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Lauren Mccann - One of the best experts on this subject based on the ideXlab platform.
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quality of life qol among renal cell carcinoma rcc Patients in a randomized double blind cross over Patient Preference study of pazopanib p versus sunitinib s
Annals of Oncology, 2012Co-Authors: David Cella, Karen Kaiser, Jennifer L Beaumont, Jose Diaz, Lauren Mccann, Faisal Mehmud, S Lata, Petri Bono, Camillo Porta, Bernard EscudierAbstract:ABSTRACT Introduction PISCES was a randomized, double blind, cross-over study of P versus S in 168 Patients with metastatic RCC. P and S are oral tyrosine kinase inhibitors with demonstrated clinical efficacy in RCC, but different side effect profiles. After exposure to both treatments, P was preferred over S by a 3:1 margin (70% vs. 22%) among the 114 Patients who completed the Patient Preference questionnaire. Methods Patients received either P for 10 weeks, followed by a 2-week washout period, and then 10 weeks of S, or S for 10 weeks, followed by a 2-week washout period, and then 10 weeks of P. The primary endpoint was Patient treatment Preference. Secondary endpoints included reason for Preference and QoL, as assessed by the Functional Assessment of Cancer Therapy-Fatigue (FACIT-F), the EQ-5D, and a Supplementary Quality of Life Questionnaire (SQLQ), which assessed worst soreness in the mouth/throat, hands, and feet and limitations due to soreness. The SQLQ and the FACIT-F were administered at baseline and every two weeks thereafter. The EQ-5D was administered at baseline, the end of the washout period, and the end of period 2. Change from period baseline to period average score were compared across treatments. Crossover analyses compared Patients' average scores on each treatment, adjusting for sequence. Results The FACIT-F crossover analyses favored P over S by 2.5 points (p = .002). SQLQ crossover analyses favored P over S on worst soreness in the hands, feet and mouth/throat (p Conclusion Patient-reported QoL crossover results favor P over S on fatigue, foot soreness, hand soreness and mouth/throat soreness. These results are consistent with Patient Preference for P over S, and should be considered in light of their comparative efficacy. Disclosure D. Cella: Dr. Cella has consulted to GSK and has received research grant support from GSK. K. Kaiser: Dr. Kaiser has received research grant support from GSK. J. Beaumont: Ms. Beaumont has received research grant support from GSK. J. Diaz: Dr. Jose Diaz is a GSK employee and stock owner. L. McCann: Dr. McCann is a GSK employee and stock owner. F. Mehmud: Dr. Mehmud is a GSK employee and stock owner. S. Lata: Dr. Lata is a GSK employee and stock owner. P. Bono: Dr. Bono has received honorarium from GSK and Pfizer. C. Porta: Dr. Porta has acted as consultant or speaker for GSK, Bayer-Schering, Pfizer, Novartis, Roche, Aveo, Astellas, Boehringer Ingellheim and Recordat and received research funding from Novartis and Bayer-Schering. B. Escudier: Dr. Escudier has received honorarium from GSK, Pfizer, Novartis, Bayer, Aveo, and BMS.
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Patient Preference between pazopanib paz and sunitinib sun results of a randomized double blind placebo controlled cross over study in Patients with metastatic renal cell carcinoma mrcc pisces study nct 01064310
Journal of Clinical Oncology, 2012Co-Authors: Bernard Escudier, Petri Bono, Camillo Porta, Ugo De Giorgi, Omi Parikh, Robert E Hawkins, Emmanuel Sevin, S Negrier, Sadya Khan, Lauren MccannAbstract:CRA4502 Background: Increasingly pt reported outcomes are being added to traditional efficacy outcomes to understand the clinical relevance of toxicity differences between therapies. This study investigated if tolerability differences were significant enough to lead a Patient to prefer continuing their treatment with Paz or Sun. Methods: Pts with mRCC were randomized 1:1 to receive as first line treatment blinded 800mg Paz for 10 weeks followed by a 2-week washout and then 50mg Sun for 10 weeks (4/2 weeks schedule) or vice versa. Pts were stratified based on ECOG performance status (0 vs 1) and number of metastatic sites (0/1 vs 2+). The primary endpoint, Patient Preference assessed at 22 weeks, was compared using Prescott’s test (α=0.10). At least 102 of 160 planned pts were required to complete the Preference questionnaire to provide 80% power to detect a Preference for one drug over another of 50% vs 30% with 20% expressing no Preference. Other endpoints included physician Preference, safety, QoL, phar...
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Patient Preference between pazopanib paz and sunitinib sun results of a randomized double blind placebo controlled cross over study in Patients with metastatic renal cell carcinoma mrcc pisces study nct 01064310
Journal of Clinical Oncology, 2012Co-Authors: Bernard Escudier, Petri Bono, Camillo Porta, Ugo De Giorgi, Omi Parikh, Robert E Hawkins, Emmanuel Sevin, S Negrier, Sadya Khan, Lauren MccannAbstract:CRA4502 Background: Increasingly pt reported outcomes are being added to traditional efficacy outcomes to understand the clinical relevance of toxicity differences between therapies. This study investigated if tolerability differences were significant enough to lead a Patient to prefer continuing their treatment with Paz or Sun. Methods: Pts with mRCC were randomized 1:1 to receive as first line treatment blinded 800mg Paz for 10 weeks followed by a 2-week washout and then 50mg Sun for 10 weeks (4/2 weeks schedule) or vice versa. Pts were stratified based on ECOG performance status (0 vs 1) and number of metastatic sites (0/1 vs 2+). The primary endpoint, Patient Preference assessed at 22 weeks, was compared using Prescott’s test (α=0.10). At least 102 of 160 planned pts were required to complete the Preference questionnaire to provide 80% power to detect a Preference for one drug over another of 50% vs 30% with 20% expressing no Preference. Other endpoints included physician Preference, safety, QoL, phar...
Bernard Escudier - One of the best experts on this subject based on the ideXlab platform.
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quality of life qol among renal cell carcinoma rcc Patients in a randomized double blind cross over Patient Preference study of pazopanib p versus sunitinib s
Annals of Oncology, 2012Co-Authors: David Cella, Karen Kaiser, Jennifer L Beaumont, Jose Diaz, Lauren Mccann, Faisal Mehmud, S Lata, Petri Bono, Camillo Porta, Bernard EscudierAbstract:ABSTRACT Introduction PISCES was a randomized, double blind, cross-over study of P versus S in 168 Patients with metastatic RCC. P and S are oral tyrosine kinase inhibitors with demonstrated clinical efficacy in RCC, but different side effect profiles. After exposure to both treatments, P was preferred over S by a 3:1 margin (70% vs. 22%) among the 114 Patients who completed the Patient Preference questionnaire. Methods Patients received either P for 10 weeks, followed by a 2-week washout period, and then 10 weeks of S, or S for 10 weeks, followed by a 2-week washout period, and then 10 weeks of P. The primary endpoint was Patient treatment Preference. Secondary endpoints included reason for Preference and QoL, as assessed by the Functional Assessment of Cancer Therapy-Fatigue (FACIT-F), the EQ-5D, and a Supplementary Quality of Life Questionnaire (SQLQ), which assessed worst soreness in the mouth/throat, hands, and feet and limitations due to soreness. The SQLQ and the FACIT-F were administered at baseline and every two weeks thereafter. The EQ-5D was administered at baseline, the end of the washout period, and the end of period 2. Change from period baseline to period average score were compared across treatments. Crossover analyses compared Patients' average scores on each treatment, adjusting for sequence. Results The FACIT-F crossover analyses favored P over S by 2.5 points (p = .002). SQLQ crossover analyses favored P over S on worst soreness in the hands, feet and mouth/throat (p Conclusion Patient-reported QoL crossover results favor P over S on fatigue, foot soreness, hand soreness and mouth/throat soreness. These results are consistent with Patient Preference for P over S, and should be considered in light of their comparative efficacy. Disclosure D. Cella: Dr. Cella has consulted to GSK and has received research grant support from GSK. K. Kaiser: Dr. Kaiser has received research grant support from GSK. J. Beaumont: Ms. Beaumont has received research grant support from GSK. J. Diaz: Dr. Jose Diaz is a GSK employee and stock owner. L. McCann: Dr. McCann is a GSK employee and stock owner. F. Mehmud: Dr. Mehmud is a GSK employee and stock owner. S. Lata: Dr. Lata is a GSK employee and stock owner. P. Bono: Dr. Bono has received honorarium from GSK and Pfizer. C. Porta: Dr. Porta has acted as consultant or speaker for GSK, Bayer-Schering, Pfizer, Novartis, Roche, Aveo, Astellas, Boehringer Ingellheim and Recordat and received research funding from Novartis and Bayer-Schering. B. Escudier: Dr. Escudier has received honorarium from GSK, Pfizer, Novartis, Bayer, Aveo, and BMS.
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Patient Preference between pazopanib paz and sunitinib sun results of a randomized double blind placebo controlled cross over study in Patients with metastatic renal cell carcinoma mrcc pisces study nct 01064310
Journal of Clinical Oncology, 2012Co-Authors: Bernard Escudier, Petri Bono, Camillo Porta, Ugo De Giorgi, Omi Parikh, Robert E Hawkins, Emmanuel Sevin, S Negrier, Sadya Khan, Lauren MccannAbstract:CRA4502 Background: Increasingly pt reported outcomes are being added to traditional efficacy outcomes to understand the clinical relevance of toxicity differences between therapies. This study investigated if tolerability differences were significant enough to lead a Patient to prefer continuing their treatment with Paz or Sun. Methods: Pts with mRCC were randomized 1:1 to receive as first line treatment blinded 800mg Paz for 10 weeks followed by a 2-week washout and then 50mg Sun for 10 weeks (4/2 weeks schedule) or vice versa. Pts were stratified based on ECOG performance status (0 vs 1) and number of metastatic sites (0/1 vs 2+). The primary endpoint, Patient Preference assessed at 22 weeks, was compared using Prescott’s test (α=0.10). At least 102 of 160 planned pts were required to complete the Preference questionnaire to provide 80% power to detect a Preference for one drug over another of 50% vs 30% with 20% expressing no Preference. Other endpoints included physician Preference, safety, QoL, phar...
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Patient Preference between pazopanib paz and sunitinib sun results of a randomized double blind placebo controlled cross over study in Patients with metastatic renal cell carcinoma mrcc pisces study nct 01064310
Journal of Clinical Oncology, 2012Co-Authors: Bernard Escudier, Petri Bono, Camillo Porta, Ugo De Giorgi, Omi Parikh, Robert E Hawkins, Emmanuel Sevin, S Negrier, Sadya Khan, Lauren MccannAbstract:CRA4502 Background: Increasingly pt reported outcomes are being added to traditional efficacy outcomes to understand the clinical relevance of toxicity differences between therapies. This study investigated if tolerability differences were significant enough to lead a Patient to prefer continuing their treatment with Paz or Sun. Methods: Pts with mRCC were randomized 1:1 to receive as first line treatment blinded 800mg Paz for 10 weeks followed by a 2-week washout and then 50mg Sun for 10 weeks (4/2 weeks schedule) or vice versa. Pts were stratified based on ECOG performance status (0 vs 1) and number of metastatic sites (0/1 vs 2+). The primary endpoint, Patient Preference assessed at 22 weeks, was compared using Prescott’s test (α=0.10). At least 102 of 160 planned pts were required to complete the Preference questionnaire to provide 80% power to detect a Preference for one drug over another of 50% vs 30% with 20% expressing no Preference. Other endpoints included physician Preference, safety, QoL, phar...
Petri Bono - One of the best experts on this subject based on the ideXlab platform.
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quality of life qol among renal cell carcinoma rcc Patients in a randomized double blind cross over Patient Preference study of pazopanib p versus sunitinib s
Annals of Oncology, 2012Co-Authors: David Cella, Karen Kaiser, Jennifer L Beaumont, Jose Diaz, Lauren Mccann, Faisal Mehmud, S Lata, Petri Bono, Camillo Porta, Bernard EscudierAbstract:ABSTRACT Introduction PISCES was a randomized, double blind, cross-over study of P versus S in 168 Patients with metastatic RCC. P and S are oral tyrosine kinase inhibitors with demonstrated clinical efficacy in RCC, but different side effect profiles. After exposure to both treatments, P was preferred over S by a 3:1 margin (70% vs. 22%) among the 114 Patients who completed the Patient Preference questionnaire. Methods Patients received either P for 10 weeks, followed by a 2-week washout period, and then 10 weeks of S, or S for 10 weeks, followed by a 2-week washout period, and then 10 weeks of P. The primary endpoint was Patient treatment Preference. Secondary endpoints included reason for Preference and QoL, as assessed by the Functional Assessment of Cancer Therapy-Fatigue (FACIT-F), the EQ-5D, and a Supplementary Quality of Life Questionnaire (SQLQ), which assessed worst soreness in the mouth/throat, hands, and feet and limitations due to soreness. The SQLQ and the FACIT-F were administered at baseline and every two weeks thereafter. The EQ-5D was administered at baseline, the end of the washout period, and the end of period 2. Change from period baseline to period average score were compared across treatments. Crossover analyses compared Patients' average scores on each treatment, adjusting for sequence. Results The FACIT-F crossover analyses favored P over S by 2.5 points (p = .002). SQLQ crossover analyses favored P over S on worst soreness in the hands, feet and mouth/throat (p Conclusion Patient-reported QoL crossover results favor P over S on fatigue, foot soreness, hand soreness and mouth/throat soreness. These results are consistent with Patient Preference for P over S, and should be considered in light of their comparative efficacy. Disclosure D. Cella: Dr. Cella has consulted to GSK and has received research grant support from GSK. K. Kaiser: Dr. Kaiser has received research grant support from GSK. J. Beaumont: Ms. Beaumont has received research grant support from GSK. J. Diaz: Dr. Jose Diaz is a GSK employee and stock owner. L. McCann: Dr. McCann is a GSK employee and stock owner. F. Mehmud: Dr. Mehmud is a GSK employee and stock owner. S. Lata: Dr. Lata is a GSK employee and stock owner. P. Bono: Dr. Bono has received honorarium from GSK and Pfizer. C. Porta: Dr. Porta has acted as consultant or speaker for GSK, Bayer-Schering, Pfizer, Novartis, Roche, Aveo, Astellas, Boehringer Ingellheim and Recordat and received research funding from Novartis and Bayer-Schering. B. Escudier: Dr. Escudier has received honorarium from GSK, Pfizer, Novartis, Bayer, Aveo, and BMS.
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Patient Preference between pazopanib paz and sunitinib sun results of a randomized double blind placebo controlled cross over study in Patients with metastatic renal cell carcinoma mrcc pisces study nct 01064310
Journal of Clinical Oncology, 2012Co-Authors: Bernard Escudier, Petri Bono, Camillo Porta, Ugo De Giorgi, Omi Parikh, Robert E Hawkins, Emmanuel Sevin, S Negrier, Sadya Khan, Lauren MccannAbstract:CRA4502 Background: Increasingly pt reported outcomes are being added to traditional efficacy outcomes to understand the clinical relevance of toxicity differences between therapies. This study investigated if tolerability differences were significant enough to lead a Patient to prefer continuing their treatment with Paz or Sun. Methods: Pts with mRCC were randomized 1:1 to receive as first line treatment blinded 800mg Paz for 10 weeks followed by a 2-week washout and then 50mg Sun for 10 weeks (4/2 weeks schedule) or vice versa. Pts were stratified based on ECOG performance status (0 vs 1) and number of metastatic sites (0/1 vs 2+). The primary endpoint, Patient Preference assessed at 22 weeks, was compared using Prescott’s test (α=0.10). At least 102 of 160 planned pts were required to complete the Preference questionnaire to provide 80% power to detect a Preference for one drug over another of 50% vs 30% with 20% expressing no Preference. Other endpoints included physician Preference, safety, QoL, phar...
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Patient Preference between pazopanib paz and sunitinib sun results of a randomized double blind placebo controlled cross over study in Patients with metastatic renal cell carcinoma mrcc pisces study nct 01064310
Journal of Clinical Oncology, 2012Co-Authors: Bernard Escudier, Petri Bono, Camillo Porta, Ugo De Giorgi, Omi Parikh, Robert E Hawkins, Emmanuel Sevin, S Negrier, Sadya Khan, Lauren MccannAbstract:CRA4502 Background: Increasingly pt reported outcomes are being added to traditional efficacy outcomes to understand the clinical relevance of toxicity differences between therapies. This study investigated if tolerability differences were significant enough to lead a Patient to prefer continuing their treatment with Paz or Sun. Methods: Pts with mRCC were randomized 1:1 to receive as first line treatment blinded 800mg Paz for 10 weeks followed by a 2-week washout and then 50mg Sun for 10 weeks (4/2 weeks schedule) or vice versa. Pts were stratified based on ECOG performance status (0 vs 1) and number of metastatic sites (0/1 vs 2+). The primary endpoint, Patient Preference assessed at 22 weeks, was compared using Prescott’s test (α=0.10). At least 102 of 160 planned pts were required to complete the Preference questionnaire to provide 80% power to detect a Preference for one drug over another of 50% vs 30% with 20% expressing no Preference. Other endpoints included physician Preference, safety, QoL, phar...
Camillo Porta - One of the best experts on this subject based on the ideXlab platform.
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quality of life qol among renal cell carcinoma rcc Patients in a randomized double blind cross over Patient Preference study of pazopanib p versus sunitinib s
Annals of Oncology, 2012Co-Authors: David Cella, Karen Kaiser, Jennifer L Beaumont, Jose Diaz, Lauren Mccann, Faisal Mehmud, S Lata, Petri Bono, Camillo Porta, Bernard EscudierAbstract:ABSTRACT Introduction PISCES was a randomized, double blind, cross-over study of P versus S in 168 Patients with metastatic RCC. P and S are oral tyrosine kinase inhibitors with demonstrated clinical efficacy in RCC, but different side effect profiles. After exposure to both treatments, P was preferred over S by a 3:1 margin (70% vs. 22%) among the 114 Patients who completed the Patient Preference questionnaire. Methods Patients received either P for 10 weeks, followed by a 2-week washout period, and then 10 weeks of S, or S for 10 weeks, followed by a 2-week washout period, and then 10 weeks of P. The primary endpoint was Patient treatment Preference. Secondary endpoints included reason for Preference and QoL, as assessed by the Functional Assessment of Cancer Therapy-Fatigue (FACIT-F), the EQ-5D, and a Supplementary Quality of Life Questionnaire (SQLQ), which assessed worst soreness in the mouth/throat, hands, and feet and limitations due to soreness. The SQLQ and the FACIT-F were administered at baseline and every two weeks thereafter. The EQ-5D was administered at baseline, the end of the washout period, and the end of period 2. Change from period baseline to period average score were compared across treatments. Crossover analyses compared Patients' average scores on each treatment, adjusting for sequence. Results The FACIT-F crossover analyses favored P over S by 2.5 points (p = .002). SQLQ crossover analyses favored P over S on worst soreness in the hands, feet and mouth/throat (p Conclusion Patient-reported QoL crossover results favor P over S on fatigue, foot soreness, hand soreness and mouth/throat soreness. These results are consistent with Patient Preference for P over S, and should be considered in light of their comparative efficacy. Disclosure D. Cella: Dr. Cella has consulted to GSK and has received research grant support from GSK. K. Kaiser: Dr. Kaiser has received research grant support from GSK. J. Beaumont: Ms. Beaumont has received research grant support from GSK. J. Diaz: Dr. Jose Diaz is a GSK employee and stock owner. L. McCann: Dr. McCann is a GSK employee and stock owner. F. Mehmud: Dr. Mehmud is a GSK employee and stock owner. S. Lata: Dr. Lata is a GSK employee and stock owner. P. Bono: Dr. Bono has received honorarium from GSK and Pfizer. C. Porta: Dr. Porta has acted as consultant or speaker for GSK, Bayer-Schering, Pfizer, Novartis, Roche, Aveo, Astellas, Boehringer Ingellheim and Recordat and received research funding from Novartis and Bayer-Schering. B. Escudier: Dr. Escudier has received honorarium from GSK, Pfizer, Novartis, Bayer, Aveo, and BMS.
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Patient Preference between pazopanib paz and sunitinib sun results of a randomized double blind placebo controlled cross over study in Patients with metastatic renal cell carcinoma mrcc pisces study nct 01064310
Journal of Clinical Oncology, 2012Co-Authors: Bernard Escudier, Petri Bono, Camillo Porta, Ugo De Giorgi, Omi Parikh, Robert E Hawkins, Emmanuel Sevin, S Negrier, Sadya Khan, Lauren MccannAbstract:CRA4502 Background: Increasingly pt reported outcomes are being added to traditional efficacy outcomes to understand the clinical relevance of toxicity differences between therapies. This study investigated if tolerability differences were significant enough to lead a Patient to prefer continuing their treatment with Paz or Sun. Methods: Pts with mRCC were randomized 1:1 to receive as first line treatment blinded 800mg Paz for 10 weeks followed by a 2-week washout and then 50mg Sun for 10 weeks (4/2 weeks schedule) or vice versa. Pts were stratified based on ECOG performance status (0 vs 1) and number of metastatic sites (0/1 vs 2+). The primary endpoint, Patient Preference assessed at 22 weeks, was compared using Prescott’s test (α=0.10). At least 102 of 160 planned pts were required to complete the Preference questionnaire to provide 80% power to detect a Preference for one drug over another of 50% vs 30% with 20% expressing no Preference. Other endpoints included physician Preference, safety, QoL, phar...
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Patient Preference between pazopanib paz and sunitinib sun results of a randomized double blind placebo controlled cross over study in Patients with metastatic renal cell carcinoma mrcc pisces study nct 01064310
Journal of Clinical Oncology, 2012Co-Authors: Bernard Escudier, Petri Bono, Camillo Porta, Ugo De Giorgi, Omi Parikh, Robert E Hawkins, Emmanuel Sevin, S Negrier, Sadya Khan, Lauren MccannAbstract:CRA4502 Background: Increasingly pt reported outcomes are being added to traditional efficacy outcomes to understand the clinical relevance of toxicity differences between therapies. This study investigated if tolerability differences were significant enough to lead a Patient to prefer continuing their treatment with Paz or Sun. Methods: Pts with mRCC were randomized 1:1 to receive as first line treatment blinded 800mg Paz for 10 weeks followed by a 2-week washout and then 50mg Sun for 10 weeks (4/2 weeks schedule) or vice versa. Pts were stratified based on ECOG performance status (0 vs 1) and number of metastatic sites (0/1 vs 2+). The primary endpoint, Patient Preference assessed at 22 weeks, was compared using Prescott’s test (α=0.10). At least 102 of 160 planned pts were required to complete the Preference questionnaire to provide 80% power to detect a Preference for one drug over another of 50% vs 30% with 20% expressing no Preference. Other endpoints included physician Preference, safety, QoL, phar...
Omi Parikh - One of the best experts on this subject based on the ideXlab platform.
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Patient Preference between pazopanib paz and sunitinib sun results of a randomized double blind placebo controlled cross over study in Patients with metastatic renal cell carcinoma mrcc pisces study nct 01064310
Journal of Clinical Oncology, 2012Co-Authors: Bernard Escudier, Petri Bono, Camillo Porta, Ugo De Giorgi, Omi Parikh, Robert E Hawkins, Emmanuel Sevin, S Negrier, Sadya Khan, Lauren MccannAbstract:CRA4502 Background: Increasingly pt reported outcomes are being added to traditional efficacy outcomes to understand the clinical relevance of toxicity differences between therapies. This study investigated if tolerability differences were significant enough to lead a Patient to prefer continuing their treatment with Paz or Sun. Methods: Pts with mRCC were randomized 1:1 to receive as first line treatment blinded 800mg Paz for 10 weeks followed by a 2-week washout and then 50mg Sun for 10 weeks (4/2 weeks schedule) or vice versa. Pts were stratified based on ECOG performance status (0 vs 1) and number of metastatic sites (0/1 vs 2+). The primary endpoint, Patient Preference assessed at 22 weeks, was compared using Prescott’s test (α=0.10). At least 102 of 160 planned pts were required to complete the Preference questionnaire to provide 80% power to detect a Preference for one drug over another of 50% vs 30% with 20% expressing no Preference. Other endpoints included physician Preference, safety, QoL, phar...
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Patient Preference between pazopanib paz and sunitinib sun results of a randomized double blind placebo controlled cross over study in Patients with metastatic renal cell carcinoma mrcc pisces study nct 01064310
Journal of Clinical Oncology, 2012Co-Authors: Bernard Escudier, Petri Bono, Camillo Porta, Ugo De Giorgi, Omi Parikh, Robert E Hawkins, Emmanuel Sevin, S Negrier, Sadya Khan, Lauren MccannAbstract:CRA4502 Background: Increasingly pt reported outcomes are being added to traditional efficacy outcomes to understand the clinical relevance of toxicity differences between therapies. This study investigated if tolerability differences were significant enough to lead a Patient to prefer continuing their treatment with Paz or Sun. Methods: Pts with mRCC were randomized 1:1 to receive as first line treatment blinded 800mg Paz for 10 weeks followed by a 2-week washout and then 50mg Sun for 10 weeks (4/2 weeks schedule) or vice versa. Pts were stratified based on ECOG performance status (0 vs 1) and number of metastatic sites (0/1 vs 2+). The primary endpoint, Patient Preference assessed at 22 weeks, was compared using Prescott’s test (α=0.10). At least 102 of 160 planned pts were required to complete the Preference questionnaire to provide 80% power to detect a Preference for one drug over another of 50% vs 30% with 20% expressing no Preference. Other endpoints included physician Preference, safety, QoL, phar...