irAE G2-4: 42% OR vs 5% OR. But, using landmark method, in pts who received ≥ 90 d ICI, this association was no longer observed: 35% of pts with early irAEs had OR vs 24% in other pts (p = 0.37), and 36% vs 25% for early irAEs of G2-4 (p = 0.47). Median [95%CI] PFS and OS were 3.6 months (m) [2.9-4.5] and 10.6m [7.6-13.2] in total cohort; 5.8 m [4.8-7.7] and 19.1 m [12.6-32.5] in ICI ≥90 d. Early irAEs were not associated with PFS or OS in this latter subgroup.
Conclusions
The impact of irAEs on outcomes could be mistaken if not taking into consideration the ICI duration because the likelihood of irAEs and OR increases with treatment duration. Using a Landmark analysis with 90 d cut-off, we did not observe an association between irAEs and outcome in R/M HNSCC.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
N. Baste Rotllan: Advisory / Consultancy, Travel / Accommodation / Expenses: Merck Serono; Advisory / Consultancy: MSD; Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol Meyers Squibb; Advisory / Consultancy, Travel / Accommodation / Expenses: Nanobiotix; Honoraria (institution), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (institution): PharmaMar. All other authors have declared no conflicts of interest.
Resources from the same session
4614 - Predictors of Response to Checkpoint Inhibitors in Naïve and Ipilimumab-Refractory Melanoma
Presenter: Domenico Mallardo
Session: Poster Display session 3
Resources:
Abstract
2901 - IFN-γ/IL-10 ratio as predictive biomarker for response to anti-PD-1 therapy in metastatic melanoma patients
Presenter: Emilio Giunta
Session: Poster Display session 3
Resources:
Abstract
2306 - Multiplex Chromogenic Immunohistochemistry (IHC) for Spatial Analysis of Checkpoint-Positive Tumor Infiltrating Lymphocytes (TILs)
Presenter: Scott Ely
Session: Poster Display session 3
Resources:
Abstract
1678 - The role of PD-L1 expression as a predictive biomarker in advanced renal cell carcinoma: a meta-analysis of randomized clinical trials.
Presenter: Alberto Carretero-Gonzalez
Session: Poster Display session 3
Resources:
Abstract
5138 - Radiomic Features as a Non-invasive Biomarker to Predict Response to Immunotherapy in Recurrent or Metastatic Urothelial Carcinoma
Presenter: Kye Jin Park
Session: Poster Display session 3
Resources:
Abstract
5800 - Integrative combination of high-plex digital profiling techniques and cluster analysis to reveal complex immune biology in the tumor microenvironment of mesothelioma
Presenter: Carmen Ballesteros-Merino
Session: Poster Display session 3
Resources:
Abstract
5736 - Predictive factors of response to immunotherapy in 198 patients with metastatic non-microcytic lung cancer (mNSCLC): real world data from 2 university hospitals in Spain
Presenter: Juan Felipe Cordoba Ortega
Session: Poster Display session 3
Resources:
Abstract
5645 - Evaluating Lung CT Density Changes Among Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC) Treated with Thoracic Radiotherapy (TRT) alone or TRT Followed by Combined Ipilimumab (IPI) and Nivolumab (NIVO).
Presenter: Kujtim Latifi
Session: Poster Display session 3
Resources:
Abstract
1540 - Immuno-oncology therapy biomarkers differences between polyoma-virus positive and negative Merkel cell carcinomas
Presenter: Zoran Gatalica
Session: Poster Display session 3
Resources:
Abstract
4538 - Can we improve patient selection for phase 1 clinical trials (Ph1) based on Immuno-Oncology score prognostic index (VIO)?
Presenter: Ignacio Matos Garcia
Session: Poster Display session 3
Resources:
Abstract