Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)

MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=\>3) based on number of criteria present such as Karnofsky performance status \< 80 %, Lactate dehydrogenase \> 1.5 \* Upper limit of Normal,Hemoglobin \< lower limit of normal, serum calcium \> 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of \< 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.

Time frame: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Population: The intent-to-treat (ITT) population included all participants who were randomized into the study regardless of whether they received study medication.

Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

Time frame: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Population: DR was calculated for the subgroup of participants from the ITT set, with a confirmed OR.

MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=\>3) based upon number of criteria present. Criteria as follows: Karnofsky performance status \< 80 %, Lactate dehydrogenase \> 1.5 \* Upper limit of Normal, Hemoglobin \< lower limit of normal for local lab, Corrected serum calcium \> 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of \< 1 year. OS was defined as time from date of start of treatment to date of death due to any cause. OS, in months, was calculated as (event date -start of treatment date + 1)/30.44.

Time frame: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Population: ITT population included all participants who were randomized into the study regardless of whether they received study medication.

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). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time frame: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Population: ITT population included all participants who were randomized into the study regardless of whether they received study medication.

FKSI-DRS is a subset of FKSI which is a questionnaire for Functional Assessment of Cancer Therapy -Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.

Time frame: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Population: ITT population included all participants who were randomized into the study regardless of whether they received study medication.

FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population.FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL(HRQoL):Physical Well-being(PWB),Social/Family Well-Being (SWB),Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much) so that FACT-G ranged between 0-108.Since questions could be reversed coded, as appropriate, before calculating FACT-G,0 and 108 could be considered worst and best health states.

Time frame: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Population: ITT population included all participants who were randomized into the study regardless of whether they received study medication.