BACKGROUND: To further explore the potential of salvage intraperitoneal cisplatin-based therapy in patients with small-volume residual ovarian cancer a Phase II trial was conducted by the Gynecologic Oncology Group. METHODS: Ninety-two patients entered into this trial were treated with a regimen of cisplatin (100 mg/m2) and etoposide (200 mg/m2) delivered intraperitoneally every 4 weeks for a maximum of six cycles. RESULTS: Of the 84 patients evaluable for toxicity, grades 3-4 neutropenia, thrombocytopenia, neurotoxicity, and nephrotoxicity were observed in 25, 12, 6, and 9% of patients, respectively. A total of 41 patients were evaluable for response to the treatment program. Of the 25 evaluable patients with favorable pretreatment characteristics (prior response to systemic cisplatin or relapse > 6 months after completing initial chemotherapy), 10 (40%) achieved a surgically documented response (S-R), including 6 (24%) who achieved a surgically documented complete response (S-CR). Of the 16 patients with unfavorable pretreatment characteristics (less than a partial response to systemic cisplatin or a response of < 6 months duration) the S-R rate was only 12% (S-CR: 6%). CONCLUSIONS: In this large multi-institutional cooperative group study, we have confirmed the activity of salvage cisplatin-based intraperitoneal chemotherapy in patients with small-volume residual ovarian cancer who have favorable pretreatment characteristics. The overall impact of these responses on disease-free and overall survival remains to be defined.
BACKGROUND: To further explore the potential of salvage intraperitoneal cisplatin-based therapy in patients with small-volume residual ovarian cancer a Phase II trial was conducted by the Gynecologic Oncology Group. METHODS: Ninety-two patients entered into this trial were treated with a regimen of cisplatin (100 mg/m2) and etoposide (200 mg/m2) delivered intraperitoneally every 4 weeks for a maximum of six cycles. RESULTS: Of the 84 patients evaluable for toxicity, grades 3-4 neutropenia, thrombocytopenia, neurotoxicity, and nephrotoxicity were observed in 25, 12, 6, and 9% of patients, respectively. A total of 41 patients were evaluable for response to the treatment program. Of the 25 evaluable patients with favorable pretreatment characteristics (prior response to systemic cisplatin or relapse > 6 months after completing initial chemotherapy), 10 (40%) achieved a surgically documented response (S-R), including 6 (24%) who achieved a surgically documented complete response (S-CR). Of the 16 patients with unfavorable pretreatment characteristics (less than a partial response to systemic cisplatin or a response of < 6 months duration) the S-R rate was only 12% (S-CR: 6%). CONCLUSIONS: In this large multi-institutional cooperative group study, we have confirmed the activity of salvage cisplatin-based intraperitoneal chemotherapy in patients with small-volume residual ovarian cancer who have favorable pretreatment characteristics. The overall impact of these responses on disease-free and overall survival remains to be defined.