High-Dose Chemotherapy with Hematopoietic Stem-Cell Rescue for High-Risk Breast Cancer

Rodenhuis, S.; Bontenbal, M.; Beex, L.V.A.M.; Wagstaff, John; Richel, Dick J.; Nooij, M.; Voest, Emile E.; Hupperets, P.; Tinteren, Harm van; Peterse, Hans; TenVergert, Elisabeth M.; Vries, Elisabeth G.E. de

doi:10.1056/nejmoa022794

Cited by 228 publications

(170 citation statements)

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“…Patients received the cyclophosphamide, thiotepa and carboplatin (CTC) high-dose chemotherapy regimen with peripheral blood progenitor cell transplantation as described previously (Rodenhuis et al, 1996(Rodenhuis et al, , 1999(Rodenhuis et al, , 2003Schrama et al, 2001). Patients had either high-risk primary breast cancer and received high-dose chemotherapy as part of their adjuvant treatment, or had advanced breast, germ-cell or ovarian cancer.…”

Section: Patients and Treatmentmentioning

confidence: 99%

“…The full-dose CTC regimen consisted of 4 days of chemotherapy with cyclophosphamide (1500 mg m À2 day À1 ) as a 1 h infusion, immediately followed by carboplatin (400 mg m À2 day À1 ) as a daily 1 h infusion, and thiotepa (120 mg m À2 day À1 ) divided over two 30-min infusions (the second daily dose of TT was administered 12 h after the first dose) (Rodenhuis et al, , 2003. The 'tiny' CTC regimen (tCTC) was identical to the CTC regimen except that it incorporated 2/3rd of the dose of each agent (Rodenhuis et al, 1996(Rodenhuis et al, , 1999Schrama et al, 2001).…”

Section: Patients and Treatmentmentioning

confidence: 99%

“…Patients received either one (high-risk primary breast cancer) or two (refractory germ-cell cancer) courses of CTC or two (metastatic ovarian cancer) or three (metastatic breast or relapsing germ-cell cancer) courses of tCTC, when possible every 4 weeks. Full details of the CTC and tCTC regimens have been published previously (Rodenhuis et al, 1996(Rodenhuis et al, , 1999(Rodenhuis et al, , 2003Schrama et al, 2001).…”

Section: Patients and Treatmentmentioning

confidence: 99%

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High exposures to bioactivated cyclophosphamide are related to the occurrence of veno-occlusive disease of the liver following high-dose chemotherapy

et al. 2006

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We investigated whether the occurrence of veno-occlusive disease of the liver (VOD) may be associated with individual variations in the pharmacokinetics of high-dose cyclophosphamide. Patients received single or multiple courses of cyclophosphamide (1000 or 1500 mg m À2 day À1 ), thiotepa (80 or 120 mg m À2 day À1 ) and carboplatin (265 -400 mg m À2 day À1 ) (CTC) for 4 consecutive days. The area under the plasma concentration -time curves (AUCs) were calculated for cyclophosphamide and its activated metabolites 4-hydroxycyclophosphamide and phosphoramide mustard based on multiple blood samples. Possible relationships between the AUCs and the occurrence of VOD were studied. A total of 59 patients (115 courses) were included. Four patients experienced VOD after a second CTC course. The first-course AUC of 4-hydroxycyclophosphamide (P ¼ 0.003) but not of phosphoramide mustard (P ¼ 0.101) appeared to be predictive of the occurrence of VOD after multiple courses. High exposures to bioactivated cyclophosphamide may lead to increased organ toxicity.

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Section: Patients and Treatmentmentioning

confidence: 99%

Section: Patients and Treatmentmentioning

confidence: 99%

Section: Patients and Treatmentmentioning

confidence: 99%

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High exposures to bioactivated cyclophosphamide are related to the occurrence of veno-occlusive disease of the liver following high-dose chemotherapy

et al. 2006

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“…As part of his treatment he received one course of high-dose chemotherapy with autologous peripheral blood progenitor cell transplantation, consisting of cyclophosphamide (1,500 mg/m 2 day ¡1 ) as 1-h infusion, immediately followed by carboplatin [dose calculated based on modiWed Calvert formula: AUC (mg min/mL) = Dose (mg)/(CL cr (mL/min) + 25) with 5 mg min/mL as daily target AUC] as 1-h infusion and thiotepa (120 mg/m 2 day ¡1 ) divided over two 30-min infusions 12 h apart, for four consecutive days. Full details of the CTC regimen have been published previously [17].…”

Section: Casementioning

confidence: 99%

Altered cyclophosphamide and thiotepa pharmacokinetics in a patient with moderate renal insufficiency

Ekhart

Kerst

Rodenhuis

et al. 2008

Cancer Chemother Pharmacol

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Purpose We report a patient with renal insuYciency (creatinine clearance, CL cr = 38 mL/min) who received high-dose chemotherapy with cyclophosphamide (1,500 mg/m 2 day ¡1 ), thiotepa (120 mg/m 2 day ¡1 ) and carboplatin (AUC = 5 mg min/mL day ¡1 ) for four consecutive days. Methods Blood samples were collected on day 1 and 3 and plasma levels of cyclophosphamide, its active metabolite 4-hydroxycyclophosphamide, thiotepa, its main metabolite tepa and carboplatin were determined. Results Pharmacokinetic analyses indicated that the elimination of cyclophosphamide, thiotepa, carboplatin, but especially tepa was strongly reduced in this patient, resulting in increased exposures to these compounds of 67, 43, 30 and 157%, respectively, compared to a reference population (n = 24) receiving similar doses. Exposure to 4-hydroxycyclophosphamide increased 11%. Conclusion These results suggest that it may not be necessary to alter the dose of cyclophosphamide in patients with moderate renal impairment. However, because high exposures to thiotepa and tepa have been correlated with increased toxicity, caution should be applied when administering thiotepa to patients with renal insuYciency.

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“…In high-risk breast cancer, there are negative trials showing no superiority for high-dose chemotherapy (Bergh et al, 2000;Hortobagyi et al, 2000;Tallman et al, 2003); in contrast, other trials have shown significant improvement in relapse-free and overall survival (Roche et al, 2003;Rodenhuis et al, 2003;Nitz et al, 2005). In metastatic breast cancer, whereas some trials have failed to demonstrate a survival benefit, others have suggested an advantage in event-free survival in favour of high-dose treatment (Stadtmauer et al, 2000;Crown et al, 2004;Lotz et al, 2005;Schmid et al, 2005).…”

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confidence: 99%

Cardiac toxicity of trastuzumab in metastatic breast cancer patients previously treated with high-dose chemotherapy: a retrospective study

et al. 2006

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HER-2 overexpression is associated to a poor prognosis in high-risk and metastatic breast cancer (MBC) patients treated with highdose chemotherapy (HDC). HER-2 status is also a predictive factor and when trastuzumab is administered in combination with or sequentially to chemotherapy, a significant disease-free and/or overall survival improvement has been observed in HER-2 þ early and MBC. Unfortunately, in both settings, trastuzumab is associated with an increased risk of cardiac dysfunction (CD). We have reviewed the clinical charts of HER-2-overexpressing MBC patients treated with trastuzumab after HDC. Age, baseline left ventricular ejection fraction (LVEF), radiation therapy on cardiac area, exposure to anthracycline, single or multiple transplant, high-dose agents, trastuzumab treatment duration were recorded as potential risk factors. In total, 53 patients have been included in the analysis. Median LVEF at baseline was 60.5%; at the end of trastuzumab (data available for 28 patients only), it was 55% (P ¼ 0.01). Five out of the 28 (17.9%) patients experienced CD. Two out of 53 (3.8%) patients developed a congestive heart failure. Age X50 years and multiple transplant procedure were potential risk factors for CD. The overall incidence of CD observed in this population of HER-2 þ MBC patients treated with trastuzumab after HDC is not superior to that reported with concomitant trastuzumab and anthracyclines. However, patients with age X50 years or receiving multiple course of HDC should be considered at risk for CD.

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High-Dose Chemotherapy with Hematopoietic Stem-Cell Rescue for High-Risk Breast Cancer

Abstract: High

Cited by 228 publications

References 21 publications

High exposures to bioactivated cyclophosphamide are related to the occurrence of veno-occlusive disease of the liver following high-dose chemotherapy

High exposures to bioactivated cyclophosphamide are related to the occurrence of veno-occlusive disease of the liver following high-dose chemotherapy

Altered cyclophosphamide and thiotepa pharmacokinetics in a patient with moderate renal insufficiency

Cardiac toxicity of trastuzumab in metastatic breast cancer patients previously treated with high-dose chemotherapy: a retrospective study

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