Southwest Oncology Group Trial S9912: Intraperitoneal cisplatin and paclitaxel plus intravenous paclitaxel and pegylated liposomal doxorubicin as primary chemotherapy of small-volume residual stage III ovarian cancer

Harriet O. Smith, James Moon, Sharon P. Wilczynski, Amy D. Tiersten, Edward V. Hannigan, William R. Robinson, Saul E. Rivkin, Garnet L. Anderson, P. Y. Liu, Maurie Markman

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Objective: While primary cisplatin-based intraperitoneal chemotherapy has been shown to favorably impact survival in small-volume residual advanced ovarian cancer, there is a need to develop strategies that improve the effectiveness of this approach. Methods: A multi-center phase 2 trial was conducted that added intravenous pegylated liposomal doxorubicin (day 8; 30-40 mg/m2) to a regimen of intraperitoneal cisplatin (day 2; 75 mg/m2) and intravenous (day 1; 135 mg/m2) plus intraperitoneal (day 8; 60 mg/m2) paclitaxel. Treatment was initially delivered on an every 3-week schedule, but was modified to an every 4-week program due to excessive toxicity. Patients were to receive 6 cycles of this regimen. Results: Of 68 patients entering this trial, 63 patients were eligible and evaluable, of whom 39 (62%) completed 6 cycles. Overall, 32 (51%) experienced at least 1 grade 4 or worse toxicity (most commonly hematologic) including 5 treatment-related deaths. Median progression-free survival (PFS) was 25 months (2-year PFS: 52%) and median overall survival 51 months, an outcome similar to previous reports of cisplatin-based intraperitoneal chemotherapy in comparable patient populations. Seventeen patients (27% of all eligible patients) were without evidence of disease recurrence > 4 years following entry into the trial. Conclusion: Both the overall trial outcome, and specifically the excessively severe systemic toxicity of this regimen would prevent its future development in this exact form. The provocative PFS in a subset of individuals should encourage the development of alternative strategies designed to optimize the delivery of regional therapy in ovarian cancer management.

Original languageEnglish (US)
Pages (from-to)206-209
Number of pages4
JournalGynecologic Oncology
Volume114
Issue number2
DOIs
StatePublished - Aug 2009
Externally publishedYes

Fingerprint

Residual Volume
Paclitaxel
Ovarian Neoplasms
Drug Therapy
Cisplatin
Disease-Free Survival
Survival
TP protocol
liposomal doxorubicin
Appointments and Schedules
Therapeutics
Recurrence
Population

Keywords

  • Intraperitoneal chemotherapy
  • Multi-center phase 2 trial
  • Ovarian cancer

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

Southwest Oncology Group Trial S9912 : Intraperitoneal cisplatin and paclitaxel plus intravenous paclitaxel and pegylated liposomal doxorubicin as primary chemotherapy of small-volume residual stage III ovarian cancer. / Smith, Harriet O.; Moon, James; Wilczynski, Sharon P.; Tiersten, Amy D.; Hannigan, Edward V.; Robinson, William R.; Rivkin, Saul E.; Anderson, Garnet L.; Liu, P. Y.; Markman, Maurie.

In: Gynecologic Oncology, Vol. 114, No. 2, 08.2009, p. 206-209.

Research output: Contribution to journalArticle

Smith, Harriet O. ; Moon, James ; Wilczynski, Sharon P. ; Tiersten, Amy D. ; Hannigan, Edward V. ; Robinson, William R. ; Rivkin, Saul E. ; Anderson, Garnet L. ; Liu, P. Y. ; Markman, Maurie. / Southwest Oncology Group Trial S9912 : Intraperitoneal cisplatin and paclitaxel plus intravenous paclitaxel and pegylated liposomal doxorubicin as primary chemotherapy of small-volume residual stage III ovarian cancer. In: Gynecologic Oncology. 2009 ; Vol. 114, No. 2. pp. 206-209.
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abstract = "Objective: While primary cisplatin-based intraperitoneal chemotherapy has been shown to favorably impact survival in small-volume residual advanced ovarian cancer, there is a need to develop strategies that improve the effectiveness of this approach. Methods: A multi-center phase 2 trial was conducted that added intravenous pegylated liposomal doxorubicin (day 8; 30-40 mg/m2) to a regimen of intraperitoneal cisplatin (day 2; 75 mg/m2) and intravenous (day 1; 135 mg/m2) plus intraperitoneal (day 8; 60 mg/m2) paclitaxel. Treatment was initially delivered on an every 3-week schedule, but was modified to an every 4-week program due to excessive toxicity. Patients were to receive 6 cycles of this regimen. Results: Of 68 patients entering this trial, 63 patients were eligible and evaluable, of whom 39 (62{\%}) completed 6 cycles. Overall, 32 (51{\%}) experienced at least 1 grade 4 or worse toxicity (most commonly hematologic) including 5 treatment-related deaths. Median progression-free survival (PFS) was 25 months (2-year PFS: 52{\%}) and median overall survival 51 months, an outcome similar to previous reports of cisplatin-based intraperitoneal chemotherapy in comparable patient populations. Seventeen patients (27{\%} of all eligible patients) were without evidence of disease recurrence > 4 years following entry into the trial. Conclusion: Both the overall trial outcome, and specifically the excessively severe systemic toxicity of this regimen would prevent its future development in this exact form. The provocative PFS in a subset of individuals should encourage the development of alternative strategies designed to optimize the delivery of regional therapy in ovarian cancer management.",
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T2 - Intraperitoneal cisplatin and paclitaxel plus intravenous paclitaxel and pegylated liposomal doxorubicin as primary chemotherapy of small-volume residual stage III ovarian cancer

AU - Smith, Harriet O.

AU - Moon, James

AU - Wilczynski, Sharon P.

AU - Tiersten, Amy D.

AU - Hannigan, Edward V.

AU - Robinson, William R.

AU - Rivkin, Saul E.

AU - Anderson, Garnet L.

AU - Liu, P. Y.

AU - Markman, Maurie

PY - 2009/8

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N2 - Objective: While primary cisplatin-based intraperitoneal chemotherapy has been shown to favorably impact survival in small-volume residual advanced ovarian cancer, there is a need to develop strategies that improve the effectiveness of this approach. Methods: A multi-center phase 2 trial was conducted that added intravenous pegylated liposomal doxorubicin (day 8; 30-40 mg/m2) to a regimen of intraperitoneal cisplatin (day 2; 75 mg/m2) and intravenous (day 1; 135 mg/m2) plus intraperitoneal (day 8; 60 mg/m2) paclitaxel. Treatment was initially delivered on an every 3-week schedule, but was modified to an every 4-week program due to excessive toxicity. Patients were to receive 6 cycles of this regimen. Results: Of 68 patients entering this trial, 63 patients were eligible and evaluable, of whom 39 (62%) completed 6 cycles. Overall, 32 (51%) experienced at least 1 grade 4 or worse toxicity (most commonly hematologic) including 5 treatment-related deaths. Median progression-free survival (PFS) was 25 months (2-year PFS: 52%) and median overall survival 51 months, an outcome similar to previous reports of cisplatin-based intraperitoneal chemotherapy in comparable patient populations. Seventeen patients (27% of all eligible patients) were without evidence of disease recurrence > 4 years following entry into the trial. Conclusion: Both the overall trial outcome, and specifically the excessively severe systemic toxicity of this regimen would prevent its future development in this exact form. The provocative PFS in a subset of individuals should encourage the development of alternative strategies designed to optimize the delivery of regional therapy in ovarian cancer management.

AB - Objective: While primary cisplatin-based intraperitoneal chemotherapy has been shown to favorably impact survival in small-volume residual advanced ovarian cancer, there is a need to develop strategies that improve the effectiveness of this approach. Methods: A multi-center phase 2 trial was conducted that added intravenous pegylated liposomal doxorubicin (day 8; 30-40 mg/m2) to a regimen of intraperitoneal cisplatin (day 2; 75 mg/m2) and intravenous (day 1; 135 mg/m2) plus intraperitoneal (day 8; 60 mg/m2) paclitaxel. Treatment was initially delivered on an every 3-week schedule, but was modified to an every 4-week program due to excessive toxicity. Patients were to receive 6 cycles of this regimen. Results: Of 68 patients entering this trial, 63 patients were eligible and evaluable, of whom 39 (62%) completed 6 cycles. Overall, 32 (51%) experienced at least 1 grade 4 or worse toxicity (most commonly hematologic) including 5 treatment-related deaths. Median progression-free survival (PFS) was 25 months (2-year PFS: 52%) and median overall survival 51 months, an outcome similar to previous reports of cisplatin-based intraperitoneal chemotherapy in comparable patient populations. Seventeen patients (27% of all eligible patients) were without evidence of disease recurrence > 4 years following entry into the trial. Conclusion: Both the overall trial outcome, and specifically the excessively severe systemic toxicity of this regimen would prevent its future development in this exact form. The provocative PFS in a subset of individuals should encourage the development of alternative strategies designed to optimize the delivery of regional therapy in ovarian cancer management.

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KW - Multi-center phase 2 trial

KW - Ovarian cancer

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