Eisenhauer 1994.

Methods	RCT of 2 x 2 factorial design.
Participants	407 patients with histologically documented progressive epithelial ovarian cancer previously treated with either one or two platinum containing chemotherapy regimens. Of all eligible patients (N = 391): Median age in the trial was 57 years in both infusion groups. There were 158 (%) women with performance status 0, 166 (%) women with status 1 and 67 (%) with status 2. Histological cell types were as follows: Serous: 222 (%), Mucinous: 23 (%), Endometroid: 42 (%), Clear cell: 16 (%), Other: 88 (%).
Interventions	Single agent paclitaxel at standard dose (135 versus 175 mg/m2) and two durations of infusion (3 versus 24 hours).
Outcomes	Toxicity, response, time to progression, overall survival and quality of life.
Notes	Trial randomised 407 patients, of which 391 were eligible. Data in this trial can be used for all the end points of the review. 106/407 (26%) women were still alive at the end of the study. There was no statistically significant difference between the two infusion groups (P = 0.3). Median times to progression in the two infusion duration groups were similar (17 versus 16 weeks), but the three hour group showed an overall trend for a longer progression‐free interval (P = 0.07). At the time of the reported analysis 27 patients were still alive. Median survival for the three hour infusion group was 51 weeks and that for the 24 hr infusion group was 48 weeks. Any degree of hypersensitivity reaction were similar for the two groups (45% versus 42% respectively). White blood cell suppression was common and was clearly related to the duration of paclitaxel infusion. Only grade IV neutropenia was reported (24 hour infusion 71% and three hour infusion 18%). Only nine patients discontinued paclitaxel because of side‐effects (four low white cell count, three hypersensitivity reactions, one sore mouth and one pulmonary oedema).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomisation lists were generated by the biostatistics and data management department at Bristol‐Myers Squibb".
Allocation concealment (selection bias)	Low risk	"On identification of an eligible patient, the study investigator completed an eligibility checklist and reported this information by telephone or facsimile to one or two regional randomisation sites".
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	% analysed: 382/407 (94%) for response and 391/407 (96%) for toxicity. 3 hr infusion: 182/195 (93%) and 187/195 (96%) patients were assessed for response and toxicity respectively. 24 hr infusion: 200/212 (94%) and 204/212 (96%) patients were assessed for response and toxicity respectively.
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