IMDC model mirrors mRCC clinical outcomes

 

In hindsight, a widely used prognostic model for patients with metastatic renal cell carcinoma (mRCC) has been shown to be effective at stratifying patient risk, and may inform the design of future clinical trials.

By retrospectively comparing clinical outcomes with risk categories determined by the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) model, Brian I Rini, MD, of the Cleveland Clinic, and his colleagues found notable differences in progression-free survival, overall survival, and objective response rates between the different risk categories among patients with mRCC treated with sunitinib (Sutent) in a major clinical trial.

“These benchmark values can aid current and future design and interpretation of clinical trials in mRCC. Results of this analysis demonstrate clear differences in patient outcomes based on IMDC prognostic risk group,” they wrote. The report was published in Clinical Genitourinary Cancer.

They also found that the Memorial Sloan Kettering Cancer Center (MSKCC) model appeared to be similar in prognostic utility to the IMDC model, and that either model could be useful for counseling patients about prognosis and treatment options.

They based their conclusions on an analysis of data from a phase 3 clinical trial comparing sunitinib with interferon alfa in patients with mRCC. Patients in this study were grouped according to prognostic risk category by the MSKCC criteria, which overlap with the IMDC criteria in five of six areas.

In the current study, Dr. Rini and his associates applied the IMDC criteria to the same population, and derived benchmark values for outcomes by IMDC risk groups based on radiologic tumor progression measurements performed by independent reviewers on images of patients in the intention-to-treat population.

They also conducted an analysis of data from investigator measurements of tumor progression, and compared the results with the independently reviewed radiologic data for patients outcomes according to the MSKCC model.

 

They found that for sunitinib-treated patients in the IMDC favorable-risk group, median PFS was 14.1 months, compared with 10.7 months for those in the intermediate-risk group, 2,4 months in the poor-risk group, and 10.6 months for the combined intermediate and poor-risk groups.

The respective objective response rates were 53%, 33.7%, 11.8%, and 30.5%.

Median overall survival for favorable-risk patients was not reached, with more than 50% of patients alive at the time of data cutoff. The respective median overall survival for the intermediate-, poor-, and intermediate-plus-poor–risk groups were 23, 5.1, and 20.3 months.

“Results of this study suggest there may be significant prognostic differences between the intermediate-1 and intermediate-2 IMDC risk groups and that this should be considered when counseling patients identified to be in one of these groups,” the investigators wrote.

Medical writing for the study was supported by Pfizer. Dr. Rini and his coauthors disclosed research funding and/or consulting fees from Pfizer and other companies. Four of the coauthors are Pfizer employees and stockholders.

SOURCE: Rini B et al. Clin Genitourin Cancer. 2018 May 3. doi: 10.1016/j.clgc.2018.04.005.

 

In hindsight, a widely used prognostic model for patients with metastatic renal cell carcinoma (mRCC) has been shown to be effective at stratifying patient risk, and may inform the design of future clinical trials.

By retrospectively comparing clinical outcomes with risk categories determined by the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) model, Brian I Rini, MD, of the Cleveland Clinic, and his colleagues found notable differences in progression-free survival, overall survival, and objective response rates between the different risk categories among patients with mRCC treated with sunitinib (Sutent) in a major clinical trial.

“These benchmark values can aid current and future design and interpretation of clinical trials in mRCC. Results of this analysis demonstrate clear differences in patient outcomes based on IMDC prognostic risk group,” they wrote. The report was published in Clinical Genitourinary Cancer.

They also found that the Memorial Sloan Kettering Cancer Center (MSKCC) model appeared to be similar in prognostic utility to the IMDC model, and that either model could be useful for counseling patients about prognosis and treatment options.

They based their conclusions on an analysis of data from a phase 3 clinical trial comparing sunitinib with interferon alfa in patients with mRCC. Patients in this study were grouped according to prognostic risk category by the MSKCC criteria, which overlap with the IMDC criteria in five of six areas.

In the current study, Dr. Rini and his associates applied the IMDC criteria to the same population, and derived benchmark values for outcomes by IMDC risk groups based on radiologic tumor progression measurements performed by independent reviewers on images of patients in the intention-to-treat population.

They also conducted an analysis of data from investigator measurements of tumor progression, and compared the results with the independently reviewed radiologic data for patients outcomes according to the MSKCC model.

 

They found that for sunitinib-treated patients in the IMDC favorable-risk group, median PFS was 14.1 months, compared with 10.7 months for those in the intermediate-risk group, 2,4 months in the poor-risk group, and 10.6 months for the combined intermediate and poor-risk groups.

The respective objective response rates were 53%, 33.7%, 11.8%, and 30.5%.

Median overall survival for favorable-risk patients was not reached, with more than 50% of patients alive at the time of data cutoff. The respective median overall survival for the intermediate-, poor-, and intermediate-plus-poor–risk groups were 23, 5.1, and 20.3 months.

“Results of this study suggest there may be significant prognostic differences between the intermediate-1 and intermediate-2 IMDC risk groups and that this should be considered when counseling patients identified to be in one of these groups,” the investigators wrote.

Medical writing for the study was supported by Pfizer. Dr. Rini and his coauthors disclosed research funding and/or consulting fees from Pfizer and other companies. Four of the coauthors are Pfizer employees and stockholders.

SOURCE: Rini B et al. Clin Genitourin Cancer. 2018 May 3. doi: 10.1016/j.clgc.2018.04.005.

 

In hindsight, a widely used prognostic model for patients with metastatic renal cell carcinoma (mRCC) has been shown to be effective at stratifying patient risk, and may inform the design of future clinical trials.

By retrospectively comparing clinical outcomes with risk categories determined by the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) model, Brian I Rini, MD, of the Cleveland Clinic, and his colleagues found notable differences in progression-free survival, overall survival, and objective response rates between the different risk categories among patients with mRCC treated with sunitinib (Sutent) in a major clinical trial.

“These benchmark values can aid current and future design and interpretation of clinical trials in mRCC. Results of this analysis demonstrate clear differences in patient outcomes based on IMDC prognostic risk group,” they wrote. The report was published in Clinical Genitourinary Cancer.

They also found that the Memorial Sloan Kettering Cancer Center (MSKCC) model appeared to be similar in prognostic utility to the IMDC model, and that either model could be useful for counseling patients about prognosis and treatment options.

They based their conclusions on an analysis of data from a phase 3 clinical trial comparing sunitinib with interferon alfa in patients with mRCC. Patients in this study were grouped according to prognostic risk category by the MSKCC criteria, which overlap with the IMDC criteria in five of six areas.

In the current study, Dr. Rini and his associates applied the IMDC criteria to the same population, and derived benchmark values for outcomes by IMDC risk groups based on radiologic tumor progression measurements performed by independent reviewers on images of patients in the intention-to-treat population.

They also conducted an analysis of data from investigator measurements of tumor progression, and compared the results with the independently reviewed radiologic data for patients outcomes according to the MSKCC model.

 

They found that for sunitinib-treated patients in the IMDC favorable-risk group, median PFS was 14.1 months, compared with 10.7 months for those in the intermediate-risk group, 2,4 months in the poor-risk group, and 10.6 months for the combined intermediate and poor-risk groups.

The respective objective response rates were 53%, 33.7%, 11.8%, and 30.5%.

Median overall survival for favorable-risk patients was not reached, with more than 50% of patients alive at the time of data cutoff. The respective median overall survival for the intermediate-, poor-, and intermediate-plus-poor–risk groups were 23, 5.1, and 20.3 months.

“Results of this study suggest there may be significant prognostic differences between the intermediate-1 and intermediate-2 IMDC risk groups and that this should be considered when counseling patients identified to be in one of these groups,” the investigators wrote.

Medical writing for the study was supported by Pfizer. Dr. Rini and his coauthors disclosed research funding and/or consulting fees from Pfizer and other companies. Four of the coauthors are Pfizer employees and stockholders.

SOURCE: Rini B et al. Clin Genitourin Cancer. 2018 May 3. doi: 10.1016/j.clgc.2018.04.005.