Back to STM Scientific Program
Efficacy of intraperitoneal drug delivery (IPDD) combined with external capacitative hyperthermia as palliation therapy in patients with recurrent epithelial ovarian cancer (ROC): a phase II clinical study.
G. Fiorentini, P. Giovanis, D. Dacomo, M. Vaira, A. Toscano, M. De Simone;
San Giuseppe Hospital ASL 11, Empoli (Florence), ITALY.
Background: The optimal salvage therapy for ROC has not been established. The choice of IPDD with taxol and CDDP seems rational, because of activity against ovarian cancer cells and favourable pharmacokinetics. In animal model and human pharmacokinetic studies, high intraperitoneal drug concentrations and exposure and high peritoneal tumour concentrations were achieved. The combination of IPDD with hyperthermia enhances the penetration and cytotoxic activity of drugs. Methods: Twelve patients out twenty, gave their written consent . Four of twelve patients relapsed after received optimal primary cytoreduction surgery followed by first line chemotherapy (Group A); eight relapsed after debulking surgery followed by two o more lines of chemotherapy (Group B). IPDD consisted of instillation of CDDP 60 mg/sqm in 1000 cc of ns infused in 1 hour followed by instillation of Taxol 175 mgr/sqm in 1000 ml of ns infused in 1 hour. The cycle was repeated every 3 weeks for 4 cycles. Hyperthermia was achieved by arrangements of capacitative electrodes applied on the whole abdomen with a radiofrequency field of 13.56 Mhz .Treatment was carried out at an applied adsorbed power of 80-150 Watt equivalent to 42°- 47° for 60 minutes, 2 sessions weekly every week for 12 folds. Results: we observed 2 CR (Group A), 6 PR ( Group A = 3 and Group B= 3) and 3 PD and 1 refusal to continue with a Response Rate of 66%. The median progression-free and overall survival rates for all patients treated in this study were 12.2 and 27.2 months, respectively.
The groups had 13.5 (A) and 9,5 (B) months of median progression-free and 29 (A) and 16.5 (B) months overall survival rates, respectively.
Grades 3 toxicity included myelosuppresion, and nephropathy was detected in 3 cases. One patient required blood transfusions due to grade 4 anemia and thrombocytopenia. Another patient developed grade 3 painfull abdominal reaction, paralitic ileus and nephrotoxicity but did not require continuous hemodialysis and refused further treatment. Conclusions: IPDD combined with EH seems feasible, produced manageable toxicity, and showed palliation in ROC patients .
Back to STM Scientific Program
| 
