Prospective Multicenter Study of Pegylated Liposomal Doxorubicin Treatment in Patients With Advanced or Refractory Mycosis Fungoides or Sézary Syndrome

Quéreux, G.; Marques, S.; Nguyen, Jean–Michel; Bédane, Christophe; D’Incan, M.; Dereure, O.; Puzenat, Elisabeth; Claudy, A; Martin, Ludovic; Joly, P.; Delaunay, M.; Beylot‐Barry, M.; Vabres, P.; Célérier, P.; Sasolas, Bruno; Grange, Florent; Khammari, Amir; Dréno, Brigitte

doi:10.1001/archderm.144.6.727

Cited by 88 publications

(44 citation statements)

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“…For example, overall response rates of 58-76% (and 41% complete response rate) have been observed in patients with MF/SS treated with low-dose, oral methotrexate [336][337][338][339]. In contrast, for patients with an adequate performance status, single-agent gemcitabine [340][341][342][343][344], pegylated liposomal doxorubicin [345][346][347][348] and pentostatin [349][350][351][352][353][354][355] are frequently utilized (Table VI). Gemcitabine, a pyrimidine nucleoside analog, is associated with overall and complete response rates of 50-70% and 10-20%, respectively, but is associated with neutropenia and nonhematologic toxicities [356].…”

Section: Systemic Chemotherapymentioning

confidence: 99%

“…Overall, seven of nine complete responders remained in continuous complete remission with a diseasefree interval ranging from 15 months to 10 years. In the largest prospective study of pegylated liposomal doxorubicin, an overall response rate of 56%, with a complete response rate of 20%, was reported [348]. Pegylated liposomal doxorubicin is generally well tolerated, with a lower incidence of neutropenia than gemcitabine, but with occasional infusion-related and mucocutaneous toxicities, including palmoplantar erythrodysesthesia.…”

Section: Systemic Chemotherapymentioning

confidence: 99%

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Cutaneous T‐cell lymphoma: 2011 update on diagnosis, risk‐stratification, and management

Wilcox

2011

American J Hematol

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Disease overview: Cutaneous T‐cell lymphomas are a heterogenous group of T‐cell lymphoproliferative disorders involving the skin, the majority of which may be classified as Mycosis fungoides (MF) or Sézary syndrome (SS).Diagnosis: The diagnosis of MF or SS requires the integration of clinical and histopathologic data.Risk‐adapted therapy: Tumor, node, metastasis, and blood (TNMB) staging remains the most important prognostic factor in MF/SS and forms the basis for a “risk‐adapted,” multidisciplinary approach to treatment. For patients with disease limited to the skin, expectant management or skin‐directed therapies is preferred, as both disease‐specific and overall survival for these patients is favorable. In contrast, patients with advanced‐stage disease with significant nodal, visceral, or blood involvement are generally approached with biologic‐response modifiers, denileukin diftitox, and histone deacetylase inhibitors before escalating therapy to include systemic, single‐agent chemotherapy. Multiagent chemotherapy may be used for those patients with extensive visceral involvement requiring rapid disease control. In highly‐selected patients with disease refractory to standard treatments, allogeneic stem‐cell transplantation may be considered. Am. J. Hematol., 2011. © 2011 Wiley‐Liss, Inc.

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Section: Systemic Chemotherapymentioning

confidence: 99%

Section: Systemic Chemotherapymentioning

confidence: 99%

Cutaneous T‐cell lymphoma: 2011 update on diagnosis, risk‐stratification, and management

Wilcox

2011

American J Hematol

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“…Thus, in patients with relatively slowly progressive disease who have failed other treatments, we would consider low-dose oral MTX, chlorambucil, cyclophosphamide, or etoposide. For patients with more rapidly progressive disease and of reasonable performance status, our preference is to use single-agent gemcitabine, 63,[93][94][95] pentostatin, 54,64,[96][97][98][99][100] or liposomal doxorubicin 65,101,102 as these agents have been investigated the most thoroughly. Gemcitabine has a high response rate, but myelosuppression can be problematic with dose-reduction frequently required.…”

Section: Systemic Chemotherapymentioning

confidence: 99%

How I treat mycosis fungoides and Sézary syndrome

Prince

Whittaker

Hoppe

2009

Blood

134

109

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The most common subtypes of primary cutaneous T-cell lymphomas are mycosis fungoides (MF) and Sézary syndrome (SS). The majority of patients have indolent disease; and given the incurable nature of MF/SS, management should focus on improving symptoms and cosmesis while limiting toxicity. Management of MF/SS should use a “stage-based” approach; treatment of early-stage disease (IA-IIA) typically involves skin directed therapies that include topical corticosteroids, phototherapy (psoralen plus ultraviolet A radiation or ultraviolet B radiation), topical chemotherapy, topical or systemic bexarotene, and radiotherapy. Systemic approaches are used for recalcitrant early-stage disease, advanced-stage disease (IIB-IV), and transformed disease and include retinoids, such as bexarotene, interferon-α, histone deacetylase inhibitors, the fusion toxin denileukin diftitox, systemic chemotherapy including transplantation, and extracorporeal photopheresis. Examples of drugs under active investigation include new histone deacetylase inhibitors, forodesine, monoclonal antibodies, proteasome inhibitors, and immunomodulatory agents, such as lenalidomide. It is appropriate to consider patients for novel agents within clinical trials if they have failed front-line therapy and before chemotherapy is used.

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“…ComPharmacodynamic and pharmacokinetic study of pegylated liposomal doxorubicin combination (CCOP) chemotherapy in patients with peripheral T-cell lymphomas www.chinaphar.com Fan Y et al Acta Pharmacologica Sinica npg pared to conventional doxorubicin injection, PLD has a longer retention time in blood circulation, lower cardiotoxicity and improved targeted efficiency [8] . Recently, there have been several clinical studies on PLD-based NHL treatment that have shown it to be superior in the treatment of the elderly or patients with primarily cutaneous T-cell lymphomas (CTCL) with aggressive NHL [9][10][11] .…”

Section: Introductionmentioning

confidence: 99%

Pharmacodynamic and pharmacokinetic study of pegylated liposomal doxorubicin combination (CCOP) chemotherapy in patients with peripheral T-cell lymphomas

et al. 2011

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Aim: To investigate the pharmacodynamic and pharmacokinetic parameters of pegylated liposomal doxorubicin (PLD) combined with cyclophosphamide, vincristine, and prednisolone in patients with peripheral T-cell lymphomas (PTCL). Methods: Seven chemonaive patients and four patients with relapsed peripheral T-cell lymphomas were treated with a CCOP regimen consisting of an intravenous administration of cyclophosphamide (750 mg/m 2 ), vincristine (1.4 mg/m 2 ), and PLD (30 mg/m 2 ) on d 1, as well as an oral administration of prednisolone (60 mg/m 2 ) on d 1-5. This regimen was repeated every 3 weeks for six cycles, and the clinical response and toxicity of the regimen were monitored. In addition, the plasma concentration of PLD at different time points was determined before and after treatment. The pharmacokinetics (PKs) software was used to estimate the pharmacokinetic parameters of PLD. Results: The 11 PTCL patients received 35 treatment cycles. Three of them achieved complete response (CR), two partial response (PR), four stable disease (SD), and two progressive disease (PD). The overall response rate (ORR) was 45.5%, and the CR rate was 27.3%. In the 7 chemonaive patients, three achieved CR, two PR, one SD, and one PD. The ORR was 71.4%, and CR rate was 42.9%. The median follow-up time was 15 months, but 6 out of 11 patients were dead at the time of data analysis. The 1-year overall survival rate was 45.5%, and the median progression-free survival (PFS) rate was 6.5 [95% confidence interval (95% CI) 3.17-19.02] with a survival rate of 11.5 months (95% CI 6.65-16.36). The main toxicity was myelosuppression. Oral mucositis and hand-foot syndrome seldom occurred. The PLD plasma concentration from nine patients ranged from 1.7036 to 9.2207 mg·L -1 after administration of the CCOP regimen (0-168 h). The pharmacokinetic parameters AUC 0-∞ , CL, t 1/2 , and V d were 910.76 mg/L·h, 0.043 L·h -1 ·m -2 , 68.40 h, and 3.56 L/m 2 , respectively. Conclusion: The CCOP regimen was effective and well tolerated in patients with peripheral T-cell lymphomas. The results of the pharmacokinetic parameters showed that PLD had long retention time in blood circulation.

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Prospective Multicenter Study of Pegylated Liposomal Doxorubicin Treatment in Patients With Advanced or Refractory Mycosis Fungoides or Sézary Syndrome

Abstract: To assess the rate of objective response to pegylated liposomal doxorubicin hydrochloride (Caelyx) in patients with advanced or refractory cutaneous T-cell lymphoma (CTCL).

Cited by 88 publications

References 45 publications

Cutaneous T‐cell lymphoma: 2011 update on diagnosis, risk‐stratification, and management

Cutaneous T‐cell lymphoma: 2011 update on diagnosis, risk‐stratification, and management

How I treat mycosis fungoides and Sézary syndrome

Pharmacodynamic and pharmacokinetic study of pegylated liposomal doxorubicin combination (CCOP) chemotherapy in patients with peripheral T-cell lymphomas

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