Pharmacokinetics of trabectedin on hemodialysis: an application for the management of cancer patients with end-stage renal disease

Thariat, Juliette; Étienne-Grimaldi, Marie-Christine; Launay-Vacher, Vincent; Soto-Matos, Arturo; Fernández-Teruel, Carlos; Ghafari, Thomas; Marcy, Pierre-Yves; Milano, Gérard; Renée, Nicole; Gastaud, Lauris; Thyss, A.

doi:10.1007/s00280-011-1718-5

Cited by 8 publications

(5 citation statements)

References 13 publications

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“…Lack of data on trabectedin administration in hemodialyzed patients is noteworthy. Thariat et al [22] present an interesting case of an individualized pharmacokinetic study in a single hemodialyzed patient treated with trabectedin for a retroperitoneal myxoid liposarcoma that recurred following immunosuppressive therapy for kidney transplantation. C max and AUC were higher, while clearance, terminal half-life, and volume of distribution were lower in the patient compared to mean values of normal kidney function patients.…”

Section: Discussionmentioning

confidence: 99%

Complete Response after Long-Term 2nd Line Treatment with Trabectedin in a Hemodialyzed Patient with Metastatic High-Grade Ovarian Sarcoma, Case Report and Short Review

Efthymiadis¹,

Christos²,

Koukoutzeli³

et al. 2019

Arch Clin Med Case Rep

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Primary ovarian sarcomas are very rare tumours and are characterized by poor prognosis. Surgical treatment is mainly based on epithelial ovarian cancer debulking approaches, while chemotherapy is based on data extrapolation from studies in sarcomas of other primary sites. Trabectedin has been established as a standard of care for the treatment of soft-tissue sarcomas in the 2nd line setting. So far, no data from randomized clinical trials support specific maximum number of cycles of trabectedin for any gynaecological sarcoma. Moreover, limited evidence in the literature supports the feasibility and safety of trabectedin administration in haemodialyzed patients. This report presents the case of a 48-year old female diagnosed with metastatic high-grade undifferentiated sarcoma of the right ovary. She underwent primary surgery followed by 1st line chemotherapy with doxorubicin plus ifosfamide, and had a partial response after cycle 3. However, treatment tolerance was very poor with grade 3 and 4 hematologic and non-hematologic toxicities, including the development of chronic kidney failure that required permanent haemodialysis. Treatment was changed to trabectedin, leading to a complete response that is ongoing and lasts for over 2 years. Our case supports safety of long-term trabectedin administration in a hemodialyzed patient with the achievement of durable complete disease response on the metastatic setting.

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Section: Discussionmentioning

confidence: 99%

Complete Response after Long-Term 2nd Line Treatment with Trabectedin in a Hemodialyzed Patient with Metastatic High-Grade Ovarian Sarcoma, Case Report and Short Review

Efthymiadis¹,

Christos²,

Koukoutzeli³

et al. 2019

Arch Clin Med Case Rep

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“…Patients with creatinine clearance <30 ml/min are not included in studies and so safety and pharmacokinetics data for these patients are limited. Another patient on haemodialysis treated with trabectedin showed good tolerance; the trabectedin clearance was low (20.5 litres/h) but within the inter-individual variability [3]. Our patient was given trabectedin after a thorough discussion with him, based on the safety information from the previously treated patient, the pharmacokinetics of trabectedin being independent of renal function and the advice from the multidisciplinary team meeting and the drug company.…”

Section: Discussionmentioning

confidence: 99%

“…However, no data are available for patients with a creatinine clearance <30 ml/min [2]. Trabectedin was reported to be safe and tolerant in a patient receiving haemodialysis for end-stage renal disease and its pharmacokinetics were shown to not be dependent on haemodialysis or renal function [3]. We report our experience with trabectedin administered to a patient who was on peritoneal dialysis for end-stage renal failure.…”

Section: Introductionmentioning

confidence: 99%

Experience with Trabectedin in an Advanced Sarcoma Patient on Peritoneal Dialysis for End-Stage Renal Failure

2013

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Background: We wanted to evaluate the impact of peritoneal dialysis on trabectedin therapy in terms of side effects, response and levels in the blood and dialysate of a patient on peritoneal dialysis for end-stage renal failure caused by previous ifosfamide therapy. This has not yet been reported in the medical literature. Methods: We measured the levels of trabectedin in the blood and peritoneal dialysate at different time points before and after the administration of a 3rd cycle of trabectedin (1.5 mg/m² over 24 h). Toxicity from the treatment was recorded and the response status was evaluated on a CT scan after the 3rd and 6th cycles. Results: Serumcreatinine clearance (Cockcroft-Gault formula) was 8.31 ml/min. The patient had a World Health Organization performance status score of ‘0' and did not suffer any significant side effects except for grade 2 anaemia. There was no difference in the plasma level of trabectedin just before and after a 3-hour session of peritoneal dialysis. The amount of trabectedin in the peritoneal dialysates was undetectable (limit of quantification: 25.9 pg/ml). The patient achieved stable disease after 3 cycles, and progressive disease was observed after 6 cycles on CT scan. Conclusion: Our patient did not suffer undue side effects from trabectedin, and peritoneal dialysis did not appear to have an impact on the clearance of the drug.

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“…However, considering the pharmacokinetic characteristics, renal elimination seems to be a minor route in trabectedin clearance. Therefore, treatment with trabectedin may be feasible even in patients on hemodialysis [5].…”

Section: Introductionmentioning

confidence: 99%

“…The benefits of trabectedin have been demonstrated in a number of clinical trials [5][6][7]. After a period of almost a quarter century without any new and promising drugs becoming available for the treatment of advanced soft tissue sarcomas, a pivotal phase II trial of two different schedules of trabectedin administration in patients with leiomyosarcoma and liposarcomas led to the approval of trabectedin for the treatment of advanced soft tissue sarcoma [7].…”

Section: Introductionmentioning

confidence: 99%

Trabectedin: Supportive care strategies and safety profile

Jordan¹,

Jahn²,

Jordan³

et al. 2015

Critical Reviews in Oncology/Hematology

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Pharmacokinetics of trabectedin on hemodialysis: an application for the management of cancer patients with end-stage renal disease

Abstract: This case reports for the first time the feasibility of trabectedin therapy in a hemodialyzed patient. Given the rising incidence of cancer in patients with end-stage renal disease, it is crucial to provide data that improve the management of anticancer drugs in dialyzed patients.

Cited by 8 publications

References 13 publications

Complete Response after Long-Term 2nd Line Treatment with Trabectedin in a Hemodialyzed Patient with Metastatic High-Grade Ovarian Sarcoma, Case Report and Short Review

Complete Response after Long-Term 2nd Line Treatment with Trabectedin in a Hemodialyzed Patient with Metastatic High-Grade Ovarian Sarcoma, Case Report and Short Review

Experience with Trabectedin in an Advanced Sarcoma Patient on Peritoneal Dialysis for End-Stage Renal Failure

Trabectedin: Supportive care strategies and safety profile

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