Abstract
Objective The aim of this multicenter, retrospective study was to evaluate the efficacy and the safety of single agent Trabectedin (ET-743, Yondelis®) in very heavily treated, relapsed ovarian cancer (ROC) patients. Patients and methods Response to treatment was classified according to RECIST criteria. Progression-free (PFS), and overall survival (OS) were also assessed. Results 98 patients were analyzed (originally 67 platinum sensitive, and 31 platinum refractory/resistant). Median number of previous regimens was 4 (range: 1-6). In the whole population, overall response rate (ORR) was 27.5%; stable disease (SD) was observed in 33 patients (33.6%), and clinical benefit was achieved in 60 cases (61.2%). ORR was 38.6% in fully platinum sensitive population, and 26.1% in partially platinum sensitive patients. In platinum refractory/resistant disease, ORR was 12.9%. Overall, median PFS and OS were 5, and 13 months, respectively. Patients responding to Trabectedin showed a more favorable PFS (median = 9 months) than patients with SD (median = 6 months), or progression (median = 2 months). Median OS of responding patients was 18 months compared to 14 months in SD patients, and 9 months in progressing patients. Grade 3-4 neutropenia was observed in 17 (17.3%) patients. Transient and non-cumulative Grade 3-4 AST and ALT level elevation was found in 7 (7.1%), and 13 (13.3%) cases, respectively. There was 1 case of Grade 3, and 1 case of Grade 4 cardiac toxicity. Conclusions Trabectedin, as a single agent, retains its efficacy in terms of rate of ORR and clinical benefit in heavily treated ROC patients, especially in the group of platinum sensitive disease.
| Original language | English |
|---|---|
| Pages (from-to) | 505-510 |
| Number of pages | 6 |
| Journal | Gynecologic Oncology |
| Volume | 130 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Sep 2013 |
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Keywords
- Ovarian cancer
- Salvage treatment
- Trabectedin
ASJC Scopus subject areas
- Obstetrics and Gynaecology
- Oncology
Cite this
Trabectedin as single agent in the salvage treatment of heavily treated ovarian cancer patients : A retrospective, multicenter study. / Ferrandina, Gabriella; Salutari, Vanda; Vincenzi, Bruno; Marinaccio, Marco; Naglieri, Emanuele; Loizzi, Vera; Carpano, Silvia; Amadio, Giulia; Tonini, Giuseppe; Scambia, Giovanni; Lorusso, Domenica.
In: Gynecologic Oncology, Vol. 130, No. 3, 09.2013, p. 505-510.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Trabectedin as single agent in the salvage treatment of heavily treated ovarian cancer patients
T2 - A retrospective, multicenter study
AU - Ferrandina, Gabriella
AU - Salutari, Vanda
AU - Vincenzi, Bruno
AU - Marinaccio, Marco
AU - Naglieri, Emanuele
AU - Loizzi, Vera
AU - Carpano, Silvia
AU - Amadio, Giulia
AU - Tonini, Giuseppe
AU - Scambia, Giovanni
AU - Lorusso, Domenica
PY - 2013/9
Y1 - 2013/9
N2 - Objective The aim of this multicenter, retrospective study was to evaluate the efficacy and the safety of single agent Trabectedin (ET-743, Yondelis®) in very heavily treated, relapsed ovarian cancer (ROC) patients. Patients and methods Response to treatment was classified according to RECIST criteria. Progression-free (PFS), and overall survival (OS) were also assessed. Results 98 patients were analyzed (originally 67 platinum sensitive, and 31 platinum refractory/resistant). Median number of previous regimens was 4 (range: 1-6). In the whole population, overall response rate (ORR) was 27.5%; stable disease (SD) was observed in 33 patients (33.6%), and clinical benefit was achieved in 60 cases (61.2%). ORR was 38.6% in fully platinum sensitive population, and 26.1% in partially platinum sensitive patients. In platinum refractory/resistant disease, ORR was 12.9%. Overall, median PFS and OS were 5, and 13 months, respectively. Patients responding to Trabectedin showed a more favorable PFS (median = 9 months) than patients with SD (median = 6 months), or progression (median = 2 months). Median OS of responding patients was 18 months compared to 14 months in SD patients, and 9 months in progressing patients. Grade 3-4 neutropenia was observed in 17 (17.3%) patients. Transient and non-cumulative Grade 3-4 AST and ALT level elevation was found in 7 (7.1%), and 13 (13.3%) cases, respectively. There was 1 case of Grade 3, and 1 case of Grade 4 cardiac toxicity. Conclusions Trabectedin, as a single agent, retains its efficacy in terms of rate of ORR and clinical benefit in heavily treated ROC patients, especially in the group of platinum sensitive disease.
AB - Objective The aim of this multicenter, retrospective study was to evaluate the efficacy and the safety of single agent Trabectedin (ET-743, Yondelis®) in very heavily treated, relapsed ovarian cancer (ROC) patients. Patients and methods Response to treatment was classified according to RECIST criteria. Progression-free (PFS), and overall survival (OS) were also assessed. Results 98 patients were analyzed (originally 67 platinum sensitive, and 31 platinum refractory/resistant). Median number of previous regimens was 4 (range: 1-6). In the whole population, overall response rate (ORR) was 27.5%; stable disease (SD) was observed in 33 patients (33.6%), and clinical benefit was achieved in 60 cases (61.2%). ORR was 38.6% in fully platinum sensitive population, and 26.1% in partially platinum sensitive patients. In platinum refractory/resistant disease, ORR was 12.9%. Overall, median PFS and OS were 5, and 13 months, respectively. Patients responding to Trabectedin showed a more favorable PFS (median = 9 months) than patients with SD (median = 6 months), or progression (median = 2 months). Median OS of responding patients was 18 months compared to 14 months in SD patients, and 9 months in progressing patients. Grade 3-4 neutropenia was observed in 17 (17.3%) patients. Transient and non-cumulative Grade 3-4 AST and ALT level elevation was found in 7 (7.1%), and 13 (13.3%) cases, respectively. There was 1 case of Grade 3, and 1 case of Grade 4 cardiac toxicity. Conclusions Trabectedin, as a single agent, retains its efficacy in terms of rate of ORR and clinical benefit in heavily treated ROC patients, especially in the group of platinum sensitive disease.
KW - Ovarian cancer
KW - Salvage treatment
KW - Trabectedin
UR - http://www.scopus.com/inward/record.url?scp=84882449972&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84882449972&partnerID=8YFLogxK
U2 - 10.1016/j.ygyno.2013.06.008
DO - 10.1016/j.ygyno.2013.06.008
M3 - Article
VL - 130
SP - 505
EP - 510
JO - Gynecologic Oncology
JF - Gynecologic Oncology
SN - 0090-8258
IS - 3
ER -