Table 1:
Patient demographics and baseline characteristics
| Patients (n=78) | |
|---|---|
| Median age, years (IQR) | 74 (65–81) |
| ≥65 years | 59 (76%) |
| Sex | |
| Female | 19 (24%) |
| Male | 59 (76%) |
| ECOG performance status | |
| 0 | 38 (49%) |
| 1 | 40 (51%) |
| Primary cutaneous squamous cell carcinoma site | |
| Head or neck* | 62 (79%) |
| Arm or leg | 14 (18%) |
| Trunk | 2 (3%) |
| Previous cancer-related systemic therapy† | 12 (15%) |
| Previous cancer-related radiotherapy | 43 (55%) |
| Reasons why patients were not considered candidates for surgery | |
| Lesion with substantial local invasion that precluded complete resection | 20 (26%) |
| Lesion in an anatomically challenging location for which surgery might result in severe disfigurement or dysfunction | 30 (38%) |
| Lesion in the same location after two or more surgical procedures and with curative resection deemed unlikely | 25 (32%) |
| Other conditions deemed contraindicating for surgery | 3 (4%) |
| Reasons why patients were not considered candidates for radiotherapy | |
| Previous radiotherapy with further radiotherapy exceeding the threshold of an acceptable cumulative dose | 10 (13%) |
| Judgment of the radiation oncologist that the tumour was unlikely to respond to radiotherapy | 17 (22%) |
| Risk-benefit assessment that radiotherapy was contraindicated for the patient | 38 (49%) |
| Other conditions deemed contraindicating for radiotherapy | 11 (14%) |
| Missing | 2 (3%) |
| Histological differentiation of tumour‡ | |
| Well differentiated | 26 (33%) |
| Moderately differentiated | 24 (31%) |
| Poorly differentiated | 22 (28%) |
| Undifferentiated | 1 (1%) |
| Unknown | 5 (6%) |
Data are n (%) unless otherwise specified. ECOG=European Cooperative Oncology Group.
*
Includes one patient with nodal metastasis who was incorrectly enrolled in the locally advanced group 2 (instead of a metastatic group) because of a protocol violation. Data for this patient were analysed in group 2 as per the intention-to-treat principle.
†
Ten patients had received one previous cancer-related systemic therapy and two had previously received two or more cancer-related systemic therapies.
‡
Based on local pathology assessment of pre-treatment tumours.