A phase I pharmacokinetic and safety study of cabazitaxel in adult cancer patients with normal and impaired renal function

Purpose This phase I study was conducted to determine the toxicities, pharmacokinetics, and recommended doses of pemetrexed in cancer patients with normal and impaired renal function. Patients and Methods Patients received a 10-minute infusion of 150 to 600 mg/m2 of pemetrexed every 3 weeks. Patients were stratified for independent dose escalation by measured glomerular filtration rate (GFR) into four cohorts ranging from ≥ 80 to less than 20 mL/min. Pemetrexed plasma and urine pharmacokinetics were evaluated for the first cycle. Patients enrolled after December 1999 were supplemented with oral folic acid and intramuscular vitamin B12. Results Forty-seven patients were treated with 167 cycles of pemetrexed. Hematologic dose-limiting toxicities occurred in vitamin-supplemented patients (two; 15%) and nonsupplemented patients (six; 18%), and included febrile neutropenia (four patients) and grade 4 thrombocytopenia (two patients). Nonhematologic toxicities included fatigue, diarrhea, and nausea, and did not correlate with renal function. Accrual was discontinued in patients with GFR less than 30 mL/min after one patient with a GFR of 19 mL/min died as a result of treatment-related toxicities. Pemetrexed plasma clearance positively correlated with GFR (r2 = 0.736), resulting in increased drug exposures in patients with impaired renal function. With vitamin supplementation, pemetrexed 600 mg/m2 was tolerated by patients with a GFR ≥ 80 mL/min, whereas patients with a GFR of 40 to 79 mL/min tolerated a dose of 500 mg/m2. Conclusion Pemetrexed was well tolerated at doses of 500 mg/m2 with vitamin supplementation in patients with GFR ≥ 40 mL/min. Additional studies are needed to define appropriate dosing for renally impaired patients receiving higher dose pemetrexed with vitamin supplementation.

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THU0138 Pharmacokinetics of fostamatinib in patients with impaired renal function: A phase I study

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2012-eular.2103 ◽

2013 ◽

Vol 71 (Suppl 3) ◽

pp. 202.1-202

Author(s):

P. Martin ◽

S. Oliver ◽

M. Gillen ◽

T. Marbury ◽

D. Millson

Keyword(s):

Renal Function ◽

Phase I ◽

Phase I Study ◽

Impaired Renal Function

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Thrombo-Embolic Events in Cancer Patients with Impaired Renal Function

Journal of Blood Disorders & Transfusion ◽

10.4172/2155-9864.1000202 ◽

2014 ◽

Vol 05 (04) ◽

Cited By ~ 1

Author(s):

Canon JL Bols A

Keyword(s):

Renal Function ◽

Cancer Patients ◽

Impaired Renal Function

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Pharmacokinetics of eribulin mesylate in cancer patients with normal and impaired renal function

Cancer Chemotherapy and Pharmacology ◽

10.1007/s00280-015-2878-5 ◽

2015 ◽

Vol 76 (5) ◽

pp. 1051-1061 ◽

Cited By ~ 13

Author(s):

Antoinette R. Tan ◽

John Sarantopoulos ◽

Lucy Lee ◽

Larisa Reyderman ◽

Yi He ◽

...

Keyword(s):

Renal Function ◽

Cancer Patients ◽

Impaired Renal Function ◽

Eribulin Mesylate

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Effect of percutaneous nephrostomy in late stage cervical cancer’s survival with impaired renal function

Majalah Obstetri & Ginekologi ◽

10.20473/mog.v24i22016.49-52 ◽

2018 ◽

Vol 24 (2) ◽

pp. 49

Author(s):

Imam Rasjidi Mashadi ◽

Ali Gunawan ◽

Christine Susanto

Keyword(s):

Cervical Cancer ◽

Renal Function ◽

Cancer Patients ◽

Median Survival ◽

Medical Records ◽

Impaired Renal Function ◽

Percutaneous Nephrostomy ◽

Advanced Cervical Cancer ◽

Probability Of Survival ◽

Consecutive Sampling

Objective: explore the association between percutaneous nephrostomy and survival of patients with advanced cervical cancer accompanied by renal impairment.Materials and Methods: Retrospective cohort, with 70 samples taken with consecutive sampling. The population was all advanced cervical cancer patients with impaired renal function (IIIB, IVA, IVB, recurrent) treated in RSUPNCM since January 1, 1998. Sample size was each 19 patients for percutaneous nephrostomy and conservative groups. Survival was measured from medical records of advanced cervical cancer patients with impaired renal function who were treated at RSUPNCM since January 1, 1998 until December 31, 2003. Percutaneous nephrostomy was measured from medical records of advanced cervical cancer patients with impaired renal function treated at RSUPNCM since 1 January 1998 until December 31, 2003.Results: Median survival of 44 respondents who underwent percutaneous nephrostomy was 203 days with probability of survival at 6 months 56.9% and 12 months by 31.1%. Median survival of 26 respondents who did not undergo percutaneous nephrostomy was 75 days with a chance of survival at 6 months 26.6% and 12 months 10%. There were significant differences between patients undergoing percutaneous nephrostomy and those without (p = 0.0470, α = 0.05).Conclusion: There was significant association between percutaneous nephrostomy and survival (p = 0.0470, α = 0.05).

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