A phase II study of gemcitabine, carboplatin and bevacizumab for the treatment of platinum-sensitive recurrent ovarian cancer

Eric L. Eisenhauer, Vanna Zanagnolo, David E. Cohn, Ritu Salani, David M. O'Malley, Gregory Sutton, Michael J. Callahan, Bobbi Cobb, Jeffrey M. Fowler, Larry J. Copeland

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Abstract

Purpose The doublet gemcitabine and carboplatin is effective for the treatment of recurrent ovarian cancer, while multi-agent chemotherapy with bevacizumab may add additional benefit. This phase II study tested the efficacy and safety of a biweekly gemcitabine, carboplatin, and bevacizumab combination in patients with platinum-sensitive recurrent ovarian, peritoneal, or tubal cancer (ROC). Patients and methods Eligible patients received concurrent gemcitabine 1000 mg/m2, carboplatin area under the curve 3, and bevacizumab 10 mg/kg administered intravenously on days 1 and 15 every 28 days for six cycles or up to 24 cycles if clinical benefit occurred. The primary end points were progression-free survival (PFS) by RECIST, and safety; the secondary end points were objective response rates and overall survival. Results Overall, 45 patients were enrolled. The median PFS was 13.3 months (95% CI, 11.3 to 15.3). The objective response rate was 69%. Grade 4 hematologic toxicities included neutropenia (27%) and thrombocytopenia (2%). Grades 3 and 4 non-hematologic toxicities included fatigue (18%), pain (9%), and nausea/vomiting (4%). There were 2 episodes of cerebrovascular accidents, 2 noted DVTs, and no episodes of bowel perforation. Median OS was 36.1 months (95% CI, 26.7 to 45.5). Conclusion Biweekly gemcitabine, carboplatin, and bevacizumab were an effective regimen in recurrent ovarian cancer, with comparable toxicity to recently reported day 1 gemcitabine, carboplatin, bevacizumab, and day 8 gemcitabine. Response rate and PFS are improved from reported outcomes of the gemcitabine carboplatin doublet. The degree to which biweekly dosing may present a more rationale schedule for this triplet should be evaluated further.

Original languageEnglish
Pages (from-to)262-266
Number of pages5
JournalGynecologic Oncology
Volume134
Issue number2
DOIs
Publication statusPublished - 2014

Fingerprint

gemcitabine
Carboplatin
Platinum
Ovarian Neoplasms
Disease-Free Survival
Therapeutics
Safety
Bevacizumab
Neutropenia
Nausea
Area Under Curve
Vomiting
Fatigue
Appointments and Schedules
Survival Rate
Stroke

Keywords

  • Bevacizumab
  • Chemotherapy
  • Gemcitabine
  • Ovarian cancer
  • Platinum-sensitive
  • Recurrent

ASJC Scopus subject areas

  • Obstetrics and Gynaecology
  • Oncology

Cite this

A phase II study of gemcitabine, carboplatin and bevacizumab for the treatment of platinum-sensitive recurrent ovarian cancer. / Eisenhauer, Eric L.; Zanagnolo, Vanna; Cohn, David E.; Salani, Ritu; O'Malley, David M.; Sutton, Gregory; Callahan, Michael J.; Cobb, Bobbi; Fowler, Jeffrey M.; Copeland, Larry J.

In: Gynecologic Oncology, Vol. 134, No. 2, 2014, p. 262-266.

Research output: Contribution to journalArticle

Eisenhauer, EL, Zanagnolo, V, Cohn, DE, Salani, R, O'Malley, DM, Sutton, G, Callahan, MJ, Cobb, B, Fowler, JM & Copeland, LJ 2014, 'A phase II study of gemcitabine, carboplatin and bevacizumab for the treatment of platinum-sensitive recurrent ovarian cancer', Gynecologic Oncology, vol. 134, no. 2, pp. 262-266. https://doi.org/10.1016/j.ygyno.2014.05.030
Eisenhauer, Eric L. ; Zanagnolo, Vanna ; Cohn, David E. ; Salani, Ritu ; O'Malley, David M. ; Sutton, Gregory ; Callahan, Michael J. ; Cobb, Bobbi ; Fowler, Jeffrey M. ; Copeland, Larry J. / A phase II study of gemcitabine, carboplatin and bevacizumab for the treatment of platinum-sensitive recurrent ovarian cancer. In: Gynecologic Oncology. 2014 ; Vol. 134, No. 2. pp. 262-266.
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abstract = "Purpose The doublet gemcitabine and carboplatin is effective for the treatment of recurrent ovarian cancer, while multi-agent chemotherapy with bevacizumab may add additional benefit. This phase II study tested the efficacy and safety of a biweekly gemcitabine, carboplatin, and bevacizumab combination in patients with platinum-sensitive recurrent ovarian, peritoneal, or tubal cancer (ROC). Patients and methods Eligible patients received concurrent gemcitabine 1000 mg/m2, carboplatin area under the curve 3, and bevacizumab 10 mg/kg administered intravenously on days 1 and 15 every 28 days for six cycles or up to 24 cycles if clinical benefit occurred. The primary end points were progression-free survival (PFS) by RECIST, and safety; the secondary end points were objective response rates and overall survival. Results Overall, 45 patients were enrolled. The median PFS was 13.3 months (95{\%} CI, 11.3 to 15.3). The objective response rate was 69{\%}. Grade 4 hematologic toxicities included neutropenia (27{\%}) and thrombocytopenia (2{\%}). Grades 3 and 4 non-hematologic toxicities included fatigue (18{\%}), pain (9{\%}), and nausea/vomiting (4{\%}). There were 2 episodes of cerebrovascular accidents, 2 noted DVTs, and no episodes of bowel perforation. Median OS was 36.1 months (95{\%} CI, 26.7 to 45.5). Conclusion Biweekly gemcitabine, carboplatin, and bevacizumab were an effective regimen in recurrent ovarian cancer, with comparable toxicity to recently reported day 1 gemcitabine, carboplatin, bevacizumab, and day 8 gemcitabine. Response rate and PFS are improved from reported outcomes of the gemcitabine carboplatin doublet. The degree to which biweekly dosing may present a more rationale schedule for this triplet should be evaluated further.",
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author = "Eisenhauer, {Eric L.} and Vanna Zanagnolo and Cohn, {David E.} and Ritu Salani and O'Malley, {David M.} and Gregory Sutton and Callahan, {Michael J.} and Bobbi Cobb and Fowler, {Jeffrey M.} and Copeland, {Larry J.}",
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T1 - A phase II study of gemcitabine, carboplatin and bevacizumab for the treatment of platinum-sensitive recurrent ovarian cancer

AU - Eisenhauer, Eric L.

AU - Zanagnolo, Vanna

AU - Cohn, David E.

AU - Salani, Ritu

AU - O'Malley, David M.

AU - Sutton, Gregory

AU - Callahan, Michael J.

AU - Cobb, Bobbi

AU - Fowler, Jeffrey M.

AU - Copeland, Larry J.

PY - 2014

Y1 - 2014

N2 - Purpose The doublet gemcitabine and carboplatin is effective for the treatment of recurrent ovarian cancer, while multi-agent chemotherapy with bevacizumab may add additional benefit. This phase II study tested the efficacy and safety of a biweekly gemcitabine, carboplatin, and bevacizumab combination in patients with platinum-sensitive recurrent ovarian, peritoneal, or tubal cancer (ROC). Patients and methods Eligible patients received concurrent gemcitabine 1000 mg/m2, carboplatin area under the curve 3, and bevacizumab 10 mg/kg administered intravenously on days 1 and 15 every 28 days for six cycles or up to 24 cycles if clinical benefit occurred. The primary end points were progression-free survival (PFS) by RECIST, and safety; the secondary end points were objective response rates and overall survival. Results Overall, 45 patients were enrolled. The median PFS was 13.3 months (95% CI, 11.3 to 15.3). The objective response rate was 69%. Grade 4 hematologic toxicities included neutropenia (27%) and thrombocytopenia (2%). Grades 3 and 4 non-hematologic toxicities included fatigue (18%), pain (9%), and nausea/vomiting (4%). There were 2 episodes of cerebrovascular accidents, 2 noted DVTs, and no episodes of bowel perforation. Median OS was 36.1 months (95% CI, 26.7 to 45.5). Conclusion Biweekly gemcitabine, carboplatin, and bevacizumab were an effective regimen in recurrent ovarian cancer, with comparable toxicity to recently reported day 1 gemcitabine, carboplatin, bevacizumab, and day 8 gemcitabine. Response rate and PFS are improved from reported outcomes of the gemcitabine carboplatin doublet. The degree to which biweekly dosing may present a more rationale schedule for this triplet should be evaluated further.

AB - Purpose The doublet gemcitabine and carboplatin is effective for the treatment of recurrent ovarian cancer, while multi-agent chemotherapy with bevacizumab may add additional benefit. This phase II study tested the efficacy and safety of a biweekly gemcitabine, carboplatin, and bevacizumab combination in patients with platinum-sensitive recurrent ovarian, peritoneal, or tubal cancer (ROC). Patients and methods Eligible patients received concurrent gemcitabine 1000 mg/m2, carboplatin area under the curve 3, and bevacizumab 10 mg/kg administered intravenously on days 1 and 15 every 28 days for six cycles or up to 24 cycles if clinical benefit occurred. The primary end points were progression-free survival (PFS) by RECIST, and safety; the secondary end points were objective response rates and overall survival. Results Overall, 45 patients were enrolled. The median PFS was 13.3 months (95% CI, 11.3 to 15.3). The objective response rate was 69%. Grade 4 hematologic toxicities included neutropenia (27%) and thrombocytopenia (2%). Grades 3 and 4 non-hematologic toxicities included fatigue (18%), pain (9%), and nausea/vomiting (4%). There were 2 episodes of cerebrovascular accidents, 2 noted DVTs, and no episodes of bowel perforation. Median OS was 36.1 months (95% CI, 26.7 to 45.5). Conclusion Biweekly gemcitabine, carboplatin, and bevacizumab were an effective regimen in recurrent ovarian cancer, with comparable toxicity to recently reported day 1 gemcitabine, carboplatin, bevacizumab, and day 8 gemcitabine. Response rate and PFS are improved from reported outcomes of the gemcitabine carboplatin doublet. The degree to which biweekly dosing may present a more rationale schedule for this triplet should be evaluated further.

KW - Bevacizumab

KW - Chemotherapy

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KW - Ovarian cancer

KW - Platinum-sensitive

KW - Recurrent

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