Phase II Evaluation of Gemcitabine Monotherapy for Cutaneous T-Cell Lymphoma

Duvic, Madeleine; Talpur, Rakhshandra; Wen, Sijin; Kurzrock, Razelle; Apisarnthanarax, Narin

doi:10.3816/clm.2006.n.039

Cited by 140 publications

(96 citation statements)

References 34 publications

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“…Gemcitabine is a widely used treatment option for MF; however, although its activity is well documented, literature data are difficult to compare. RRs ranged between 62% and 75% according to different reports, [33][34][35] but inclusion criteria for treatment were different; one study included only untreated patients, 33 whereas another also included those with early-stage MF. 34 Moreover, with respect to the present EORTC study, treated patients included those with erythrodermic MF, SS, and non-MF/SS CTCLs.…”

Section: Discussionmentioning

confidence: 99%

Prospective International Multicenter Phase II Trial of Intravenous Pegylated Liposomal Doxorubicin Monochemotherapy in Patients With Stage IIB, IVA, or IVB Advanced Mycosis Fungoides: Final Results From EORTC 21012

Dummer

Quaglino

Becker

et al. 2012

JCO

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PURPOSE: Mycosis fungoides (MF) is the most common primary cutaneous T-cell lymphoma.There is a need for multicenter trials involving defined patient populations using rigorous assessment criteria. We have investigated pegylated liposomal doxorubicin (PLD) in a clearly defined patient population with advanced MF. PATIENTS AND METHODS: Eligible patients had stage IIB, IVA, or IVB MF, refractory or recurrent after at least two previous systemic therapies. Patients were registered to receive a maximum of six cycles of PLD 20 mg/m2 on days 1 and 15, every 28 days (one cycle). The primary end point was response rate (RR). RESULTS: Nine centers recruited 49 eligible patients. The median number of chemotherapy cycles received was five. There were no grade 3 to 4 hematologic toxicities. Grade 3 or 4 nonhematologic/nonbiochemical toxicities included cardiac symptom (2%), allergy/hypersensitivity (2%), constitutional symptom (4%), hand and foot reaction (2%), other dermatologic toxicity (6%), other GI toxicity (4%), infection (4%), pulmonary embolism (2%), and cardiac ischemia (2%). Of 49 patients, 20 (40.8%) were responders (complete clinical response [CCR] or partial response [PR] as overall response): three (6.1%) experienced CCRs, and 17 (34.7%) experienced PRs. A 50% or greater reduction of cutaneous manifestations was observed in 26 (60.5%) of 43 assessable patients. Two early deaths were reported, resulting from related cardiovascular toxicity and disease progression. The lower limit of the one-sided 90% CI for RR was 31.2%. Median time to progression and median duration of response were 7.4 and 6 months, respectively. CONCLUSION: PLD has an acceptable safety profile in patients with advanced MF. The efficacy of PLD seems promising. A B S T R A C T PurposeMycosis fungoides (MF) is the most common primary cutaneous T-cell lymphoma. There is a need for multicenter trials involving defined patient populations using rigorous assessment criteria. We have investigated pegylated liposomal doxorubicin (PLD) in a clearly defined patient population with advanced MF. Patients and MethodsEligible patients had stage IIB, IVA, or IVB MF, refractory or recurrent after at least two previous systemic therapies. Patients were registered to receive a maximum of six cycles of PLD 20 mg/m 2 on days 1 and 15, every 28 days (one cycle). The primary end point was response rate (RR). ResultsNine centers recruited 49 eligible patients. The median number of chemotherapy cycles received was five. There were no grade 3 to 4 hematologic toxicities. Grade 3 or 4 nonhematologic/ nonbiochemical toxicities included cardiac symptom (2%), allergy/hypersensitivity (2%), constitutional symptom (4%), hand and foot reaction (2%), other dermatologic toxicity (6%), other GI toxicity (4%), infection (4%), pulmonary embolism (2%), and cardiac ischemia (2%). Of 49 patients, 20 (40.8%) were responders (complete clinical response [CCR] or partial response [PR] as overall response): three (6.1%) experienced CCRs, and 17 (34.7%) experienced PRs. A...

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Section: Discussionmentioning

confidence: 99%

Prospective International Multicenter Phase II Trial of Intravenous Pegylated Liposomal Doxorubicin Monochemotherapy in Patients With Stage IIB, IVA, or IVB Advanced Mycosis Fungoides: Final Results From EORTC 21012

Dummer

Quaglino

Becker

et al. 2012

JCO

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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%

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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“…In phase I clinical trials of gemcitabine use, significant reduction in LVEF occurred in 0.2% of patient, whereas 0.4–1.7% of patients developed cardiac arrhythmias 13. Review of the literature of phase II clinical trials of approximately 979 patients revealed 0.2% arrhythmias, 0.4% cardiomyopathies, and 0.2% with exudative pericarditis 14. In these trials, patients who developed cardiomyopathies had underlying coronary artery disease, whereas our patient had no history of coronary disease.…”

Section: Discussionmentioning

confidence: 70%

Gemcitabine induced cardiomyopathy: a case of multiple hit cardiotoxicity

2016

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Gemcitabine is a commonly used antineoplastic agent used to treat a variety of cancers with rarely reported cardiac side effects. We describe a case of a 67‐year‐old woman with follicular lymphoma who experienced a rarely reported side effect of gemcitabine: cardiomyopathy. This case highlights a multiple hit mechanism of myocyte damage that may occur following the use of multiple cardio‐toxic agents despite their administration in doses not associated with cardiotoxicity.

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Phase II Evaluation of Gemcitabine Monotherapy for Cutaneous T-Cell Lymphoma

Cited by 140 publications

References 34 publications

Prospective International Multicenter Phase II Trial of Intravenous Pegylated Liposomal Doxorubicin Monochemotherapy in Patients With Stage IIB, IVA, or IVB Advanced Mycosis Fungoides: Final Results From EORTC 21012

Prospective International Multicenter Phase II Trial of Intravenous Pegylated Liposomal Doxorubicin Monochemotherapy in Patients With Stage IIB, IVA, or IVB Advanced Mycosis Fungoides: Final Results From EORTC 21012

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

Gemcitabine induced cardiomyopathy: a case of multiple hit cardiotoxicity

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