YONDELIS® was studied in 6 open-label, single-arm trials, in which 377 patients received YONDELIS®, and 1 open-label, randomized, active-controlled clinical trial, in which 378 patients received YONDELIS®. In these trials, 26% (197) of patients were treated with YONDELIS® for 6 months or longer, and 8% (57) were treated with YONDELIS® for 1 year or longer.1
|
Laboratory Abnormalities |
YONDELIS® |
Dacarbazine |
||
|
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
|
|
Chemistry |
||||
|
Increased ALT |
90 |
31 |
33 |
0.6 |
|
Increased AST |
84 |
17 |
32 |
1.2 |
|
Increased ALP |
70 |
1.6 |
60 |
0.6 |
|
Hypoalbuminemia |
63 |
3.7 |
51 |
3.0 |
|
Increased creatinine |
46 |
4.2 |
29 |
1.2 |
|
Increased CPK |
33 |
6.4 |
9 |
0.6 |
|
Hyperbilirubinemia |
13 |
1.9 |
5 |
0.6 |
|
Hematology |
||||
|
Anemia |
96 |
19 |
79 |
12 |
|
Neutropenia |
66 |
43 |
47 |
26 |
|
Thrombocytopenia |
59 |
21 |
57 |
20 |
|
Laboratory Abnormalities |
YONDELIS® |
|
|
All Grades (%) |
Grades 3-4 (%) |
|
|
Chemistry |
||
|
Increased ALT |
90 |
31 |
|
Increased AST |
84 |
17 |
|
Increased alkaline phosphatase |
70 |
1.6 |
|
Hypoalbuminemia |
63 |
3.7 |
|
Increased creatinine |
46 |
4.2 |
|
Increased creatine phosphokinase |
33 |
6.4 |
|
Hyperbilirubinemia |
13 |
1.9 |
|
Hematology |
||
|
Anemia |
96 |
19 |
|
Neutropenia |
66 |
43 |
|
Thrombocytopenia |
59 |
21 |
|
Laboratory Abnormalities |
Dacarbazine |
|
|
All Grades (%) |
Grades 3-4 (%) |
|
|
Chemistry |
||
|
Increased ALT |
33 |
0.6 |
|
Increased AST |
32 |
1.2 |
|
Increased alkaline phosphatase |
60 |
0.6 |
|
Hypoalbuminemia |
51 |
3.0 |
|
Increased creatinine |
29 |
1.2 |
|
Increased creatine phosphokinase |
9 |
0.6 |
|
Hyperbilirubinemia |
5 |
0.6 |
|
Hematology |
||
|
Anemia |
79 |
12 |
|
Neutropenia |
47 |
26 |
|
Thrombocytopenia |
57 |
20 |
ALP = alkaline phosphatase; ALT = alanine aminotransferase; AST = aspartate aminotransferase; CPK = creatine phosphokinase.
*Treatment-emergent laboratory abnormalities included those higher in the trabectedin arm compared with the dacarbazine arm by ≥5% (all grades) or by ≥2% (Grades 3-4). Incidence based on number of patients who had both baseline and at least 1 on-study laboratory measurement.
YONDELIS® group (range: 373 to 377 patients) and dacarbazine group (range: 166 to168 patients).
Read about the efficacy of YONDELIS®.
Selected adverse reactions† occurring in ≥10% of patients receiving YONDELIS® and at a higher incidence than in the control arm in the pivotal trial‡1
|
System Organ Class |
YONDELIS® (N=378) |
Dacarbazine (N=172) |
||
|
Adverse Reaction |
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
|
Gastrointestinal disorders |
||||
|
Nausea |
75 |
7 |
50 |
1.7 |
|
Vomiting |
46 |
6 |
22 |
1.2 |
|
Constipation |
37 |
0.8 |
31 |
0.6 |
|
Diarrhea |
35 |
1.6 |
23 |
0 |
|
General disorders and administration-site conditions |
||||
|
Fatigue§ |
69 |
8 |
52 |
1.7 |
|
Peripheral edema |
28 |
0.8 |
13 |
0.6 |
|
Metabolism and nutrition disorders |
||||
|
Decreased appetite |
37 |
1.9 |
21 |
0.6 |
|
Respiratory, thoracic, and mediastinal disorders |
||||
|
Dyspnea |
25 |
4.2 |
20 |
1.2 |
|
Nervous system disorders |
||||
|
Headache |
25 |
0.3 |
19 |
0 |
|
Musculoskeletal and connective tissue disorders |
||||
|
Arthralgia |
15 |
0 |
8 |
1.2 |
|
Myalgia |
12 |
0 |
6 |
0 |
|
Psychiatric disorders |
||||
|
Insomnia |
15 |
0.3 |
9 |
0 |
|
System Organ Class |
YONDELIS® (N=378) |
|
|
Adverse Reaction |
All Gradesb (%) |
Grades 3-4 (%) |
|
Gastrointestinal disorders |
||
|
Nausea |
75 |
7 |
|
Vomiting |
46 |
6 |
|
Constipation |
37 |
0.8 |
|
Diarrhea |
35 |
1.6 |
|
General disorders and administration site conditions |
||
|
Fatigue§ |
69 |
8 |
|
Peripheral edema |
28 |
0.8 |
|
Metabolism and nutrition disorders |
||
|
Decreased appetite |
37 |
1.9 |
|
Respiratory, thoracic, and mediastinal disorders |
||
|
Dyspnea |
25 |
4.2 |
|
Nervous system disorders |
||
|
Headache |
25 |
0.3 |
|
Musculoskeletal and connective tissue disorders |
||
|
Arthralgia |
15 |
0 |
|
Myalgia |
12 |
0 |
|
Psychiatric disorders |
||
|
Insomnia |
15 |
0.3 |
|
System Organ Class |
Dacarbazine (N=172) |
|
|
Adverse Reaction |
All Grades (%) |
Grades 3-4 (%) |
|
Gastrointestinal disorders |
||
|
Nausea |
50 |
1.7 |
|
Vomiting |
22 |
1.2 |
|
Constipation |
31 |
0.6 |
|
Diarrhea |
23 |
0 |
|
General disorders and administration site conditions |
||
|
Fatigue§ |
52 |
1.7 |
|
Peripheral edema |
13 |
0.6 |
|
Metabolism and nutrition disorders |
||
|
Decreased appetite |
21 |
0.6 |
|
Respiratory, thoracic and mediastinal disorders |
||
|
Dyspnea |
20 |
1.2 |
|
Nervous system disorders |
||
|
Headache |
19 |
0 |
|
Musculoskeletal and connective tissue disorders |
||
|
Arthralgia |
8 |
1.2 |
|
Myalgia |
6 |
0 |
|
Psychiatric disorders |
||
|
Insomnia |
9 |
0 |
†Limited to adverse reactions occurring at a rate of ≥10% in the trabectedin arm and at a rate higher in the trabectedin arm compared with the dacarbazine arm by ≥5% in overall incidence or by ≥2% for Grades 3-4 adverse reactions.
‡Toxicity grade is based on National Cancer Institute common toxicity criteria, version 4.0.
§Fatigue is a composite of the following adverse event terms: fatigue, asthenia, and malaise.
Read about the efficacy of YONDELIS®.
Reference: