A phase II study of liposomal doxorubicin in recurrent epithelial ovarian carcinoma

Carmela Arcuri, Roberto Sorio, Germana Tognon, Angela Gambino, Simona Scalone, Antonio Lucenti, Orazio Caffo, Francesco Valduga, Emilio Arisi, Enzo Galligioni

Research output: Contribution to journalArticle

Abstract

Background: We conducted a phase II trial to evaluate the efficacy and safety of liposomal formulation of doxorubicin in recurrent ovarian carcinoma patients. Methods: Thirty patients were included in the study after having obtained an informed consent. Their main characteristics were: median age, 64 years (range, 45-80), ECOG performance status 0 in 17 patients (56%), 1 in 11 patients (36%) and 2 in 2 patients (6.6%). Eighteen patients had metastatic disease and 12 locally advanced disease. All patients were pretreated with a platinum-based chemotherapy: 3 were considered refractory to platinum (progression or stable disease), 2 were platinum resistant (relapse 2 every 4 weeks. Results: The overall response rate was 26.6%, with 2 complete responses and 6 partial responses lasting 3.5 months. The incidence of grade 3-4 toxicity was 23.3% for neutropenia, 10% for mucositis and 10% for plantar-palmar erythrodysesthesia. Median survival was 12+ months (range, 2-26+). Conclusions: Liposomal doxorubicin appears to be a moderately active drug in pretreated patients, and its activity seems to be similar to that reported for other active regimens in terms of response rate. The toxicological profile of liposomal doxorubicin suggests that it may be combined with other drugs in the treatment of patients with ovarian cancer.

Original languageEnglish
Pages (from-to)556-561
Number of pages6
JournalTumori
Volume90
Issue number6
Publication statusPublished - Nov 2004

Fingerprint

Carcinoma
Platinum
liposomal doxorubicin
Mucositis
Neutropenia
Informed Consent
Pharmaceutical Preparations
Ovarian Neoplasms
Toxicology
Safety
Recurrence
Drug Therapy
Survival
Incidence

Keywords

  • Liposomal doxorubicin
  • Ovarian cancer
  • Pegylation
  • Phase II study

ASJC Scopus subject areas

  • Cancer Research

Cite this

Arcuri, C., Sorio, R., Tognon, G., Gambino, A., Scalone, S., Lucenti, A., ... Galligioni, E. (2004). A phase II study of liposomal doxorubicin in recurrent epithelial ovarian carcinoma. Tumori, 90(6), 556-561.

A phase II study of liposomal doxorubicin in recurrent epithelial ovarian carcinoma. / Arcuri, Carmela; Sorio, Roberto; Tognon, Germana; Gambino, Angela; Scalone, Simona; Lucenti, Antonio; Caffo, Orazio; Valduga, Francesco; Arisi, Emilio; Galligioni, Enzo.

In: Tumori, Vol. 90, No. 6, 11.2004, p. 556-561.

Research output: Contribution to journalArticle

Arcuri, C, Sorio, R, Tognon, G, Gambino, A, Scalone, S, Lucenti, A, Caffo, O, Valduga, F, Arisi, E & Galligioni, E 2004, 'A phase II study of liposomal doxorubicin in recurrent epithelial ovarian carcinoma', Tumori, vol. 90, no. 6, pp. 556-561.
Arcuri C, Sorio R, Tognon G, Gambino A, Scalone S, Lucenti A et al. A phase II study of liposomal doxorubicin in recurrent epithelial ovarian carcinoma. Tumori. 2004 Nov;90(6):556-561.
Arcuri, Carmela ; Sorio, Roberto ; Tognon, Germana ; Gambino, Angela ; Scalone, Simona ; Lucenti, Antonio ; Caffo, Orazio ; Valduga, Francesco ; Arisi, Emilio ; Galligioni, Enzo. / A phase II study of liposomal doxorubicin in recurrent epithelial ovarian carcinoma. In: Tumori. 2004 ; Vol. 90, No. 6. pp. 556-561.
@article{3a0a80cd042a402fa1c3b0821283cb1d,
title = "A phase II study of liposomal doxorubicin in recurrent epithelial ovarian carcinoma",
abstract = "Background: We conducted a phase II trial to evaluate the efficacy and safety of liposomal formulation of doxorubicin in recurrent ovarian carcinoma patients. Methods: Thirty patients were included in the study after having obtained an informed consent. Their main characteristics were: median age, 64 years (range, 45-80), ECOG performance status 0 in 17 patients (56{\%}), 1 in 11 patients (36{\%}) and 2 in 2 patients (6.6{\%}). Eighteen patients had metastatic disease and 12 locally advanced disease. All patients were pretreated with a platinum-based chemotherapy: 3 were considered refractory to platinum (progression or stable disease), 2 were platinum resistant (relapse 2 every 4 weeks. Results: The overall response rate was 26.6{\%}, with 2 complete responses and 6 partial responses lasting 3.5 months. The incidence of grade 3-4 toxicity was 23.3{\%} for neutropenia, 10{\%} for mucositis and 10{\%} for plantar-palmar erythrodysesthesia. Median survival was 12+ months (range, 2-26+). Conclusions: Liposomal doxorubicin appears to be a moderately active drug in pretreated patients, and its activity seems to be similar to that reported for other active regimens in terms of response rate. The toxicological profile of liposomal doxorubicin suggests that it may be combined with other drugs in the treatment of patients with ovarian cancer.",
keywords = "Liposomal doxorubicin, Ovarian cancer, Pegylation, Phase II study",
author = "Carmela Arcuri and Roberto Sorio and Germana Tognon and Angela Gambino and Simona Scalone and Antonio Lucenti and Orazio Caffo and Francesco Valduga and Emilio Arisi and Enzo Galligioni",
year = "2004",
month = "11",
language = "English",
volume = "90",
pages = "556--561",
journal = "Tumori",
issn = "0300-8916",
publisher = "SAGE Publications Ltd",
number = "6",

}

TY - JOUR

T1 - A phase II study of liposomal doxorubicin in recurrent epithelial ovarian carcinoma

AU - Arcuri, Carmela

AU - Sorio, Roberto

AU - Tognon, Germana

AU - Gambino, Angela

AU - Scalone, Simona

AU - Lucenti, Antonio

AU - Caffo, Orazio

AU - Valduga, Francesco

AU - Arisi, Emilio

AU - Galligioni, Enzo

PY - 2004/11

Y1 - 2004/11

N2 - Background: We conducted a phase II trial to evaluate the efficacy and safety of liposomal formulation of doxorubicin in recurrent ovarian carcinoma patients. Methods: Thirty patients were included in the study after having obtained an informed consent. Their main characteristics were: median age, 64 years (range, 45-80), ECOG performance status 0 in 17 patients (56%), 1 in 11 patients (36%) and 2 in 2 patients (6.6%). Eighteen patients had metastatic disease and 12 locally advanced disease. All patients were pretreated with a platinum-based chemotherapy: 3 were considered refractory to platinum (progression or stable disease), 2 were platinum resistant (relapse 2 every 4 weeks. Results: The overall response rate was 26.6%, with 2 complete responses and 6 partial responses lasting 3.5 months. The incidence of grade 3-4 toxicity was 23.3% for neutropenia, 10% for mucositis and 10% for plantar-palmar erythrodysesthesia. Median survival was 12+ months (range, 2-26+). Conclusions: Liposomal doxorubicin appears to be a moderately active drug in pretreated patients, and its activity seems to be similar to that reported for other active regimens in terms of response rate. The toxicological profile of liposomal doxorubicin suggests that it may be combined with other drugs in the treatment of patients with ovarian cancer.

AB - Background: We conducted a phase II trial to evaluate the efficacy and safety of liposomal formulation of doxorubicin in recurrent ovarian carcinoma patients. Methods: Thirty patients were included in the study after having obtained an informed consent. Their main characteristics were: median age, 64 years (range, 45-80), ECOG performance status 0 in 17 patients (56%), 1 in 11 patients (36%) and 2 in 2 patients (6.6%). Eighteen patients had metastatic disease and 12 locally advanced disease. All patients were pretreated with a platinum-based chemotherapy: 3 were considered refractory to platinum (progression or stable disease), 2 were platinum resistant (relapse 2 every 4 weeks. Results: The overall response rate was 26.6%, with 2 complete responses and 6 partial responses lasting 3.5 months. The incidence of grade 3-4 toxicity was 23.3% for neutropenia, 10% for mucositis and 10% for plantar-palmar erythrodysesthesia. Median survival was 12+ months (range, 2-26+). Conclusions: Liposomal doxorubicin appears to be a moderately active drug in pretreated patients, and its activity seems to be similar to that reported for other active regimens in terms of response rate. The toxicological profile of liposomal doxorubicin suggests that it may be combined with other drugs in the treatment of patients with ovarian cancer.

KW - Liposomal doxorubicin

KW - Ovarian cancer

KW - Pegylation

KW - Phase II study

UR - http://www.scopus.com/inward/record.url?scp=20044373812&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=20044373812&partnerID=8YFLogxK

M3 - Article

C2 - 15762356

AN - SCOPUS:20044373812

VL - 90

SP - 556

EP - 561

JO - Tumori

JF - Tumori

SN - 0300-8916

IS - 6

ER -