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Fractioned dose regimen of sunitinib for patients with gastrointestinal stromal tumor: a pharmacokinetic and treatment efficacy study.

Chen YY, Yeh CN, Cheng CT, Wu CE, Chiang KC, Chen TW, Wang CC, Chen JS, Yeh TS - Transl Oncol (2014)

Bottom Line: The clinical benefit was 65.2%.The rates of adverse effects of hand-foot syndrome, mucositis, and yellow skin were significantly decreased by fractioned doses of sunitinib.However, the treatment efficacy is not reduced by this regimen.

View Article: PubMed Central - PubMed

Affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan.

ABSTRACT

Aim: Sunitinib has shown benefit in patients with imatinib (IM)-resistant gastrointestinal stromal tumor (GIST). However, its advantages are somewhat diminished because of associated toxicities. Herein, we clarify the efficacy and safety of fractioned dose regimen of sunitinib by a pharmacokinetic and efficacy study.

Materials and methods: Between 2001 and March 2013, a total of 214 patients with metastatic GIST was treated at Chang Gung Memorial Hospital. Among them, 55 (11.6%) patients who received sunitinib were investigated. One group of patients was administered with standard dose of once-daily sunitinib (standard dose group) and the other group was administered with standard total daily dose of sunitinib in fractioned doses (fractioned dose group).

Results: Thirty-two male and 23 female patients with a median age of 55 years received sunitinib. The median duration of sunitinib administration was 9.2 months. The clinical benefit was 65.2%. The mean peak blood level of sunitinib in patients with fractioned doses was significantly lower than that in those with once-daily dose (83.4 vs 50.1 ng/ml, P = .01). The rates of adverse effects of hand-foot syndrome, mucositis, and yellow skin were significantly decreased by fractioned doses of sunitinib. However, the progression-free and overall survival did not differ between patients with different treatment regimens.

Conclusion: The fractioned dose regimen of sunitinib appears to be a safe and effective treatment for patients with IM-resistant/intolerant GISTs. Significantly decreased toxicity of this regimen could be explained by significantly lower peak sunitinib blood level. However, the treatment efficacy is not reduced by this regimen.

No MeSH data available.


Related in: MedlinePlus

OS of two groups after initiation of sunitinib.
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f0020: OS of two groups after initiation of sunitinib.

Mentions: The median follow-up time after initiation of sunitinib was 9.2 months. Overall, 1 patient (1.8%) had a complete response, 20 (36.4%) had partial responses, 13 had stable diseases (23.6 %), and 21 had progressive diseases (38.2%). A clinical benefit was observed in 61.8% of GIST patients. During the median 9.2-month follow-up after sunitinib use, the median PFS and OS of these 55 GIST patients were 9.5 and 22.6 months, respectively (Figures 1 and 2). The median PFS for the 29 patients who were in the fractioned dose group was 11.7 months, which is similar to the median PFS of 8.3 months for the 26 patients in the standard dose group (P = .664; Figure 3). At the same time, the median OS was 20.1 months for the 29 patients who were in the fractioned dose group and 38.9 months for the 26 patients who were in the standard dose group, which also did not reach statistical significance (P = .439; Figure 4).


Fractioned dose regimen of sunitinib for patients with gastrointestinal stromal tumor: a pharmacokinetic and treatment efficacy study.

Chen YY, Yeh CN, Cheng CT, Wu CE, Chiang KC, Chen TW, Wang CC, Chen JS, Yeh TS - Transl Oncol (2014)

OS of two groups after initiation of sunitinib.
© Copyright Policy - CC BY-NC-ND
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4225693&req=5

f0020: OS of two groups after initiation of sunitinib.
Mentions: The median follow-up time after initiation of sunitinib was 9.2 months. Overall, 1 patient (1.8%) had a complete response, 20 (36.4%) had partial responses, 13 had stable diseases (23.6 %), and 21 had progressive diseases (38.2%). A clinical benefit was observed in 61.8% of GIST patients. During the median 9.2-month follow-up after sunitinib use, the median PFS and OS of these 55 GIST patients were 9.5 and 22.6 months, respectively (Figures 1 and 2). The median PFS for the 29 patients who were in the fractioned dose group was 11.7 months, which is similar to the median PFS of 8.3 months for the 26 patients in the standard dose group (P = .664; Figure 3). At the same time, the median OS was 20.1 months for the 29 patients who were in the fractioned dose group and 38.9 months for the 26 patients who were in the standard dose group, which also did not reach statistical significance (P = .439; Figure 4).

Bottom Line: The clinical benefit was 65.2%.The rates of adverse effects of hand-foot syndrome, mucositis, and yellow skin were significantly decreased by fractioned doses of sunitinib.However, the treatment efficacy is not reduced by this regimen.

View Article: PubMed Central - PubMed

Affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan.

ABSTRACT

Aim: Sunitinib has shown benefit in patients with imatinib (IM)-resistant gastrointestinal stromal tumor (GIST). However, its advantages are somewhat diminished because of associated toxicities. Herein, we clarify the efficacy and safety of fractioned dose regimen of sunitinib by a pharmacokinetic and efficacy study.

Materials and methods: Between 2001 and March 2013, a total of 214 patients with metastatic GIST was treated at Chang Gung Memorial Hospital. Among them, 55 (11.6%) patients who received sunitinib were investigated. One group of patients was administered with standard dose of once-daily sunitinib (standard dose group) and the other group was administered with standard total daily dose of sunitinib in fractioned doses (fractioned dose group).

Results: Thirty-two male and 23 female patients with a median age of 55 years received sunitinib. The median duration of sunitinib administration was 9.2 months. The clinical benefit was 65.2%. The mean peak blood level of sunitinib in patients with fractioned doses was significantly lower than that in those with once-daily dose (83.4 vs 50.1 ng/ml, P = .01). The rates of adverse effects of hand-foot syndrome, mucositis, and yellow skin were significantly decreased by fractioned doses of sunitinib. However, the progression-free and overall survival did not differ between patients with different treatment regimens.

Conclusion: The fractioned dose regimen of sunitinib appears to be a safe and effective treatment for patients with IM-resistant/intolerant GISTs. Significantly decreased toxicity of this regimen could be explained by significantly lower peak sunitinib blood level. However, the treatment efficacy is not reduced by this regimen.

No MeSH data available.


Related in: MedlinePlus