Table 5. Grade 3/4 adverse events in MPC and LAPC cohorts and historical control.
| Adverse event | MPC & LAPC (N=74) no. of pts/total no. (%) | Historical (N=171) no. of pts/total no. (%) | P-valuea |
|---|---|---|---|
|
Haematologic | |||
| Neutropenia | 9/74 (12.2) | 75/164 (45.7) | <0.0001 |
| Thrombocytopenia | 7/74 (9.5) | 15/165 (9.1) | 0.83 |
| Anaemia | 4/74 (5.4) | 13/166 (7.8) | 0.66 |
| Febrile neutropenia | 3/74 (4.1) | 9/166 (5.4) | 0.79 |
|
Nonhaematologic | |||
| Diarrhoea | 12/74 (16.2) | 21/165 (12.7) | 0.38 |
| Fatigue | 9/74 (12.2) | 39/165 (23.6) | 0.02 |
| Alanine aminotransferase (ALT) increased | 3/74 (4.1) | 12/165 (7.3) | 0.37 |
| Thromboembolic event | 3/74 (4.1) | 11/166 (6.6) | 0.48 |
| Peripheral sensory neuropathy | 2/74 (2.7) | 15/166 (9.0) | 0.06 |
| Vomiting | 2/74 (2.7) | 24/166 (14.5) | 0.001 |
P-value is based on Fisher's exact test.
a
Comparison between MPC and LAPC cohorts and the historical control group treated with standard FOLFIRINOX as reported by Conroy et al.