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A randomized phase II evaluation of weekly gemcitabine plus pazopanib versus weekly gemcitabine alone in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma.

Publication ,  Journal Article
Duska, LR; Petroni, GR; Varhegyi, N; Brown, J; Jelovac, D; Moore, KN; McGuire, WP; Darus, C; Barroilhet, LM; Secord, AA
Published in: Gynecol Oncol
June 2020

OBJECTIVE: Angiogenesis inhibition is a valuable strategy for ovarian cancer (EOC). Pazopanib (paz) is a potent small molecular inhibitor of VEGF-1, -2, -3, PDGFR, c-kit, and has activity as a single agent in ovarian cancer. We designed a trial to assess the benefit of adding paz to gemcitabine (gem) in patients with recurrent EOC. METHODS: An open-label, randomized, multi-site, phase 2 trial was conducted (NCT01610206) including patients with platinum resistant or sensitive disease, ≤ 3 prior lines of chemotherapy, and measurable/evaluable disease. Patients were randomly assigned to weekly gem 1000 mg/m2 on days 1 and 8 of a 21 day cycle, with or without paz 800 mg QD, stratified by platinum sensitivity and number of prior lines (1 vs 2 or 3). The primary endpoint was PFS. RESULTS: 148 patients were enrolled 2012-2017. Median age was 63 years (30-82); 60% were platinum resistant; median surveillance was 13 months (0.4-54 months). Median PFS was 5.3 (95% CI, 4.2-5.8) vs 2.9 months (95% CI, 2.1-4.1) in the gem arm. The PFS effect was most pronounced in the platinum resistant group (5.32 vs 2.33 months Tarone-Ware p < 0.001). There was no difference in OS. Overall RR (PR 20% vs 11%, Chi-squre p = 0.02) and DCR (80% vs 60%, Chi-square p < 0.001) were higher in the combination. High grade AEs in the combination arm included ≥ Grade 3: hypertension (15%), neutropenia (35%), and thrombocytopenia (12%). CONCLUSIONS: The addition of paz to gem enhanced anti-tumor activity; those with platinum-resistant disease derived the most benefit from combination therapy, even in the setting of receiving prior bevacizumab.

Duke Scholars

Published In

Gynecol Oncol

DOI

EISSN

1095-6859

Publication Date

June 2020

Volume

157

Issue

3

Start / End Page

585 / 592

Location

United States

Related Subject Headings

  • Sulfonamides
  • Pyrimidines
  • Peritoneal Neoplasms
  • Oncology & Carcinogenesis
  • Middle Aged
  • Indazoles
  • Humans
  • Gemcitabine
  • Female
  • Fallopian Tube Neoplasms
 

Citation

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Duska, L. R., Petroni, G. R., Varhegyi, N., Brown, J., Jelovac, D., Moore, K. N., … Secord, A. A. (2020). A randomized phase II evaluation of weekly gemcitabine plus pazopanib versus weekly gemcitabine alone in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. Gynecol Oncol, 157(3), 585–592. https://doi.org/10.1016/j.ygyno.2019.10.014
Duska, L. R., G. R. Petroni, N. Varhegyi, J. Brown, D. Jelovac, K. N. Moore, W. P. McGuire, C. Darus, L. M. Barroilhet, and A. A. Secord. “A randomized phase II evaluation of weekly gemcitabine plus pazopanib versus weekly gemcitabine alone in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma.Gynecol Oncol 157, no. 3 (June 2020): 585–92. https://doi.org/10.1016/j.ygyno.2019.10.014.
Duska LR, Petroni GR, Varhegyi N, Brown J, Jelovac D, Moore KN, McGuire WP, Darus C, Barroilhet LM, Secord AA. A randomized phase II evaluation of weekly gemcitabine plus pazopanib versus weekly gemcitabine alone in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. Gynecol Oncol. 2020 Jun;157(3):585–592.
Journal cover image

Published In

Gynecol Oncol

DOI

EISSN

1095-6859

Publication Date

June 2020

Volume

157

Issue

3

Start / End Page

585 / 592

Location

United States

Related Subject Headings

  • Sulfonamides
  • Pyrimidines
  • Peritoneal Neoplasms
  • Oncology & Carcinogenesis
  • Middle Aged
  • Indazoles
  • Humans
  • Gemcitabine
  • Female
  • Fallopian Tube Neoplasms