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Gynecol Oncol. 2019 Mar;152(3):548-553. doi: 10.1016/j.ygyno.2018.12.008. Epub 2018 Dec 23.

A randomized phase II study of cabozantinib versus weekly paclitaxel in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer: An NRG Oncology/Gynecologic Oncology Group study.

Author information

1
Dana Farber Cancer Institute, Division of Gynecologic Oncology, Dept. of Medical Oncology, Boston, MA 02215, United States of America. Electronic address: ursula_matulonis@dfci.harvard.edu.
2
NRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY 14263, United States of America. Electronic address: msill@gogstats.org.
3
Memorial Sloan Kettering Cancer Center, Medical Oncology, New York, NY 10065, United States of America. Electronic address: makkerv@mskcc.org.
4
Washington University School of Medicine, Division of Gynecologic Oncology, Saint Louis, MO 63110, United States of America. Electronic address: mutchd@wudosis.wustl.edu.
5
Cancer Research for the Ozarks, Dept. of Obstetrics and Gynecology, Springfield, MO 65804, United States of America. Electronic address: jay.carlson@mercy.net.
6
Maine Medical Center, Dept. of Gynecologic Oncology, Scarborough, ME 04074, United States of America. Electronic address: darusc@mmc.org.
7
University of Oklahoma Health Sciences Center, Dept. of Obstetrics and Gynecology, Oklahoma City, OK 73104, United States of America. Electronic address: robert-mannel@ouhsc.edu.
8
University of Iowa Hospitals and Clinics, Gyn/Onc Division, Iowa City, IA 52242, United States of America. Electronic address: david-bender@uiowa.edu.
9
Levine Cancer Institute, Division of Gynecologic Oncology, Charlotte, NC 28204, United States of America. Electronic address: erin.crane@carolinashealthcare.org.
10
Memorial Sloan Kettering Cancer Center, Medical Oncology, New York, NY 10065, United States of America. Electronic address: aghajanc@mskcc.org.

Abstract

INTRODUCTION:

Cabozantinib is a receptor tyrosine kinases inhibitor that targets MET (c-MET), VEGF receptor 2 (VEGFR2), RET, AXL, KIT, FLT-3, and TIE-2 and previously showed promising single agent activity in recurrent ovarian cancer.

METHODS:

This was an open label, 1:1 randomized study of cabozantinib 60 mg orally (PO) daily versus weekly paclitaxel 80 mg/m2 given 3 out of 4 weeks (NCT01716715); 111 patients were enrolled. Eligibility included persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma and at least one but no >3 prior chemotherapy regimens.

RESULTS:

Median PFS was similar for both treatment groups and was 5.3 months for cabozantinib and 5.5 months for weekly paclitaxel (HR 1.11 (90% CI 0.77-1.61, p = 0.64)). Secondary analyses of overall survival (OS) and event free survival (EFS) showed that cabozantinib did not perform as well as weekly paclitaxel. Median OS for cabozantinib was 19.4 months and was not reached for weekly paclitaxel (HR 2.27 (90% CI 1.17-4.41, p = 0.04). EFS was also worse in the cabozantinib arm, 3.5 months, compared to weekly paclitaxel at 5.0 months (HR 1.81 (90% CI 1.24-2.63, p = 0.01). Overall response rate (ORR) was less for cabozantinib compared to weekly paclitaxel (7% versus 24.1%). Gastrointestinal toxicities, specifically nausea, diarrhea, and abdominal pain were worse in the cabozantinib arm.

CONCLUSIONS:

Median PFS was similar for cabozantinib and weekly paclitaxel. However, OS, EFS, and ORR were worse for cabozantinib compared to weekly paclitaxel. Cabozantinib given at this dose and schedule cannot be recommended as a treatment for recurrent ovarian cancer.

KEYWORDS:

Anti-vascular; Cabozantinib; Ovarian cancer; Paclitaxel

PMID:
30587441
PMCID:
PMC6542283
[Available on 2020-03-01]
DOI:
10.1016/j.ygyno.2018.12.008
[Indexed for MEDLINE]

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