<p>Efficacy of Nivolumab for Head and Neck Cancer Patients with Primary Sites and Histological Subtypes Excluded from the CheckMate-141 Trial</p>

Abstract

Background: In the CheckMate-141 trial, nivolumab conferred a survival benefit in patients with recurrent or metastatic refractory squamous cell carcinoma (SCC) head and neck cancer (HNC). Here, we examined the efficacy of nivolumab in patients with histological subtypes or primary sites of HNC not included in the CheckMate-141 trial. Methods: This was a retrospective analysis of data collected prospectively from 97 patients who were treated with nivolumab for recurrent or metastatic HNC at our institution. The patients were assigned to three groups based on HNC primary site: 1) oral cavity, pharynx, and larynx, which were included in CheckMate-141 (n = 68), 2) nasopharynx (excluded in CheckMate-141, n = 7) and 3) other primary sites excluded in CheckMate-141 (n = 22) and assigned to two groups according to histological subtype: 1) SCC (included in CheckMate-141, n = 83) and 2) non-SCC (all sites excluded in CheckMate-141, n = 14). Survival outcomes and nivolumab treatment response were compared between the primary site and histological subgroups. Results: The median number of nivolumab treatments was 7 cycles (range, 1-53 cycles) and the median follow-up time was 9.1 months (range, 0.66-33.0 months). There were no significant differences in response rates between the three primary site subgroups (CheckMate-141 sites 22%, nasopharynx 43%, others 18%; p=0) or the two histological subtype subgroups (SCC 25%, non-SCC 7%, p=0). Similarly, overall survival and progression-free survival were comparable for patients stratified by primary site or histological subtype. Conclusion: No significant difference in response rates or survival outcomes was detected between nivolumab-treated HNC patients with primary sites and histological subtypes that were included versus excluded in the CheckMate-141 trial. These data provide a potential rationale for nivolumab therapy for all HNC patients in clinical practice.

Intestinal Microbiome Associated With Immune-Related Adverse Events for Patients Treated With Anti-PD-1 Inhibitors, a Real-World Study

“…ICIs play antitumor effect through boosting the body’s natural defense against carcinoma cells. The high-speed development of immune checkpoint therapies was owing to their inspiring clinical efficacy in numbers of tumors ( 4 , 5 ). It has been widely evidenced that several host factors, including the expression level of PD-L1, tumor mutational burden (TMB), microsatellite instability (MSI), and gut microbiome diversity, can be used to predict the treatment outcomes of ICI treatment ( 6 , 7 ).…”

Quality-of-Life Evaluation of Patients with Unresectable Locally Advanced or Locally Recurrent Head and Neck Carcinoma Treated with Head and Neck Photoimmunotherapy

“…In the CheckMate 141 study [ 2 , 16 ], the median OS for nivolumab was 7.7 months (95% CI 5.7--8.8), with a 2-year OS rate of 16.9% (95% CI 12.4–22.0); the median PFS was 2.1 months (95% CI 2.0–3.4), and the ORR was 13.3%. Real-world studies of nivolumab in Japanese patients with head and neck cancer showed a median OS of 6.3–13.4 months, a median PFS of 2.5–6.5 months, and an ORR of 15.0–46.2% [ 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 ]. The results of the current study compared favorably with pharmacotherapy with immune checkpoint inhibitors.…”

Shooting at Moving and Hidden Targets—Tumour Cell Plasticity and the Notch Signalling Pathway in Head and Neck Squamous Cell Carcinomas

“…No validated tool for personalized medicine has been approved for clinical use, to identify beneficial, molecular, or targeted versus standard-of care therapies or potentially beneficial drug combinations to be prioritized over others. Nevertheless, different molecular subtypes have recently been identified in HNSCC [ 46 , 63 , 64 ] and nasopharyngeal carcinomas [ 65 ], mainly based on histological evaluation, single-cell sequencing, and genomic analysis. One critical distinction has been mentioned: between HPV + and HPV − cancers.…”