Prognostic Factors in Patients with Advanced Renal Cell Carcinoma

Bukowski, Ronald M.; Négrier, Sylvie; Elson, Paul

doi:10.1158/1078-0432.ccr-050000

Cited by 69 publications

(31 citation statements)

References 22 publications

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“…The median number of treatment cycles ranged from one to five, across the three non-continuous phase I trials, and the maximum number of cycles received by any patient was 30 (100 mg bid group, 7 days on/7 days off). In these three trials, patients received a median of either three or four treatment cycles (range, [1][2][3][4][5][6][7][8][9][10][11][12][13][14] at the MTD of 400 mg bid. There was no clear dose-dependent decrease in the number of cycles that patients received, up to 600 mg bid.…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

Safety, Pharmacokinetics, and Preliminary Antitumor Activity of Sorafenib: A Review of Four Phase I Trials in Patients with Advanced Refractory Solid Tumors

Strumberg¹,

et al. 2007

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LEARNING OBJECTIVESAfter completing this course, the reader will be able to:1. Describe the mechanisms of action of sorafenib.2. Discuss the safety and toxicity data from phase I trials of sorafenib.3. Evaluate phase I and II trials of sorafenib with activity data. 4. Discuss future areas for research in the development of this drug.Access and take the CME test online and receive 1 AMA PRA Category 1 Credit ™ at CME.TheOncologist.com CME CME ABSTRACTSorafenib is an oral multikinase inhibitor that inhibits Raf serine/threonine kinases and receptor tyrosine kinases involved in tumor growth and angiogenesis. It has demonstrated preclinical and clinical activity in several tumor types. Sorafenib 400 mg twice daily (bid) has been approved in several countries worldwide for the treatment of renal cell carcinoma. This review summarizes key safety, pharmacokinetic, and efficacy data from four phase I, single-agent, dose-escalation studies with sorafenib in patients with advanced refractory solid tumors (n ‫؍‬ 173). These trials followed different treatment regimens (7 days on/7 days off, n ‫؍‬ 19; 21 days on/7 days off, n ‫؍‬ 44; 28 days on/7 days off, n ‫؍‬ 41; or continuous dosing, n ‫؍‬ 69) to establish the optimum dosing schedule. Sorafenib was generally well tolerated; most adverse events were mild to moderate in severity up to the defined maximum-tolerated dose of 400 mg twice daily (bid). The most frequently reported drugrelated adverse events at any grade included fatigue (40%), anorexia (35%), diarrhea (34%), rash/desquamation (27%), and hand-foot skin reaction (25%). Sorafenib demonstrated preliminary antitumor activity, particularly among patients with renal cell carcinoma or hepatocellular carcinoma: overall, two of 137 evaluable patients achieved partial responses and 38 (28%) had stable disease. Although there was high interpatient variability in plasma pharmacokinetics across these studies, this was not associated with an increased incidence or severity of toxicity. Preliminary studies suggest that phosphorylated extracellular signal-related kinase in tumor cells or peripheral blood lymphocytes may be a useful biomarker for measuring and, ultimately, predicting the effects of sorafenib. Based on these findings, continuous daily 400 mg bid sorafenib was chosen as the optimal regimen for phase II/III studies. Trials are ongoing in renal cell carcinoma, hepatocellular carcinoma, melanoma, and non-small cell lung cancer. The Oncologist 2007;12: 426 -437 Disclosure of potential conflicts of interest is found at the end of this article.

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Section: Safety and Tolerabilitymentioning

confidence: 99%

Safety, Pharmacokinetics, and Preliminary Antitumor Activity of Sorafenib: A Review of Four Phase I Trials in Patients with Advanced Refractory Solid Tumors

Strumberg¹,

et al. 2007

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“…Using these expanded criteria, favorable risk is defined as zero or one poor prognostic factor, intermediate risk is two poor prognostic factors, and poor risk is more than two poor prognostic factors. Median overall survival times of these groups were 26.0, 14,4, and 7,3 months, respectively (P < ,0001) (Bukowski & Negrier, 2004, Mekhail et.al, 2005.…”

Section: Prognostic Modelsmentioning

confidence: 88%

“…Patients with short predicted survival time should be evaluated carefully and best quality of life should be the primary goal of their treatment (Bukowski & Negrier, 2004). …”

Section: Prognostic Modelsmentioning

confidence: 99%

Treatment of Renal Cell Carcinoma in Elderly and Frail Patients

Rajer¹

2012

Emerging Research and Treatments in Renal Cell Carcinoma

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“…The prognosis of advanced cancer depends on several clinical and laboratory factors and concerns patients with multiple organ metastases [4]. The classification commonly used in clinical practice is the MSKCC (Memorial Sloan-Kettering Cancer Center) scale based on five risk criteria (low overall performance status, low haemoglobin, elevated lactate dehydrogenase, elevated calcium level and short time from diagnosis to recurrence).…”

Section: Theoretical Backgroundmentioning

confidence: 99%

Pharmacotherapy of patients with metastatic renal-cell carcinoma – algorithm vs. Polish reality [Polish version: Leczenie farmakologiczne chorych na rozsianego raka nerki – algorytm a polskie realia p. 299]

Żołnierek¹

2011

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Prognostic Factors in Patients with Advanced Renal Cell Carcinoma

Abstract: ABSTRACT

Cited by 69 publications

References 22 publications

Safety, Pharmacokinetics, and Preliminary Antitumor Activity of Sorafenib: A Review of Four Phase I Trials in Patients with Advanced Refractory Solid Tumors

Safety, Pharmacokinetics, and Preliminary Antitumor Activity of Sorafenib: A Review of Four Phase I Trials in Patients with Advanced Refractory Solid Tumors

Treatment of Renal Cell Carcinoma in Elderly and Frail Patients

Pharmacotherapy of patients with metastatic renal-cell carcinoma – algorithm vs. Polish reality [Polish version: Leczenie farmakologiczne chorych na rozsianego raka nerki – algorytm a polskie realia p. 299]

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