Statement: the primary trial results suggest that 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle + Capecitabine, triples patient OS, compared to Capecitabine alone.
Primary_evidence: Outcome Measurement:    Overall Survival (OS)   Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.   Time frame: from date of randomization until death Results 1:    Arm/Group Title: Ixabepilone + Capecitabine   Arm/Group Description: Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.   Overall Number of Participants Analyzed: 609   Median (95% Confidence Interval)   Unit of Measure: months  16.39        (14.95 to 17.91) Results 2:    Arm/Group Title: Capecitabine   Arm/Group Description: Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.   Overall Number of Participants Analyzed: 612   Median (95% Confidence Interval)   Unit of Measure: months  15.64        (13.86 to 17.02)