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Eur Urol. 2010 Dec;58(6):906-11. doi: 10.1016/j.eururo.2010.09.008. Epub 2010 Sep 24.

Third-line sorafenib after sequential therapy with sunitinib and mTOR inhibitors in metastatic renal cell carcinoma.

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1
Dipartimento di Endocrinologia ed Oncologia Clinica e Molecolare, Università Federico II, Napoli, Italy. giuseppedilorenzoncol@hotmail.com

Abstract

BACKGROUND:

Sunitinib and everolimus have been approved for first- and second-line treatment, respectively, in metastatic renal cell carcinoma (mRCC). The role of sorafenib, which is approved for second-line treatment after cytokines failure, is presently to be defined.

OBJECTIVE:

To determine whether third-line sorafenib after sequential use of sunitinib and mammalian target of rapamycin inhibitors (everolimus or temsirolimus) is feasible and effective.

DESIGN, SETTING, AND PARTICIPANTS:

One hundred fifty medical records of patients with mRCC treated with first-line sunitinib between January 2006 and January 2010 were reviewed at four participating centers. Data regarding patients treated with the sequence sunitinib-everolimus or temsirolimus-sorafenib were extracted. Central analysis of radiographic images was performed using RECIST criteria to determine progression-free survival (PFS) and overall response rate (oRR) to sorafenib treatment.

MEASUREMENTS:

PFS and oRR to sorafenib were the primary end points. Secondary outcomes were safety and overall survival (OS).

RESULTS AND LIMITATIONS:

Thirty-four patients were eligible for the study. A median PFS of 4 mo (range: 3-6 mo) and a median OS of 7 mo since sorafenib treatment (range: 6-10 mo) were reported. Of the patients, 23.5% showed response to sorafenib, with an overall disease control rate (complete responses plus partial responses plus stable disease) of 44%. Selection bias, data incompleteness, and absence of study design are inevitable limitations of the study, although central review can strengthen the quality of presented data.

CONCLUSIONS:

Third-line sorafenib appears to be active and well tolerated in mRCC after first-line sunitinib and second-line everolimus or temsirolimus, with no patients interrupting sorafenib because of toxicity or lack of compliance. Prospective, placebo-controlled trials are completely lacking and are required in this setting.

PMID:
20884115
DOI:
10.1016/j.eururo.2010.09.008
[Indexed for MEDLINE]
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