Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis |
Time to CR: difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures <10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site. Heng prognostic model identified KPS of <80 at treatment initiation, period from diagnosis to start of treatment for metastatic disease <1year, anemia, hypercalcemia, neutrophilia, thrombocytosis as prognostic factors. Participants were classified into 3 prognosis group: favorable(0 factor), intermediate(1-2 factors) and poor(3 or more factors). KPS measured ability of participants with cancer to perform ordinary tasks. KPS scores range: 0 (dead) to 100 (normal, no complaint). High KPS score= participant better able to carry out daily activities. |
From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) |
|
| Other |
Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis at Least 2 Consecutive CT Scans |
Time to CR: difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures <10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site. Heng prognostic model identified KPS of <80 at treatment initiation, period from diagnosis to start of treatment for metastatic disease <1year, anemia, hypercalcemia, neutrophilia, thrombocytosis as prognostic factors. Participants were classified into 3 prognosis group: favorable(0 factor), intermediate(1-2 factors) and poor(3 or more factors). KPS measured ability of participants with cancer to perform ordinary tasks. KPS scores range: 0(dead) to 100(normal, no complaint). High KPS score=participant better able to carry out daily activities. |
From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) |
|
| Other |
Time to Achieve CR in Participants Classified According to Previous Nephrectomy Status |
Time to achieve CR according to previous nephrectomy status were reported in this outcome measure. Time to CR was calculated as the difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures <10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site. |
From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) |
|
| Other |
Time to Achieve CR in Participants Classified According to Histology Type |
Time to achieve CR according to type of histology as clear cell, non-clear cell and sarcomatoid were reported in this outcome measure. Time to CR was calculated as the difference between treatment start date and CR confirmation date. As per RECIST v1.1, CR=disappearance of all known target and all non-target lesions and absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures <10mm. CR was confirmed with 2 consecutive CT scans performed with at least 4 weeks between them. Confirmation from oncologist and radiologist was required at each site. |
From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) |
|
| Other |
Duration of Response Based on Type of Treatment Received |
Duration of response was defined as the time from date on which the CR was identified until the date of the CT scan conforming tumor progression, the change of treatment due to unacceptable toxicity, death from any cause or until the date of the last follow-up at the close of study. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Analysis was performed using Kaplan-Meier method. |
From first documented CR date until progression/death or change of treatment due to unacceptable toxicity or last follow-up date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) |
|
| Other |
Number of Participants With Dose Interruption |
|
From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) |
|
| Other |
Number of Participants Who Received Subsequent Local Treatment |
Local treatments were the following: traditional surgery, radiotherapy, or stereotactic body radiation therapy (SBRT), to achieve the total macroscopic disappearance of the disease along with CR, according to the opinion of the physician responsible for the participant. |
Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) |
|
| Other |
Number of Participants Who Discontinued Sunitinib Treatment Due to Toxicity |
Number of participants who discontinued sunitinib treatment due to toxicity were reported in this outcome measure. |
From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) |
|
| Other |
Number of Participants With Grade 3 or Higher Toxicity to Sunitinib |
Number of participants with Grade 3 or higher toxicity as per common terminology criteria for adverse events (CTCAE) version 4 were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death. |
From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) |
|
| Primary |
Time to Complete Remission of Lesions |
Time to complete remission of lesions was calculated as the difference between treatment start date and complete response (CR) confirmation date. As per response evaluation criteria in solid tumors (RECIST) version (v) 1.1, CR = disappearance of all known target and all non-target lesions and the absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 millimeter (mm). CR was confirmed with 2 consecutive computed tomography (CT) scans performed with at least 4 weeks between them during the follow-up of participants. Confirmation from the oncologist and radiologist was required at each site. |
From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) |
|
| Primary |
Duration of Complete Remission (DOR) |
DOR was defined as the time from date on which the CR was identified until tumor progression, the change of treatment due to unacceptable toxicity, death from any cause or until the date of the last follow-up at the close of study. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. |
From first documented CR date until progression/death or change of treatment due to unacceptable toxicity or last follow-up date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months) |
|
| Primary |
Progression Free Survival (PFS) |
PFS was calculated as the time from the date of CR confirmation (2nd CT scan) until the date of progression/death or change of treatment for unacceptable toxicity or censored on the date of the last follow-up. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Analysis was performed using Kaplan-Meier method. |
From CR confirmation date until progression/death or change of treatment due to unacceptable toxicity/last follow-up date, up to maximum of approximately 13 years (data collected, observed retrospectively for approximately 10 months) |
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