Intraperitoneal Cisplatin and Paclitaxel in Ovarian Cancer
Disease site
Ovary
Pubmed link
Publication month/year
January, 2006
Study question
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)
Interventions compared
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
Control arm
Six cycles of IV paclitaxel plus IV cisplatin
Primary outcome
- Progression-free survival (PFS)
- Overall survival (OS)
Secondary outcome
- Toxicity
- Quality of Life (QoL)
Inclusion criteria
- 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.
Exclusion criteria
Nil
Results
| Intervention arm | Control arm | |
|---|---|---|
| Randomised(n) | 205 | 210 |
| Received treatment(n) | 174 | 189 |
| 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 |
Other results
- 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
Conclusions
- 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.
Study limitations
The study didn’t take into consideration the effect of treatment duration on clinical outcome