REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA

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.

Time frame: 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)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. This outcome measure was evaluated in participants who achieved CR at respective CT scans.

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.

Time frame: 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)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable.

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.

Time frame: 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)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. This outcome measure was evaluated in participants who achieved CR at respective CT scans.

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.

Time frame: 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)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here, number analyzed signifies number of participants evaluable for specified rows.

Number of participants who discontinued sunitinib treatment due to toxicity were reported in this outcome measure.

Time frame: From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here overall number of participants analyzed signifies participants evaluable for this outcome measure.

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.

Time frame: Up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable.

Time frame: From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable.

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.

Time frame: From start of drug up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here overall number of participants analyzed signifies participants evaluable for this outcome measure.

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.

Time frame: 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)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies number of participants evaluable for specified rows.

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.

Time frame: 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)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies number of participants evaluable for specified rows.

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.

Time frame: 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)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable. Here overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies number of participants evaluable for specified rows.

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.

Time frame: 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)

Population: FAS included all participants who met the inclusion criteria and who did not meet any of the exclusion criteria and received treatment with sunitinib prior to participation in the registry were considered evaluable.