XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer

Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first.

Time frame: From the date of randomization up to 104 weeks (study cut-off)

Population: Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).

Tumor Overall Response Rate (ORR) (only in patients with measurable disease): Objective responses (Complete Response and Partial Response) for measurable disease as assessed by investigators according to RECIST criteria. Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference baseline sum LD. Confirmation of objective responses will be performed by repeat tumor imaging (CT scans, MRI, bone scans) after the first documentation of response.

Time frame: From the date of randomization up to 104 weeks (study cut-off)

Population: Tumor response rate was evaluated only for patients, in the Intention-To-Treat (ITT) population, with measurable disease by Response Evaluation Criteria in Solid Tumor (RECIST).

Pain Response was defined as a two-point or greater reduction from baseline median Present Pain Intensity (PPI) score without an increased Analgesic Score (AS) or a decrease of ≥50% in the AS without an increase in the PPI score, maintained for at least 3 weeks.

Time frame: from baseline up to 104 weeks (study cut-off)

Population: Pain Response (applies only to patients, in the Intention-To-Treat (ITT) population, with median PPI ≥2 on McGill-Melzack scale and/or mean Analgesic Score ≥10 points at baseline)

PSA response was defined as a ≥ 50% reduction in serum PSA, determined only for patients with a serum PSA ≥ 20ng/mL at baseline, confirmed by a repeat PSA ≥ 3 weeks later.

Time frame: from baseline up to 104 weeks (study cut-off)

Population: Prostate Specific Antigen (PSA) response was evaluated only in patients, in the Intention-To-Treat population, with a baseline PSA \>20ng/mL.

Pain Progression is defined as an increase of ≥1 point in the median Personal Pain Intensity (PPI) from its nadir noted on 2 consecutive 3-week-apart visits or ≥25 % increase in the mean analgesic score compared with the baseline score & noted on 2 consecutive 3-week-apart visits or requirement for local palliative radiotherapy. Evaluation of the PPI & analgesic scores are based on the short-form McGill Pain Questionnaire which consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none (best) 1=mild 2=moderate 3=severe (worst) (TOTAL: 0=best 45=worst)

Time frame: from baseline up to 104 weeks (study cut-off)

Population: Analysis was performed on the intention To Treat (ITT) population. Data from 265 and 279 patients in the cabazitaxel and mitoxantrone groups, respectively, were censored as a results of \> 2 PPI and/or AS assessments being missed during the same week (unless a complete evaluation of ≥5 values showed pain progression).

Progression free survival was defined as a composite endpoint evaluated from the date of randomization to the date of tumor progression, PSA progression, pain progression, or death due to any cause, whichever occurred first

Time frame: From the date of randomization up to 104 weeks (study cut-off)

Population: Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).

In PSA non-responders, progression will be defined as a 25% increase over nadir and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later. In PSA responders and in patients not evaluable for PSA response at baseline, progression will be defined as a ≥50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later.

Time frame: at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)

Population: Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).

Time to tumor progression is defined as the number of months from randomization until evidence of progressive disease (RECIST)

Time frame: From the date of randomization up to 104 weeks (study cut-off)

Population: Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).