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Predictive factors for severe toxicity of sunitinib in unselected patients with advanced renal cell cancer.

van der Veldt AA, Boven E, Helgason HH, van Wouwe M, Berkhof J, de Gast G, Mallo H, Tillier CN, van den Eertwegh AJ, Haanen JB - Br. J. Cancer (2008)

Bottom Line: Importantly, 47 patients (57%) needed a dose reduction, 35 (43%) because of treatment-related adverse events, 10 (12%) because of continuous dosing, and two because of both.Stomatitis, fatigue, hand-foot syndrome and a combination of grade 1-2 adverse events were the most frequent reasons for dose reduction.In 40 patients (49%), there was severe toxicity, defined as dose reduction or permanent discontinuation, which was highly correlated with low body surface area, high age and female gender.

View Article: PubMed Central - PubMed

Affiliation: Department of Medical Oncology, VU University medical center, Amsterdam, The Netherlands.

ABSTRACT
Sunitinib has been registered for the treatment of advanced renal cell cancer (RCC). As patient inclusion was highly selective in previous studies, experience with sunitinib in general oncological practice remains to be reported. We determined the efficacy and safety of sunitinib in patients with advanced RCC included in an expanded access programme. ECOG performance status >1, histology other than clear cell and presence of brain metastases were no exclusion criteria. Eighty-two patients were treated: 23% reached a partial response, 50% had stable disease, 20% progressed and six patients were not evaluable. Median progression-free survival (PFS) was 9 months and median overall survival (OS) was 15 months. Importantly, 47 patients (57%) needed a dose reduction, 35 (43%) because of treatment-related adverse events, 10 (12%) because of continuous dosing, and two because of both. Stomatitis, fatigue, hand-foot syndrome and a combination of grade 1-2 adverse events were the most frequent reasons for dose reduction. In 40 patients (49%), there was severe toxicity, defined as dose reduction or permanent discontinuation, which was highly correlated with low body surface area, high age and female gender. On the basis of age and gender, a model was developed that could predict the probability of severe toxicity.

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Kaplan–Meier curves for progression-free survival and overall survival of mRCC patients treated with sunitinib for risk groups 1 (…), 2 (—) and 3 (– –) according to the MSKCC criteria (Motzer et al, 2002) (A and C) and the criteria according to Choueiri et al (2007) (B and D).
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fig1: Kaplan–Meier curves for progression-free survival and overall survival of mRCC patients treated with sunitinib for risk groups 1 (…), 2 (—) and 3 (– –) according to the MSKCC criteria (Motzer et al, 2002) (A and C) and the criteria according to Choueiri et al (2007) (B and D).

Mentions: Additional analyses were carried out with respect to individual patient characteristics and the course of the disease. Both the MSKCC criteria (Motzer et al, 2002) and the criteria according to Choueiri et al (2007) correctly predicted the PFS (P=0.001 and P=0.007, respectively) as well as the OS (P<0.001 and P=0.002, respectively; Table 2 and Figure 1). The predictive value of the number of disease sites was rather low, but for OS, the number of disease sites still had prognostic value (P=0.039).


Predictive factors for severe toxicity of sunitinib in unselected patients with advanced renal cell cancer.

van der Veldt AA, Boven E, Helgason HH, van Wouwe M, Berkhof J, de Gast G, Mallo H, Tillier CN, van den Eertwegh AJ, Haanen JB - Br. J. Cancer (2008)

Kaplan–Meier curves for progression-free survival and overall survival of mRCC patients treated with sunitinib for risk groups 1 (…), 2 (—) and 3 (– –) according to the MSKCC criteria (Motzer et al, 2002) (A and C) and the criteria according to Choueiri et al (2007) (B and D).
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2480961&req=5

fig1: Kaplan–Meier curves for progression-free survival and overall survival of mRCC patients treated with sunitinib for risk groups 1 (…), 2 (—) and 3 (– –) according to the MSKCC criteria (Motzer et al, 2002) (A and C) and the criteria according to Choueiri et al (2007) (B and D).
Mentions: Additional analyses were carried out with respect to individual patient characteristics and the course of the disease. Both the MSKCC criteria (Motzer et al, 2002) and the criteria according to Choueiri et al (2007) correctly predicted the PFS (P=0.001 and P=0.007, respectively) as well as the OS (P<0.001 and P=0.002, respectively; Table 2 and Figure 1). The predictive value of the number of disease sites was rather low, but for OS, the number of disease sites still had prognostic value (P=0.039).

Bottom Line: Importantly, 47 patients (57%) needed a dose reduction, 35 (43%) because of treatment-related adverse events, 10 (12%) because of continuous dosing, and two because of both.Stomatitis, fatigue, hand-foot syndrome and a combination of grade 1-2 adverse events were the most frequent reasons for dose reduction.In 40 patients (49%), there was severe toxicity, defined as dose reduction or permanent discontinuation, which was highly correlated with low body surface area, high age and female gender.

View Article: PubMed Central - PubMed

Affiliation: Department of Medical Oncology, VU University medical center, Amsterdam, The Netherlands.

ABSTRACT
Sunitinib has been registered for the treatment of advanced renal cell cancer (RCC). As patient inclusion was highly selective in previous studies, experience with sunitinib in general oncological practice remains to be reported. We determined the efficacy and safety of sunitinib in patients with advanced RCC included in an expanded access programme. ECOG performance status >1, histology other than clear cell and presence of brain metastases were no exclusion criteria. Eighty-two patients were treated: 23% reached a partial response, 50% had stable disease, 20% progressed and six patients were not evaluable. Median progression-free survival (PFS) was 9 months and median overall survival (OS) was 15 months. Importantly, 47 patients (57%) needed a dose reduction, 35 (43%) because of treatment-related adverse events, 10 (12%) because of continuous dosing, and two because of both. Stomatitis, fatigue, hand-foot syndrome and a combination of grade 1-2 adverse events were the most frequent reasons for dose reduction. In 40 patients (49%), there was severe toxicity, defined as dose reduction or permanent discontinuation, which was highly correlated with low body surface area, high age and female gender. On the basis of age and gender, a model was developed that could predict the probability of severe toxicity.

Show MeSH
Related in: MedlinePlus