A phase II study of two topotecan regimens evaluated in recurrent platinum-sensitive ovarian, fallopian tube or primary peritoneal cancer: A Gynecologic Oncology Group Study (GOG 146Q)

Thomas J. Herzog, Michael W. Sill, Joan L. Walker, David O'Malley, Mark Shahin, Koenraad De Geest, Sheldon A. Weiner, David Mutch, Robert L. Debernardo, Samuel S. Lentz

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Objective.: To evaluate the efficacy and safety of topotecan in patients with recurrent ovarian, primary peritoneal, and fallopian tube carcinomas. Methods.: A randomized phase II analysis of platinum-sensitive patients with measurable disease was performed independently assessing intravenous topotecan 1.25 mg/m2 daily × 5 every 21 days (regimen I) and topotecan 4.0 mg/m2/day on days 1, 8, and 15 of a 28-day cycle (regimen II). All patients were treated until disease progression, unmanageable toxicity, or patient refusal. Insufficient accrual related to regimen I resulted in a redesign of the study as a single arm phase II trial assessing only regimen II. More complete efficacy data is presented for regimen II as enrollment on regimen I was insufficient for some analyses. Results.: A total of 81 patients were enrolled. One patient was ineligible. Fifteen patients received regimen I, while 65 patients were treated with regimen II. The response rate on regimen I (daily × 5) was 27% (90% CI: 10-51%) and 12% (90% CI: 6-21%) on regimen II (weekly). The median PFS and OS were 4.8 and 27.8 months, respectively, for regimen II. Grade 3/4 neutropenia rate was 93% with daily × 5 dosing and 28% for weekly treatment. Febrile neutropenia was very low in both groups. Conclusion.: The weekly regimen of topotecan appeared less active but resulted in less toxicity than the daily regimen in platinum-sensitive recurrent ovarian cancer patients.

Original languageEnglish (US)
Pages (from-to)454-458
Number of pages5
JournalGynecologic Oncology
Volume120
Issue number3
DOIs
StatePublished - Mar 2011
Externally publishedYes

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Topotecan
Fallopian Tubes
Platinum
Neoplasms
Febrile Neutropenia
Neutropenia
Ovarian Neoplasms
Disease Progression
Carcinoma
Safety

Keywords

  • Platinum sensitive
  • Recurrent ovarian cancer
  • Topotecan
  • Weekly chemotherapy

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

A phase II study of two topotecan regimens evaluated in recurrent platinum-sensitive ovarian, fallopian tube or primary peritoneal cancer : A Gynecologic Oncology Group Study (GOG 146Q). / Herzog, Thomas J.; Sill, Michael W.; Walker, Joan L.; O'Malley, David; Shahin, Mark; De Geest, Koenraad; Weiner, Sheldon A.; Mutch, David; Debernardo, Robert L.; Lentz, Samuel S.

In: Gynecologic Oncology, Vol. 120, No. 3, 03.2011, p. 454-458.

Research output: Contribution to journalArticle

Herzog, Thomas J. ; Sill, Michael W. ; Walker, Joan L. ; O'Malley, David ; Shahin, Mark ; De Geest, Koenraad ; Weiner, Sheldon A. ; Mutch, David ; Debernardo, Robert L. ; Lentz, Samuel S. / A phase II study of two topotecan regimens evaluated in recurrent platinum-sensitive ovarian, fallopian tube or primary peritoneal cancer : A Gynecologic Oncology Group Study (GOG 146Q). In: Gynecologic Oncology. 2011 ; Vol. 120, No. 3. pp. 454-458.
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abstract = "Objective.: To evaluate the efficacy and safety of topotecan in patients with recurrent ovarian, primary peritoneal, and fallopian tube carcinomas. Methods.: A randomized phase II analysis of platinum-sensitive patients with measurable disease was performed independently assessing intravenous topotecan 1.25 mg/m2 daily × 5 every 21 days (regimen I) and topotecan 4.0 mg/m2/day on days 1, 8, and 15 of a 28-day cycle (regimen II). All patients were treated until disease progression, unmanageable toxicity, or patient refusal. Insufficient accrual related to regimen I resulted in a redesign of the study as a single arm phase II trial assessing only regimen II. More complete efficacy data is presented for regimen II as enrollment on regimen I was insufficient for some analyses. Results.: A total of 81 patients were enrolled. One patient was ineligible. Fifteen patients received regimen I, while 65 patients were treated with regimen II. The response rate on regimen I (daily × 5) was 27{\%} (90{\%} CI: 10-51{\%}) and 12{\%} (90{\%} CI: 6-21{\%}) on regimen II (weekly). The median PFS and OS were 4.8 and 27.8 months, respectively, for regimen II. Grade 3/4 neutropenia rate was 93{\%} with daily × 5 dosing and 28{\%} for weekly treatment. Febrile neutropenia was very low in both groups. Conclusion.: The weekly regimen of topotecan appeared less active but resulted in less toxicity than the daily regimen in platinum-sensitive recurrent ovarian cancer patients.",
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T1 - A phase II study of two topotecan regimens evaluated in recurrent platinum-sensitive ovarian, fallopian tube or primary peritoneal cancer

T2 - A Gynecologic Oncology Group Study (GOG 146Q)

AU - Herzog, Thomas J.

AU - Sill, Michael W.

AU - Walker, Joan L.

AU - O'Malley, David

AU - Shahin, Mark

AU - De Geest, Koenraad

AU - Weiner, Sheldon A.

AU - Mutch, David

AU - Debernardo, Robert L.

AU - Lentz, Samuel S.

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N2 - Objective.: To evaluate the efficacy and safety of topotecan in patients with recurrent ovarian, primary peritoneal, and fallopian tube carcinomas. Methods.: A randomized phase II analysis of platinum-sensitive patients with measurable disease was performed independently assessing intravenous topotecan 1.25 mg/m2 daily × 5 every 21 days (regimen I) and topotecan 4.0 mg/m2/day on days 1, 8, and 15 of a 28-day cycle (regimen II). All patients were treated until disease progression, unmanageable toxicity, or patient refusal. Insufficient accrual related to regimen I resulted in a redesign of the study as a single arm phase II trial assessing only regimen II. More complete efficacy data is presented for regimen II as enrollment on regimen I was insufficient for some analyses. Results.: A total of 81 patients were enrolled. One patient was ineligible. Fifteen patients received regimen I, while 65 patients were treated with regimen II. The response rate on regimen I (daily × 5) was 27% (90% CI: 10-51%) and 12% (90% CI: 6-21%) on regimen II (weekly). The median PFS and OS were 4.8 and 27.8 months, respectively, for regimen II. Grade 3/4 neutropenia rate was 93% with daily × 5 dosing and 28% for weekly treatment. Febrile neutropenia was very low in both groups. Conclusion.: The weekly regimen of topotecan appeared less active but resulted in less toxicity than the daily regimen in platinum-sensitive recurrent ovarian cancer patients.

AB - Objective.: To evaluate the efficacy and safety of topotecan in patients with recurrent ovarian, primary peritoneal, and fallopian tube carcinomas. Methods.: A randomized phase II analysis of platinum-sensitive patients with measurable disease was performed independently assessing intravenous topotecan 1.25 mg/m2 daily × 5 every 21 days (regimen I) and topotecan 4.0 mg/m2/day on days 1, 8, and 15 of a 28-day cycle (regimen II). All patients were treated until disease progression, unmanageable toxicity, or patient refusal. Insufficient accrual related to regimen I resulted in a redesign of the study as a single arm phase II trial assessing only regimen II. More complete efficacy data is presented for regimen II as enrollment on regimen I was insufficient for some analyses. Results.: A total of 81 patients were enrolled. One patient was ineligible. Fifteen patients received regimen I, while 65 patients were treated with regimen II. The response rate on regimen I (daily × 5) was 27% (90% CI: 10-51%) and 12% (90% CI: 6-21%) on regimen II (weekly). The median PFS and OS were 4.8 and 27.8 months, respectively, for regimen II. Grade 3/4 neutropenia rate was 93% with daily × 5 dosing and 28% for weekly treatment. Febrile neutropenia was very low in both groups. Conclusion.: The weekly regimen of topotecan appeared less active but resulted in less toxicity than the daily regimen in platinum-sensitive recurrent ovarian cancer patients.

KW - Platinum sensitive

KW - Recurrent ovarian cancer

KW - Topotecan

KW - Weekly chemotherapy

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