TABLE 1.

Baseline Characteristics

ParameterPatients (n = 33)
Age (y)Median, 64.5; range, 49–80
Sex (n)
 Male26, 79%
ECOG PS (n)
 010, 30%
 123, 70%
Smoking (n)
 Current4, 12%
 Never or former29, 88%
Alcohol (n)
 Current24, 73%
 Never or former9, 27%
Primary tumor location (n)
 Hypopharynx4, 13%
 Larynx7, 22%
 Oral cavity10, 30%
 Oropharynx8, 24%
 Unknown3, 10%
Disease extent at baseline (n)
 Loco/regional recurrence12, 36%
 Metastatic disease21, 64%
Location metastases
 Lung28, 45%
 Lymph node24, 39%
 Bone5, 8%
 Other (liver, adrenal gland, muscle)4, 8%
Prior treatments with curative intent* (n)
 Surgery alone3, 9%
 Surgery with adjuvant radiation8, 24%
 Surgery with adjuvant chemoradiation9, 27%
 Radiation alone5, 15%
 Chemoradiation8, 24%
Time from last platinum therapy (n)
 ≤6 mo1, 6%
 >6 mo16, 94%
Histologic/cytologic biopsy
 Archival17, 52%
 Fresh16, 48%
PD-L1 status (n)
 PD-L1 CPS < 113, 40%
 PD-L1 CPS 1–208, 24%
 PD-L1 CPS ≥ 206, 18%
 No assessment possible6, 18%
  • * Chemotherapy regimen included monotherapy cisplatin or carboplatin, or combination regimens, for example, docetaxel, cisplatin and 5-fluorouracil or carboplatin and 5-fluorouracil.

  • A fresh biopsy was defined as histologic or cytologic tumor biopsy performed at study enrollment up to < 1 mo before study enrollment.

  • PD-L1 assessment was performed on biopsy tissue from R/M disease. PD-L1 staining was performed using VENTANA SP263.

  • ECOG PS = Eastern Cooperative Oncology Group performance status.

  • Data are median and range, or n and %.