A phase II study of pegylated liposomal doxorubicin oxaliplatin and cyclophosphamide as second-line treatment in relapsed ovarian carcinoma

M. R. Valerio, P. Tagliaferri, F. Raspagliesi, F. Fulfaro, G. Badalamenti, C. Arcara, G. Cicero, A. Russo, S. Venuta, G. Guarneri, N. Gebbia

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Abstract

We carried out a phase II nonrandomized study to examine the level of activity of oxaliplatin, pegylated liposomal doxorubicin, and cyclophosphamide in a patient population with relapsed ovarian cancer pretreated with platinum derivatives and paclitaxel. Patients received oxaliplatin (85 mg/m2), pegylated liposomal doxorubicin (30 mg/m2), and cyclophosphamide (750 mg/m2). A total of 49 patients (39 assessable for toxicity and response) were enrolled in this trial. Neutropenia grade 3 was observed in six patients (15%) and anemia grade 3 in one patient (0.2%). Fatigue grade 1-2 occurred in 26 patients (66%), nausea/vomiting grade 1 in 23 patients (58%), and alopecia grade 1-2 in 19 patients (48%). Twenty-one (53%) patients experienced grade 1-2 peripheral neuropathy. The overall response rate was 46% (95% CI 23.6-68.7). Median progression-free survival was 28 weeks (range 12-52 weeks) and median survival was 45 weeks (range 26-136+ weeks). The mean duration of response was 34 weeks (range 16-52 weeks). In platinum-resistant and -refractory ovarian cancer patients, the overall response rate was 37% (CI 95% 14.4-60.8) with a progression-free survival of 28 weeks (range 12-52 weeks) and a median survival of 42 weeks (range 28-84 weeks). This combination chemotherapy is generally well tolerated and is an active second-line regimen against ovarian cancer.

Original languageEnglish
Pages (from-to)79-85
Number of pages7
JournalInternational Journal of Gynecological Cancer
Volume16
Issue numberSUPPL. 1
DOIs
Publication statusPublished - Feb 2006

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oxaliplatin
Cyclophosphamide
Carcinoma
Ovarian Neoplasms
Therapeutics
Platinum
Disease-Free Survival
liposomal doxorubicin

Keywords

  • Chemotherapy
  • Liposomal doxorubicin
  • Ovarian cancer
  • Oxaliplatin
  • Second-line therapy

ASJC Scopus subject areas

  • Obstetrics and Gynaecology
  • Oncology
  • Cancer Research

Cite this

A phase II study of pegylated liposomal doxorubicin oxaliplatin and cyclophosphamide as second-line treatment in relapsed ovarian carcinoma. / Valerio, M. R.; Tagliaferri, P.; Raspagliesi, F.; Fulfaro, F.; Badalamenti, G.; Arcara, C.; Cicero, G.; Russo, A.; Venuta, S.; Guarneri, G.; Gebbia, N.

In: International Journal of Gynecological Cancer, Vol. 16, No. SUPPL. 1, 02.2006, p. 79-85.

Research output: Contribution to journalArticle

Valerio, MR, Tagliaferri, P, Raspagliesi, F, Fulfaro, F, Badalamenti, G, Arcara, C, Cicero, G, Russo, A, Venuta, S, Guarneri, G & Gebbia, N 2006, 'A phase II study of pegylated liposomal doxorubicin oxaliplatin and cyclophosphamide as second-line treatment in relapsed ovarian carcinoma', International Journal of Gynecological Cancer, vol. 16, no. SUPPL. 1, pp. 79-85. https://doi.org/10.1111/j.1525-1438.2006.00324.x
Valerio, M. R. ; Tagliaferri, P. ; Raspagliesi, F. ; Fulfaro, F. ; Badalamenti, G. ; Arcara, C. ; Cicero, G. ; Russo, A. ; Venuta, S. ; Guarneri, G. ; Gebbia, N. / A phase II study of pegylated liposomal doxorubicin oxaliplatin and cyclophosphamide as second-line treatment in relapsed ovarian carcinoma. In: International Journal of Gynecological Cancer. 2006 ; Vol. 16, No. SUPPL. 1. pp. 79-85.
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