Intraperitoneal cisplatin and whole abdomen hyperthermia for relapsed ovarian carcinoma.
5038 Background:The study was designed to determine the maximum tolerated dose (MTD) of intraperitoneal cisplatin [CDDP] combined with intravenous thiosulfate and concurrent whole abdomen hyperthermia for advanced, recurrent or progressive ovarian carcinoma. Furthermore, clinical activity, toxicity and feasibility of the treatment regimen were assessed. METHODS: Between September 1991 and November of 1998 forty one patients with advanced epithelial ovarian cancer received escalating doses of intraperitoneal cisplatin (6 cycles given every 3-4 weeks) and whole abdomen hyperthermia with intravenous thiosulfate as second line treatment. Thermometry was obtained both intraperitoneally as well as intravaginally and intrarectally. RESULTS: The first three patients started at a dose of 60 mg/m2 of intraperitoneal cisplatin. All patients completed this dose without complication. Nine patients were entered at the 100 mg/m2 dose, nine patients at 140 mg/m2 and twenty patients at 180 mg/m2. Seven patients completed the full six cycles at 180 mg/m2 dose level and this was deemed to be the maximally tolerated dose (MTD). There were two clinical partial responses (PR) at 60 mg/m2, and one pathologic complete response (CR) and two clinical PR at 100 mg/m2. At 140 mg/m2 there was one pathologic CR, one clinical CR, and two clinical PR. At 180 mg/m2 there were three pathologic CR, four clinical CR, and two clinical PR. This was determined both by CA 125 measurements as well as third look laproscopic evaluation. Median survival for all patients from protocol entry was 30 months (range 2 to 107 months). Median duration of complete response for those achieving a pathologic CR was 14 months (range 2 - 27 months), and median survival for those achieving a CR to this regimen was 35 months (range 14 - 71 months, 95% CI 16 - 54 months). CONCLUSIONS: Salvage platinum based intraperitoneal cisplatin with hyperthermia did achieve pathologic complete response in selected patients, and the proportion of responders increased with greater cisplatin doses. These promising results suggest a role for the use of adjuvant whole abdomen hyperthermia as a means of augmenting chemosensitization. No significant financial relationships to disclose.
Jones, EL; Prosnitz, LR; Samulski, TV; Soper, J; Berchuck, A; Clarke-Pearson, D; Dewhirst, MW; Vujaskovic, Z
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