Table 1.
Effect of Anticancer Treatment on the Tolerability of the BNT162b2 and mRNA-1273 Vaccines in Patients With Thymic Epithelial Tumors
| Both Vaccines Combined | ||||||
|---|---|---|---|---|---|---|
| Symptoms | AEs After Vaccination, n (%) |
p Value | AEs After Vaccination, n (%) |
p Value | ||
| On Concurrent Anticancer Treatment | No Concurrent Anticancer Treatment | On Concurrent Chemotherapy | No Concurrent Chemotherapy | |||
| Local pain | 20 (76.9) | 20 (76.9) | 1.00 | 8 (66.7) | 32 (80) | 0.44 |
| Local redness | 1 (3.9) | 1 (3.9) | 1.00 | 1 (8.3) | 1 (2.5) | 0.41 |
| Local swelling | 2 (7.7) | 3 (11.5) | 1.00 | 1 (8.3) | 4 (10) | 1.00 |
| Axillary LAD | 1 (3.9) | 1 (3.9) | 1.00 | 1 (8.3) | 1 (2.5) | 0.41 |
| Fatigue | 7 (26.9) | 5 (19.2) | 0.74 | 2 (16.7) | 10 (25) | 0.71 |
| Headache | 7 (26.9) | 3 (11.5) | 0.29 | 3 (25) | 7 (17.5) | 0.68 |
| Myalgia | 3 (11.5) | 1 (3.9) | 0.61 | 1 (8.3) | 3 (7.5) | 1.00 |
| Arthralgia | 2 (7.7) | 2 (7.7) | 1.00 | 1 (8.3) | 3 (7.5) | 1.00 |
| Chills | 2 (7.7) | 2 (7.7) | 1.00 | 1 (8.3) | 3 (7.5) | 1.00 |
| Fever | 1 (3.9) | 0 (0) | 1.00 | 0 (0) | 1 (2.5) | 1.00 |
| Nausea | 1 (3.9) | 0 (0) | 1.00 | 0 (0) | 1 (2.5) | 1.00 |
| Vomiting | 0 (0) | 0 (0) | — | 0 (0) | 0 (0) | — |
| Diarrhea | 3 (11.5) | 0 (0) | 0.24 | 2 (16.7) | 1 (2.5) | 0.13 |
| BNT-162b2 | ||||||
|---|---|---|---|---|---|---|
| Symptoms | AEs After Vaccination, n (%) |
p Value | AEs After Vaccination, n (%) |
p Value | ||
| On Concurrent Anticancer Treatment | No Concurrent Anticancer Treatment | On Concurrent Chemotherapy | No Concurrent Chemotherapy | |||
| Local pain | 6 (60) | 9 (64.3) | 1.00 | 3 (50) | 12 (66.7) | 0.63 |
| Local redness | 0 (0) | 1 (7.14) | 1.00 | 0 (0) | 1 (5.6) | 1.00 |
| Local swelling | 0 (0) | 2 (14.3) | 0.49 | 0 (0) | 2 (11.1) | 1.00 |
| Axillary LAD | 1 (10) | 1 (7.1) | 1.00 | 1 (16.7) | 1 (5.6) | 0.45 |
| Fatigue | 3 (30) | 4 (28.6) | 1.00 | 1 (16.7) | 6 (33.3) | 0.63 |
| Headache | 3 (30) | 1 (7.1) | 0.27 | 1 (16.7) | 3 (16.7) | 1.00 |
| Myalgia | 1 (10) | 0 (0) | 0.42 | 0 (0) | 1 (5.6) | 1.00 |
| Arthralgia | 1 (10) | 1 (7.1) | 1.00 | 0 (0) | 2 (11.1) | 1.00 |
| Chills | 1 (10) | 1 (7.1) | 1.00 | 0 (0) | 2 (11.1) | 1.00 |
| Fever | 1 (10) | 0 (0) | 0.42 | 0 (0) | 1 (5.6) | 1.00 |
| Nausea | 1 (10) | 0 (0) | 0.42 | 0 (0) | 1 (5.6) | 1.00 |
| Vomiting | 0 (0) | 0 (0) | — | 0 (0) | 0 (0) | — |
| Diarrhea | 0 (0) | 0 (0) | — | 0 (0) | 0 (0) | — |
| mRNA-1273 | ||||||
|---|---|---|---|---|---|---|
| Symptoms | AEs After Vaccination, n (%) |
p Value | AEs After Vaccination, n (%) |
p Value | ||
| On Concurrent Anticancer Treatment | No Concurrent Anticancer Treatment | On Concurrent Chemotherapy | No Concurrent Chemotherapy | |||
| Local pain | 14 (87.5) | 11 (91.7) | 1.00 | 5 (83.3) | 20 (90.9) | 0.53 |
| Local redness | 1 (6.3) | 0 (0) | 1.00 | 1 (16.7) | 0 (0) | 0.21 |
| Local swelling | 2 (12.5) | 1 (8.3) | 1.00 | 1 (16.7) | 2 (9.1) | 0.53 |
| Axillary LAD | 0 (0) | 0 (0) | — | 0 (0) | 0 (0) | — |
| Fatigue | 4 (25) | 1 (8.3) | 0.36 | 1 (16.7) | 4 (18.2) | 1.00 |
| Headache | 4 (25) | 2 (16.7) | 0.67 | 2 (33.3) | 4 (18.2) | 0.58 |
| Myalgia | 2 (12.5) | 1 (8.3) | 1.00 | 1 (16.7) | 2 (9.1) | 0.53 |
| Arthralgia | 1 (6.3) | 1 (8.3) | 1.00 | 1 (16.7) | 1 (4.6) | 0.39 |
| Chills | 1 (6.3) | 1 (8.3) | 1.00 | 2 (16.7) | 1 (4.6) | 0.39 |
| Fever | 0 (0) | 0 (0) | — | 0 (0) | 0 (0) | — |
| Nausea | 0 (0) | 0 (0) | — | 0 (0) | 0 (0) | — |
| Vomiting | 0 (0) | 0 (0) | — | 0 (0) | 0 (0) | — |
| Diarrhea | 3 (18.8) | 0 (0) | 0.24 | 3 (33.3) | 1 (4.6) | 0.11 |
Note: AE data are presented for the first dose of vaccination for the combined study population and for individuals receiving each vaccine. Concurrent anticancer treatment, including chemotherapy, does not seem to have a substantial impact on the tolerability of the BNT162b2 and mRNA-1273 vaccines. Anticancer treatment includes chemotherapy (n = 12), immunotherapy (immune checkpoint inhibitors, n = 7; immunocytokine, n = 1; antibody-drug conjugate, n = 1), and targeted therapy (small molecule inhibitors, n = 4; somatostatin analogue, n = 1).
AE, adverse event; LAD, lymphadenopathy.