Randomized trial of pegylated liposomal doxorubicin (PLD) plus carboplatin versus carboplatin in platinum-sensitive (PS) patients with recurrent epithelial ovarian or peritoneal carcinoma after failure of initial platinum-based chemotherapy (Southwest Oncology Group Protocol S0200)

David S Alberts, P. Y. Liu, Sharon P. Wilczynski, Mary C. Clouser, Ana Maria Lopez, David P. Michelin, Victor J. Lanzotti, Maurie Markman

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Abstract

Objective.: Because debate continues over the role of combination, platinum-based chemotherapy for platinum-sensitive (PS), recurrent ovarian cancer (OC), we compared overall survival (OS), progression-free survival (PFS), confirmed complete response rate and time to treatment failure in this population. Methods.: Patients with recurrent stage III or IV OC, a progression-free and platinum-free interval of 6-24 months after first-line platinum-based chemotherapy and up to 12 courses of a non-platinum containing consolidation treatment were eligible. Patients were randomized to IV pegylated liposomal doxorubicin (PLD) (30 mg/m2) plus IV carboplatin (AUC = 5 mg/mL min) once every 4 weeks (PLD arm) or IV carboplatin alone (AUC = 5 mg/mL min) once every 4 weeks. Results.: The PLD arm enrolled 31 patients and the carboplatin alone arm 30 for a total of 61 patients out of 900 planned. Response rates were 67% for the PLD arm and 32% for the carboplatin only arm (Fisher's exact p = 0.02). The estimated median PFS was 12 and 8 months for PLD versus carboplatin alone. The estimated median OS on the PLD arm was 26 months and 18 months on the carboplatin only arm (p = 0.02). Twenty-six percent of the patients on the PLD arm reported grade 4 toxicities, all hematological in nature. Conclusion.: This study was closed early because of slow patient accrual. The response rate, median PFS and OS results are intriguing. These data suggest that there may be an advantage to the PLD plus carboplatin combination treatment in patients with PS, recurrent OC. The regimen should be further tested.

Original languageEnglish (US)
Pages (from-to)90-94
Number of pages5
JournalGynecologic Oncology
Volume108
Issue number1
DOIs
StatePublished - Jan 2008

Fingerprint

Carboplatin
Platinum
Carcinoma
Drug Therapy
Ovarian Neoplasms
Disease-Free Survival
Area Under Curve
Survival
liposomal doxorubicin
Treatment Failure
Therapeutics
Population

Keywords

  • Carboplatin
  • Ovarian cancer
  • Pegylated liposomal doxorubicin
  • Platinum-sensitive

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

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title = "Randomized trial of pegylated liposomal doxorubicin (PLD) plus carboplatin versus carboplatin in platinum-sensitive (PS) patients with recurrent epithelial ovarian or peritoneal carcinoma after failure of initial platinum-based chemotherapy (Southwest Oncology Group Protocol S0200)",
abstract = "Objective.: Because debate continues over the role of combination, platinum-based chemotherapy for platinum-sensitive (PS), recurrent ovarian cancer (OC), we compared overall survival (OS), progression-free survival (PFS), confirmed complete response rate and time to treatment failure in this population. Methods.: Patients with recurrent stage III or IV OC, a progression-free and platinum-free interval of 6-24 months after first-line platinum-based chemotherapy and up to 12 courses of a non-platinum containing consolidation treatment were eligible. Patients were randomized to IV pegylated liposomal doxorubicin (PLD) (30 mg/m2) plus IV carboplatin (AUC = 5 mg/mL min) once every 4 weeks (PLD arm) or IV carboplatin alone (AUC = 5 mg/mL min) once every 4 weeks. Results.: The PLD arm enrolled 31 patients and the carboplatin alone arm 30 for a total of 61 patients out of 900 planned. Response rates were 67{\%} for the PLD arm and 32{\%} for the carboplatin only arm (Fisher's exact p = 0.02). The estimated median PFS was 12 and 8 months for PLD versus carboplatin alone. The estimated median OS on the PLD arm was 26 months and 18 months on the carboplatin only arm (p = 0.02). Twenty-six percent of the patients on the PLD arm reported grade 4 toxicities, all hematological in nature. Conclusion.: This study was closed early because of slow patient accrual. The response rate, median PFS and OS results are intriguing. These data suggest that there may be an advantage to the PLD plus carboplatin combination treatment in patients with PS, recurrent OC. The regimen should be further tested.",
keywords = "Carboplatin, Ovarian cancer, Pegylated liposomal doxorubicin, Platinum-sensitive",
author = "Alberts, {David S} and Liu, {P. Y.} and Wilczynski, {Sharon P.} and Clouser, {Mary C.} and Lopez, {Ana Maria} and Michelin, {David P.} and Lanzotti, {Victor J.} and Maurie Markman",
year = "2008",
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T1 - Randomized trial of pegylated liposomal doxorubicin (PLD) plus carboplatin versus carboplatin in platinum-sensitive (PS) patients with recurrent epithelial ovarian or peritoneal carcinoma after failure of initial platinum-based chemotherapy (Southwest Oncology Group Protocol S0200)

AU - Alberts, David S

AU - Liu, P. Y.

AU - Wilczynski, Sharon P.

AU - Clouser, Mary C.

AU - Lopez, Ana Maria

AU - Michelin, David P.

AU - Lanzotti, Victor J.

AU - Markman, Maurie

PY - 2008/1

Y1 - 2008/1

N2 - Objective.: Because debate continues over the role of combination, platinum-based chemotherapy for platinum-sensitive (PS), recurrent ovarian cancer (OC), we compared overall survival (OS), progression-free survival (PFS), confirmed complete response rate and time to treatment failure in this population. Methods.: Patients with recurrent stage III or IV OC, a progression-free and platinum-free interval of 6-24 months after first-line platinum-based chemotherapy and up to 12 courses of a non-platinum containing consolidation treatment were eligible. Patients were randomized to IV pegylated liposomal doxorubicin (PLD) (30 mg/m2) plus IV carboplatin (AUC = 5 mg/mL min) once every 4 weeks (PLD arm) or IV carboplatin alone (AUC = 5 mg/mL min) once every 4 weeks. Results.: The PLD arm enrolled 31 patients and the carboplatin alone arm 30 for a total of 61 patients out of 900 planned. Response rates were 67% for the PLD arm and 32% for the carboplatin only arm (Fisher's exact p = 0.02). The estimated median PFS was 12 and 8 months for PLD versus carboplatin alone. The estimated median OS on the PLD arm was 26 months and 18 months on the carboplatin only arm (p = 0.02). Twenty-six percent of the patients on the PLD arm reported grade 4 toxicities, all hematological in nature. Conclusion.: This study was closed early because of slow patient accrual. The response rate, median PFS and OS results are intriguing. These data suggest that there may be an advantage to the PLD plus carboplatin combination treatment in patients with PS, recurrent OC. The regimen should be further tested.

AB - Objective.: Because debate continues over the role of combination, platinum-based chemotherapy for platinum-sensitive (PS), recurrent ovarian cancer (OC), we compared overall survival (OS), progression-free survival (PFS), confirmed complete response rate and time to treatment failure in this population. Methods.: Patients with recurrent stage III or IV OC, a progression-free and platinum-free interval of 6-24 months after first-line platinum-based chemotherapy and up to 12 courses of a non-platinum containing consolidation treatment were eligible. Patients were randomized to IV pegylated liposomal doxorubicin (PLD) (30 mg/m2) plus IV carboplatin (AUC = 5 mg/mL min) once every 4 weeks (PLD arm) or IV carboplatin alone (AUC = 5 mg/mL min) once every 4 weeks. Results.: The PLD arm enrolled 31 patients and the carboplatin alone arm 30 for a total of 61 patients out of 900 planned. Response rates were 67% for the PLD arm and 32% for the carboplatin only arm (Fisher's exact p = 0.02). The estimated median PFS was 12 and 8 months for PLD versus carboplatin alone. The estimated median OS on the PLD arm was 26 months and 18 months on the carboplatin only arm (p = 0.02). Twenty-six percent of the patients on the PLD arm reported grade 4 toxicities, all hematological in nature. Conclusion.: This study was closed early because of slow patient accrual. The response rate, median PFS and OS results are intriguing. These data suggest that there may be an advantage to the PLD plus carboplatin combination treatment in patients with PS, recurrent OC. The regimen should be further tested.

KW - Carboplatin

KW - Ovarian cancer

KW - Pegylated liposomal doxorubicin

KW - Platinum-sensitive

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