Trabectedin Plus Pegylated Liposomal Doxorubicin in Recurrent Ovarian Cancer
The objective of this study was to compare the efficacy and safety of trabectedin plus pegylated liposomal doxorubicin (PLD) with that of PLD alone in women with recurrent ovarian cancer after failure of first-line, platinum-based chemotherapy. Women > or = 18 years, stratified by performance sta...
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| Published in | Journal of clinical oncology Vol. 28; no. 19; pp. 3107 - 3114 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
American Society of Clinical Oncology
01.07.2010
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| Subjects | |
| Online Access | Get full text |
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| Abstract | The objective of this study was to compare the efficacy and safety of trabectedin plus pegylated liposomal doxorubicin (PLD) with that of PLD alone in women with recurrent ovarian cancer after failure of first-line, platinum-based chemotherapy.
Women > or = 18 years, stratified by performance status (0 to 1 v 2) and platinum sensitivity, were randomly assigned to receive an intravenous infusion of PLD 30 mg/m(2) followed by a 3-hour infusion of trabectedin 1.1 mg/m(2) every 3 weeks or PLD 50 mg/m(2) every 4 weeks. The primary end point was progression-free survival (PFS) by independent radiology assessment.
Patients (N = 672) were randomly assigned to trabectedin/PLD (n = 337) or PLD (n = 335). Median PFS was 7.3 months with trabectedin/PLD v 5.8 months with PLD (hazard ratio, 0.79; 95% CI, 0.65 to 0.96; P = .0190). For platinum-sensitive patients, median PFS was 9.2 months v 7.5 months, respectively (hazard ratio, 0.73; 95% CI, 0.56 to 0.95; P = .0170). Overall response rate (ORR) was 27.6% for trabectedin/PLD v 18.8% for PLD (P = .0080); for platinum-sensitive patients, it was 35.3% v 22.6% (P = .0042), respectively. ORR, PFS, and overall survival among platinum-resistant patients were not statistically different. Neutropenia was more common with trabectedin/PLD. Grade 3 to 4 transaminase elevations were also more common with the combination but were transient and noncumulative. Hand-foot syndrome and mucositis were less frequent with trabectedin/PLD than with PLD alone.
When combined with PLD, trabectedin improves PFS and ORR over PLD alone with acceptable tolerance in the second-line treatment of recurrent ovarian cancer. |
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| AbstractList | The objective of this study was to compare the efficacy and safety of trabectedin plus pegylated liposomal doxorubicin (PLD) with that of PLD alone in women with recurrent ovarian cancer after failure of first-line, platinum-based chemotherapy.PURPOSEThe objective of this study was to compare the efficacy and safety of trabectedin plus pegylated liposomal doxorubicin (PLD) with that of PLD alone in women with recurrent ovarian cancer after failure of first-line, platinum-based chemotherapy.Women > or = 18 years, stratified by performance status (0 to 1 v 2) and platinum sensitivity, were randomly assigned to receive an intravenous infusion of PLD 30 mg/m(2) followed by a 3-hour infusion of trabectedin 1.1 mg/m(2) every 3 weeks or PLD 50 mg/m(2) every 4 weeks. The primary end point was progression-free survival (PFS) by independent radiology assessment.PATIENTS AND METHODSWomen > or = 18 years, stratified by performance status (0 to 1 v 2) and platinum sensitivity, were randomly assigned to receive an intravenous infusion of PLD 30 mg/m(2) followed by a 3-hour infusion of trabectedin 1.1 mg/m(2) every 3 weeks or PLD 50 mg/m(2) every 4 weeks. The primary end point was progression-free survival (PFS) by independent radiology assessment.Patients (N = 672) were randomly assigned to trabectedin/PLD (n = 337) or PLD (n = 335). Median PFS was 7.3 months with trabectedin/PLD v 5.8 months with PLD (hazard ratio, 0.79; 95% CI, 0.65 to 0.96; P = .0190). For platinum-sensitive patients, median PFS was 9.2 months v 7.5 months, respectively (hazard ratio, 0.73; 95% CI, 0.56 to 0.95; P = .0170). Overall response rate (ORR) was 27.6% for trabectedin/PLD v 18.8% for PLD (P = .0080); for platinum-sensitive patients, it was 35.3% v 22.6% (P = .0042), respectively. ORR, PFS, and overall survival among platinum-resistant patients were not statistically different. Neutropenia was more common with trabectedin/PLD. Grade 3 to 4 transaminase elevations were also more common with the combination but were transient and noncumulative. Hand-foot syndrome and mucositis were less frequent with trabectedin/PLD than with PLD alone.RESULTSPatients (N = 672) were randomly assigned to trabectedin/PLD (n = 337) or PLD (n = 335). Median PFS was 7.3 months with trabectedin/PLD v 5.8 months with PLD (hazard ratio, 0.79; 95% CI, 0.65 to 0.96; P = .0190). For platinum-sensitive patients, median PFS was 9.2 months v 7.5 months, respectively (hazard ratio, 0.73; 95% CI, 0.56 to 0.95; P = .0170). Overall response rate (ORR) was 27.6% for trabectedin/PLD v 18.8% for PLD (P = .0080); for platinum-sensitive patients, it was 35.3% v 22.6% (P = .0042), respectively. ORR, PFS, and overall survival among platinum-resistant patients were not statistically different. Neutropenia was more common with trabectedin/PLD. Grade 3 to 4 transaminase elevations were also more common with the combination but were transient and noncumulative. Hand-foot syndrome and mucositis were less frequent with trabectedin/PLD than with PLD alone.When combined with PLD, trabectedin improves PFS and ORR over PLD alone with acceptable tolerance in the second-line treatment of recurrent ovarian cancer.CONCLUSIONWhen combined with PLD, trabectedin improves PFS and ORR over PLD alone with acceptable tolerance in the second-line treatment of recurrent ovarian cancer. The objective of this study was to compare the efficacy and safety of trabectedin plus pegylated liposomal doxorubicin (PLD) with that of PLD alone in women with recurrent ovarian cancer after failure of first-line, platinum-based chemotherapy. Women > or = 18 years, stratified by performance status (0 to 1 v 2) and platinum sensitivity, were randomly assigned to receive an intravenous infusion of PLD 30 mg/m(2) followed by a 3-hour infusion of trabectedin 1.1 mg/m(2) every 3 weeks or PLD 50 mg/m(2) every 4 weeks. The primary end point was progression-free survival (PFS) by independent radiology assessment. Patients (N = 672) were randomly assigned to trabectedin/PLD (n = 337) or PLD (n = 335). Median PFS was 7.3 months with trabectedin/PLD v 5.8 months with PLD (hazard ratio, 0.79; 95% CI, 0.65 to 0.96; P = .0190). For platinum-sensitive patients, median PFS was 9.2 months v 7.5 months, respectively (hazard ratio, 0.73; 95% CI, 0.56 to 0.95; P = .0170). Overall response rate (ORR) was 27.6% for trabectedin/PLD v 18.8% for PLD (P = .0080); for platinum-sensitive patients, it was 35.3% v 22.6% (P = .0042), respectively. ORR, PFS, and overall survival among platinum-resistant patients were not statistically different. Neutropenia was more common with trabectedin/PLD. Grade 3 to 4 transaminase elevations were also more common with the combination but were transient and noncumulative. Hand-foot syndrome and mucositis were less frequent with trabectedin/PLD than with PLD alone. When combined with PLD, trabectedin improves PFS and ORR over PLD alone with acceptable tolerance in the second-line treatment of recurrent ovarian cancer. |
| Author | Hextan Yuen-Sheung Ngan Anatoly N. Makhson Youn Choi Park Jan B. Vermorken Alla S. Lisyanskaya Ignace B. Vergote Thomas J. Herzog Joo-Hyun Nam Janusz Rolski Bradley J. Monk Eric Pujade-Lauraine Carolyn N. Krasner Franco M. Muggia Keng Shen Claudia A. Lebedinsky Stanley B. Kaye Vera A. Gorbounova Prafull Ghatage Mariusz Bidzinski Andrés M. Poveda |
| Author_xml | – sequence: 1 givenname: Bradley J. surname: Monk fullname: Monk, Bradley J. organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 2 givenname: Thomas J. surname: Herzog fullname: Herzog, Thomas J. organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 3 givenname: Stanley B. surname: Kaye fullname: Kaye, Stanley B. organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 4 givenname: Carolyn N. surname: Krasner fullname: Krasner, Carolyn N. organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 5 givenname: Jan B. surname: Vermorken fullname: Vermorken, Jan B. organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 6 givenname: Franco M. surname: Muggia fullname: Muggia, Franco M. organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 7 givenname: Eric surname: Pujade-Lauraine fullname: Pujade-Lauraine, Eric organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 8 givenname: Alla S. surname: Lisyanskaya fullname: Lisyanskaya, Alla S. organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 9 givenname: Anatoly N. surname: Makhson fullname: Makhson, Anatoly N. organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 10 givenname: Janusz surname: Rolski fullname: Rolski, Janusz organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 11 givenname: Vera A. surname: Gorbounova fullname: Gorbounova, Vera A. organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 12 givenname: Prafull surname: Ghatage fullname: Ghatage, Prafull organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 13 givenname: Mariusz surname: Bidzinski fullname: Bidzinski, Mariusz organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 14 givenname: Keng surname: Shen fullname: Shen, Keng organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 15 givenname: Hextan Yuen-Sheung surname: Ngan fullname: Ngan, Hextan Yuen-Sheung organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 16 givenname: Ignace B. surname: Vergote fullname: Vergote, Ignace B. organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 17 givenname: Joo-Hyun surname: Nam fullname: Nam, Joo-Hyun organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 18 givenname: Youn Choi surname: Park fullname: Park, Youn Choi organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 19 givenname: Claudia A. surname: Lebedinsky fullname: Lebedinsky, Claudia A. organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City – sequence: 20 givenname: Andrés M. surname: Poveda fullname: Poveda, Andrés M. organization: From the University of California at Irvine (UCI) and UCI Medical Center, Orange, CA; Columbia University College of Physicians and Surgeons; New York University Hospital, New York, NY; the Royal Marsden Hospital, Surrey, United Kingdom; Gillette Center for Women's Studies, Massachusetts General Hospital, Boston, MA; Antwerp University Hospital, Edegem; University Hospital, Leuven, Belgium; Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France; SPBSIH City |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/20516432$$D View this record in MEDLINE/PubMed |
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| SubjectTerms | Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Dioxoles - administration & dosage Dioxoles - adverse effects Doxorubicin - administration & dosage Doxorubicin - adverse effects Doxorubicin - analogs & derivatives Drug Administration Schedule Female Humans Kaplan-Meier Estimate Leukopenia - chemically induced Middle Aged Multivariate Analysis Neoplasm Recurrence, Local Neutropenia - chemically induced Ovarian Neoplasms - drug therapy Ovarian Neoplasms - pathology Polyethylene Glycols - administration & dosage Polyethylene Glycols - adverse effects Stomatitis - chemically induced Tetrahydroisoquinolines - administration & dosage Tetrahydroisoquinolines - adverse effects Treatment Outcome |
| Title | Trabectedin Plus Pegylated Liposomal Doxorubicin in Recurrent Ovarian Cancer |
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