Real-world data of nivolumab (nivo) in squamous cell cancer of the head and neck (SCCHN) are still very limited. In addition, predictive tools to identify patients (pts) that will benefit from PD-1 inhibitors are lacking.
Retrospective study of pts with SCCHN treated with nivo from 4 third-level hospitals in Spain. Demographics, objective response rate (ORR), duration of response (DOR), time to progression (PD) in responders (TPR), PD-free survival (PFS), overall survival (OS), safety, and predictive value of baseline NLR (NLRBL), NLR at progression (NLRPD), NRL at 12 weeks (NLR12WK) and change in NLR between baseline and 12 weeks after starting IO (NLRBL-12WK), were evaluated. Results expressed as medians (min-max or 95%CI).
Between January 2017 and March 2019, 34 pts (male: n = 26). Age 63 y (51-92). Primary subsite: Larynx (n = 6), oropharynx (n = 12; HPV+: 2), oral cavity (n = 12; HPV+: 4), hypopharynx (n = 6), nasopharynx (n = 1), parotid gland (n = 1). Lines for LA/R-M diseases pre-nivo: 2 (0-4). Strict platinum-refractory pre-nivo: n = 15 (44%). Eight pts (23.5%) received nivo as first-line. Five pts (15%) continued nivo beyond PD. Eight pts (24%) ³1 line post-nivo. No. of nivo cycles: 10 (2-46). ORR: 41% (2 CR, 12 PR, 11 SD, 9 PD). DOR: 16 weeks (2-57). TPR: 29 weeks (12-68). After follow-up (F-U) of 5 m (1-14), estimated PFS: 6 m (95%CI: 3,4-8,6). After F-U of 6,5 m (1-26), estimated OS: 19 m (95%CI 14,6-23,4). Median NLRBL: 3.43 (1.63-7.56). Longer OS with NLRBL < 3.43 vs > 3.43: 22.5 vs 14.5 m (P = 0.072). Among 22 pts with evaluable NLR12WK, median NLR12WK: 3.92 (1.33-22). Longer PFS with NLR12WK < 3.92 vs > 3.92: 9 vs 4 m (P = 0.046). Median NLRBL-12WK: 1.58 (0.12-14.86). No difference in OS or PFS between NLRBL-12WK < 1.58 vs > 1.58 (P = 0.59; P = 0.84). Toxicity G1-2: 73%; G3: 2% (diarrhea).
Baseline and 12-wk NLR may allow to distinguish between long and short-term survivors. Improved response rates and survival in our series may be explained by the lower rate of platinum-refractory disease and the use of nivolumab in the first-line setting as well as beyond progression in a substantial proportion of patients. Treatment was well tolerated. These results merit confirmation in a larger sample.
The authors.
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S. Cabezas-Camarero: Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Advisory / Consultancy: Bristol-Myers Squibb; Travel / Accommodation / Expenses: Bristol-Myers Squibb. All other authors have declared no conflicts of interest.