Abstract
Three phase II studies evaluated trabectedin monotherapy as second-/third-line therapy in patients with refractory/recurrent ovarian cancer (ROC). Three different schedules were investigated: 3-h infusion every 3 weeks (3-h-q3w), 24-h infusion q3w (24-h-q3w), and 3-h weekly infusion for 3 weeks of a 4-week cycle. This retrospective pooled analysis evaluated the efficacy and the safety profile of trabectedin according to each administered regimen. Data from 295 patients were used to compare weekly versus q3w schedules, and 3-h versus 24-h infusion given q3w. Both q3w regimens showed higher overall response rate (36 vs. 16 %; p = 0.0001), disease control rate (66 vs. 46 %; p = 0.0007), and longer median progression-free survival (5.6 vs. 2.8 months; p <0.0001) than the weekly schedule. Comparable activity was observed for the 3- and 24-h infusions q3w. Common adverse events were nausea, fatigue, vomiting, transient neutropenia, and transaminase increases. A better safety profile regarding neutropenia, fatigue, and vomiting was seen for the 3-h-q3w regimen as compared to the 24-h-q3w one. Trabectedin given as a single agent q3w as 3-h infusion is the schedule of choice for the treatment of ROC, and its efficacy and safety profile favorably compares with other active salvage treatments.
| Original language | English |
|---|---|
| Article number | 435 |
| Journal | Medical Oncology |
| Volume | 30 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Mar 2013 |
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Keywords
- Pooled analysis
- Recurrent ovarian cancer
- Trabectedin
ASJC Scopus subject areas
- Oncology
- Cancer Research
- Hematology
- Medicine(all)
Cite this
Trabectedin as single agent in relapsed advanced ovarian cancer : Results from a retrospective pooled analysis of three phase II trials. / Del Campo, José María; Sessa, Cristiana; Krasner, Carolyn N.; Vermorken, Jan B.; Colombo, Nicoletta; Kaye, Stan; Gore, Martin; Zintl, Patrik; Gómez, Javier; Parekh, Trilok; Park, Youn Choi; McMeekin, Scott.
In: Medical Oncology, Vol. 30, No. 1, 435, 03.2013.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Trabectedin as single agent in relapsed advanced ovarian cancer
T2 - Results from a retrospective pooled analysis of three phase II trials
AU - Del Campo, José María
AU - Sessa, Cristiana
AU - Krasner, Carolyn N.
AU - Vermorken, Jan B.
AU - Colombo, Nicoletta
AU - Kaye, Stan
AU - Gore, Martin
AU - Zintl, Patrik
AU - Gómez, Javier
AU - Parekh, Trilok
AU - Park, Youn Choi
AU - McMeekin, Scott
PY - 2013/3
Y1 - 2013/3
N2 - Three phase II studies evaluated trabectedin monotherapy as second-/third-line therapy in patients with refractory/recurrent ovarian cancer (ROC). Three different schedules were investigated: 3-h infusion every 3 weeks (3-h-q3w), 24-h infusion q3w (24-h-q3w), and 3-h weekly infusion for 3 weeks of a 4-week cycle. This retrospective pooled analysis evaluated the efficacy and the safety profile of trabectedin according to each administered regimen. Data from 295 patients were used to compare weekly versus q3w schedules, and 3-h versus 24-h infusion given q3w. Both q3w regimens showed higher overall response rate (36 vs. 16 %; p = 0.0001), disease control rate (66 vs. 46 %; p = 0.0007), and longer median progression-free survival (5.6 vs. 2.8 months; p <0.0001) than the weekly schedule. Comparable activity was observed for the 3- and 24-h infusions q3w. Common adverse events were nausea, fatigue, vomiting, transient neutropenia, and transaminase increases. A better safety profile regarding neutropenia, fatigue, and vomiting was seen for the 3-h-q3w regimen as compared to the 24-h-q3w one. Trabectedin given as a single agent q3w as 3-h infusion is the schedule of choice for the treatment of ROC, and its efficacy and safety profile favorably compares with other active salvage treatments.
AB - Three phase II studies evaluated trabectedin monotherapy as second-/third-line therapy in patients with refractory/recurrent ovarian cancer (ROC). Three different schedules were investigated: 3-h infusion every 3 weeks (3-h-q3w), 24-h infusion q3w (24-h-q3w), and 3-h weekly infusion for 3 weeks of a 4-week cycle. This retrospective pooled analysis evaluated the efficacy and the safety profile of trabectedin according to each administered regimen. Data from 295 patients were used to compare weekly versus q3w schedules, and 3-h versus 24-h infusion given q3w. Both q3w regimens showed higher overall response rate (36 vs. 16 %; p = 0.0001), disease control rate (66 vs. 46 %; p = 0.0007), and longer median progression-free survival (5.6 vs. 2.8 months; p <0.0001) than the weekly schedule. Comparable activity was observed for the 3- and 24-h infusions q3w. Common adverse events were nausea, fatigue, vomiting, transient neutropenia, and transaminase increases. A better safety profile regarding neutropenia, fatigue, and vomiting was seen for the 3-h-q3w regimen as compared to the 24-h-q3w one. Trabectedin given as a single agent q3w as 3-h infusion is the schedule of choice for the treatment of ROC, and its efficacy and safety profile favorably compares with other active salvage treatments.
KW - Pooled analysis
KW - Recurrent ovarian cancer
KW - Trabectedin
UR - http://www.scopus.com/inward/record.url?scp=84873351398&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84873351398&partnerID=8YFLogxK
U2 - 10.1007/s12032-012-0435-1
DO - 10.1007/s12032-012-0435-1
M3 - Article
C2 - 23397080
AN - SCOPUS:84873351398
VL - 30
JO - Medical Oncology
JF - Medical Oncology
SN - 1357-0560
IS - 1
M1 - 435
ER -