Table 2. Major Toxic Effects and Complications in the Ovarian Cancer Patientsa.
| Adverse event | Patients, No. (%) | P value | PS-weighted P value | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Receiving PCS with HIPEC (n = 425) | Receiving PCS alone (n = 159) | |||||||||
| Untested | Grade 1-2 | Grade 3 | Grade 4 | Untested | Grade 1-2 | Grade 3 | Grade 4 | |||
| Hypoalbunemia | 17 (4.0) | 381 (93.4) | 15 (3.7) | 0 | 14 (8.8) | 123 (84.8) | 3 (2.1) | 0 | <.001 | .001 |
| Anemia | 4 (0.9) | 309 (73.4) | 87 (20.7) | 0 | 4 (2.5) | 117 (75.5) | 21 (13.5) | 0 | .03 | .10 |
| Nausea | 1 (0.2) | 298 (70.3) | 0 | 0 | 2 (1.3) | 79 (50.3) | 0 | 0 | <.001 | <.001 |
| Vomiting | 1 (0.2) | 257 (60.6) | 0 | 0 | 2 (1.3) | 64 (40.8) | 0 | 0 | <.001 | <.001 |
| Electrolyte disturbanceb | 5 (1.2) | 250 (59.5) | 109 (26.0) | 9 (2.1) | 3 (1.9) | 70 (44.9) | 14 (9.0) | 4 (2.6) | <.001 | <.001 |
| Abdominal bloating | 1 (0.2) | 201 (47.4) | 0 | 0 | 2 (1.3) | 79 (50.3) | 0 | 0 | .53 | .39 |
| Fever | 1 (0.2) | 175 (41.3) | 3 (0.7) | 0 | 2 (1.3) | 55 (35.0) | 2 (1.3) | 0 | .34 | .33 |
| Leukopenia | 4 (0.9) | 148 (35.2) | 70 (16.6) | 30 (7.1) | 4 (2.5) | 40 (25.8) | 19 (12.3) | 9 (5.8) | .02 | .22 |
| Abdominal pain | 1 (0.2) | 148 (34.9) | 4 (0.9) | 0 | 2 (1.3) | 69 (43.9) | 3 (1.9) | 0 | .08 | .03 |
| Neutropenia | 4 (0.9) | 119 (28.3) | 65 (15.4) | 61 (14.5) | 4 (2.5) | 40 (25.8) | 14 (9.0) | 16 (10.3) | .03 | .37 |
| AST increased | 11 (2.6) | 88 (21.3) | 3 (0.7) | 0 | 6 (3.8) | 28 (18.3) | 1 (0.7) | 0 | .73 | .96 |
| ALT increased | 11 (2.6) | 77 (18.6) | 4 (1.0) | 0 | 6 (3.8) | 24 (15.7) | 0 | 0 | .20 | .46 |
| Thrombocytopenia | 4 (0.9) | 73 (17.3) | 14 (3.3) | 2 (0.5) | 4 (2.5) | 22 (14.2) | 6 (3.9) | 0 | .75 | .77 |
| Pulmonary infection | 1 (0.2) | 52 (12.3) | 0 | 0 | 1 (0.6) | 16 (10.1) | 1 (0.6) | 0 | .26 | .23 |
| Diarrhea | 1 (0.2) | 36 (8.5) | 1 (0.2) | 0 | 2 (1.3) | 10 (6.4) | 2 (1.3) | 0 | .20 | .44 |
| Pleural effusion | 1 (0.2) | 23 (5.4) | 0 | 0 | 1 (0.6) | 6 (3.8) | 0 | 0 | .42 | .67 |
| Creatinine increased | 11 (2.6) | 22 (5.3) | 2 (0.5) | 0 | 5 (3.1) | 2 (1.3) | 0 | 0 | .07 | .03 |
| Constipation | 1 (0.2) | 17 (4.0) | 0 | 0 | 2 (1.3) | 10 (6.4) | 0 | 0 | .23 | .20 |
| Neurotoxicity | 1 (0.2) | 11 (2.6) | 0 | 0 | 2 (1.3) | 2 (1.3) | 0 | 0 | .52 | .59 |
| Ileus | 1 (0.2) | 7 (1.7) | 0 | 0 | 2 (1.3) | 6 (3.8) | 0 | 0 | .21 | .21 |
| Thromboembolic event | 1 (0.2) | 2 (0.5) | 0 | 0 | 2 (1.3) | 0 | 0 | 0 | .99 | .39 |
| Incisional infection | 1 (0.2) | 1 (0.2) | 0 | 0 | 4 (2.5) | 0 | 0 | 0 | .99 | .54 |
| Adhesions | 1 (0.2) | 1 (0.2) | 0 | 0 | 2 (1.3) | 1 (0.6) | 0 | 0 | .47 | .21 |
| Dyspnea | 1 (0.2) | 1 (0.2) | 1 (0.2) | 0 | 1 (0.6) | 2 (1.3) | 1 (0.6) | 0 | .16 | .16 |
| Cardiotoxicity | 1 (0.2) | 1 (0.2) | 0 | 0 | 2 (1.3) | 1 (0.6) | 0 | 0 | .47 | .47 |
| Rash | 1 (0.2) | 1 (0.2) | 0 | 0 | 2 (1.3) | 2 (1.3) | 0 | 0 | .18 | .09 |
| Anastomotic leakage | 1 (0.2) | 0 | 0 | 0 | 4 (2.5) | 1 (0.6) | 0 | 0 | .27 | .10 |
| Pancreatitis | 1 (0.2) | 0 | 1 (0.2) | 0 | 4 (2.5) | 0 | 0 | 0 | .99 | .54 |
| Intra-abdominal infection | 1 (0.2) | 0 | 0 | 0 | 4 (2.5) | 1 (0.6) | 0 | 0 | .27 | .10 |
| Intra-abdominal bleeding | 1 (0.2) | 0 | 1 (0.2) | 0 | 4 (2.5) | 1 (0.6) | 0 | 0 | .46 | .16 |
| ARDS | 1 (0.2) | 0 | 0 | 1 (0.2) | 1 (0.6) | 0 | 0 | 0 | .99 | .54 |
Abbreviations: ALT, alanine aminotransferase; ARDS, acute respiratory distress syndrome; AST, aspartate aminotransferase; HIPEC, hyperthermic intraperitoneal chemotherapy; PCS, primary cytoreductive surgery; PS, propensity score.
a
According to Common Terminology Criteria for Adverse Events version 4.
b
Electrolyte disturbances including hypokalemia, hyperkalemia, hyponatremia, hypernatremia, hypomagnesemia, hypophosphatemia, and hypercalcemia.