Second-Line Treatment with Intravenous Gemcitabine and Oral Etoposide in Platinum-Resistant Advanced Ovarian Cancer Patients: Results of a Phase II Study

Objective: The outcome of advanced ovarian cancer patients has not significantly improved since the introduction of platinum. One of the major reasons for this failure is the lack of an effective second-line treatment. In this phase II trial we tested the combination of gemcitabine and etoposide in...

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Veröffentlicht in:Oncology 2011-01, Vol.80 (3-4), p.238-246
Hauptverfasser: Bruzzone, M., Centurioni, M.G., Giglione, P., Gualco, M., Merlo, D.F., Miglietta, L., Cosso, M., Giannelli, F., Cristoforoni, P., Ferrarini, M.
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container_end_page 246
container_issue 3-4
container_start_page 238
container_title Oncology
container_volume 80
creator Bruzzone, M.
Centurioni, M.G.
Giglione, P.
Gualco, M.
Merlo, D.F.
Miglietta, L.
Cosso, M.
Giannelli, F.
Cristoforoni, P.
Ferrarini, M.
description Objective: The outcome of advanced ovarian cancer patients has not significantly improved since the introduction of platinum. One of the major reasons for this failure is the lack of an effective second-line treatment. In this phase II trial we tested the combination of gemcitabine and etoposide in 2 different groups of patients. Group 1 consisted of patients showing disease progression or relapse within 6 months of first-line platinum-based chemotherapy. Group 2 comprised heavily pretreated patients showing progression during the last chemotherapy attempt. Methods: Thirty-four patients were enrolled. Gemcitabine was administered at a dose of 1,000 mg/m 2 on days 1 and 8 and etoposide was administered orally at 100 mg/day on days 8–12 for 6 courses. Results: Eighteen patients (52.9%) had an objective response and the median duration of the response was 10.3 months. Our chemotherapy regimen showed a low toxicity and good patient compliance. In 5 patients the treatment had to be delayed and in only 2 patients it was discontinued. Conclusions: The combination of gemcitabine and oral etoposide seems to be a safe and effective second-line treatment for platinum-resistant ovarian cancer patients. Additional data on larger series are warranted to better define the activity of this combination regimen.
doi_str_mv 10.1159/000328451
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One of the major reasons for this failure is the lack of an effective second-line treatment. In this phase II trial we tested the combination of gemcitabine and etoposide in 2 different groups of patients. Group 1 consisted of patients showing disease progression or relapse within 6 months of first-line platinum-based chemotherapy. Group 2 comprised heavily pretreated patients showing progression during the last chemotherapy attempt. Methods: Thirty-four patients were enrolled. Gemcitabine was administered at a dose of 1,000 mg/m 2 on days 1 and 8 and etoposide was administered orally at 100 mg/day on days 8–12 for 6 courses. Results: Eighteen patients (52.9%) had an objective response and the median duration of the response was 10.3 months. Our chemotherapy regimen showed a low toxicity and good patient compliance. In 5 patients the treatment had to be delayed and in only 2 patients it was discontinued. Conclusions: The combination of gemcitabine and oral etoposide seems to be a safe and effective second-line treatment for platinum-resistant ovarian cancer patients. 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One of the major reasons for this failure is the lack of an effective second-line treatment. In this phase II trial we tested the combination of gemcitabine and etoposide in 2 different groups of patients. Group 1 consisted of patients showing disease progression or relapse within 6 months of first-line platinum-based chemotherapy. Group 2 comprised heavily pretreated patients showing progression during the last chemotherapy attempt. Methods: Thirty-four patients were enrolled. Gemcitabine was administered at a dose of 1,000 mg/m 2 on days 1 and 8 and etoposide was administered orally at 100 mg/day on days 8–12 for 6 courses. Results: Eighteen patients (52.9%) had an objective response and the median duration of the response was 10.3 months. Our chemotherapy regimen showed a low toxicity and good patient compliance. In 5 patients the treatment had to be delayed and in only 2 patients it was discontinued. 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One of the major reasons for this failure is the lack of an effective second-line treatment. In this phase II trial we tested the combination of gemcitabine and etoposide in 2 different groups of patients. Group 1 consisted of patients showing disease progression or relapse within 6 months of first-line platinum-based chemotherapy. Group 2 comprised heavily pretreated patients showing progression during the last chemotherapy attempt. Methods: Thirty-four patients were enrolled. Gemcitabine was administered at a dose of 1,000 mg/m 2 on days 1 and 8 and etoposide was administered orally at 100 mg/day on days 8–12 for 6 courses. Results: Eighteen patients (52.9%) had an objective response and the median duration of the response was 10.3 months. Our chemotherapy regimen showed a low toxicity and good patient compliance. In 5 patients the treatment had to be delayed and in only 2 patients it was discontinued. Conclusions: The combination of gemcitabine and oral etoposide seems to be a safe and effective second-line treatment for platinum-resistant ovarian cancer patients. Additional data on larger series are warranted to better define the activity of this combination regimen.</abstract><cop>Basel, Switzerland</cop><pub>Karger</pub><pmid>21734415</pmid><doi>10.1159/000328451</doi><tpages>9</tpages></addata></record>
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source Karger Journals; MEDLINE; Alma/SFX Local Collection
subjects Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biological and medical sciences
CA-125 Antigen - blood
Chemotherapy
Clinical Study
Clinical trials
Deoxycytidine - administration & dosage
Deoxycytidine - analogs & derivatives
Drug resistance
Drug Resistance, Neoplasm
Etoposide - administration & dosage
Female
Female genital diseases
Gynecology. Andrology. Obstetrics
Humans
Medical sciences
Middle Aged
Ovarian cancer
Ovarian Neoplasms - blood
Ovarian Neoplasms - drug therapy
Ovarian Neoplasms - pathology
Ovarian Neoplasms - surgery
Platinum - therapeutic use
Survival Analysis
Treatment Outcome
Tumors
title Second-Line Treatment with Intravenous Gemcitabine and Oral Etoposide in Platinum-Resistant Advanced Ovarian Cancer Patients: Results of a Phase II Study
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