Id |
Subject |
Object |
Predicate |
Lexical cue |
T1 |
203-380 |
DRI_Challenge |
denotes |
Purpose We examined the efficacy and safety of thalidomide (THD) for the prevention of delayed nausea and vomiting in patients who received highly emetogenic chemotherapy (HEC). |
T2 |
381-570 |
DRI_Background |
denotes |
Patients and Methods In a randomized, double-blind, active-controlled, phase III trial, chemotherapy-naive patients with cancer who were scheduled to receive HEC that contained cisplatin or |
T3 |
614-822 |
DRI_Background |
denotes |
50 mg/m2 regimens were randomly assigned to a THD group (100 mg twice daily on days 1 to 5) or placebo group, both with palonosetron (0.25 mg on day 1) and dexamethasone (12 mg on day 1; 8 mg on days 2 to 4). |
T4 |
823-948 |
DRI_Approach |
denotes |
Primary end point was complete response to vomiting-no emesis or use of rescue medication-in the delayed phase (25 to 120 h). |
T5 |
949-1055 |
DRI_Background |
denotes |
Nausea and anorexia on days 1 to 5 were evaluated by the 4-point Likert scale (0, no symptoms; 3, severe). |
T6 |
1056-1200 |
DRI_Background |
denotes |
Quality of life was assessed by the European Organization for Research and Treatment of Cancer QLQ-C30 version 3 questionnaire on days -1 and 6. |
T7 |
1201-1296 |
DRI_Background |
denotes |
Results Of 656 patients, 638 were evaluable: 317 in the THD group and 321 in the control group. |
T8 |
1297-1505 |
DRI_Outcome |
denotes |
Compared with placebo, delayed and overall (0 to 120 h) complete response rates to vomiting were significantly higher with THD: 76.9% versus 61.7% ( P < .001) and 66.1% versus 53.3% ( P = .001), respectively. |
T9 |
1506-1714 |
DRI_Approach |
denotes |
Rates of no nausea were also higher in the THD group (delayed: 47.3% v 33.3%; P < .001; overall: 41% v 29.6%; P = .003), and mean scores of anorexia were lower overall (0.44 ± 0.717 v 0.64 ± 0.844; P = .003). |
T10 |
1715-1753 |
DRI_Background |
denotes |
Adverse effects were mild to moderate. |
T11 |
1754-1890 |
DRI_Background |
denotes |
The THD group had increased sedation, dizziness, constipation, and dry mouth, but experienced better quality of life after chemotherapy. |
T12 |
1891-2064 |
DRI_Outcome |
denotes |
Conclusion Thalidomide combined with palonosetron and dexamethasone significantly improved HEC-induced delayed nausea and vomiting prevention in chemotherapy-naive patients. |