Abstract 2576
Background
Surgical salvage is often the only potentially curative treatment in patients with recurrent head and neck squamous cell carcinoma (HNSCC). However, local control rates after salvage remain at 33-50% with a dismal long term overall survival of 20-40%. Many patients are ineligible for re-irradiation and chemotherapy alone has no survival benefit after salvage surgery necessitating new therapies. Although immune checkpoint inhibitors have demonstrated clinical activity in the metastatic setting, immunotherapy has not been explored after salvage surgery. Therefore, we initiated a multi-center Phase II investigation of adjuvant nivolumab after salvage resection in HNSCC patients (NCT03355560) supported by BMS.
Methods
HNSCC patients who failed definitive radiation, subsequently treated with curative intent salvage resection, were enrolled to receive 6 months of nivolumab beginning 4 to 11 weeks after surgery. Safety was evaluated with CTCAE v5.0 and disease free survival (DFS) was evaluated using time to event endpoints and Kaplan-Meier curves.
Results
Eighteen of 35 planned patients have been enrolled. Median age is 70 years (range, [45-85]), 4/18 (22%) were female, 17/18 (94%) were white, disease sites included oropharyngeal 3/18 (17%), oral cavity 8/18 (44%) and larynx 7/18 (39%), and 5/18 (28%) had high risk (positive margins or extranodal spread) pathological features. Four patients have recurred with DFS estimated at 55% at 10.2 months. Although estimated DFS is less than the predicted 62.3% DFS at 10.2 months (extrapolated from 2-year DFS of 33%), the chi-square p-value was 0.861 suggesting there is not enough evidence to reject the null hypothesis and the trial should proceed to the 2nd stage. Most common adverse events included fever (22%), fatigue (17%), arthralgias (22%), cough (28%) and infections (28%) most of which were unrelated. Grade 3 related events included arthralgia and cough.
Conclusions
Adjuvant nivolumab after salvage surgery in HNSCC patients is safe however, increased enrollment is required to establish efficacy.
Clinical trial identification
NCT03355560.
Editorial acknowledgement
Legal entity responsible for the study
Trisha Wise-Draper.
Funding
BMS.
Disclosure
T. Wise-Draper: Research grant / Funding (self): BMS; Research grant / Funding (self): AstraZeneca; Research grant / Funding (self): Merck; Research grant / Funding (institution): Tesaro. All other authors have declared no conflicts of interest.
Resources from the same session
3664 - Longitudinal changes in cell-free DNA (cfDNA) methylation levels identify early non-responders to treatment in advanced solid tumors
Presenter: Andrew Davis
Session: Poster Display session 3
Resources:
Abstract
3212 - Multigene panel testing results for hereditary breast cancer in 1325 individuals: implications for gene selection and considerations for guidelines.
Presenter: Georgios Tsaousis
Session: Poster Display session 3
Resources:
Abstract
2591 - PIK3R5 genetic predictors of hypertension induced by VEGF-pathway inhibitors
Presenter: Julia Quintanilha
Session: Poster Display session 3
Resources:
Abstract
4377 - ERBB2 mRNA as a predictor in HER2-positive (HER2+)/hormone receptor-positive (HR+) metastatic breast cancer (BC) treated with HER2 blockade in combination with endocrine therapy (ET): a retrospective analysis of the ALTERNATIVE and SOLTI-PAMELA trials.
Presenter: Nuria Chic
Session: Poster Display session 3
Resources:
Abstract
3439 - Early on-treatment vs pre-treatment tumor transcriptomes as predictors of response to neoadjuvant therapy for HER2-positive inflammatory breast cancer
Presenter: Sonia Pernas
Session: Poster Display session 3
Resources:
Abstract
2512 - AXL expression predicts poor prognosis and lack of efficacy of anti-angiogenic and anti-epidermal growth factor receptor (EGFR) agents in patients (pts) with RAS wild type (WT) metastatic colorectal cancer (mCRC)
Presenter: Claudia Cardone
Session: Poster Display session 3
Resources:
Abstract
4061 - Prevalence of EGFR mutations and its correlation with Egyptian patients’ human kinetics (PEEK Study)
Presenter: Adel Ibrahim
Session: Poster Display session 3
Resources:
Abstract
2547 - Evaluation of tumor microenvironment identifies immune correlates of response to combination immunotherapy with margetuximab (M) and pembrolizumab (P) in HER2+ gastroesophageal adenocarcinoma (GEA)
Presenter: Sergio Rutella
Session: Poster Display session 3
Resources:
Abstract
4671 - Clinicopathological and molecular criteria assessment for the screening of hypermutated proficient mismatch repair (pMMR) colorectal cancers (CRC) with exonucleasic domain POLE (edPOLE) mutations (mt).
Presenter: Benoit Rousseau
Session: Poster Display session 3
Resources:
Abstract
3862 - Tumor mutation burden and microsatellite instability in colorectal cancer
Presenter: Francesca Fenizia
Session: Poster Display session 3
Resources:
Abstract