Improved intraperitoneal chemotherapeutic toxicity profile for ovarian cancer: A modification of the taxane-platinum protocol in GOG-172

Abstract

5583 Background: GOG 172 demonstrated a significant survival advantage for intraperitoneal (IP) versus intravenous (IV) chemotherapy in optimally debulked ovarian cancer patients; however this treatment was also more toxic. Our objective is to describe the toxicity profile of a modified IP regimen. Methods: A chart review of all ovarian cancer patients who received IP chemotherapy from 12/2005 to 1/2008 was performed. All optimally debulked patients after primary surgery for ovarian cancer who underwent day 1 IV docetaxel 60–70 mg/m2, IP cisplatin 80–85 mg/m2 and day 8 IP paclitaxel 60–70 mg/m2 every 21 days were included. All patients received G-CSF support. Toxicities were recorded using CTCAEv3.0 criteria. Results: 37 patients met inclusion criteria, including 6 patients who previously received 3–4 cycles of neoadjuvant chemotherapy. 34 patients have completed chemotherapy and 3 patients are still undergoing treatment. 59% of patients (20/34) completed all planned cycles of IP chemotherapy and 85% (29/34) completed 50% or more of the planned cycles. 5 patients did not complete ≥ 50% of cycles. 3 of these 5 resulted from port failure, 1 patient developed an abdominal wall abscess requiring port removal, and a final patient had a vaginal vault evisceration during the first cycle of chemotherapy. Toxicity was evaluable for 37 patients and survival in 34 patients. The median number of completed cycles was 5 (range 0.5–7). Overall, 150.5 cycles were delivered with only 6 cycle delays. 9 patients required minor (10–15 %) dose reductions due to side effects. Grade 3 and 4 hematologic toxicities occurred in 12% of patients (4/34). 6 patients experienced grade 3 or 4 non-hematologic events. The overall response rate was 100% (CR=92%, PR=8%) with a median follow up time of 9 months (range 2–27 months). 7 patients have recurred (4 of these patients were platinum resistant). Conclusions: This modified IP regimen is well tolerated. In contrast to GOG 172, major toxicities were markedly reduced and most patients were able to complete > 50% of the planned cycles. These findings suggest that modification of the drugs, dose and schedule of IP chemotherapy should be further studied in future prospective chemotherapy trials in ovarian cancer. No significant financial relationships to disclose.