OBJECTIVE: It was the aim of this study to assess the role, feasibility and safety of consolidation intraperitoneal (IP) paclitaxel in patients affected by advanced ovarian cancer. METHODS: Patients affected by advanced ovarian cancer with complete pathological response after standard treatment were enrolled in this study. The consolidation chemotherapy schedule consisted of 12-16 cycles of IP paclitaxel, 60 mg/mq weekly (group A). Chemotherapy was delivered with a direct puncture under ultrasonographic guidance at each cycle. Survival data of this group of patients were compared with those from a control group with analogous characteristics submitted to observation only (group B). RESULTS: Seventy patients were included in the study, 28 in group A and 42 in group B. Treatment-related toxicity was mild. In 3/28 patients (11%), technical difficulties in accessing the peritoneum were observed. Median time to recurrence was 25 months (range 4-64) in group A and 17.5 months (range 2-60) in group B. Estimated 3-year disease-free survival was 56 and 33% (p < 0.05) in group A and B, respectively; no significant difference in 3-year overall survival was observed (87 vs. 83%; p value not significant). CONCLUSION: Weekly IP consolidation chemotherapy with paclitaxel 60 mg/mq is well tolerated and, in this experience, a prolongation of progression-free survival was observed. Copyright 2010 S. Karger AG, Basel.
OBJECTIVE: It was the aim of this study to assess the role, feasibility and safety of consolidation intraperitoneal (IP) paclitaxel in patients affected by advanced ovarian cancer. METHODS:Patients affected by advanced ovarian cancer with complete pathological response after standard treatment were enrolled in this study. The consolidation chemotherapy schedule consisted of 12-16 cycles of IP paclitaxel, 60 mg/mq weekly (group A). Chemotherapy was delivered with a direct puncture under ultrasonographic guidance at each cycle. Survival data of this group of patients were compared with those from a control group with analogous characteristics submitted to observation only (group B). RESULTS: Seventy patients were included in the study, 28 in group A and 42 in group B. Treatment-related toxicity was mild. In 3/28 patients (11%), technical difficulties in accessing the peritoneum were observed. Median time to recurrence was 25 months (range 4-64) in group A and 17.5 months (range 2-60) in group B. Estimated 3-year disease-free survival was 56 and 33% (p < 0.05) in group A and B, respectively; no significant difference in 3-year overall survival was observed (87 vs. 83%; p value not significant). CONCLUSION: Weekly IP consolidation chemotherapy with paclitaxel 60 mg/mq is well tolerated and, in this experience, a prolongation of progression-free survival was observed. Copyright 2010 S. Karger AG, Basel.