Spriggs 2007.
| Methods | RCT | |
| Participants | 293 women with sub‐optimal stage III or IV epithelial ovarian cancer, fallopian tube or primary peritoneal cancer. Of the 280 assessable patients: Median age in the trial was 58.3 years in the 24 hour infusion group and 60.2 years in the 96 hour infusion group (Range in trial: 24.4 to 85.8 years). 92 (33%) women had a performance status of 0, 155 (55%) had status of 1 and 33 (12%) women had a status of 2. Histological cell types were as follows: Serous adenocarcinoma: 211 (75.25%), Mucinous adenocarcinoma: 3 (1%), Endometroid adenocarcinoma: 19 (7%), Clear cell adenocarcinoma: 11 (4%), adenocarcinoma unspecified: 6 (2%), Mixed epithelial: 17 (6%), Undifferentiated adenocarcinoma: 9 (3.25%), Other: 4 (1.5%). |
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| Interventions | Six cycles of cisplatin and either paclitaxel 135 mg/m2 during 24 hours or paclitaxel 120mg/m2 during 96 hours. | |
| Outcomes | Progression‐free and overall survival, response, toxicity. | |
| Notes | 293 women were randomised, but 13 women were deemed ineligible. 140 in each arm were assessable. Hazard ratio for PFS was adjusted for initial measurable disease status, performance status, histology and stage of disease. Hazard ratio for OS was adjusted for measurable disease status and additionally adjusted using the same variables as for PFS. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Study regimens were allocated from randomly permuted blocks of treatments with an equal number of each study treatment within each block". |
| Allocation concealment (selection bias) | Unclear risk | "The assigned study treatment for each patient remained concealed until the patient was registered successfully". |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | High risk | % analysed: 280/293 (96%) for survival outcomes, 276/293 (94%) for toxicity, but only 181/293 (62%) for response. |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
| Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists |