Table 1.
Baseline patient characteristics.
| Number of patients (%)a | |
|---|---|
| Characteristic | N = 28 |
| Age, years | 66 (36–85) |
| Gender | |
| Male | 23 (82) |
| Female | 5 (18) |
| Race and ethnicity | |
| White/Caucasian | 26 (92) |
| Black | 1 (4) |
| Other | 1 (4) |
| ECOG performance status | |
| 0 | 12 (43) |
| 1 | 16 (57) |
| Smoking history | |
| Never | 4 (14) |
| Former smoker (>10 pack-years) | 22 (79) |
| Current smoker | 2 (7) |
| Primary site of disease | |
| Oral cavity | 9 (32) |
| Oropharynx | 9 (32) |
| Larynx | 9 (32) |
| Hypopharynx | 1 (4) |
| Human papillomavirus (HPV) status, N = 9 | |
| p16 positive (by IHC) | 6 (67) |
| HPV ISH or PCR positive | 5 (56) |
| Clinical stageb at initial diagnosis | |
| I | 3 (11) |
| II | 6 (21) |
| III | 5 (18) |
| IV (A/B) | 13 (46) |
| Unknown | 1 (4) |
| Prior therapy for initial head and neck cancer diagnosis | |
| Prior surgery | 15 (54) |
| Prior radiation | 27 (96) |
| Prior chemotherapy | 19 (68) |
| Median time from initial diagnosis to confirmed recurrence, DFI (in years)c | 3.4 (0.5–26.4) |
| Recurrent tumor site | |
| Local | 20 (71) |
| Regional lymph nodes | 3 (11) |
| Both | 5 (18) |
| Clinical stagingb at recurrence prior to salvage surgery | |
| T0–2 | 6 (21) |
| T3 | 3 (11) |
| T4 | 19 (69) |
| N0–1 | 23 (82) |
| N2 | 2 (7) |
| N3 | 3 (11) |
| Stages I–II | 3 (11) |
| Stage III | 3 (11) |
| Stage IV (A/B) | 22 (79) |
| Registration to salvage surgery (in days) | 14 (7–28) |
| First dose of immunotherapy to surgery (in days) | 13 (6–24) |
| Pathologic staging after salvage surgeryb | |
| Stages I–II | 9 (32) |
| Stage III | 5 (18) |
| Stage IV (A/B) | 14 (50) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; IHC, immunohistochemistry; ISH, in situ hybridization; PCR, polymerase chain reaction; DFI = disease-free interval.
aValues are numbers and percentages, except age, median time to recurrence, first visit to surgery, and first dose of immunotherapy to surgery: noted as median and range in parentheses.
bAmerican Joint Committee on Cancer (AJCC) 2017 8th edition staging utilized except for HPV+ oropharynx cancers, which are reported using AJCC 2010 7th edition staging.
cIf the patient experienced multiple recurrences prior to trial enrollment, the date of completing initial therapy to first recurrence event was recorded.