Table 1.
Characteristics of patients with paraneoplastic syndromes selected for analysis after central review. Patients were included in two observational cohorts, defined as follows: cohort 1 comprised patients with a PNS diagnosed before the initiation of immunotherapy, and cohort 2 comprised patients with a PNS diagnosed after the initiation of immunotherapy
| Patient characteristics | Cohort 1 (pre-existing PNS) n = 16 patients |
Cohort 2 (newly diagnosed PNS) n = 16 patients |
Total n = 32 patients (%) |
|---|---|---|---|
| Age, in years, median (range) | 64 (48–86) | 68 (45–88) | 64 (45–88) |
| Sex ratio (male/female) | 4.3 | 0.5 | 1.8 |
| Tumor type, n patients (%) | |||
| - NSCLC | 10 | 5 | 15 (47) |
| - Melanoma | 1 | 5 | 6 (19) |
| - Renal carcinoma | 1 | 2 | 3 (9) |
| - Merkel carcinoma | 1 | 1 | 2 (6) |
| - Neuroendocrine carcinoma | 1 | 0 | 1 (3) |
| - Pulmonary sarcomatoid carcinoma | 1 | 0 | 1 (3) |
| - HNSCC | 1 | 0 | 1 (3) |
| - Esthesioneuroblastoma | 0 | 1 | 1 (3) |
| - Mesothelioma | 0 | 1 | 1 (3) |
| - Breast cancer | 0 | 1 | 1 (3) |
| Number of prior courses of systemic cancer treatment, median (range) | 1.0 (0–2) | 0.5 (0–5) | 1.0 (0–5) |
| Immunotherapy received, n (%) | |||
| - Anti-PD-1 | 14 (88) | 14 (88) | 28 (88) |
| - Nivolumab | 9 | 9 | 18 |
| - Pembrolizumab | 5 | 5 | 10 |
| - Anti-PDL-1 | 2 (12) | 1 (6) | 3 (9) |
| - Avelumab | 1 | 1 | 2 |
| - Durvalumab | 1 | 0 | 1 |
| - Combination immunotherapy | |||
| - Nivolumab + ipilimumab | 0 | 1 (6) | 1 (3) |
| Best overall antitumor response during immunotherapy, n (%)a | |||
| - Objective response | 9 (56) | 6 (38) | 15 (47) |
| - CR | 2 (12) | 1 (6) | 3 (9) |
| - PR | 7 (44) | 5 (31) | 12 (38) |
| - SD | 3 (19) | 8 (50) | 11 (34) |
| - PD | 4 (25) | 2 (13) | 6 (19) |
| Immune-related adverse events other than PNSs (all severity grades), n (%)b | 4 (25) | 6 (38) | 10 (31) |
| - Dysthyroidism | 1 | 1 | 2 (6) |
| - Vitiligo | 0 | 2 | 2 (6) |
| - Hepatitis | 0 | 1 | 1 (3) |
| - Oligo-arthritis | 1 | 0 | 1 (3) |
| - Myocarditis | 1 | 0 | 1 (3) |
| - Rash | 1 | 0 | 1 (3) |
| - Pneumonitis | 0 | 1 | 1 (3) |
| - Fever | 0 | 1 | 1 (3) |
| Length of follow-up after immunotherapy initiation, median (range), months | 7.9 (0.9;17.7) | 10.5 (4;17.4) | 9.6 (0.9;17.7) |
CR Complete response, HNSCC Head and neck squamous cell carcinoma, NSCLC Non-small-cell lung carcinoma, PD Progressive disease, PNS Paraneoplastic syndrome, PR Partial response, SD Stable disease
aAccording to the iRECIST criteria. In patients allocated to cohort 1 who did not experienced worsening of PNS, the best overall response is shown
bAll-grade severity, according to the CTCAE v4.03