A phase II trial of weekly topotecan for patients with secondary platinum-resistant recurrent epithelial ovarian carcinoma following the failure of second-line therapy

Whitney A. Spannuth, Charles A. Leath, Warner K. Huh, Mack N. Barnes, Susan A. Davidson, Larry Kilgore, Edward E. Partridge, J. Maxwell Austin, Ronald D. Alvarez

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Abstract

Objective: To determine the response rate, progression-free survival and toxicity associated with weekly topotecan administered to patients with platinum-sensitive recurrent epithelial ovarian (EOC) in the third-line setting. Methods: Patients with measurable platinum-sensitive EOC following failure of second-line chemotherapy were eligible for this phase II study. All patients were initially treated with cytoreductive surgery and platinum/paclitaxel-based chemotherapy. Continuous, weekly topotecan was administered at a starting dose of 4 mg/m2. Toxicity and efficacy were assessed at various time points after initiation of therapy. Results: Twenty nine patients were enrolled in this prospective study. Toxicity was acceptable with grade 1/2 nausea being the most commonly experienced side effect (52%). Nine patients (31%) had grade 3/4 leukopenia; however, only 3 patients had febrile neutropenia. Thirteen patients had a treatment delay and six required dose reductions. Twenty two patients were evaluable for efficacy. The overall response rate for weekly topotecan was 13.6% [95% CI; - 0.7-27.9%] with 1 complete response, and 2 partial responses. Twelve patients (54.5%), including 2 with minor responses, had stable disease for a median duration of 18 weeks. Conclusions: Weekly topotecan at the current schedule in the third-line setting in patients with platinum-sensitive recurrent EOC has modest clinical activity. Toxicity associated with this regimen is acceptable but growth factor support, dose reductions, or schedule alterations may need to be considered in many of these patients.

Original languageEnglish (US)
Pages (from-to)591-595
Number of pages5
JournalGynecologic oncology
Volume104
Issue number3
DOIs
StatePublished - Mar 1 2007

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Topotecan
Platinum
Carcinoma
Therapeutics
Appointments and Schedules
Drug Therapy
Febrile Neutropenia
Leukopenia
Paclitaxel
Nausea
Disease-Free Survival
Intercellular Signaling Peptides and Proteins

All Science Journal Classification (ASJC) codes

  • Oncology
  • Obstetrics and Gynecology

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A phase II trial of weekly topotecan for patients with secondary platinum-resistant recurrent epithelial ovarian carcinoma following the failure of second-line therapy. / Spannuth, Whitney A.; Leath, Charles A.; Huh, Warner K.; Barnes, Mack N.; Davidson, Susan A.; Kilgore, Larry; Partridge, Edward E.; Austin, J. Maxwell; Alvarez, Ronald D.

In: Gynecologic oncology, Vol. 104, No. 3, 01.03.2007, p. 591-595.

Research output: Contribution to journalArticle

Spannuth, Whitney A. ; Leath, Charles A. ; Huh, Warner K. ; Barnes, Mack N. ; Davidson, Susan A. ; Kilgore, Larry ; Partridge, Edward E. ; Austin, J. Maxwell ; Alvarez, Ronald D. / A phase II trial of weekly topotecan for patients with secondary platinum-resistant recurrent epithelial ovarian carcinoma following the failure of second-line therapy. In: Gynecologic oncology. 2007 ; Vol. 104, No. 3. pp. 591-595.
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abstract = "Objective: To determine the response rate, progression-free survival and toxicity associated with weekly topotecan administered to patients with platinum-sensitive recurrent epithelial ovarian (EOC) in the third-line setting. Methods: Patients with measurable platinum-sensitive EOC following failure of second-line chemotherapy were eligible for this phase II study. All patients were initially treated with cytoreductive surgery and platinum/paclitaxel-based chemotherapy. Continuous, weekly topotecan was administered at a starting dose of 4 mg/m2. Toxicity and efficacy were assessed at various time points after initiation of therapy. Results: Twenty nine patients were enrolled in this prospective study. Toxicity was acceptable with grade 1/2 nausea being the most commonly experienced side effect (52{\%}). Nine patients (31{\%}) had grade 3/4 leukopenia; however, only 3 patients had febrile neutropenia. Thirteen patients had a treatment delay and six required dose reductions. Twenty two patients were evaluable for efficacy. The overall response rate for weekly topotecan was 13.6{\%} [95{\%} CI; - 0.7-27.9{\%}] with 1 complete response, and 2 partial responses. Twelve patients (54.5{\%}), including 2 with minor responses, had stable disease for a median duration of 18 weeks. Conclusions: Weekly topotecan at the current schedule in the third-line setting in patients with platinum-sensitive recurrent EOC has modest clinical activity. Toxicity associated with this regimen is acceptable but growth factor support, dose reductions, or schedule alterations may need to be considered in many of these patients.",
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AU - Leath, Charles A.

AU - Huh, Warner K.

AU - Barnes, Mack N.

AU - Davidson, Susan A.

AU - Kilgore, Larry

AU - Partridge, Edward E.

AU - Austin, J. Maxwell

AU - Alvarez, Ronald D.

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N2 - Objective: To determine the response rate, progression-free survival and toxicity associated with weekly topotecan administered to patients with platinum-sensitive recurrent epithelial ovarian (EOC) in the third-line setting. Methods: Patients with measurable platinum-sensitive EOC following failure of second-line chemotherapy were eligible for this phase II study. All patients were initially treated with cytoreductive surgery and platinum/paclitaxel-based chemotherapy. Continuous, weekly topotecan was administered at a starting dose of 4 mg/m2. Toxicity and efficacy were assessed at various time points after initiation of therapy. Results: Twenty nine patients were enrolled in this prospective study. Toxicity was acceptable with grade 1/2 nausea being the most commonly experienced side effect (52%). Nine patients (31%) had grade 3/4 leukopenia; however, only 3 patients had febrile neutropenia. Thirteen patients had a treatment delay and six required dose reductions. Twenty two patients were evaluable for efficacy. The overall response rate for weekly topotecan was 13.6% [95% CI; - 0.7-27.9%] with 1 complete response, and 2 partial responses. Twelve patients (54.5%), including 2 with minor responses, had stable disease for a median duration of 18 weeks. Conclusions: Weekly topotecan at the current schedule in the third-line setting in patients with platinum-sensitive recurrent EOC has modest clinical activity. Toxicity associated with this regimen is acceptable but growth factor support, dose reductions, or schedule alterations may need to be considered in many of these patients.

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