Intraperitoneal Cisplatin and Paclitaxel in Ovarian Cancer

Disease site

Ovary

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

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