Clinical Trial ARTICLE
Phase II clinical trial of robotic stereotactic body radiosurgery for metastatic gynecologic malignancies
- 1Department of Radiation Oncology, University Hospitals Case Medical Center and Case Western Reserve University, School of Medicine, Cleveland, OH, USA
- 2Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University Hospitals Case Medical Center and Case Western Reserve University, School of Medicine, Cleveland, OH, USA
Background: Recurrent gynecologic cancers are often difficult to manage without significant morbidity. We conducted a phase II study to assess the safety and the efficacy of ablative robotic stereotactic body radiosurgery (SBRT) in women with metastatic gynecologic cancers. Methods: A total of 50 patients with recurrent gynecologic cancer who had single or multiple (≤4) metastases underwent robotic-armed Cyberknife SBRT (24Gy/3 daily doses). Toxicities were graded prospectively by common toxicity criteria for adverse events (version 4.0). SBRT target responses were recorded following RECIST criteria (version 1.0). Rates of clinical benefit for SBRT and non-radiosurgical disease relapse were calculated. Disease-free and overall survivals were estimated by the Kaplan–Meier method and the Cox proportional hazards model was used to control for prognostic variables. Findings: SBRT was safely delivered, with 49 (98%) of 50 patients completing three prescribed fractions. The most frequent grade 2 or higher adverse events attributed to SBRT included fatigue (16%), nausea (8%), and diarrhea (4%). One (2%) grade four hyperbilirubinemia occurred. SBRT target response was 96% (48 of 50 patients). A 6-month clinical benefit was recorded in 34 [68% (95% CI, 53.2, 80.1)] patients. No SBRT targeted disease progressed. Non-radiosurgical disease relapse occurred in 31 (62%) patients. Median disease-free survival was 7.8 months (95% CI, 4.0, 11.6). Median overall survival was 20.2 months (95% CI, 10.9, 29.5). Interpretation: SBRT safely controlled metastatic gynecologic cancer targets. Given an observed high rate of non-radiosurgical disease relapse, a phase I trial assessing co-administration of SBRT and cytotoxic chemotherapy is underway. Funding: Case Comprehensive Cancer Center.
Keywords: robotic radiosurgery, Cyberknife, gynecologic cancer
Citation: Kunos CA, Brindle J, Waggoner S, Zanotti K, Resnick K, Fusco N, Adams R and Debernardo R (2012) Phase II clinical trial of robotic stereotactic body radiosurgery for metastatic gynecologic malignancies. Front. Oncol. 2:181. doi: 10.3389/fonc.2012.00181
Received: 08 October 2012; Paper pending published: 03 November 2012;
Accepted: 10 November 2012; Published online: 05 December 2012.
Edited by:Brian Timothy Collins, Georgetown University Hospital, USA
Reviewed by:Sean Collins, Georgetown University Hospital, USA
John E. Mignano, Tufts Medical Center, USA
Copyright: © 2012 Kunos, Brindle, Waggoner, Zanotti, Resnick, Fusco, Adams and Debernardo. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in other forums, provided the original authors and source are credited and subject to any copyright notices concerning any third-party graphics etc.
*Correspondence: Charles A. Kunos, Department of Radiation Oncology, University Hospitals of Cleveland, 11100 Euclid Avenue, LTR 6068, Cleveland, OH 44106, USA. e-mail: firstname.lastname@example.org