Table 1.
Participant characteristics at baseline for enrolled population (analysis population is all subjects).
| Characteristic | Total patients N = 12 | Dose escalation cohortc (15.6 mCi/m2) N = 8 | Dose expansion cohortd (15.6 mCi/m2) N = 4 |
|---|---|---|---|
| Sexa | n (%) | ||
| Female | 3 (25) | 3 | 0 |
| Male | 9 (75) | 5 | 4 |
| Age | |||
| Median age at baseline in years (range) | 65.5 (47–84) | 65.5 (55–75) | 64.5 (47–84) |
| Race | |||
| White | 12 | 8 | 4 |
| Other | 0 | 0 | 0 |
| Ethnicity | |||
| Hispanic | 0 | 0 | 0 |
| Non-Hispanic | 12 | 8 | 4 |
| ECOG performance status: | n (%) | ||
| ECOG 0 | 9 (75) | 7 | 2 |
| ECOG 1 | 3 (25) | 1 | 2 |
| Primary tumour site: | n (%) | ||
| Oropharynx | 5 (42) | 3 | 2 |
| p16 positive | 4 (80) | 2 | 2 |
| p16 negative | 1 (20) | 1 | 0 |
| Nasopharynx | 1 (8) | 0 | 1 |
| Larynx | 1 (8) | 1 | 0 |
| Oral cavity | 4 (33) | 3 | 1 |
| Salivary gland | 1 (8) | 1 | 0 |
| T stage, AJCC 8th ed. | |||
| T1–T2 | 6 (50) | 2 | 4 |
| T3–T4 | 6 (50) | 6 | 0 |
| N stage, AJCC 8th ed. | |||
| N0–1 | 6 (50) | 3 | 3 |
| N2–3 | 6 (50) | 5 | 1 |
| AJCC 8th ed. stage | |||
| I | 2 (17) | 0 | 2 |
| II | 3 (25) | 1 | 2 |
| III | 3 (25) | 3 | 0 |
| IV A | 2 (17) | 2 | 0 |
| IV B | 2 (17) | 2 | 0 |
| Initial treatment at diagnosis | |||
| Surgical resection | 7 (58) | 6 | 1 |
| No adjuvant treatment | 1 (8) | 1 | 0 |
| Adjuvant radiation | 4 (33) | 3 | 1 |
| Adjuvant chemoradiation | 2 (17) | 2 | 0 |
| Definitive chemoradiation | 5 (42) | 2 | 3 |
| Recurrence status at study entry | |||
| First Recurrenceb | 6 (50) | 4 | 2 |
| Multiply recurrent | 6 (50) | 4 | 2 |
| Metastatic diseaseb | 1 (8) | 1 | 0 |
| Quality of life and swallow function | |||
| MDADI | 10 (83) | 6 | 4 |
| EORTC QLQ-C30 | 9 (75) | 6 | 4 |
| XeQoLS | 10 (83) | 6 | 4 |
| Xerostomia inventory | 10 (83) | 6 | 4 |
| Salivary flow rate | 10 (83) | 6 | 4 |
| DIGEST | 10 (83) | 6 | 4 |
AJCC, American Joint Committee on Cancer; ECOG, Eastern Cooperative Oncology Group; MDADI, MD Anderson Dysphagia Inventory; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; XeQoLS, Xerostomia-Related Quality of Life Scale; DIGEST, Dynamic Imaging Grade of Swallowing Toxicity.
Participants were asked to report their biological sex (male/female) through a self-report questionnaire.
Participant developed metastatic disease at the first recurrence.
All participants in the dose escalation cohort received CLR 131 at a dose of 15.6 mCi/m2. CLR 131 dose was not escalated higher than the initial starting dose of 15.6 mCi/m2.
All participants in the dose expansion cohort received CLR 131 at a dose of 15.6 mCi/m2 as this dose was selected for the dose expansion portion of the study.