Table 1.
Patient Characteristics
| Characteristics | All patients (n=70) | Diarrhea (+) (n=22) | Diarrhea (−) (n=48) | P value |
|---|---|---|---|---|
| Age (years) | 67 [30–85] | 63 [37–81] | 67 [30–85] | 0.714 |
| Female | 30 (43) | 13 (59) | 17 (36) | 0.074 |
| Body weight (kg) | 52.5 [31.0–76.8] | 51.3 [38.6–72.6] | 54.6 [31.0–76.8] | 0.786 |
| CCr (mL/min) | 67.5 [5.1–140.0] | 71.5 [27.7–120.5] | 63.0 [5.1–140.0] | 0.305 |
| Performance status (3–4) | 12 (17) | 6 (27) | 6 (13) | 0.174 |
| NAL dose (μg/kg) | 3.8 [2.6–6.5] | 3.9 [2.8–5.2] | 3.7 [2.6–6.5] | 0.849 |
| Opioid dose (morphine base, mg) | 17.5 [2.5–390.0] | 30.0 [7.5–390.0] | 15.0 [2.5–180.0] | 0.094 |
| Duration of opioid therapy before NAL administration (day) | 6 [0–1365] | 27 [0–1365] | 4 [0–268] | 0.002 |
| Co-administrated drugs | ||||
| Drugs with risk of constipation | 61 (87) | 19 (86) | 42 (88) | 1.000 |
| PPI or H2-blocker | 49 (70) | 18 (82) | 31 (65) | 0.171 |
| Laxative | 58 (83) | 20 (91) | 38 (79) | 0.316 |
| Oral anticancer drug | 13 (19) | 6 (27) | 7 (15) | 0.320 |
| Intravenous anticancer drug | 30 (43) | 10 (45) | 20 (42) | 0.800 |
| Antimicrobial agent | 36 (51) | 12 (55) | 24 (50) | 0.800 |
| Tubal feeding | 5 (7) | 2 (9) | 3 (6) | 0.646 |
| Opioid analgesics | ||||
| Oxycodone | 49 (70) | 16 (73) | 33 (69) | 0.787 |
| Morphine | 3 (4) | 0 (0) | 3 (6) | 0.547 |
| Fentanyl | 7 (10) | 4 (18) | 3 (6) | 0.195 |
| Tramadol | 9 (13) | 1 (5) | 8 (17) | 0.255 |
| Methadone | 1 (1) | 1 (5) | 0 (0) | 0.314 |
| Hydromorphone | 1 (1) | 0 (0) | 1 (2) | 1.000 |
| Primary tumor | ||||
| Pancreatic | 12 (17) | 6 (27) | 6 (13) | 0.174 |
| Head and neck | 8 (11) | 2 (9) | 6 (13) | 1.000 |
| Lung | 6 (9) | 2 (9) | 4 (8) | 1.000 |
| Breast | 5 (7) | 1 (5) | 4 (8) | 1.000 |
| Soft tissue | 5 (7) | 0 (0) | 5 (10) | 0.173 |
| Hepatic | 4 (6) | 2 (9) | 2 (4) | 0.585 |
| Stomach | 3 (4) | 1 (5) | 2 (4) | 1.000 |
| Colorectal | 2 (3) | 0 (0) | 2 (4) | 1.000 |
| Others and non-cancer | 25 (36) | 8 (36) | 17 (35) | 1.000 |
Values are presented as median [range] or number (%)
CCr Creatinine clearance, NAL Naldemedine, PPI Proton-pump inhibitor