Table 1.
Baseline patient characteristics.
| Characteristic | N = 149 (%) |
|---|---|
| Sex | |
| Male | 89 (59.7) |
| Female | 60 (40.3) |
| Median age at treatment (years) (range) | 72 (38–96) |
| Performance Status (PS) | |
| 0/1/2/3/4 | 15/25/38/50/21 (10.1)/(16.8)/(25.5)/(33.6)/(14.1) |
| Primary tumor | |
| Thoracic cancer | 37 (24.9) |
| Liver, biliary, and pancreatic cancer | 34 (22.8) |
| Gastrointestinal cancer | 33 (22.1) |
| Urinary tract, renal cell, and prostate cancer | 17 (11.4) |
| Hematologic cancer | 10 (6.7) |
| Gynecological cancer | 8 (5.4) |
| Head and neck cancer | 4 (2.7) |
| Breast cancer | 4 (2.7) |
| Others | 2 (1.3) |
| Therapy before and during naldemedine administration *, ** | |
| Chemotherapy | 40 (26.8) |
| Radiotherapy | 19 (12.6) |
| Chemoradiotherapy | 3 (2.0) |
| Surgery | 1 (0.6) |
| Best supportive care alone | 95 (63.8) |
| Central nervous system metastases | |
| Yes | 14 (9.4) |
| No | 135 (90.6) |
| Cancerous peritonitis | |
| Yes | 19 (12.8) |
| No | 130 (87.2) |
| Gastrointestinal obstruction | |
| Yes | 0 (0) |
| No | 149 (100) |
| History of abdominal surgery before starting naldemedine | |
| Yes | 52 (34.9) |
| No | 97 (65.1) |
| History of radiation to the abdomen and pelvic region before starting naldemedine | |
| Yes | 22 (14.8) |
| No | 127 (85.2) |
| Presence of diabetes mellitus | |
| Yes | 21 (14.1) |
| No | 128 (85.9) |
| Body mass index (BMI) (kg/m2) | |
| <22/≥22 | 106/43 (71.1)/(28.9) |
| Median BMI (range) | 20.4 (13.7–34.8) |
| Discontinuation within 7 days | |
| Yes | 19 (12.8) |
| No | 130 (87.2) |
| Use of laxatives before starting naldemedine administration | |
| Yes | 123 (82.6) |
| No | 26 (17.4) |
| Use of laxatives after starting naldemedine administration | |
| Yes | 118 (79.2) |
| No | 31 (20.8) |
| Regular use of antiemetic medication after initiation of naldemedine | |
| Yes | 44 (29.5) |
| No or unknown | 105 (70.5) |
| Irregular use of antiemetic agents after starting naldemedine | |
| Yes | 25 (16.8) |
| No or unknown | 124 (83.2) |
| Survival status at data-cutoff date | |
| Dead | 117 (78.5) |
| Alive | 32 (21.5) |
| Period from naldemedine initiation to death | |
| Median period (days) (range) | 35 (7–790) |
* Within three weeks before starting naldemedine administration; ** Total number of patients.