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Sorafenib for older patients with renal cell carcinoma: subset analysis from a randomized trial.

Eisen T, Oudard S, Szczylik C, Gravis G, Heinzer H, Middleton R, Cihon F, Anderson S, Shah S, Bukowski R, Escudier B, TARGET Study Gro - J. Natl. Cancer Inst. (2008)

Bottom Line: Median progression-free survival was similar in sorafenib-treated younger patients (23.9 weeks; hazard ratio [HR] for progression compared with placebo = 0.55, 95% confidence interval [CI] = 0.47 to 0.66) and older patients (26.3 weeks; HR = 0.43, 95% CI = 0.26 to 0.69).Clinical benefit rates among younger and older sorafenib-treated patients were also similar (83.5% and 84.3%, respectively) and were superior to those of younger and older placebo-treated patients (53.8% and 62.2%, respectively).Sorafenib treatment delayed the time to self-reported health status deterioration among both older patients (121 days with sorafenib vs 85 days with placebo; HR = 0.66, 95% CI = 0.43 to 1.03) and younger patients (90 days with sorafenib vs 52 days with placebo; HR = 0.69, 95% CI = 0.59 to 0.81) and improved quality of life over that time.

View Article: PubMed Central - PubMed

Affiliation: The Royal Marsden Hospital NHS Trust, Sutton, Surrey, UK. tgqe2@cam.ac.uk

ABSTRACT

Background: The perception that older cancer patients may be at higher risk than younger patients of toxic effects from cancer therapy but may obtain less clinical benefit from it may be based on the underrepresentation of older patients in clinical trials and the known toxic effects of cytotoxic chemotherapy. It is not known how older patients respond to targeted therapy.

Methods: This retrospective subgroup analysis of data from the phase 3, randomized Treatment Approach in Renal Cancer Global Evaluation Trial examined the safety and efficacy of sorafenib in older (age >or=70 years, n = 115) and younger patients (age <70 years, n = 787) who received treatment for advanced renal cell carcinoma. Patient demographics and progression-free survival were recorded. Best tumor response, clinical benefit rate (defined as complete response plus partial response plus stable disease), time to self-reported health status deterioration, and toxic effects were assessed by descriptive statistics. Health-related quality of life was assessed with a Cox proportional hazards model. Kaplan-Meier analyses were used to summarize time-to-event data.

Results: Median progression-free survival was similar in sorafenib-treated younger patients (23.9 weeks; hazard ratio [HR] for progression compared with placebo = 0.55, 95% confidence interval [CI] = 0.47 to 0.66) and older patients (26.3 weeks; HR = 0.43, 95% CI = 0.26 to 0.69). Clinical benefit rates among younger and older sorafenib-treated patients were also similar (83.5% and 84.3%, respectively) and were superior to those of younger and older placebo-treated patients (53.8% and 62.2%, respectively). Adverse events were predictable and manageable regardless of age. Sorafenib treatment delayed the time to self-reported health status deterioration among both older patients (121 days with sorafenib vs 85 days with placebo; HR = 0.66, 95% CI = 0.43 to 1.03) and younger patients (90 days with sorafenib vs 52 days with placebo; HR = 0.69, 95% CI = 0.59 to 0.81) and improved quality of life over that time.

Conclusions: Among patients with advanced renal cell carcinoma receiving sorafenib treatment, outcomes of older (>or=70 years) and younger (<70 years) patients were similar.

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Related in: MedlinePlus

CONSORT trial flow diagram. Patient enrollment and outcomes are shown for all patients with renal cell carcinoma (aged <70 or ≥70 y) who were randomly assigned to treatment with sorafenib or placebo. An intent-to-treat analysis was used.
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fig1: CONSORT trial flow diagram. Patient enrollment and outcomes are shown for all patients with renal cell carcinoma (aged <70 or ≥70 y) who were randomly assigned to treatment with sorafenib or placebo. An intent-to-treat analysis was used.

Mentions: From November 24, 2003, through March 31, 2005, 903 patients were randomly assigned to receive treatment with sorafenib (n = 451) or placebo (n = 452). Of these 903 patients, 902 received a study drug and were evaluated for safety in this analysis. Of the 115 patients who were 70 years or older, 70 were randomly assigned to receive sorafenib and 45 were assigned to placebo. Of the 788 patients who were younger than 70 years, 381 were randomly assigned to sorafenib and 407 were assigned to placebo (Figure 1). Baseline characteristics for the two age groups are listed in Table 1. The median age of older sorafenib-treated patients was 72 years (range = 70–86 years) and that of older placebo-treated patients was 73 years (range = 70–84 years). There were no clinically significant differences in baseline characteristics between sorafenib arms, except that older patients had a higher proportion of female patients, an increased proportion of patients with Eastern Cooperative Oncology Group performance scores of 1 or 2, and more patients with an intermediate risk according to the Memorial Sloan-Kettering Cancer Center criteria. At baseline, older sorafenib-treated patients had higher incidences of vascular hypertensive disorders (66% vs 36%), diabetes mellitus (20% vs 11%), coronary artery disorders (7% vs 6%), anemias (14% vs 7%), and breathing abnormalities (16% vs 9%) than younger sorafenib-treated patients.


Sorafenib for older patients with renal cell carcinoma: subset analysis from a randomized trial.

Eisen T, Oudard S, Szczylik C, Gravis G, Heinzer H, Middleton R, Cihon F, Anderson S, Shah S, Bukowski R, Escudier B, TARGET Study Gro - J. Natl. Cancer Inst. (2008)

CONSORT trial flow diagram. Patient enrollment and outcomes are shown for all patients with renal cell carcinoma (aged <70 or ≥70 y) who were randomly assigned to treatment with sorafenib or placebo. An intent-to-treat analysis was used.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2567417&req=5

fig1: CONSORT trial flow diagram. Patient enrollment and outcomes are shown for all patients with renal cell carcinoma (aged <70 or ≥70 y) who were randomly assigned to treatment with sorafenib or placebo. An intent-to-treat analysis was used.
Mentions: From November 24, 2003, through March 31, 2005, 903 patients were randomly assigned to receive treatment with sorafenib (n = 451) or placebo (n = 452). Of these 903 patients, 902 received a study drug and were evaluated for safety in this analysis. Of the 115 patients who were 70 years or older, 70 were randomly assigned to receive sorafenib and 45 were assigned to placebo. Of the 788 patients who were younger than 70 years, 381 were randomly assigned to sorafenib and 407 were assigned to placebo (Figure 1). Baseline characteristics for the two age groups are listed in Table 1. The median age of older sorafenib-treated patients was 72 years (range = 70–86 years) and that of older placebo-treated patients was 73 years (range = 70–84 years). There were no clinically significant differences in baseline characteristics between sorafenib arms, except that older patients had a higher proportion of female patients, an increased proportion of patients with Eastern Cooperative Oncology Group performance scores of 1 or 2, and more patients with an intermediate risk according to the Memorial Sloan-Kettering Cancer Center criteria. At baseline, older sorafenib-treated patients had higher incidences of vascular hypertensive disorders (66% vs 36%), diabetes mellitus (20% vs 11%), coronary artery disorders (7% vs 6%), anemias (14% vs 7%), and breathing abnormalities (16% vs 9%) than younger sorafenib-treated patients.

Bottom Line: Median progression-free survival was similar in sorafenib-treated younger patients (23.9 weeks; hazard ratio [HR] for progression compared with placebo = 0.55, 95% confidence interval [CI] = 0.47 to 0.66) and older patients (26.3 weeks; HR = 0.43, 95% CI = 0.26 to 0.69).Clinical benefit rates among younger and older sorafenib-treated patients were also similar (83.5% and 84.3%, respectively) and were superior to those of younger and older placebo-treated patients (53.8% and 62.2%, respectively).Sorafenib treatment delayed the time to self-reported health status deterioration among both older patients (121 days with sorafenib vs 85 days with placebo; HR = 0.66, 95% CI = 0.43 to 1.03) and younger patients (90 days with sorafenib vs 52 days with placebo; HR = 0.69, 95% CI = 0.59 to 0.81) and improved quality of life over that time.

View Article: PubMed Central - PubMed

Affiliation: The Royal Marsden Hospital NHS Trust, Sutton, Surrey, UK. tgqe2@cam.ac.uk

ABSTRACT

Background: The perception that older cancer patients may be at higher risk than younger patients of toxic effects from cancer therapy but may obtain less clinical benefit from it may be based on the underrepresentation of older patients in clinical trials and the known toxic effects of cytotoxic chemotherapy. It is not known how older patients respond to targeted therapy.

Methods: This retrospective subgroup analysis of data from the phase 3, randomized Treatment Approach in Renal Cancer Global Evaluation Trial examined the safety and efficacy of sorafenib in older (age >or=70 years, n = 115) and younger patients (age <70 years, n = 787) who received treatment for advanced renal cell carcinoma. Patient demographics and progression-free survival were recorded. Best tumor response, clinical benefit rate (defined as complete response plus partial response plus stable disease), time to self-reported health status deterioration, and toxic effects were assessed by descriptive statistics. Health-related quality of life was assessed with a Cox proportional hazards model. Kaplan-Meier analyses were used to summarize time-to-event data.

Results: Median progression-free survival was similar in sorafenib-treated younger patients (23.9 weeks; hazard ratio [HR] for progression compared with placebo = 0.55, 95% confidence interval [CI] = 0.47 to 0.66) and older patients (26.3 weeks; HR = 0.43, 95% CI = 0.26 to 0.69). Clinical benefit rates among younger and older sorafenib-treated patients were also similar (83.5% and 84.3%, respectively) and were superior to those of younger and older placebo-treated patients (53.8% and 62.2%, respectively). Adverse events were predictable and manageable regardless of age. Sorafenib treatment delayed the time to self-reported health status deterioration among both older patients (121 days with sorafenib vs 85 days with placebo; HR = 0.66, 95% CI = 0.43 to 1.03) and younger patients (90 days with sorafenib vs 52 days with placebo; HR = 0.69, 95% CI = 0.59 to 0.81) and improved quality of life over that time.

Conclusions: Among patients with advanced renal cell carcinoma receiving sorafenib treatment, outcomes of older (>or=70 years) and younger (<70 years) patients were similar.

Show MeSH
Related in: MedlinePlus