TY - JOUR
T1 - Southwest Oncology Group Trial S9912
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
N1 - Funding Information:
This investigation was supported in part by the following PHS Cooperative Agreement grant numbers awarded by the National Cancer Institute, DHHS: CA32102, CA38926, CA22433, CA46368, CA35431, CA67575, CA12213, CA86780, CA58861, CA13612, CA46113, CA12644, CA35119, CA46441, CA105409 and in part by Alza Corporation (now part of Johnson and Johnson).
PY - 2009/8
Y1 - 2009/8
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.
KW - Intraperitoneal chemotherapy
KW - Multi-center phase 2 trial
KW - Ovarian cancer
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U2 - 10.1016/j.ygyno.2009.04.023
DO - 10.1016/j.ygyno.2009.04.023
M3 - Article
C2 - 19464730
AN - SCOPUS:67549135467
SN - 0090-8258
VL - 114
SP - 206
EP - 209
JO - Gynecologic Oncology
JF - Gynecologic Oncology
IS - 2
ER -