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A phase II trial of docetaxel and bevacizumab in recurrent ovarian cancer within 12 months of prior platinum-based chemotherapy.

Publication ,  Journal Article
Wenham, RM; Lapolla, J; Lin, H-Y; Apte, SM; Lancaster, JM; Judson, PL; Gonzalez-Bosquet, J; Herschberger, A; Havrilesky, LJ; Secord, AA
Published in: Gynecol Oncol
July 2013

OBJECTIVES: The efficacy and safety of bevacizumab and docetaxel were evaluated in women who developed recurrent epithelial ovarian, fallopian, or peritoneal cancer within 12 months of platinum-based therapy. METHODS: Patients received docetaxel (40 mg/m(2)) on days 1 and 8 and bevacizumab (15 mg/kg) on day 1 of a 21-daycycle. Primary endpoint was 6-month progression-free survival (PFS). RESULTS: Forty-one patients were evaluable for PFS and 38 for best response; 46% had platinum-free intervals (PFI) of <6 months and 54% between 6 and 12 months. The 6-month PFS was 43.9% (95% confidence interval (CI(95%))=28.6-58.2%). Median PFS (months) was 5.2 (CI(95%)=4.4-7.2) for all patients, 6.2 (CI(95%)=4.1-7.4) for patients with PFI <6 months, and 5.1 (CI(95%)=3.0-7.2) for those with PFI ≥ 6 months. Twenty-two patients showed overall response (CR+PR) (57.9%; CI(95%)=40.8-73.7%), and 32 showed clinical benefit (CR+PR+SD) (84.2%; CI(95%)=68.8-94.0%). For those with complete or partial responses, median duration of response was 4.8 months (0.7-14.5). Median overall survival was 12.4 months (CI(95%)=10.0-21.9). The most common grade 3/4 adverse events (AEs) were neutropenia (14.6% of patients), followed by leukopenia, fatigue, metabolic, and gastrointestinal, with 66% showing any grade 3/4 toxicity. Most common AEs of any grade were gastrointestinal (93%), fatigue (73%), and pain (73%). Four (10%) patients developed hypertension, 1 a gastrointestinal perforation, and another a colovesicular fistula. CONCLUSIONS: Bevacizumab and docetaxel administered in patients with recurrent ovarian cancer is an active regimen without new unanticipated toxicities. This combination should be an option for further study or clinical use in recurrent ovarian cancer.

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Published In

Gynecol Oncol

DOI

EISSN

1095-6859

Publication Date

July 2013

Volume

130

Issue

1

Start / End Page

19 / 24

Location

United States

Related Subject Headings

  • Taxoids
  • Peritoneal Neoplasms
  • Ovarian Neoplasms
  • Organoplatinum Compounds
  • Oncology & Carcinogenesis
  • Neoplasms, Glandular and Epithelial
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Infusions, Intravenous
  • Humans
 

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Wenham, R. M., Lapolla, J., Lin, H.-Y., Apte, S. M., Lancaster, J. M., Judson, P. L., … Secord, A. A. (2013). A phase II trial of docetaxel and bevacizumab in recurrent ovarian cancer within 12 months of prior platinum-based chemotherapy. Gynecol Oncol, 130(1), 19–24. https://doi.org/10.1016/j.ygyno.2013.04.049
Wenham, Robert M., James Lapolla, Hui-Yi Lin, Sachin M. Apte, Johnathan M. Lancaster, Patricia L. Judson, Jesus Gonzalez-Bosquet, Amber Herschberger, Laura J. Havrilesky, and Angeles Alvarez Secord. “A phase II trial of docetaxel and bevacizumab in recurrent ovarian cancer within 12 months of prior platinum-based chemotherapy.Gynecol Oncol 130, no. 1 (July 2013): 19–24. https://doi.org/10.1016/j.ygyno.2013.04.049.
Wenham RM, Lapolla J, Lin H-Y, Apte SM, Lancaster JM, Judson PL, et al. A phase II trial of docetaxel and bevacizumab in recurrent ovarian cancer within 12 months of prior platinum-based chemotherapy. Gynecol Oncol. 2013 Jul;130(1):19–24.
Wenham, Robert M., et al. “A phase II trial of docetaxel and bevacizumab in recurrent ovarian cancer within 12 months of prior platinum-based chemotherapy.Gynecol Oncol, vol. 130, no. 1, July 2013, pp. 19–24. Pubmed, doi:10.1016/j.ygyno.2013.04.049.
Wenham RM, Lapolla J, Lin H-Y, Apte SM, Lancaster JM, Judson PL, Gonzalez-Bosquet J, Herschberger A, Havrilesky LJ, Secord AA. A phase II trial of docetaxel and bevacizumab in recurrent ovarian cancer within 12 months of prior platinum-based chemotherapy. Gynecol Oncol. 2013 Jul;130(1):19–24.
Journal cover image

Published In

Gynecol Oncol

DOI

EISSN

1095-6859

Publication Date

July 2013

Volume

130

Issue

1

Start / End Page

19 / 24

Location

United States

Related Subject Headings

  • Taxoids
  • Peritoneal Neoplasms
  • Ovarian Neoplasms
  • Organoplatinum Compounds
  • Oncology & Carcinogenesis
  • Neoplasms, Glandular and Epithelial
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Infusions, Intravenous
  • Humans