Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma

Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.

Time frame: Baseline up to Month 80

Population: Intent-to-treat (ITT) Population: all randomized participants

DR: Time from first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented, taking as a reference for PD, the smallest sum LD recorded since randomization.

Time frame: Baseline, every month until tumor progression or death (up to Month 80)

Population: ITT subset of participants who had a response

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. EQ-5D index measured 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Range of EQ-5D index score = -0.594 to 1 where higher scores indicated a better health state.

Time frame: Baseline

Population: ITT;(N)=participants with evaluable data. Week 12 and 32 data collected for individual participants but not summarized.

Clinical benefit: confirmed CR or PR or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and non target lesions. PR was at least a 30% decrease in sum of the LD of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Time frame: Baseline, every 2 months until tumor progression or death (up to Month 80)

Population: ITT

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was the disappearance of all target lesions and non target lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Time frame: Baseline, every 2 months until tumor progression or death (up to Month 80)

Population: ITT

PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact.

Time frame: Baseline, monthly until tumor progression or death (up to Month 80)

Population: ITT

The Q-Twist is not a score calculated for each participant but is defined only on a by treatment group basis. For each treatment group, it is the weighted sum of the mean durations of the health states Tox, Twist, and Relapse. Tox is defined as time with severe toxicity related to treatment; Twist: time without symptoms or toxic side effects; and Relapse: time after relapse/progression. The mean duration of each health state is calculated based on the area under the Kaplan Meier curve pertaining to that health state. There is no direct method for calculating the dispersion of Q-Twist, and it is typically done using bootstrap method for purposes of inference (see, e.g., Glasziou PP, Simes RJ, Gelber RD. Quality adjusted survival analysis. Stat Med 1990; 9: 1259-76). In practice, as apparently in the case with this study, the intermediate values resulting from the bootstrap exercise were not displayed.

Time frame: Baseline to Month 80

Population: ITT

TTF is defined as the time from the date of randomization to the date of PD or death, withdrawal from treatment due to an adverse event (AE), withdrawal of voluntary consent, or lost to follow-up, whichever occurred first, censored at the date of the conclusion of treatment phase.

Time frame: Baseline, every month until tumor progression or death (up to Month 80)

Population: ITT