| Methods |
RCT conducted in Taiwan. Patients randomized postoperatively between Jan 2001 and Dec 2007. Overall survival duration was calculated from cytoreductive surgery to disease‐specific death or last follow‐up. |
| Participants |
367 women with Stage III epithelial ovarian cancer following cytoreductive surgery. |
| Interventions |
IP versus IV chemotherapy following standard cytoreductive surgery. Chemotherapy consisted of paclitaxel on day 1 combined with cisplatin or carboplatin administered IP or IV on day 2. This was repeated every 3 weeks for 6 cycles provided serum creatinine was < or equal to 2 mg/dl, WCC > 3000/mm3, and platelet count was > 80,000/mm3. IP therapy was discontinued and shifted to IV chemo if tube problems occurred. |
| Outcomes |
Nomogram construction/model for survival using age, CA‐125, IV/IP, Stage, histology, upper abdominal metastases |
| Notes |
Patients who had a sub‐optimal cytoreductive status (tumour greater than 1 cm) or incomplete clinicopathological data or were operated on by a non‐sub specialist were excluded from the analysis. Patients lost to follow‐up were 'censored'. 298 included in final analyses (152 in IV group and 146 in IP group). Baseline characteristics similar. Analyzed the impact of delivered IP cycles on survival and found that 5 or more IP cycles were needed to achieve better survival. Authors provided additional unpublished data (including survival data and adverse effect data) and methodological details. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer generated random numbers (additional unpublished information) |
| Allocation concealment (selection bias) |
Unclear risk |
Not described |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not possible |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Group sizes were similar, as were baseline characteristics. Unpublished data was complete for survival outcomes and adverse effects. |
| Selective reporting (reporting bias) |
Low risk |
Objective was to construct a nomogram for survival. Analyses by ITT (unpublished information). |
| Other bias |
Low risk |
Considered a high quality trial |
