5540 Background: Excessive toxicity and difficulty in completing prescribed cycles are cited as factors behind the lack of routine acceptance of IP therapy in O/P cancer. In an effort to increase the probability of completing 6 cycles of IP therapy, we evaluated a modified IP regimen with the addition of bevacizumab to determine the proportion of patients able to receive 6 cycles successfully.
METHODS
An open label phase II study was conducted in patients (pts) with stage II-III O/P cancers with residual disease < 1 cm. The primary outcome measure the feasibility of delivering 6 cycles of IP therapy with a completion rate of > 80% being clinically relevant. Pts received paclitaxel 135 mg/m2 IV on day 1 followed by cisplatin 75 mg/m2 IP day 2. Bevacizumab 15 mg/kg day 1 IV was started with the second cycle. Cycles were administered every 21 days for a total of 6 cycles. Following completion of primary therapy, bevacizumab @ 15mg/kg IV was given in consolidation every 21 days for 12 cycles. Pts were assessed for toxicity and disease status. This preliminary analysis reports data from experience with 6 cycles of IP therapy.
RESULTS
22 patients have been enrolled (21-O, 1-P) with a median age of 58 yrs. Two pts discontinued therapy due to IP port problems (following cycle 1 and 4) and per protocol, were replaced. Two pts are on active treatment (completed cycle 5). Of 20 evaluable pts, 2 pts discontinued prematurely (1 after cycle 1 due to elevated liver function tests, 1 after cycle 4 due to grade 3 neuropathy), and 1 pt received cycle 6 by IV route secondary to abdominal pain with IP infusion. The proportion of patients successfully completing 5 cycles of IP therapy was 18/20 (90%), and to date 15/18 (83%) pts have completed 6 cycles. One patient developed a DVT, one had an intra-abdominal fistula requiring surgical intervention after cycle 6.
CONCLUSIONS
The addition of bevacizumab to an IP regimen for O/P cancers did not add to enhanced acute toxicity. The present regimen using 75 mg/m2 CDDP IP and no day 8 paclitaxel appears to be tolerable, with >80% of pts able to receive 6 cycles of therapy. [Table: see text].