The median duration of progression free survival was increased in the intraperitoneal (IP) group 23.8 months vs. 18.3 months for the IV therapy group (p=0.05). The median duration of overall survival was significantly increased in the IP group. 65.6 months vs 49.7 months (p=0.03). Quality of life was significantly worse in the IP group before cycle 4 but not one year after treatment.r
Interpretation of the results of this trial has generated considerable controversy. However the evidence has been considered sufficient to generate an NCI alert in favour of IP treatment.
The trial has been criticised because of the differing dose intensity between the two arms. It should however be noted that increasing the dose intensity of cisplatin or paclitaxel has not been associated with increased survival in previous trials. This trial confirms results from previous randomised trials, that have also shown a survival advantage for IP therapy.
The combined trial data together provide "proof" of principle that intraperitoneal therapy is advantageous but do not define an optimal regimen. This regimen, which reduces the dose of cisplatin and the duration of paclitaxel infusion, is used in many centres.
(A) Progression-free survival, and (B) Overall survival:r
© New England Journal of Medicine 2006