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e-Poster Display Session

56P - Efficacy and safety of nivolumab (Nivo) in recurrent and/or metastatic platinum-refractory squamous cell carcinoma of head and neck (R/M SCCHN): A real-world data study

Date

09 Dec 2020

Session

e-Poster Display Session

Presenters

Juan José Soto Castillo

Citation

Annals of Oncology (2020) 31 (suppl_7): S1428-S1440. 10.1016/annonc/annonc391

Authors

J.J. Soto Castillo, J. Esteban Villarrubia, P. Alvarez Ballesteros, P. Garrido Lopez, A. Soria Rivas

Author affiliations

  • Hospital Universitario Ramon y Cajal, Madrid/ES
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Abstract 56P

Background

Nivo prolonged overall survival (OS) and was associated with fewer adverse events compared to standard therapy in patients with platinum-refractory R/M SCCHN, as the CheckMate 141 trial showed. Progression-free survival (PFS) improvement is difficult to achieve in this disease, with few additional therapeutic options, as well as symptomatic control, specially in elderly patients (EP) who present significant local morbidity.

Methods

We retrospectively reviewed R/M SCCHN patients treated with Nivo (3 mg/kg every 2 weeks) after platinum-based therapy, from March 2017 to August 2020, in our institution. Efficacy (PFS and response rates (RR) of different disease locations) and safety profile (immune-related adverse events (irAEs)) in EP (≥70 yr) were collected. Stata 15.1 was used for the statistic analysis.

Results

Thirty patients were included. Mean age was 66.7 yr (50-89), men represented 73.3% and ECOG 0-1 was present in 93.3%. Tumor primary site was oral cavity 30%, oropharynx 20%, hypopharynx 13.3%, larynx 20% and unknown origin 13.3%. 20% had loco regional disease, 33.3% had distant metastases and 46.6% had both. Nivo constituted the 2nd line of treatment in 90% of patients. Median number of immunotherapy cycles was 9 (3-38). In the overall population, RR was 33.3% (partial response 23.3%, complete response 10%). Median PFS was higher in patients who only had metastatic disease, compared to patients who presented both loco regional and metastatic disease (8.8 vs. 5.1 months). RR was higher in metastatic lesions than in loco regional disease (41.6% vs. 20%). Regarding toxicity, 30% irAEs were reported. There were no statistically significant differences in terms of irAEs incidence between patients <70 and ≥70 yr (38.4% vs. 50%; p = 0.528). Three grade 3-4 irAEs occured (1 G3 gastritis, 1 G4 colitis and 1 G3 psoriasiform disorder). The development of serious irAEs was significantly associated with higher probability of response (100% vs. 30%; p = 0.008).

Conclusions

Our retrospective study suggest that 2nd line therapy with Nivo for R/M SCCHN provide higher RR in metastatic lesions, without increasing toxicity in EP. High-grade irAEs could be a good predictive response factor.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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