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Gynecol Oncol. 2018 Jul;150(1):9-13. doi: 10.1016/j.ygyno.2018.04.572. Epub 2018 May 5.

Phase II study of single-agent cabozantinib in patients with recurrent clear cell ovarian, primary peritoneal or fallopian tube cancer (NRG-GY001).

Author information

1
Gynecologic Medical Oncology Program, Dana-Farber Cancer Institute, Boston, MA, United States. Electronic address: Panagiotis_Konstantinopoulos@DFCI.Harvard.edu.
2
NRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Cancer Institute, Buffalo, NY, United States. Electronic address: bbrady@gogstats.org.
3
Department of Obstetrics & Gynecology, Uniformed Serviced University of the Health Sciences, Bethesda, MD, United States. Electronic address: John.Farley@DignityHealth.org.
4
Obstetrics and Gynecology, CWRU School of Medicine, Cleveland, OH, United States. Electronic address: Amy.Armstrong@UHhospitals.org.
5
Gynecologic Oncology, Medical School of Wisconsin, Milwaukee, WI 53226, United States. Electronic address: duyar@mcw.edu.
6
Department of Gynecologic Oncology & Reproductive Medicine, Unit 1362, The University of Texas, MD Anderson Cancer Center, Houston, TX, United States. Electronic address: dgershen@mdanderson.org.

Abstract

OBJECTIVE:

To evaluate the efficacy and tolerability of cabozantinib in recurrent clear cell ovarian, primary peritoneal or fallopian tube cancer.

METHODS:

Patients with recurrent ovarian, fallopian or primary peritoneal tumors with at least 50% clear cell histomorphology, measurable disease, one or two prior regimens and ECOG performance status 0-2 received cabozantinib 60 mg orally once daily continuously, in 4-week cycles until disease progression or unacceptable toxicity. Primary endpoints were progression-free survival (PFS) at six months and complete or partial tumor response (as assessed by RECIST 1.1). Secondary endpoints included toxicity, PFS, and overall survival (OS).

RESULTS:

Over 19 months, 13 patients were accrued. Fifty-four percent of patients were ≥60 years of age. Performance statuses of 0 and 1 comprised 8 and 5 patients. No objective tumor responses were seen. Three (23% [95% CI: 5%, 54%]) of 13 patients had PFS ≥6 months, including one patient who received cabozantinib for 23 cycles and was still on treatment as of the data cut-off date. Median PFS and OS were 3.6 and 8.1 months, respectively. There was one patient with a grade 5 event: a thromboembolic event considered possibly related to study therapy; patient's cause of death was determined to be due to disease and protocol treatment. Four other patients had thromboembolic events (two grade 3 and one each grade 1 and grade 2). Other grade 3 or higher events reported in two or more patients were nausea, vomiting, fatigue, dyspnea, and dehydration.

CONCLUSIONS:

Cabozantinib demonstrated minimal activity in the second- and third-line treatments of clear cell ovarian, fallopian tube or primary peritoneal carcinoma.

KEYWORDS:

Anti-angiogenic therapy; Cabozantinib; Clear cell ovarian cancer; MET inhibition

PMID:
29739622
PMCID:
PMC6365003
[Available on 2019-07-01]
DOI:
10.1016/j.ygyno.2018.04.572
[Indexed for MEDLINE]

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