Journal article
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
Gynecologic Oncology, Vol.152(3), pp.548-553
03/2019
DOI: 10.1016/j.ygyno.2018.12.008
PMCID: PMC6542283
PMID: 30587441
Abstract
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. 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. 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. 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. •Cabozantinib is a targeted kinase inhibitor with anti-ovarian cancer activity.•Cabozantinib compared to weekly paclitaxel had similar PFS but had worse OS and ORR.•Cabozantinib had worse gastrointestinal toxicities compared to paclitaxel.
Details
- Title: Subtitle
- 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
- Creators
- Ursula A Matulonis - Dana Farber Cancer Institute, Division of Gynecologic Oncology, Dept. of Medical Oncology, Boston, MA 02215, United States of AmericaMichael W Sill - NRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY 14263, United States of AmericaVicky Makker - Memorial Sloan Kettering Cancer Center, Medical Oncology, New York, NY 10065, United States of AmericaDavid G Mutch - Washington University School of Medicine, Division of Gynecologic Oncology, Saint Louis, MO 63110, United States of AmericaJay W Carlson - Cancer Research for the Ozarks, Dept. of Obstetrics and Gynecology, Springfield, MO 65804, United States of AmericaChristopher J Darus - Maine Medical Center, Dept. of Gynecologic Oncology, Scarborough, ME 04074, United States of AmericaRobert S Mannel - University of Oklahoma Health Sciences Center, Dept. of Obstetrics and Gynecology, Oklahoma City, OK 73104, United States of AmericaDavid P Bender - University of Iowa Hospitals and Clinics, Gyn/Onc Division, Iowa City, IA 52242, United States of AmericaErin K Crane - Levine Cancer Institute, Division of Gynecologic Oncology, Charlotte, NC 28204, United States of AmericaCarol Aghajanian - Memorial Sloan Kettering Cancer Center, Medical Oncology, New York, NY 10065, United States of America
- Resource Type
- Journal article
- Publication Details
- Gynecologic Oncology, Vol.152(3), pp.548-553
- Publisher
- Elsevier Inc
- DOI
- 10.1016/j.ygyno.2018.12.008
- PMID
- 30587441
- PMCID
- PMC6542283
- ISSN
- 0090-8258
- eISSN
- 1095-6859
- Grant note
- P30 CA008748 / MSK Cancer Center Breast Cancer Research Foundation (https://doi.org/10.13039/100001006) CA 27469 / National Cancer Institute (https://doi.org/10.13039/100000054) CA 37517 / Gynecologic Oncology Group Statistical and Data Center U10CA180868; UG1CA189867 / NRG Operations U10 CA180822 / NRG Oncology
- Language
- English
- Date published
- 03/2019
- Academic Unit
- Obstetrics and Gynecology
- Record Identifier
- 9983931823402771
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