Intraperitoneal Cisplatin and Paclitaxel in Ovarian Cancer
The effectiveness of intraperitoneal Cisplatin and Paclitaxel in addition to intravenous Paclitaxel in women with stage III ovarian cancer who had optimal debulking surgery?
Type of study
Randomised controlled trial (RCT)
IV Paclitaxel 135 mg/square followed by either:
- IP cisplatin(D2) and paclitaxel(D8)
- IV cisplatin
Experimental arm (Intervention)
Six cycles of IV paclitaxel plus IP cisplatin and paclitaxel
Six cycles of IV paclitaxel plus IV cisplatin
- Progression-free survival (PFS)
- Overall survival (OS)
- Quality of Life (QoL)
- Stage III epithelial ovarian or peritoneal carcinoma with no residual mass greater than 1.0 cm after surgery
- Gynaecologic Oncology Group (GOG) performance status of 0 to 2
- Normal blood count
- Adequate renal and hepatic function.
|Intervention arm||Control arm|
|Toxicity||5 treatment related deaths||4 treatment related deaths|
|Progression-free survival*||23.8 months||18.3 months|
|Overall survival*||65.6 months||49.7 months|
- Significantly lower QoL scores before cycle 4 and three to six weeks after treatment in IP arm.
- No statistical significance in QoL scores between the two treatment arms is found one year after treatment
- IV paclitaxel followed by IP cisplatin plus paclitaxel significantly improved progression free survival and overall survival in women with optimally debulked stage III ovarian cancer.
- IP regimen was associated with significantly more toxic events.
The study didn’t take into consideration the effect of treatment duration on clinical outcome