The aim of this study was to evaluate the safety and efficacy of liposome-encapsulated doxorubicin citrate (LEDC) in patients affected by recurrent/metastatic gynecological malignancies scheduled for palliative chemotherapy. Inclusion criteria were proven recurrent/advanced gynecological neoplasms, measurable/assessable disease, adequate organ function, left ventricular ejection fraction > 50% as determined by echocardiography, informed consent. LEDC was administered intravenously over 1 h at the dose of either 75 mg/m(2) or 60 mg/m(2) (every 3 weeks until disease progression or toxicity prohibiting further therapy). From May 2003 to September 2005, 36 patients were enrolled. Primary disease was ovarian, endometrial, and cervical cancers in 15 (42%), 11 (30%), and 10 (28%) patients, respectively. LEDC was employed as third- or fourth-line chemotherapy in 25 (70%) and 11 (30%) patients, respectively. The median number of courses of LEDC received was 3 (range 2-9). Six patients (17%) achieved a partial response to treatment lasting 27 weeks and 10 patients (28%) experienced stable disease lasting 18 weeks. The predominant toxicity was hematological, especially neutropenia. Among patients receiving a dose of 75 mg/m(2), two (11%) suspended therapy for febrile neutropenia, and nine (50%) required a dose reduction of 25%. As a result, the next 18 patients were treated at a reduced dose (60 mg/m(2)) of LEDC. Severe neutropenia (G3-G4) was significantly less common in this group (61% versus 22%; P = 0.04). LEDC has shown antineoplastic activity in previously treated recurrent/metastatic gynecological cancer patients and the toxicity profile could be considered acceptable at a 60 mg/m(2) dosage.

Liposome-encapsulated doxorubicin citrate in previously treated recurrent/metastatic gynecological malignancies / R., Angioli; Palaia, Innocenza; Calcagno, Marco; N., Manci; M. a., Zullo; Bellati, Filippo; Perniola, Giorgia; A., De Vivo; BENEDETTI PANICI, Pierluigi. - In: INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER. - ISSN 1048-891X. - 17:1(2007), pp. 88-93. [10.1111/j.1525-1438.2007.00825.x]

Liposome-encapsulated doxorubicin citrate in previously treated recurrent/metastatic gynecological malignancies

PALAIA, INNOCENZA;CALCAGNO, MARCO;BELLATI, FILIPPO;PERNIOLA, GIORGIA;BENEDETTI PANICI, PIERLUIGI
2007

Abstract

The aim of this study was to evaluate the safety and efficacy of liposome-encapsulated doxorubicin citrate (LEDC) in patients affected by recurrent/metastatic gynecological malignancies scheduled for palliative chemotherapy. Inclusion criteria were proven recurrent/advanced gynecological neoplasms, measurable/assessable disease, adequate organ function, left ventricular ejection fraction > 50% as determined by echocardiography, informed consent. LEDC was administered intravenously over 1 h at the dose of either 75 mg/m(2) or 60 mg/m(2) (every 3 weeks until disease progression or toxicity prohibiting further therapy). From May 2003 to September 2005, 36 patients were enrolled. Primary disease was ovarian, endometrial, and cervical cancers in 15 (42%), 11 (30%), and 10 (28%) patients, respectively. LEDC was employed as third- or fourth-line chemotherapy in 25 (70%) and 11 (30%) patients, respectively. The median number of courses of LEDC received was 3 (range 2-9). Six patients (17%) achieved a partial response to treatment lasting 27 weeks and 10 patients (28%) experienced stable disease lasting 18 weeks. The predominant toxicity was hematological, especially neutropenia. Among patients receiving a dose of 75 mg/m(2), two (11%) suspended therapy for febrile neutropenia, and nine (50%) required a dose reduction of 25%. As a result, the next 18 patients were treated at a reduced dose (60 mg/m(2)) of LEDC. Severe neutropenia (G3-G4) was significantly less common in this group (61% versus 22%; P = 0.04). LEDC has shown antineoplastic activity in previously treated recurrent/metastatic gynecological cancer patients and the toxicity profile could be considered acceptable at a 60 mg/m(2) dosage.
2007
liposome-encapsulated doxorubicin citrate; gynecological neoplasms; palliative chemotherapy
01 Pubblicazione su rivista::01a Articolo in rivista
Liposome-encapsulated doxorubicin citrate in previously treated recurrent/metastatic gynecological malignancies / R., Angioli; Palaia, Innocenza; Calcagno, Marco; N., Manci; M. a., Zullo; Bellati, Filippo; Perniola, Giorgia; A., De Vivo; BENEDETTI PANICI, Pierluigi. - In: INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER. - ISSN 1048-891X. - 17:1(2007), pp. 88-93. [10.1111/j.1525-1438.2007.00825.x]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/364922
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