"Retrospective Study to Identify Clinical Factors Related to a High Benefit of Axitinib in mRCC"

Carcinoma, Renal Cell Clinical Trial

Official title:

Retrospective Analysis of Clinical Factors Associated With Greater Benefit of Axitinib in Metastatic Renal Cancer (AXILONG Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03538717
• Other study ID #: A4061089
• Secondary ID: AXILONG
• Status: Completed
• Start date: April 19, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: February 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective study to collect data from Patients with advanced/metastatic renal cell carcinoma previously treated with Axitinib under standard clinical practice, to describe the clinical profile of the patients with a long response to Axitinib and to try to identify clinical factors which could be related with the long response to Axitinib, through the comparison between long responder patients and a group of refractory patients

Description:

To describe the clinical profile of patients with a long response to Axitinib and to identify clinical factors which could be related with the long response to Axitinib, through the comparison between long responder patients and a group of refractory patients. For this study are defined as "long responder", those patients who has a Progression Free Survival (PFS) of at least 9 months since the initiation of Axitinib treatment, and "refractory patients" those who have Progression Disease (PD) in the first response assessment since the initiation of Axitinib treatment (estimated PFS ≤3 months] Secondary Objectives - To describe the efficacy of Axitinib treatment in the long responders group, and in relation with the treatment received before Axitinib, in terms of PFS, ORR, CB, OS, TTP ... - To describe the tolerability and drug management of Axitinib in this population. - To describe treatment received after Axitinib in this population. Study procedures: For the recruitment, the Investigator should review the inclusion / exclusion criteria. In case of patients alive at the moment of the inclusion, the investigator will require them to sign the IC. With the data available in the medical records, the information requested will be recorded in the electronic data collection tool.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• Patients with advanced or metastatic renal cell carcinoma, histologically confirmed, with at least one radiological response assessment
• Patients who had received Axitinib treatment in second or further line with a PFS =9 months or DP (disease progression) at the first tumor assessment.
• For the patients alive at the moment of the inclusion, patients must have a signed informed consent document

Exclusion Criteria:

• Axitinib received out of the approved indication Patients who do not meet any of the inclusion criteria

Related Conditions & MeSH terms

• Carcinoma, Renal Cell

Locations

Country	Name	City	State
Spain	Hospital Universitario Principe de Asturias	Alcalá de Henares	Madrid
Spain	Complejo Hospitalario la Mancha Centro	Alcazar de San Juan	Ciudad REAL
Spain	Hospital Universitario Fundacion Alcorcón	Alcorcón	Madrid
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Sant Pau i Santa Creu	Barcelona
Spain	Hospital Universitario Vall d'Hebrón	Barcelona
Spain	HU Clinic i Provincial	Barcelona
Spain	Hospital General Universitario de Ciudad Real	Ciudad Real
Spain	Hospital Reina Sofía	Córdoba
Spain	Hospital Duran i Reynals	Hospitalet de Llobregat	Barcelona
Spain	Complejo Hospitalario de Jaén	Jaén
Spain	Hospital Universitario de Canarias	La Cuesta, Santa Cruz De Tenerife	Tenerife
Spain	Hospital Universitario Severo Ochoa	Leganés	Madrid
Spain	HU De León	León
Spain	Hospital Universitario Lucus Augusti (HULA_ Lugo)	Lugo
Spain	Centro Integral Oncológico Clara Campal	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Fundación Jimenez Diaz	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Rey Juan carlos	Mostoles	Madrid
Spain	Complejo Hospitalario Universitario de Ourense CHUOU	Orense
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Universitario Son Espases	Palma de Mallorca	Mallorca
Spain	HU de Navarra, Pamplona	Pamplona	Navarra
Spain	Hospital Infanta Cristina	Parla	Madrid
Spain	Hospital Universitario Parc Taulí	Sabadell	Barcelona
Spain	Hospital Universitario Infanta Sofía	San Sebatián De Los Reyes	Madrid
Spain	Hospital Universitario Nuestra Señora de la Candelaria, Tenerife	Santa Cruz de Tenerife	Tenerife
Spain	Hospital Universitario Santiago de Compostela	Santiago de Compostela
Spain	Hospita General Nuestra Señora del Prado	Talavera de la Reina	Toledo
Spain	Hospital Sant Pau i Santa Tecla	Tarragona	Barcelona
Spain	Hospital Universitario Mutua Terrassa	Terrassa	Barcelona
Spain	Hospita Virgen de la Salud de Toledo	Toledo
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitario y Politécnico La Fe	Valencia
Spain	Instituto Valenciano de Oncología	Valencia
Spain	Hospital Universitario de Vigo- Hospital Álvaro Cunqueiro	Vigo
Spain	H. Universitario Miguel Servet, Zaragoza	Zaragoza
Spain	Hospital Clínico Uiversitario Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Age Less Than or Equal to (<=) 65 Years and Greater Than (>) 65 Years at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants		At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Primary	Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Before First Line Treatment Initiation: Long Responders Versus Refractory Participants	ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, >=2: before first line treatment initiation), was compared between long responders and refractory participants.	Prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Primary	Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants	ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, >=2: at initiation of axitinib), was compared between long responders and refractory participants.	At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Primary	Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status on Axitinib Discontinuation: Long Responders Versus Refractory Participants	ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, >=2: on axitinib discontinuation), was compared between long responders and refractory participants.	On discontinuation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Primary	Number of Participants With 1 or More Different Treatment Lines Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants		Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Primary	Number of Participants With Nephrectomy Procedure Status Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants	Nephrectomy is a surgical removal of kidney. Data for participants was categorized as yes and no to depict their nephrectomy status before axitinib treatment initiation and comparison was done between long responders and refractory participants.	Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Primary	Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group Before First Line Treatment Initiation: Long Responders Versus Refractory Participants	MSKCC risk system stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 adverse prognostic factors. Poor-risk group: participants had more than 2 poor prognostic factors. Poor prognostic factors included a Karnofsky performance status (KPS) of less than (<) 80 (KPS score quantify participant's general well-being and activities of daily life, based on their functional impairment. KPS score ranges between 0= death to 100= no evidence of disease; higher score means higher ability to perform daily tasks), time from diagnosis to treatment for more than 12 months, serum lactate dehydrogenase (LDH) >1.5*upper limit of normal (ULN), corrected serum calcium level >10.0 milligram per deciliter (mg/dL) and hemoglobin < lower limit of normal (LLN).	Prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Primary	Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants	MSKCC risk system stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 adverse prognostic factors. Poor-risk group: participants had more than 2 poor prognostic factors. Poor prognostic factors included a KPS of <80 (KPS score quantify participant's general well-being and activities of daily life, based on their functional impairment. KPS score ranges between 0= death to 100= no evidence of disease; higher score means higher ability to perform daily tasks), time from diagnosis to treatment for more than 12 months, serum LDH >1.5*ULN, corrected serum calcium level >10.0 mg/dL and hemoglobin < LLN.	At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Primary	Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group on Discontinuation of Axitinib Treatment: Long Responders Versus Refractory Participants	MSKCC risk system stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 adverse prognostic factors. Poor-risk group: participants had more than 2 poor prognostic factors. Poor prognostic factors included a KPS of <80 (KPS score quantify participant's general well-being and activities of daily life, based on their functional impairment. KPS score ranges between 0= death to 100= no evidence of disease; higher score means higher ability to perform daily tasks), time from diagnosis to treatment for more than 12 months, serum LDH >1.5*ULN, corrected serum calcium level >10.0 mg/dL and hemoglobin < LLN.	On discontinuation of axitinib treatment, within axitinib therapy during treatment of maximum 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)
Primary	Number of Participants With International Metastatic Database Consortium (IMDC) Risk Group at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants	IMDC risk group stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 poor prognostic factors. Poor-risk group: participants had 3 to 6 poor prognostic factors. Poor prognostic factors included KPS score of <80 at the initiation of treatment, time from diagnosis to metastasis treatment of <12 months, anemia, hypercalcemia (corrected calcium >10 mg/dL), neutrophilia and thrombocythemia. In this outcome measure, IMDC risk group (favorable, intermediate, poor: at initiation of axitinib) was compared between long responders and refractory participants.	At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Primary	Number of Participants With International Metastatic Database Consortium (IMDC) Risk Group on Discontinuation of Axitinib Treatment: Long Responders Versus Refractory Participants	IMDC risk group stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 poor prognostic factors. Poor-risk group: participants had 3 to 6 poor prognostic factors. Poor prognostic factors included KPS score of <80 at the initiation of treatment, time from diagnosis to metastasis treatment of <12 months, anemia, hypercalcemia (corrected calcium >10 mg/dL), neutrophilia and thrombocythemia. In this outcome measure, IMDC risk group (favorable, intermediate, poor: on discontinuation of axitinib) was compared between long responders and refractory participants.	On discontinuation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Primary	Number of Participants With Different Type of Renal Cells Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants	In this outcome measure, data for participants who had renal cells with different type of histology as 100% clear cells, 100% non-clear cells, majority component of clear cells and majority component of non-clear cells was compared between long responders and refractory participants.	Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Primary	Number of Participants With Duration of First Line Treatment With Tyrosine Kinase Inhibitor (TKI) Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants	Duration of first line treatment with TKI was stratified into 0-3 months, 3-6 months, 6-9 months, 9-12 months and >12 months and compared between long responders and refractory participants.	First dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Primary	Number of Participants With Best Response to First Line Treatment With Tyrosine Kinase Inhibitor (TKI) Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants	In this outcome measure, data for participants with their best response as complete response (CR) and partial response (PR), stable disease (SD) or progressive-disease (PD) to the first line treatment with TKI, was compared between long responders and refractory participants. As per response evaluation criteria in solid tumors (RECIST) 1.1 criteria: CR = disappearance of all target lesions. PR = greater than equal to (>=) 30% decrease in sum of target lesions taking as reference baseline sum diameters. PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm), or the appearance of >=1 new lesions. SD =neither shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters during treatment.	First dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Primary	Number of Participants With 1 or More Metastatic Locations at Diagnosis of Advance or Metastatic Renal Cell Carcinoma Before First Line Treatment Initiation: Long Responders Versus Refractory Participants		At diagnosis of advance or mRCC prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Primary	Number of Participants With Different Metastatic Sites Locations at Diagnosis of Advance or Metastatic Renal Cell Carcinoma Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants	In this outcome measure, data for participants with different metastatic sites as lymph nodes, central nervous system (CNS), hepatic, pulmonary, bone and another site of metastasis at diagnosis of advance or mRCC before axitinib treatment initiation, was compared between long responders and refractory participants.	At diagnosis of advance or mRCC prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Primary	Number of Participants With Laboratory Parameters at Initiation of First Line Treatment: Long Responders Versus Refractory Participants	In this outcome measure, data for different laboratory parameters at initiation of first line treatment: LDH level >1.5*ULN, haemoglobin (Hgb) levels <=LLN, corrected Ca levels >10 mg/dL, neutrophil levels >ULN, platelet levels >ULN and neutrophil-to-lymphocyte ratio of <=3 was compared between long responders and refractory participants.	At initiation of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Primary	Number of Participants With Smoking Habits at Initiation of First Line Treatment: Long Responders Versus Refractory Participants	In this outcome measure, data for smoking habit of participants was compared between long responders and refractory participants.	At initiation of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Secondary	Progression-free Survival (PFS) to Axitinib Treatment in Group of Long Responders	PFS was defined as the time from the start of axitinib treatment to disease progression or death by any cause. If there was no progression or death, the case was censored as PFS at date of latest follow-up. PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions.	Day 1 of axitinib dose to disease progression or death due to any cause or date of latest follow-up in case of censored up to a maximum axitinib therapy of 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)
Secondary	Time to Progression (TTP) to Axitinib Treatment in Group of Long Responders	TTP was defined as the time from the start of axitinib treatment to date of disease progression. If there was no progression, the case was censored as TTP at latest follow-up. As per RECIST 1.1, PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions.	Day 1 of axitinib dose to disease progression or date of latest follow-up in case of censored up to a maximum (max.)axitinib therapy duration of 5.4 years(yrs.)approximately(approx.)(from the data collected, observed retrospectively during 1 year [yr.])
Secondary	Overall Survival (OS) From Axitinib Treatment in Group of Long Responders	OS was defined as the time from the date of start of axitinib treatment to the date of death due to any cause. If there was no death, the case was censored as OS at latest follow-up.	Day 1 of axitinib dose to death due to any cause or date of latest follow-up in case of censored up to a maximum axitinib therapy of 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)
Secondary	Number of Participants With Best Response to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders	In this outcome measure, data for number of participants with best response to axitinib as second line of treatment and subsequent treatment was collected. Best response is CR and PR, SD or PD. As per RECIST1.1 criteria: CR = disappearance of all target lesions; PR = >= 30% decrease in sum of target lesions taking as reference baseline sum diameters; PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions; SD =neither shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameters while on treatment. Subsequent treatment referred to further treatment after second line of treatment.	From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)
Secondary	Progression-free Survival (PFS) to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders	PFS was defined as the time from the start of axitinib as second line of treatment and subsequent treatment to disease progression or death by any cause. If there was no progression or death, the case was censored as PFS at date of latest follow-up. As per RECIST 1.1, PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions.	From first dose of axitinib as second line and from first dose of axitinib as subsequent lines to PD/death by any cause/date of latest follow-up if censored up to a max. axitinib therapy of 5.4 yrs. approx. (data collected, observed retrospectively 1 yr.)
Secondary	Objective Response Rate (ORR) to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders	ORR was defined as the number of participants with CR or PR. As per RECIST1.1 criteria: CR = disappearance of all target lesions; PR = >= 30% decrease in sum of target lesions taking as reference baseline sum diameters.	From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)
Secondary	Clinical Benefit Rate (CBR) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders	CBR was defined as the frequency of participants with CR, PR or SD. As per RECIST1.1 criteria: CR = disappearance of all target lesions; PR = >= 30% decrease in sum of target lesions taking as reference baseline sum diameters; PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions; SD =neither shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameters while on treatment.	From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)
Secondary	Time to Progression (TTP) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders	TTP was defined as the time from the start of second line of treatment and subsequent treatment to date of disease progression. If there was no progression, the case was censored as TTP at latest follow-up. PD: >=20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions.	From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment to PD/date of latest follow-up if censored up to max. treatment duration of 5.4 yrs., approx. (data collected, observed retrospectively 1 year)
Secondary	Overall Survival (OS) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders	OS was defined as the time from the date of start of second line of treatment and subsequent treatment till the date of death due to any cause. If there was no death, the case was censored as OS at latest follow-up.	From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment to death due to any cause/date of latest follow-up if censored upto max. of 5.4 yrs., approx. (data collected, observed retrospectively 1 year)
Secondary	Duration of Axitinib Treatment: All Participants	Duration of treatment with axitinib was the time from date of start of axitinib treatment to date of end of axitinib treatment or of latest follow-up if not suspended.	Day 1 of axitinib treatment to end of treatment or date of latest follow-up if not suspended for maximum axitinib therapy duration of 5.4 years, approximately (from data collected and observed retrospectively for 1 year)
Secondary	Percentage of Participants With Titrated (Increased) Doses of Axitinib of More Than 5 Milligram (mg) Twice Daily: All Participants	Percentage of participants whose axitinib dose was titrated and increased to more than 5mg dose at least 1 time in 12 hours (twice daily), are reported in this outcome measure.	For maximum axitinib treatment duration of 5.4 years, approximately (from data collected and observed retrospectively for 1 year)
Secondary	Percentage of Participants With Reduced Doses of Axitinib of More Than 5 Milligram (mg) Twice Daily: All Participants	Percentage of participants whose axitinib dose was reduced 5 mg dose at least 1 time in 12 hours (twice daily) are reported in this outcome measure.	For maximum axitinib treatment duration of 5.4 years, approximately (data collected and observed retrospectively for 1 year)
Secondary	Number of Participants With Adverse Events (AE): All Participants	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse events (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. AEs included both SAEs and non-SAEs.	For first line treatment: maximum of 6.6 years approximately; for axitinib treatment: maximum of 5.4 years approximately; for post-axitinib subsequent treatments: maximum of 2.9 years approximately (data collected and observed retrospectively for 1 year)
Secondary	Number of Participants Receiving Subsequent Treatment Post Axitinib Treatment: All Participants		Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
Secondary	Number of Participants as Per Number of Subsequent Lines of Treatment Received Post Axitinib Treatment: All Participants		Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
Secondary	Duration of Subsequent Treatments Post Axitinib Treatment: All Participants		Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
Secondary	Number of Participants With First Best Response to Subsequent Treatments Post Axitinib Treatment	Best response is CR and PR, SD or PD. As per RECIST1.1 criteria: CR = disappearance of all target lesions; PR = >= 30% decrease in sum of target lesions taking as reference baseline sum diameters; PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions; SD =neither shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameters while on treatment.	From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
Secondary	Number of Participants With Reasons to Discontinue Subsequent Treatments Post Axitinib Treatment: All Participants	In this outcome measure, participants who stopped subsequent treatments after axitinib discontinuation due to any reasons like PD, toxicity and others are reported.	From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
Secondary	Overall Survival (OS) From Subsequent Treatments Post Axitinib Treatment	OS was defined as the time from the date of randomization to treatment up to the date of death due to any cause.	From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)

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